67. 多発性嚢胞腎 Polycystic kidney disease Clinical trials / Disease details
臨床試験数 : 216 / 薬物数 : 219 - (DrugBank : 50) / 標的遺伝子数 : 39 - 標的パスウェイ数 : 151
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05190744 (ClinicalTrials.gov) | March 1, 2022 | 29/12/2021 | PB to Treat Hereditary Nephrogenic Diabetes Insipidus, ADPKD Treated With Tolvaptan, and Severely Polyuric Patients With Previous Lithium Administration | A Multi-center, Open-Label, Exploratory Study to Assess the Efficacy of PB in Decreasing the Urine Output and Increasing the Urine Osmolality in Patients With Hereditary Nephrogenic Diabetes Insipidus, Patients With Autosomal Dominant Polycystic Kidney Disease Treated With Tolvaptan, And Severely Polyuric Patients With Previous Lithium Administration (Serendipity-PB1) | Autosomal Dominant Polycystic Kidney Disease;Nephrogenic Diabetes Insipidus;Acquired Nephrogenic Diabetes Insipidus;Congenital Nephrogenic Diabetes Insipidus | Drug: PB | Mayo Clinic | Hopital du Sacre-Coeur de Montreal | Recruiting | 18 Years | N/A | All | 20 | Phase 2 | United States |
| 2 | NCT04782258 (ClinicalTrials.gov) | April 1, 2021 | 19/2/2021 | A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD) | A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 Days to Less Than 18 Years of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD) | Autosomal Recessive Polycystic Kidney (ARPKD) | Drug: Tolvaptan Suspension;Drug: Tolvaptan Tablets | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not yet recruiting | N/A | 18 Years | All | 20 | Phase 3 | NULL |
| 3 | NCT04786574 (ClinicalTrials.gov) | April 1, 2021 | 19/2/2021 | A Study to See if Tolvaptan Can Delay Dialysis in Infants and Children Who at Enrollment Are 28 Days to Less Than 12 Weeks Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD) | A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 Days to Less Than 12 Weeks of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD) | Autosomal Recessive Polycystic Kidney Disease (ARPKD) | Drug: Tolvaptan (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not yet recruiting | N/A | 12 Weeks | All | 20 | Phase 3 | NULL |
| 4 | NCT04152837 (ClinicalTrials.gov) | September 2, 2020 | 31/10/2019 | Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease | An Open-Label Study of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Who Previously Experienced Abnormal Liver Chemistry Test Results While Receiving Tolvaptan: The ALERT Study | Polycystic Kidney Disease, Adult | Drug: Lixivaptan | Palladio Biosciences | NULL | Recruiting | 18 Years | 65 Years | All | 50 | Phase 3 | United States |
| 5 | NCT03949894 (ClinicalTrials.gov) | July 1, 2019 | 16/4/2019 | Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease | Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Drug: Tolvaptan | Korea Otsuka Pharmaceutical Co., Ltd. | NULL | Active, not recruiting | 19 Years | 50 Years | All | 118 | Phase 4 | Korea, Republic of |
| 6 | JPRN-jRCTs031180259 | 01/04/2019 | 14/03/2019 | Tolvaptan Intervention study and Genetic mutation of AutosomalDominant Polycystic Kidney Disease | Tolvaptan Intervention study to Autosomal Dominant PolycysticKidney Disease patients without Genetic mutation of disease gene - TIAG | ADPKD | Tolvaptan treatment | Horie Shigeo | NULL | Complete | >= 20age old | Not applicable | Both | 10 | N/A | Japan |
| 7 | NCT03764605 (ClinicalTrials.gov) | January 30, 2019 | 29/11/2018 | Metformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney Disease | Metformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney Disease. A Phase 3a, Indipendent, Multicentre, Two Parallel Arms, Randomized Controlled Trial | ADPKD | Drug: Metformin;Drug: Tolvaptan | Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari | NULL | Not yet recruiting | 18 Years | 50 Years | All | 150 | Phase 3 | Italy |
| 8 | NCT03541447 (ClinicalTrials.gov) | December 12, 2018 | 17/5/2018 | Tolvaptan-Octreotide LAR Combination in ADPKD | A Pilot, Phase II Study With a Prospective, Randomized, Cross-Over, Placebo-Controlled, Double-Blind Design to Assess the Short-Term Effects of Tolvaptan Plus Placebo vs Tolvaptan Plus Octreotide LAR Combination Therapy in ADPKD Patients With Normal Kidney Function or Hyperfiltration | Autosomal Dominant Polycystic Kidney Disease | Drug: Tolvaptan;Drug: Octreotide LAR;Other: Placebo | Mario Negri Institute for Pharmacological Research | Otsuka Pharmaceutical Italy S.r.l. | Completed | 18 Years | N/A | All | 20 | Phase 2 | Italy |
