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 | 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 |
| 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-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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 |
| 18 | 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 |
| 19 | 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 | |||
| 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 | ||
| 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 | EUCTR2010-018401-10-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 | ||
| 23 | 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 | ||
| 24 | 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 | |||
| 25 | 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 |
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | 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 | ||
| 30 | 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 | ||
| 31 | 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 |
| 32 | 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 |
| 33 | 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 | |||
| 34 | 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 |