Opc-41061 (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 67 | 多発性嚢胞腎 | 24 |
| 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 | 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 | ||
| 2 | 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 | ||
| 3 | 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] | 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 | |||
| 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 | EUCTR2014-001516-19-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 | ||
| 9 | 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] | Otsuka Pharmaceutical Development & Commercialization | ,NULL | Not Recruiting | 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;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Norway;Sweden | |||
| 10 | 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 |
| 11 | 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 |
| 12 | 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 |
| 13 | 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 | |||
| 14 | 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 | ||
| 15 | 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 | ||
| 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 | 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 | ||
| 17 | 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 | |||
| 18 | NCT01022424 (ClinicalTrials.gov) | November 2009 | 27/11/2009 | A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002] | A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002] | Autosomal Dominant Polycystic Kidney Disease | Drug: OPC-41061 | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | N/A | N/A | All | 13 | Phase 3 | Japan |
| 19 | 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 | ||
| 20 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1500 | Phase 3 | Germany;United Kingdom;Denmark;France;Italy | ||
| 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 | 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 | ||
| 22 | 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 | ||
| 23 | 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 |
| 24 | NCT00841568 (ClinicalTrials.gov) | April 2006 | 9/2/2009 | A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001] | A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001] | Autosomal Dominant Polycystic Kidney Disease | Drug: OPC-41061 | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | N/A | N/A | All | 17 | Phase 2 | Japan |