| 9 | EUCTR2018-000477-77-IT (EUCTR) | 08/11/2018 | 04/11/2020 | Evaluation of Metformin and Tolvaptan in slowing disease progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Metformin versus Tolvaptan in adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD): a phase 3a, independent, multi-centre, 2 parallel arms randomized controlled trial - METROPOLIS | Autosomal Dominant Polycystic Kidney Disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: ZUGLIMET - 500 MG COMPRESSE RIVESTITE CON FILM 30 COMPRESSE IN BLISTER PVC/AL Product Name: METFORMINA Product Code: [METFORMINA] INN or Proposed INN: METFORMINA Other descriptive name: METFORMIN Trade Name: JINARC - 15 MG - COMPRESSA - USO ORALE - BLISTER (ALU/PVC) - 28 COMPRESSE Product Name: TOLVAPTAN 15 Product Code: [TOLVAPTAN 15] INN or Proposed INN: TOLVAPTAN Other descriptive name: TOLVAPTAN Trade Name: JINARC - 30 MG - COMPRESSA - USO ORALE - BLISTER (ALU/PVC) - 28 COMPRESSE Product Name: TOLVAPTAN 30 Product Code: [TOLVAPTAN 30] INN or Proposed INN: TOLVAPTAN Other descriptive name: TOLVAPTAN Trade Name: JINARC - 15 MG +45 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28X15 MG + 28 X 45 MG) Product Name: TOLVAPTAN 45/15 Product Code: [TOLVAPTAN 45/15] INN or Proposed INN: TOLVAPTAN Other descriptive name: TOLVAPTAN Trade Name: JINARC - 30 MG + 60 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 60 MG) Product Name: TOLVAPTAN 60/30 Product Code: [TOL | U.O. NEFROLOGIA, DIALISI E TRAPIANTO AZIENDA OSPEDALIERO UNIVERSITARIA POLICLINICO DI BARI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Italy | ||
| 10 | NCT03596957 (ClinicalTrials.gov) | September 12, 2018 | 14/2/2018 | Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease | Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney | Drug: Tolvaptan | Lisbet Brandi | NULL | Unknown status | 18 Years | 65 Years | All | 90 | Phase 4 | Denmark |
| 11 | EUCTR2017-004701-40-IT (EUCTR) | 06/08/2018 | 26/09/2019 | STUDY TO ASSESS THE SHORT-TERM EFFECT OF THE ADMINISTRATION OF TOLVAPTAN AND OCTREOTIDE LAR COMPARED TO THE COMBINATION OF TOLVAPTAN AND PLACEBO IN PATIENTS AFFECTED BY ADPKD WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATION | A PILOT, PHASE II STUDY WITH A PROSPECTIVE, RANDOMIZED, CROSS-OVER, PLACEBO-CONTROLLED, DOUBLE-BLIND DESIGN TO ASSESS THE SHORT-TERM EFFECTS OF TOLVAPTAN PLUS PLACEBO VS TOLVAPTAN PLUS OCTREOTIDE LAR COMBINATION THERAPY IN ADPKD PATIENTS WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATION - Tolvaptan-Octreotide combination in ADPKD | Autosomal Dominant Policiytic Kidney Disease MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: JINARC - 15 MG +45 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28X15 MG + 28 X 45 MG) Product Name: Jinarc INN or Proposed INN: TOLVAPTAN Other descriptive name: TOLVAPTAN Trade Name: JINARC - 30 MG + 60 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 60 MG) Product Name: Jinarc INN or Proposed INN: TOLVAPTAN Other descriptive name: TOLVAPTAN Trade Name: JINARC - 30 MG +90 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28 X 30 MG + 28 X 90 MG) Product Name: Jinarc INN or Proposed INN: TOLVAPTAN Other descriptive name: TOLVAPTAN Trade Name: SANDOSTATINA - LAR 20 MG/2.5 ML POLVERE E SOLVENTE PER SOSPENSIONE INIETTABILE FLACONE POLVERE + SIRINGA PRERIEMPITA 2.5 ML + 2 AGHI Product Name: sandostatina LAR Product Code: sandostatina | IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Italy | ||
| 12 | EUCTR2017-003864-10-NL (EUCTR) | 02/05/2018 | 08/03/2018 | Medication for excessive urine production in patients treated with tolvaptan | Hydrochlorothiazide and metformin cross-over study for attenuating aquaretic side-effects in ADPKD patients treated with tolvaptan | Autosomal dominant polycystic kidney disease;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Hydrochlorothiazide Product Code: HCT Product Name: Metformin | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | Netherlands | ||
| 13 | EUCTR2017-004115-39-DK (EUCTR) | 08/02/2018 | 13/12/2017 | Same as above | Subacute Effect of Tolvaptan on Total Kidney Volumen in Adult Patients with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney DIsease MedDRA version: 20.0;Level: LLT;Classification code 10036045;Term: Polycystic kidney;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Jinarc 15 mg tablets, Jinarc 45 mg tablets Product Name: Jinarc - Tolvaptan tablets Product Code: 15 or 45 mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN Trade Name: Jinarc 30 mg tablets, Jinarc 60 mg tablets Product Name: Jinarc - Tolvaptan tablets Product Code: 30 or 60 mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN Trade Name: Jinarc 30 mg tablets, 90 mg tablets Product Name: Jinarc - Tolvaptan tablets Product Code: 30 or 90 mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN | Nordsjællands Hospital, Department of Cardiology, Nephrology and Endocrinology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 4 | Denmark | ||
| 14 | EUCTR2016-000187-42-GB (EUCTR) | 24/10/2016 | 06/05/2016 | A Phase 3b, Two-part, Multicenter, Three Year Trial of the Effects of Tolvaptan in Children and Adolescents with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Tolvaptan 7.5 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Trade Name: Jinarc® 15mg Tablet Product Name: Tolvaptan 15 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Trade Name: Jinarc® 30 Tablet Product Name: Tolvaptan 30 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | Belgium;Germany;Italy;United Kingdom | ||
| 15 | EUCTR2016-000187-42-DE (EUCTR) | 13/10/2016 | 10/05/2016 | A Phase 3b, Two-part, Multicenter, Three Year Trial of the Effects of Tolvaptan in Children and Adolescents with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Tolvaptan 7.5 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Trade Name: Jinarc® 15mg Tablet Product Name: Tolvaptan 15 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Trade Name: Jinarc® 30 Tablet Product Name: Tolvaptan 30 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Belgium;Germany;United Kingdom;Italy | ||
