DDrare: Database of Drug Development for Rare Diseases

67. 多発性嚢胞腎
［臨床試験数：186，薬物数：196（DrugBank：47），標的遺伝子数：35，標的パスウェイ数：146］

Searched query = "Polycystic kidney disease", "PKD", "PCKD", "Polycystic kidney", "ADPKD", "ARPKD"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 15 or 45 mg; 30 or 60 mg; 30 or 90 mg; AL; AMIAS; AMLODIPINE; APRINOX; Acetate; Amias; Aminohippurate; Aminohippurate Sodium Inj 20%; Amlodipine; Anti-hypertensive medications; Antihypertensive drugs; Aprinox; Arginine; BARDOXOLONE METHYL; BENDROFLUMETHIAZIDE; BIM 23014; BISOPROLOL; BOSUTINIB; Bardoxolone; Bardoxolone Methyl; Bardoxolone methyl; Bardoxolone methyl 10 mg; Bardoxolone methyl 15 mg; Bardoxolone methyl 20 mg; Bardoxolone methyl 5 mg; Bardoxolone methyl capsules; Bardoxolone methyl oral capsule; Behavioral: Diet and water adjustment; Bendroflumethiazide; Bisoprolol; Bosutinib; Bosutinib (anhydrous); C03XA01; CANDESARTAN; CARDURA; Calcineurin inhibitors maintenance; Candesartan; Candesartan and Cilnidipine; Candesartan plus non-CCB agents; Certican; Certican Tabletten; Cilnidipine; Conventional therapy; Curcumin; DOXAZOSIN; Doxazosin; Emodin; Equal; Everolimus; G1117337; GENZ-682452; GLPG2737; GZ402671; Genz-682452-AU; HCT; High water intake; Hydralazine; Hydrochlorothiazide; ISTIN; Imidapril; Intravenous injection autologous mesenchymal stem cells; Iohexol; Iohexol Inj 300 milligrams per milliliter (MG/ML); Istin; JINARC - 15 MG +45 MG - COMPRESSA - USO ORALE - BLISTER(ALU/PVC) IN CONFEZIONE A PORTAFOGLIO - 56 COMPRESSE (28X15 MG + 28 X 45 MG); JINARC - 15 MG - COMPRESSA - USO ORALE - BLISTER (ALU/PVC) - 28 COMPRESSE; 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); 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); JINARC - 30 MG - COMPRESSA - USO ORALE - BLISTER (ALU/PVC) - 28 COMPRESSE; Jinarc; Jinarc - Tolvaptan tablets; Jinarc 15 mg tablets, Jinarc 45 mg tablets; Jinarc 30 mg tablets, 90 mg tablets; Jinarc 30 mg tablets, Jinarc 60 mg tablets; Jinarc® 15mg Tablet; Jinarc® 30 Tablet; KD019 (tesevatinib); LANREOTIDE ACETATE; LISINOPRIL; Lanreotide; Lisinopril; Lixivaptan; Long-acting somatostatin; Losartan; METFORMIN; METFORMINA; MONOCOR; Metformin; Metformina; Monocor; NG-Monomethyl-L-arginine; Ng-monomethyl-L-arginine (drug); Niacinamide; OPC-41061; OPC-41061 (tolvaptan); Octeotride; Octreotide; Octreotide LAR; Octreotide-LAR; Other: Ad libitum water intake; Other: High Water Intake; Other: Low Blood Pressure Control; Other: Saline solution; Other: Saline solution.; Other: Standard; Other: Standard Blood Pressure Control; Other: Water; Other: Water prescription; Other: water; PF-05208763; Pasireotide; Pasireotide LAR; Pioglitazone; Placebo; Potassium; Pravastatin; Procedure: renal sympathetic denervation; Protein; RAD001; RAPAMUNE*100CPR RIV 1MG; RAPAMUNE*30CPR RIV 1MG; RAPAMUNE*30CPR RIV 2MG; RGLS4326; RTA 402; Radiation: PET/CT Scan; Ramipril; Rapamune; Rapamune 1mg tablets; Rapamycin; SANDOSTATINA - LAR 20 MG/2.5 ML POLVERE E SOLVENTE PER SOSPENSIONE INIETTABILE FLACONE POLVERE + SIRINGA PRERIEMPITA 2.5 ML + 2 AGHI; SANDOSTATINA LAR; SAR402671, GZ402671 or GZ/SAR402671; SIROLIMUS; SKI-606; Saline; Samsca; Samsca 15 mg tablets; Samsca 30 mg tablets; Sandostatin LAR; Sandostatina; Sandostatina LAR; Sandostatina Lar IM Fl 20mg +2F; Sirolimus; Sodium citrate; Sodiumchloride; Somatostatin; Somatuline; Somatuline Autogel; Somatuline Autosolution; Spironolactone; Sugar pill; TOLVAPTAN; TOLVAPTAN (OPC-41061); TOLVAPTAN 15; TOLVAPTAN 30; TOLVAPTAN 45/15; TOLVAPTAN 60/30; Telmisartan; Tesevatinib; Tetracosactin; Tolvaptan; Tolvaptan (OPC-41061); Tolvaptan 15 mg Tablet; Tolvaptan 15 mg tablets; Tolvaptan 15mg; Tolvaptan 30 mg Tablet; Tolvaptan 30 mg tablets; Tolvaptan 30mg; Tolvaptan 7.5 mg Tablet; Tolvaptan IR; Tolvaptan MR; Tripterygium; Tripterygium Wilfordii; Tripterygium wilfordii; Triptolide; Triptolide-Containing Formulation; UDCA; URSOCHOL 300; Unknown; Ursochol; Ursodeoxycholic Acid; Ursodeoxycholic acid; Venglustat; Venglustat GZ/SAR402671; Venglustat GZ402671; Water; ZESTRIL; ZUGLIMET - 500 MG COMPRESSE RIVESTITE CON FILM 30 COMPRESSE IN BLISTER PVC/AL; [METFORMINA]; [TOL; [TOLVAPTAN 15]; [TOLVAPTAN 30]; [TOLVAPTAN 45/15]

