22 completed. 22 Phase 2, 1 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 22 | Completed 22 |
| Phase 1 | 1 | Completed 1 |
| Phase 3 | 1 | Completed 1 |
Follow Tolvaptan: new trials by email Literature Review of Tolvaptan trials Research Report on Tolvaptan
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Tolvaptan-Octreotide LAR Combination in ADPKD Tolvaptan, Octreotide LAR, Placebo - Autosomal Dominant Polycystic Kidney Disease | Phase 2 | Completed | Mario Negri Institute for Pharmacological Research | 20 | 2018-12-12 | 2022-11-03 |
| Effect of the Aquaretic Tolvaptan on Nitric Oxide System Tolvaptan, Placebo - Autosomal Dominant Polycystic Kidney Disease | Phase 2 | Completed | Regional Hospital Holstebro | 18 | 2015-02-01 | 2017-03-01 |
| A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration OPC-41061, Placebo - Chronic Renal Failure | Phase 2 | Completed | Otsuka Pharmaceutical Co., Ltd. | 124 | 2014-12-01 | 2019-10-22 |
| Effect of the Aquaretic Tolvaptan on Nitric Oxide System. A Dose-response Study (DOVA) 15 mg tolvaptan, 30 mg tolvaptan, 45 mg tolvaptan - Nephropathy | Phase 2 | Completed | Regional Hospital Holstebro | 15 | 2014-03-01 | 2017-03-01 |
| A PK Study of 3 Dosages of Tolvaptan in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) tolvaptan - Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) | Phase 1 / Phase 2 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 30 | 2013-11-01 | 2016-05-16 |
| Role of Midodrine and Tolvaptan in Patients With Cirrhosis With Refractory or Recurrent Ascites Standard medical therapy, Tolvaptan, Midodrine - Cirrhosis, Refractory/Recurrent Ascites | Phase 2 / Phase 3 | Completed | Post Graduate Institute of Medical Education and Research, Chandigarh | 50 | 2013-07-01 | 2017-09-19 |
| Open-label Dose-finding Trial of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis OPC-41061 - Chronic Renal Failure | Phase 2 | Completed | Otsuka Pharmaceutical Co., Ltd. | 20 | 2013-07-01 | 2016-01-01 |
| A Phase 2, Multi-center, Open-label, Dose-finding Trial to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of OPC-41061 in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration OPC-41061 - Chronic Renal Failure | Phase 2 | Completed | Otsuka Pharmaceutical Co., Ltd. | 26 | 2013-06-01 | 2018-08-24 |
| A Multicenter, Open-label, Dose-finding Trial of OPC-41061 to Investigate Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety in Patients With Carcinomatous Edema (Phase 2) OPC-41061 - Carcinomatous Edema | Phase 2 | Completed | Otsuka Pharmaceutical Co., Ltd. | 43 | 2012-07-01 | 2021-03-18 |
| Effect of the Aquaretic Tolvaptan on Nitric Oxide System (TORA) Tolvaptan, Placebo - Cardiovascular Diseases, Nephropathy | Phase 2 | Completed | Regional Hospital Holstebro | 20 | 2012-05-01 | 2014-10-09 |
| 8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Tolvaptan MR, Tolvaptan IR, Placebo - Autosomal Dominant Polycystic Kidney Disease | Phase 2 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 178 | 2011-10-01 | 2018-09-27 |
| Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD Tolvaptan MR, Tolvaptan IR - Autosomal Dominant Polycystic Kidney Disease | Phase 2 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 25 | 2010-10-01 | 2018-06-14 |
| Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) Tolvaptan - Autosomal Dominant Polycystic Kidney Disease | Phase 2 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 29 | 2010-10-01 | 2019-03-05 |
| Dose Exploring and Setting Study for Tolvaptan to Treat Hepatic Cirrhosis With Ascites Tolvaptan, placebo - Ascites, Hepatic Cirrhosis | Phase 2 | Completed | Otsuka Beijing Research Institute | 180 | 2009-04-01 | 2012-10-12 |
| A Phase 2 Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia Tolvaptan, Placebo - Hypovolemic Hyponatremia | Phase 2 | Completed | Otsuka Beijing Research Institute | 241 | 2008-05-01 | 2025-03-25 |
| A Dose-defining Study of OPC-41061 in Treatment of Hepatic Edema OPC-41061 7.5mg, OPC-41061 placebo, OPC-41061 15mg - Cirrhosis | Phase 2 | Completed | Otsuka Pharmaceutical Co., Ltd. | 104 | 2007-06-01 | 2014-03-14 |
| A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001] OPC-41061 - Autosomal Dominant Polycystic Kidney Disease | Phase 2 | Completed | Otsuka Pharmaceutical Co., Ltd. | 17 | 2006-04-01 | 2018-09-11 |
| Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Tolvaptan - Polycystic Kidney, Autosomal Dominant | Phase 2 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 46 | 2005-12-01 | 2017-07-02 |
| Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure tolvaptan - Heart Failure, Congestive | Phase 2 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 140 | 2004-12-01 | 2012-05-03 |
| A Dose-finding Study of OPC-41061 in Treatment of Cardiac Edema (Congestive Heart Failure) OPC-41061(Tolvaptan) - Heart Failure, Congestive, Edema | Phase 2 | Completed | Otsuka Pharmaceutical Co., Ltd. | 122 | 2004-08-01 | 2013-12-25 |
Showing 20 of 22. Sign in to see all of them.
Polycystic Kidney, Autosomal Dominant (7) · Heart Failure (4) · Kidney Diseases (4) · Ascites (3) · Kidney Failure, Chronic (3) · Fibrosis (2) · Polycystic Kidney Diseases (2) · Cardiovascular Diseases (1) · Edema (1) · Hyponatremia (1) · Inappropriate ADH Syndrome (1) · Liver Cirrhosis (1)
Otsuka Pharmaceutical Development & Commercialization, Inc. (8) · Otsuka Pharmaceutical Co., Ltd. (7) · Regional Hospital Holstebro (3) · Otsuka Beijing Research Institute (2) · Mario Negri Institute for Pharmacological Research (1) · Post Graduate Institute of Medical Education and Research, Chandigarh (1)
Japan (7) · United States (6) · Denmark (4) · China (2) · Canada (1) · Czechia (1) · Germany (1) · Hungary (1) · India (1) · Italy (1) · Netherlands (1) · Romania (1) · Spain (1) · Sweden (1) · United Kingdom (1)
Frank Czerwiec, M.D., Ph.D. (2) · Katsuhisa Saito (2) · Kyoji Imaoka, Mr (2) · Erling B Pedersen (1) · Feng Gu (1) · Frank Czerweic, MD (1) · Frank Czerwiec, MD, PhD (1) · Frank H Mose, MD, PhD (1) · Giuseppe Remuzzi, MD (1) · James Udelson, MD (1) · Jidong Jia (1) · Junichi Hahimoto, PhD (1) · Minde Zeng (1) · Ron T Gansevoort, MD (1)
PMID 39356039, PMID 21903984, PMID 30180806, PMID 37250503, PMID 17543634, PMID 19007589, PMID 19095138, PMID 24906029, PMID 27614145, PMID 28288570, PMID 28810844, PMID 36754009, PMID 37349694, PMID 37986188
2014 (1), 2017 (1)