| 16 | NCT02729662 (ClinicalTrials.gov) | October 1, 2016 | 11/3/2016 | Efficacy of Tolvaptan on ADPKD Patients | Longitudinal Efficacy and Safety Study of Tolvaptan on Autosomal Dominant Polycystic Kidney Disease Patients (LET-PKD Study) | Autosomal Dominant Polycystic Kidney Disease | Drug: Tolvaptan | Kyorin University | NULL | Active, not recruiting | 18 Years | N/A | All | 118 | N/A | Japan |
| 17 | EUCTR2016-000187-42-IT (EUCTR) | 26/09/2016 | 12/05/2016 | A Phase 3b, Two-part, Multicenter, Three Year Trial of the Effects of Tolvaptan in Children and Adolescents with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 19.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Tolvaptan 7.5 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Trade Name: Jinarc® 15mg Tablet Product Name: Tolvaptan 15 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Trade Name: Jinarc® 30 Tablet Product Name: Tolvaptan 30 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Hungary;Poland;Belgium;Spain;Germany;United Kingdom;Italy | ||
| 18 | NCT02964273 (ClinicalTrials.gov) | September 2016 | 15/9/2016 | Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease) | A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan Followed by a Two Year Open-label Extension in Children and Adolescent Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Drug: Phase A Tolvaptan;Drug: Placebo Phase A;Drug: Phase B Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 4 Years | 17 Years | All | 91 | Phase 3 | Belgium;Germany;Italy;United Kingdom |
| 19 | EUCTR2016-000187-42-BE (EUCTR) | 24/08/2016 | 24/05/2016 | A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-label Extension in Children and Adolescent Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Tolvaptan 7.5 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Trade Name: Jinarc® 15mg Tablet Product Name: Tolvaptan 15 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Trade Name: Jinarc® 30 Tablet Product Name: Tolvaptan 30 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Belgium;Germany;United Kingdom;Italy | ||
| 20 | NCT03406286 (ClinicalTrials.gov) | July 19, 2016 | 22/12/2017 | Samsca PMS in ADPKD Patients | Post-Marketing Surveillance(PMS) of Safety and Efficacy of Samsca® Tablets in Korean Patients With ADPKD | Safety | Drug: Tolvaptan | Korea Otsuka Pharmaceutical Co., Ltd. | NULL | Recruiting | 18 Years | N/A | All | 600 | Korea, Republic of | |
| 21 | EUCTR2014-001516-19-DK (EUCTR) | 15/06/2016 | 14/04/2016 | This is a study to evaluate the long term safety of Tolvaptan in adults with chronic kidney disease. | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 19.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | Female: yes Male: yes | 2500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Denmark;Australia;South Africa;Norway;Netherlands;Germany;Sweden | ||
| 22 | EUCTR2014-001516-19-HU (EUCTR) | 02/05/2016 | 01/03/2016 | This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease. | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 19.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | Female: yes Male: yes | 2500 | Phase 3 | United States;Spain;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Denmark;Australia;South Africa;Norway;Netherlands;Germany;Sweden | ||
| 23 | EUCTR2014-001516-19-CZ (EUCTR) | 06/04/2016 | 28/01/2016 | This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease. | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 19.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | Female: yes Male: yes | 2500 | Phase 3 | United States;Spain;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;South Africa;Norway;Germany;Netherlands;Sweden | ||
| 24 | EUCTR2014-001516-19-SE (EUCTR) | 04/02/2016 | 05/11/2014 | This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease. | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | Female: yes Male: yes | 2500 | Phase 3 | United States;Spain;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;South Africa;Norway;Netherlands;Germany;Sweden | ||
| 25 | EUCTR2014-001501-41-BE (EUCTR) | 16/01/2016 | 17/12/2015 | A Multinational Trial to Collect Blood Samples to Explore Potential Genetic/Biomarkers Related to Increased Risk of Liver Injury in Adult Subjects from Prior Tolvaptan Clinical Trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Multinational Trial to Collect Blood Samples to Explore Potential Genetic/Biomarkers Related to Increased Risk of Liver Injury in Adult Subjects from Prior Tolvaptan Clinical Trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD), Patients with Increased Risk of Liver Injury;Therapeutic area: Not possible to specify | Trade Name: Jinarc INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 3 | France;United States;Argentina;Belgium;Germany;Japan | ||
