29 completed, 3 terminated, 3 withdrawn, 2 unknown. 38 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 38 | Completed 29, Terminated 3, Withdrawn 3, Unknown 2, Recruiting 1 |
| Phase 2 | 2 | Completed 1, Unknown 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 |
|---|---|---|---|---|---|---|
| A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD) Tolvaptan Suspension, Tolvaptan Tablets - Autosomal Recessive Polycystic Kidney (ARPKD) | Phase 3 | Recruiting | Otsuka Pharmaceutical Development & Commercialization, Inc. | 20 | 2023-01-23 | 2026-10-23 |
| 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Kidney Disease (ARPKD) Tolvaptan (OPC-41061) - Autosomal Recessive Polycystic Kidney Disease (ARPKD) | Phase 3 | Withdrawn | Otsuka Pharmaceutical Development & Commercialization, Inc. | 2022-07-01 | 2025-12-24 | |
| Metformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney Disease Metformin, Tolvaptan - ADPKD | Phase 3 | Unknown | Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari | 150 | 2019-01-30 | 2018-12-07 |
| Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure OPC-61815, Tolvaptan Tab 15 MG - Congestive Heart Failure | Phase 3 | Completed | Otsuka Pharmaceutical Co., Ltd. | 294 | 2019-01-16 | 2021-08-05 |
| Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload Tolvaptan - Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload | Phase 3 | Completed | Otsuka Pharmaceutical Co., Ltd. | 60 | 2018-03-07 | 2024-08-23 |
| A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH Tolvaptan Oral Tablet - Syndrome of Inappropriate Antidiuretic Hormone Secretion | Phase 3 | Completed | Otsuka Pharmaceutical Co., Ltd. | 16 | 2017-03-02 | 2020-11-02 |
| Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease) Tolvaptan, Tolvaptan Matching-placebo - Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 91 | 2016-09-23 | 2023-01-03 |
| An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia Tolvaptan - Hyponatremia | Phase 3 | Terminated | Otsuka Pharmaceutical Development & Commercialization, Inc. | 3 | 2016-04-22 | 2020-04-17 |
| Effect of Tolvaptan on Renal Plasma Flow (RPF) and Glomerular Filtration Rate (GFR) in ADPKD Tolvaptan, Placebo - Polycystic Kidney, Autosomal Dominant | Phase 3 | Completed | Regional Hospital Holstebro | 20 | 2015-12-01 | 2019-01-14 |
| A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia Tolvaptan, Placebo - Hyponatremia | Phase 3 | Withdrawn | Otsuka Pharmaceutical Development & Commercialization, Inc. | 2015-11-01 | 2017-07-31 | |
| Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia Tolvaptan - Hyponatremia | Phase 3 | Terminated | Otsuka Pharmaceutical Development & Commercialization, Inc. | 9 | 2015-09-22 | 2018-09-26 |
| Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Tolvaptan - Polycystic Kidney, Autosomal Dominant | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 1803 | 2014-10-17 | 2019-11-27 |
| 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 Tolvaptan (OPC-41061), Placebo - Chronic Kidney Disease, Autosomal Dominant Polycystic Kidney Disease | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 1370 | 2014-05-01 | 2018-08-08 |
| 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 |
| Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure Tolvaptan, Placebo - Heart Failure, Dyspnea | Phase 3 | Completed | Duke University | 257 | 2012-10-01 | 2017-04-27 |
| Efficacy and Safety Study of Tolvaptan to Treat Patients With Cardiac Edema Tolvaptan, Placebo - Cardiac Edema | Phase 3 | Completed | Otsuka Beijing Research Institute | 244 | 2012-07-01 | 2013-12-30 |
| Efficacy and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients With Heart Failure Tolvaptan, Placebo - Cardiac-induced Edema | Phase 3 | Completed | Taiwan Otsuka Pharm. Co., Ltd | 85 | 2012-07-01 | 2015-06-02 |
| Randomized, Double-Blind, Placebo Controlled Study of the Short Term Clinical Effects of Tolvaptan in Patients Hospitalized for Worsening Heart Failure With Challenging Volume Management Tolvaptan or Samsca, placebo or sugar pill - Heart Failure | Phase 3 | Completed | Cardiovascular Clinical Sciences Inc | 250 | 2012-06-01 | 2016-09-27 |
| Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia Tolvaptan, Placebo - Non-hypovolemic Non-acute Hyponatremia | Phase 2 / Phase 3 | Unknown | Jiangsu HengRui Medicine Co., Ltd. | 240 | 2012-01-01 | 2012-01-11 |
| Effect of Tolvaptan on Cognitive Function in Cirrhosis Tolvaptan - Cirrhosis, Hepatic Encephalopathy | Phase 3 | Completed | Hunter Holmes Mcguire Veteran Affairs Medical Center | 25 | 2011-04-01 | 2014-02-07 |
Showing 20 of 38. Sign in to see all of them.
Hyponatremia (10) · Polycystic Kidney, Autosomal Dominant (8) · Fibrosis (7) · Heart Failure (6) · Ascites (5) · Edema, Cardiac (5) · Inappropriate ADH Syndrome (4) · Diabetes Insipidus (3) · Metabolic Diseases (3) · Water-Electrolyte Imbalance (3) · Oligohydramnios (2) · Polycystic Kidney Diseases (2) · Polycystic Kidney, Autosomal Recessive (2) · Renal Insufficiency, Chronic (2) · Cysts (1)
Otsuka Pharmaceutical Development & Commercialization, Inc. (16) · Otsuka Pharmaceutical Co., Ltd. (11) · Otsuka Beijing Research Institute (2) · Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari (1) · Cardiovascular Clinical Sciences Inc (1) · Duke University (1) · Hunter Holmes Mcguire Veteran Affairs Medical Center (1) · Jiangsu HengRui Medicine Co., Ltd. (1) · Maisel, Alan, M.D. (1) · Post Graduate Institute of Medical Education and Research, Chandigarh (1) · Regional Hospital Holstebro (1) · Taiwan Otsuka Pharm. Co., Ltd (1)
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Katsuhisa Saito (4) · Ann Dandurand, MD (2) · Frank Czerwiec, MD, PhD (2) · Osamu Sato (2) · Alan S Maisel, MD (1) · Chuen-Den Tseng (1) · Frank Mose, MD, Ph D (1) · Jasmohan S Bajaj, MD (1) · Joseph Verbalis, MD (1) · Loreto Gesualdo (1) · Marvin Konstam, MD (1) · Michael Felker, MD (1) · Minde Zeng (1)
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2016 (1)