76 completed, 12 unknown, 10 terminated, 5 withdrawn. 38 Phase 3, 25 Phase 2, 18 Phase 4, 11 Phase 1, 8 Not applicable.
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 of HRS-9057 in Patients With Heart Failure and Volume Overload HRS-9057, Tolvaptan - Heart Failure With Volume Overload | Phase 1 | Completed | Fujian Shengdi Pharmaceutical Co., Ltd. | 25 | 2024-08-16 | 2025-11-17 |
| Low-dose Tolvaptan for Inpatient Hyponatraemia. Tolvaptan - Hyponatremia, SIADH | Unknown | King's College Hospital NHS Trust | 180 | 2024-03-15 | 2024-03-08 | |
| 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Kidney Disease (ARPKD) Tolvaptan (OPC-41061) - Autosomal Recessive Polycystic Kidney Disease (ARPKD) | Phase 3 | Withdrawn | Otsuka Pharmaceutical Development & Commercialization, Inc. | 2022-07-01 | 2025-12-24 | |
| Tolvaptan add-on Therapy to Overcome Loop Diuretic Resistance in Acute Heart Failure With Renal Dysfunction Tolvaptan 15 MG - Acute Heart Failure | Not applicable | Unknown | Gia Dinh People Hospital | 128 | 2021-12-01 | 2022-08-11 |
| To Study Effect of the Combination of Midodrine and Tolvaptan Versus Tolvaptan Alone in Patients With Severe Hyponatremia in Cirrhosis(TOLMINA Trial) Tolvaptan Tablets, Midodrine Oral Tablet, Placebo - Liver Cirrhosis | Not applicable | Unknown | Institute of Liver and Biliary Sciences, India | 220 | 2021-09-19 | 2021-11-29 |
| Efficacy and Safety Evaluation of Tolvaptan in the Treatment of Patients With RHF Caused by PAH Tolvaptan, Furosemide - Pulmonary Arterial Hypertension, Randomized Controlled Trial | Not applicable | Unknown | Chinese Pulmonary Vascular Disease Research Group | 100 | 2021-04-06 | 2022-10-06 |
| Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH Tolvaptan (SAMSCA) - Antidiuretic Hormone, Inappropriate Secretion | Active not recruiting | Otsuka Pharmaceutical Co., Ltd. | 300 | 2021-03-29 | 2026-06-22 | |
| Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST) Tolvaptan 15 MG - Healthy Volunteers | Phase 2 | Unknown | Assistance Publique - Hôpitaux de Paris | 60 | 2019-09-06 | 2019-09-10 |
| Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease Tolvaptan - Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Phase 4 | Completed | Korea Otsuka Pharmaceutical Co., Ltd. | 118 | 2019-07-01 | 2022-06-16 |
| Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients tolvaptan - Heart Failure, Heart Assist Device | Completed | University of Chicago | 28 | 2019-03-28 | 2022-06-07 | |
| 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 |
| 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 |
| Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease Tolvaptan - Autosomal Dominant Polycystic Kidney | Phase 4 | Unknown | Lisbet Brandi | 90 | 2018-09-12 | 2018-11-26 |
| 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 |
| Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure OPC-61815 injection 2mg, OPC-61815 injection 4mg, OPC-61815 injection 8mg - Congestive Heart Failure | Not applicable | Completed | Otsuka Pharmaceutical Co., Ltd. | 61 | 2017-11-06 | 2021-07-28 |
| 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 |
| A Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects OPC-41061 - Healthy Adult Male | Phase 1 | Completed | Otsuka Pharmaceutical Co., Ltd. | 84 | 2017-01-06 | 2021-06-28 |
| TCUPS- Tolvaptan Use in Cystinuria and Urolithiasis: A Pilot Study Tolvaptan - Cystinuria | Not applicable | Completed | Caleb Nelson | 4 | 2016-10-01 | 2020-07-10 |
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Hyponatremia (23) · Heart Failure (20) · Polycystic Kidney, Autosomal Dominant (19) · Inappropriate ADH Syndrome (11) · Ascites (10) · Fibrosis (9) · Diabetes Insipidus (8) · Liver Cirrhosis (6) · Edema, Cardiac (5) · Kidney Diseases (5) · Polycystic Kidney Diseases (4) · Kidney Failure, Chronic (3) · Metabolic Diseases (3) · Water-Electrolyte Imbalance (3) · Cardiovascular Diseases (2)
Otsuka Pharmaceutical Development & Commercialization, Inc. (24) · Otsuka Pharmaceutical Co., Ltd. (23) · Otsuka Beijing Research Institute (7) · Korea Otsuka Pharmaceutical Co., Ltd. (5) · Regional Hospital Holstebro (4) · University of North Carolina, Chapel Hill (4) · Mario Negri Institute for Pharmacological Research (2) · NYU Langone Health (2) · Assistance Publique - Hôpitaux de Paris (1) · Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari (1) · Beijing Friendship Hospital (1) · Brigham and Women's Hospital (1) · Caleb Nelson (1) · Cardiology Research UBC (1) · Cardiovascular Clinical Sciences Inc (1)
United States (38) · Japan (25) · Italy (12) · United Kingdom (12) · Germany (11) · Denmark (10) · China (9) · Belgium (8) · Canada (8) · Romania (7) · Spain (7) · Netherlands (6) · Poland (6) · South Korea (6) · Argentina (5)
Katsuhisa Saito (6) · Frank Czerwiec, MD, PhD (3) · Minde Zeng (3) · Ann Dandurand, MD (2) · Frank Czerwiec, M.D., Ph.D. (2) · Kirkwood F Adams, MD (2) · Kyoji Imaoka, Mr (2) · Osamu Sato (2) · Vicente Torres, MD, PhD (2) · Yasuhiko Fukuta, PhD (2) · Abdulla K. Salahudeen, MD (1) · Alan S Maisel, MD (1) · Barry E Bleske, Pharm. D. (1)
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