| 26 | EUCTR2014-001501-41-FR (EUCTR) | 30/12/2015 | 15/01/2016 | A Multinational Trial to Collect Blood Samples to Explore Potential Genetic/Biomarkers Related to Increased Risk of Liver Injury in Adult Subjects from Prior Tolvaptan Clinical Trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Multinational Trial to Collect Blood Samples to Explore Potential Genetic/Biomarkers Related to Increased Risk of Liver Injury in Adult Subjects from Prior Tolvaptan Clinical Trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD), Patients with Increased Risk of Liver Injury;Therapeutic area: Not possible to specify | Trade Name: Jinarc INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;France;Argentina;Belgium;Germany;Japan | ||
| 27 | NCT03803124 (ClinicalTrials.gov) | December 2015 | 7/1/2019 | Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKD | Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKD | Polycystic Kidney, Autosomal Dominant | Drug: Tolvaptan;Drug: Placebo | Regional Hospital Holstebro | NULL | Completed | 18 Years | N/A | All | 20 | Phase 3 | Denmark |
| 28 | EUCTR2014-001516-19-ES (EUCTR) | 30/10/2015 | 11/09/2015 | This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease. | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 18.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | Female: yes Male: yes | 2500 | Phase 3 | United States;Spain;Chile;Israel;Russian Federation;Colombia;Italy;Switzerland;France;Denmark;Australia;Peru;South Africa;Netherlands;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden | ||
| 29 | EUCTR2014-000226-38-FR (EUCTR) | 16/10/2015 | 11/12/2015 | This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden;Italy;Switzerland;Colombia;Israel;Chile;Russian Federation;Spain;Taiwan;United States | ||
| 30 | EUCTR2015-001903-30-DK (EUCTR) | 26/06/2015 | 13/05/2015 | Effect of tolvaptan on renal blood flow and glomerular filtration in patients with polycystic kidney disease | Effect of tolvaptan on RBF and GFR in ADPKD - Tolvaptan and RPF in ADPKD | Adult dominant polycystic kidney disease (ADPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Physical Phenomena [G01] | Trade Name: Samsca INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN | Department of Medical Research | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Denmark | ||
| 31 | EUCTR2014-001516-19-PL (EUCTR) | 27/05/2015 | 19/02/2015 | This is a study to evaluate the long term safety of Tolvaptan in adults with chronic kidney disease. | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | Female: yes Male: yes | 2500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Denmark;Australia;South Africa;Norway;Netherlands;Germany;Sweden | ||
| 32 | EUCTR2014-001516-19-FR (EUCTR) | 30/03/2015 | 07/01/2015 | This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease. | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 17.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2500 | Phase 3 | United States;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Peru;South Africa;Netherlands;United Kingdom;Czech Republic;Hungary;Mexico;Sweden;Norway;Germany;Romania;Poland;Belgium;Brazil;Argentina;Canada | ||
| 33 | EUCTR2014-001516-19-GB (EUCTR) | 26/03/2015 | 30/09/2014 | This is a study to evaluate the long term safety of Tolvaptan in adults with chronic kidney disease. | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease - Otsuka_156-13-211 | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | Female: yes Male: yes | 2500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Peru;South Africa;Netherlands;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden | ||
| 34 | EUCTR2014-000226-38-PL (EUCTR) | 10/03/2015 | 08/12/2014 | This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 19.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Norway;Germany;Sweden | ||
| 35 | EUCTR2014-001516-19-NL (EUCTR) | 09/03/2015 | 06/11/2014 | This is a study to evaluate the long term safety of Tolvaptan in adults with chronic kidney disease. | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | Female: yes Male: yes | 2500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Germany;Norway;Sweden;Romania;Poland;Belgium;Brazil;Argentina;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Netherlands;South Africa;Peru;Denmark;Australia;France;Italy;Switzerland;Colombia;Israel;Chile;Russian Federation;Spain;United States | ||
| 36 | EUCTR2014-001516-19-BE (EUCTR) | 11/02/2015 | 17/11/2014 | This is a study to evaluate the long term safety of Tolvaptan in adults with chronic kidney disease. | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | Female: yes Male: yes | 2500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Peru;South Africa;Netherlands;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden | ||
| 37 | NCT02527863 (ClinicalTrials.gov) | February 2015 | 18/2/2015 | Effect of the Aquaretic Tolvaptan on Nitric Oxide System | The Effects of Tolvaptan on Renal Handling of Water and Sodium, Vasoactive Hormones and Central Hemodynamics During Baseline Conditions and After Inhibition of the Nitric Oxide System in Patients With Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease | Drug: Tolvaptan;Drug: Placebo | Regional Hospital Holstebro | Aarhus University Hospital | Completed | 18 Years | 65 Years | All | 18 | Phase 2 | Denmark |
| 38 | EUCTR2014-000226-38-CZ (EUCTR) | 21/01/2015 | 13/11/2014 | This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 18.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden | ||