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	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
2	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
3	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 3	Hungary;Poland;Belgium;Spain;Germany;United Kingdom;Italy
4	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
5	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
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
6	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
7	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
8	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	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
9	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 3b	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
10	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
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
11	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
12	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
13	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
14	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
15	EUCTR2014-001516-19-IT (EUCTR)	10/12/2014	16/10/2014	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 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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2500	Phase 3b	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
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
16	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
17	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
18	EUCTR2014-000226-38-IT (EUCTR)	11/11/2014	05/08/2014	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: 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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1300	Phase 3b	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
19	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
20	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
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
21	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
22	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 2a	Netherlands
23	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

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

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

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

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)

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]

Otsuka Pharmaceutical Development & Commercialization, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 3

Hungary;Poland;Belgium;Spain;Germany;United Kingdom;Italy

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

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

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.

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

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

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.

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]

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

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]

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

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

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

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.

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]

Otsuka Pharmaceutical Development & Commercialization

,NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2500

Phase 3b

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

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

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

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

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

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

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

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

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

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

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

EUCTR2014-001516-19-IT
(EUCTR)

10/12/2014

16/10/2014

This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease.

Otsuka Pharmaceutical Development & Commercialization

,NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2500

Phase 3b

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

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

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

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

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

EUCTR2014-000226-38-IT
(EUCTR)

11/11/2014

05/08/2014

This is a study to evaluate the safety and effectiveness of Tolvaptan in adults with chronic kidney disease

Product Name: Tolvaptan 15mg
INN or Proposed INN: Tolvaptan
Product Name: Tolvaptan 30mg
INN or Proposed INN: Tolvaptan

Otsuka Pharmaceutical Development & Commercialization, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1300

Phase 3b

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

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

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)

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

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

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)

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant

Otsuka Pharmaceutical Development & Commercialization, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

France;Belgium;Netherlands;Germany;Italy;United Kingdom

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

Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant

Otsuka Pharmaceutical Development Commercialization, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Netherlands

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)

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