| 39 | EUCTR2014-000226-38-GB (EUCTR) | 08/01/2015 | 31/07/2014 | This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden | ||
| 40 | EUCTR2014-000226-38-ES (EUCTR) | 02/01/2015 | 16/10/2014 | This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden | ||
| 41 | EUCTR2014-000226-38-NL (EUCTR) | 22/12/2014 | 24/09/2014 | This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden | ||
| 42 | EUCTR2014-000226-38-BE (EUCTR) | 17/12/2014 | 26/09/2014 | This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 19.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden | ||
| 43 | EUCTR2014-001516-19-IT (EUCTR) | 10/12/2014 | 16/10/2014 | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Titrated Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | Female: yes Male: yes | 2500 | Phase 3 | United States;Spain;Chile;Israel;Russian Federation;Colombia;Italy;Switzerland;France;Denmark;Australia;Peru;South Africa;Netherlands;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden | ||
| 44 | EUCTR2014-000226-38-DK (EUCTR) | 02/12/2014 | 11/09/2014 | This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden | ||
| 45 | EUCTR2014-000226-38-SE (EUCTR) | 21/11/2014 | 14/08/2014 | This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 18.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden | ||
| 46 | JPRN-UMIN000015715 | 2014/11/20 | 25/11/2014 | Clinical Efficacy Study of Tolvaptan on Patients with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease | Tolvaptan administration | Kyorin University School of Medicine | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 100 | Phase 4 | Japan | |
| 47 | EUCTR2014-001973-15-DK (EUCTR) | 18/11/2014 | 27/06/2014 | The effcts of tolvaptan on renal handling of water and salt, hormones in the blood at the circulation, during blocking of the nitric oxide (NO) system in patients with autosomal dominant polycystic kidney disease | Renal Handling of Water and Sodium in Autosomal Dominant Polycystic Kidney Disease.The effects of tolvaptan on renal handling of water and sodium , vasoactive hormones and central hemodynamics during baseline conditions and after inhibition of the nitric oxide system in patients with autosomal dominant polycystic kidney disease - TOPO | HyponatreamiaSIADH ( Syndrome of Inappropriate Antidiuretic Hormone Secretion) OverhydrationAutosomal dominant polycystic kidney disease MedDRA version: 17.0;Level: LLT;Classification code 10021038;Term: Hyponatremia;System Organ Class: 100000004861 MedDRA version: 17.0;Classification code 10040626;Term: SIADH;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07] | Trade Name: Samsca Product Name: Tolvaptan Product Code: C03XA01 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN | University Clinic in Nephrology and Hypertension, Department of Medical Research | NULL | Not Recruiting | Female: yes Male: yes | Denmark | ||||
| 48 | EUCTR2014-000226-38-IT (EUCTR) | 11/11/2014 | 05/08/2014 | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | United States;Taiwan;Spain;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden | ||
| 49 | EUCTR2014-000226-38-HU (EUCTR) | 03/11/2014 | 21/08/2014 | This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind,Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day,Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to EarlyStage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 18.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 15mg INN or Proposed INN: Tolvaptan Product Name: Tolvaptan 30mg INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1300 | Phase 3 | United States;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;Sweden | ||
| 50 | NCT02251275 (ClinicalTrials.gov) | October 17, 2014 | 25/9/2014 | Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease | A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/Day, Split Dose) in Subjects With Autosomal Dominant Polycystic Kidney Disease | Polycystic Kidney, Autosomal Dominant | Drug: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | N/A | All | 1803 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;Czechia;Denmark;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Romania;Russian Federation;South Africa;Spain;Sweden;United Kingdom;Czech Republic |
| 51 | JPRN-UMIN000015245 | 2014/09/25 | 25/09/2014 | Confirmatory study of patients with progressive autosomal dominant polycystic kidney disease (ADPKD) to establish the determinants of disease progression and response to tolvaptan treatment. | Confirmatory study of patients with progressive autosomal dominant polycystic kidney disease (ADPKD) to establish the determinants of disease progression and response to tolvaptan treatment. - ADPKD confirmatory study to establish the determinants of disease progression and response to tolvaptan treatment. | autosomal dominant polycystic kidney disease (ADPKD) | tolvaptan 60~120mg/day tolvaptan less than 60mg/day (in case of minimize dose recommended, for example; kidney dysfunction) tolvaptan less than 60mg/day (in case of minimize dose recommended, for example; kidney dysfunction) no medication tolvaptan less than 60mg/day of start dose (in case of minimize start dose recommended, for example; less than 20 years old or more than 65 years old) | Department of Nephrology, Tokyo Women's Medical University | NULL | Complete: follow-up complete | 15years-old | Not applicable | Male and Female | 100 | Not applicable | Japan |
| 52 | NCT02160145 (ClinicalTrials.gov) | May 2014 | 6/6/2014 | Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease | A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/Day, Split-dose) in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease | Chronic Kidney Disease;Autosomal Dominant Polycystic Kidney Disease | Drug: Tolvaptan (OPC-41061);Drug: Placebo | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | 65 Years | All | 1370 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Sweden;United Kingdom;Czech Republic |
| 53 | NCT02847624 (ClinicalTrials.gov) | March 2014 | 25/7/2016 | Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD | Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD in Japan | Polycystic Kidney, Autosomal Dominant | Drug: tolvaptan | Otsuka Pharmaceutical Co., Ltd. | NULL | Recruiting | N/A | N/A | All | 1600 | Japan | |
| 54 | NCT01451827 (ClinicalTrials.gov) | October 2011 | 11/10/2011 | 8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Placebo-masked, Parallel-group Pilot Trial to Compare the Efficacy, Tolerability, and Safety of Tolvaptan Modified-release and Immediate-release Formulations in Subjects With Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease | Drug: Tolvaptan MR;Drug: Tolvaptan IR;Drug: Placebo | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | 50 Years | All | 178 | Phase 2 | United States |
| 55 | EUCTR2010-018401-10-NL (EUCTR) | 14/01/2011 | 21/10/2010 | A global clinical research study using a drug that is used in patients for the treatment of multiple cysts which form on the kidneys. | A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 17.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Samsca Product Name: Tolvaptan Product Code: OPC-41061 INN or Proposed INN: Tolvaptan INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1500 | France;United States;Canada;Poland;Belgium;Romania;Russian Federation;Afghanistan;Germany;Netherlands;Italy;United Kingdom | |||
| 56 | EUCTR2010-018401-10-IT (EUCTR) | 24/11/2010 | 10/09/2010 | Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) - ND | Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) - ND | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 9.1;Level: LLT;Classification code 10036046 | OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALISATION INC | NULL | Not Recruiting | Female: yes Male: yes | 1500 | France;Netherlands;Germany;United Kingdom;Italy | ||||
| 57 | EUCTR2010-018401-10-BE (EUCTR) | 23/11/2010 | 03/09/2010 | A global clinical research study using a drug that is used in patients for the treatment of multiple cysts which form on the kidneys. | A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Samsca 15 mg tablets Product Name: Tolvaptan 15 mg tablets Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Trade Name: Samsca 30 mg tablets Product Name: Tolvaptan 30 mg tablets Product Code: OPC-41061 INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | France;United States;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;Netherlands;Germany;Italy;United Kingdom | ||
| 58 | EUCTR2010-018401-10-FR (EUCTR) | 15/11/2010 | 27/07/2010 | A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant | Trade Name: Samsca 15 mg tablets Product Name: Tolvaptan 15 mg tablets Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Trade Name: Samsca 30 mg tablets Product Name: Tolvaptan 30 mg tablets Product Code: OPC-41061 INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | France;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 59 | JPRN-JapicCTI-101362 | 01/11/2010 | 03/12/2010 | A multicenter, open-label extension study to investigate the long-term safety and efficacy of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) [Extension of Trial 156-04-251] | A multicenter, open-label extension study to investigate the long-term safety and efficacy of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) [Extension of Trial 156-04-251] | Autosomal dominant polycystic kidney disease (ADPKD) | Intervention name : Tolvaptan Dosage And administration of the intervention : Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg. | Otsuka Pharmaceutical Co., Ltd. | NULL | 23 | 53 | BOTH | 150 | Phase 3 | NULL | |
| 60 | NCT01280721 (ClinicalTrials.gov) | November 2010 | 6/12/2010 | A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan] | A Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan] | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Drug: tolvaptan | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 23 Years | 53 Years | All | 135 | Phase 3 | Japan |
| 61 | EUCTR2010-018401-10-GB (EUCTR) | 05/10/2010 | 26/08/2010 | A global clinical research study using a drug that is used in patients for the treatment of multiple cysts which form on the kidneys. | A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 17.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Samsca 15 mg tablets Product Name: Tolvaptan 15 mg tablets Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Trade Name: Samsca 30 mg tablets Product Name: Tolvaptan 30 mg tablets Product Code: OPC-41061 INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;Netherlands;Germany;Italy;United Kingdom | ||
| 62 | NCT01336972 (ClinicalTrials.gov) | October 2010 | 15/4/2011 | Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Phase 2a, Single-center Study Investigating the Short-term Renal Hemodynamic Effects, Safety and Pharmacokinetics/ Pharmacodynamics of Oral Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal Function | Autosomal Dominant Polycystic Kidney Disease | Drug: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | 70 Years | All | 29 | Phase 2 | Netherlands |
| 63 | NCT01210560 (ClinicalTrials.gov) | October 2010 | 21/9/2010 | Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD | A Multi-center, Parallel-group, Randomized, Double-blind, Placebo-masked, Multiple Dose Trial of Modified-release (MR) and Immediate-release (IR) Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease | Drug: Tolvaptan MR;Drug: Tolvaptan IR | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | 50 Years | All | 25 | Phase 2 | United States |
| 64 | EUCTR2010-019025-33-NL (EUCTR) | 31/08/2010 | 27/07/2010 | A Phase IIa, Single-Center Study, Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/Pharmacodynamics of Oral Tolvaptan (OPC-41061) in Subjects with Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal Function | A Phase IIa, Single-Center Study, Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/Pharmacodynamics of Oral Tolvaptan (OPC-41061) in Subjects with Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal Function | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant | Trade Name: Samsca 15 mg tablets Product Name: Tolvaptan 15 mg tablets Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Trade Name: Samsca 30 mg tablets Product Name: Tolvaptan 30 mg tablets Product Code: OPC-41061 INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Netherlands | ||
| 65 | EUCTR2010-018401-10-DE (EUCTR) | 07/07/2010 | 10/06/2010 | A global clinical research study using a drug that is used in patients for the treatment of multiple cysts which form on the kidneys. | A Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 17.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Samsca 15 mg tablets Product Name: Tolvaptan 15 mg tablets Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Trade Name: Samsca 30 mg tablets Product Name: Tolvaptan 30 mg tablets Product Code: OPC-41061 INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1500 | France;United States;Canada;Argentina;Poland;Belgium;Romania;Russian Federation;Netherlands;Germany;Italy;United Kingdom | |||
| 66 | NCT01214421 (ClinicalTrials.gov) | May 2010 | 26/9/2010 | Open-Label Tolvaptan Study in Subjects With ADPKD | Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Drug: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | N/A | All | 1083 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Romania;Russian Federation;United Kingdom |
| 67 | EUCTR2006-002768-24-DE (EUCTR) | 03/05/2007 | 15/12/2006 | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 8.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant | Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) INN or Proposed INN: Tolvaptan Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | France;Denmark;Germany;Italy;United Kingdom | ||
| 68 | EUCTR2006-002768-24-GB (EUCTR) | 23/04/2007 | 07/12/2006 | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 8.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant | Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) INN or Proposed INN: Tolvaptan Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Belgium;Denmark;Germany;Italy;United Kingdom | ||
| 69 | EUCTR2006-002768-24-FR (EUCTR) | 18/04/2007 | 29/12/2006 | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 8.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant | Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) INN or Proposed INN: Tolvaptan Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) INN or Proposed INN: Tolvaptan | Otsuka Maryland Research Institute, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | France;Belgium;Denmark;Germany;Italy;United Kingdom | ||
| 70 | EUCTR2006-002768-24-IT (EUCTR) | 16/04/2007 | 23/07/2007 | Phase III multicenter, double blind,placebo controlled, parallel arm trial to determine long-term safety and efficacy of oral tolvaptan tablet regimen in adult subjects with autosomal dominant polycystic kidney disease | Phase III multicenter, double blind,placebo controlled, parallel arm trial to determine long-term safety and efficacy of oral tolvaptan tablet regimen in adult subjects with autosomal dominant polycystic kidney disease | Autosomal dominant polycystic kidney disease MedDRA version: 14.1;Level: PT;Classification code 10010428;Term: Congenital cystic kidney disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: tolvaptan Product Code: NA INN or Proposed INN: tolvaptan Product Name: tolvaptan Product Code: NA INN or Proposed INN: tolvaptan Product Name: tolvaptan Product Code: NA INN or Proposed INN: tolvaptan | OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALISATION INC | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | France;Denmark;Germany;United Kingdom;Italy | ||
| 71 | EUCTR2006-002768-24-BE (EUCTR) | 26/03/2007 | 05/12/2006 | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 8.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant | Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) INN or Proposed INN: Tolvaptan Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | France;Belgium;Denmark;Germany;Italy;United Kingdom | ||
| 72 | EUCTR2006-002768-24-DK (EUCTR) | 26/01/2007 | 29/11/2006 | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease - - | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant Polycystic Kidney Disease - - | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 8.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant | Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) INN or Proposed INN: Tolvaptan Product Name: Tolvaptan (OPC-41061) Product Code: Tolvaptan (OPC-41061) INN or Proposed INN: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | France;Denmark;Germany;Italy;United Kingdom | ||
| 73 | JPRN-JapicCTI-070402 | 25/1/2007 | 21/05/2007 | Tolvaptan efficacy and safety in management of polycystic kidney desease and its outcomes (TEMPO3/4) | A phase 3, multi-center, double-blind, placebo-controlled, parallel-arm trial to determine long-term safety and efficacy of oral tolvaptan regimens in adult subjects with autosomal dominant polycystic kidney disease (ADPKD) | Autosomal dominant polycystic kidney disease (ADPKD) | Intervention name : OPC-41061 (tolvaptan) INN of the intervention : Tolvaptan Dosage And administration of the intervention : Oral, 45/15 mg Intervention name : OPC-41061 (tolvaptan) INN of the intervention : Tolvaptan Dosage And administration of the intervention : Oral, 60/30 mg Intervention name : OPC-41061 (tolvaptan) INN of the intervention : Tolvaptan Dosage And administration of the intervention : Oral, 90/30 mg Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Oral | Otsuka Pharmaceutical Co., Ltd. | NULL | complete | 20 | 50 | BOTH | 1500 | Phase 3 | Japan, North America, South America, Europe, Oceania |
| 74 | NCT00428948 (ClinicalTrials.gov) | January 2007 | 26/1/2007 | Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablets Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease | Polycystic Kidney Disease, Autosomal Dominant | Drug: Tolvaptan;Drug: Placebo | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical Co., Ltd. | Completed | 18 Years | 50 Years | All | 1445 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Japan;Netherlands;Poland;Romania;Russian Federation;United Kingdom |
| 75 | NCT00413777 (ClinicalTrials.gov) | December 2005 | 18/12/2006 | Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD) | A Phase 2, Multi-center, Open-label Study to Determine Long-term Safety, Tolerability and Efficacy of Split-dose Oral Regimens of Tolvaptan Tablets in a Range of 30 to 120 mg/d in Patients With Autosomal Dominant Polycystic Kidney Disease | Polycystic Kidney, Autosomal Dominant | Drug: Tolvaptan | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical Co., Ltd. | Completed | 18 Years | N/A | All | 46 | Phase 2 | United States |
| 76 | EUCTR2020-005992-10-DE (EUCTR) | 26/05/2021 | A trial to see if tolvaptan is safe in infants and children who at enrollment are 28 days to less than 18 years old with Autosomal Recessive Polycystic Kidney Disease (ARPKD) | A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 days to less than 18 years of Age with Autosomal Recessive Polycystic Kidney Disease (ARPKD) | Autosomal Recessive Polycystic Kidney Disease (ARPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036047;Term: Polycystic kidney, autosomal recessive;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: SAMSCA 7.5 mg oral tablet Product Name: Tolvaptan 7.5 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Trade Name: Jinarc® 15mg Tablet Product Name: Tolvaptan 15 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Trade Name: Jinarc 30 mg Tablet Product Name: Tolvaptan 30 mg Tablet Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) Product Name: Tolvaptan 50mg Granules Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | NA | Female: yes Male: yes | 10 | Phase 3 | United States;Belgium;Germany;United Kingdom;Italy | |||
| 77 | EUCTR2020-005991-36-DE (EUCTR) | 26/05/2021 | A trial to see if tolvaptan can delay dialysis in infants and children who at enrollment are 28 days to less than 12 weeks old with Autosomal Recessive Polycystic Kidney Disease (ARPKD) | A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 days to less than 12 weeks of Age with Autosomal Recessive Polycystic Kidney Disease (ARPKD) | Autosomal Recessive Polycystic Kidney Disease (ARPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036047;Term: Polycystic kidney, autosomal recessive;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Tolvaptan 50mg Granules Product Code: OPC-41061 INN or Proposed INN: Tolvaptan Other descriptive name: TOLVAPTAN (OPC-41061) | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | NA | Female: yes Male: yes | 20 | Phase 3 | United States;Belgium;Germany;United Kingdom;Italy |