10 completed, 4 terminated, 3 unknown, 1 withdrawn. 18 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 18 | Completed 10, Terminated 4, Unknown 3, Withdrawn 1 |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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| Tolvaptan for Advanced or Refractory Heart Failure Tolvaptan, Standard of care diuretic therapy - Heart Failure, Hyponatremia | Phase 4 | Terminated | University of Calgary | 9 | 2016-10-01 | 2020-07-27 |
| Regional Tolvaptan Registry Tolvaptan, No intervention - Decompensated Heart Failure, Hyponatremia | Phase 4 | Unknown | Cardiology Research UBC | 25 | 2016-05-01 | 2018-08-10 |
| Comparison of Oral or Intravenous Thiazides vs Tolvaptan in Diuretic Resistant Decompensated Heart Failure tolvaptan, Chlorothiazide, Metolazone - Heart Failure | Phase 4 | Completed | Vanderbilt University | 60 | 2016-02-01 | 2019-11-08 |
| Tolvaptan For Worsening Outpatient Heart Failure: Role of Copeptin In Identifying Responders tolvaptan, Placebo - Congestive Heart Failure | Phase 4 | Completed | University of North Carolina, Chapel Hill | 40 | 2015-07-01 | 2022-05-05 |
| Aquaresis Utility for Hyponatremic Acute Heart Failure Study Tolvaptan, Furosemide - Heart Failure | Phase 4 | Completed | University of Southern California | 33 | 2014-12-01 | 2019-05-28 |
| Effects of Tolvaptan in Healthy Adults Tolvaptan, Hypertonic saline infusion - Healthy | Phase 4 | Completed | Northwestern University | 17 | 2013-11-01 | 2026-10-15 |
| Tolvaptan/Ultrafiltration in the Treatment of Acute Heart Failure loop diuretic, tolvaptan, ultrafiltration - Acute Decompensated Heart Failure | Phase 4 | Completed | The Christ Hospital | 45 | 2013-05-01 | 2016-01-28 |
| Outcome and Treatment Quality Study of Tolvaptan to Treat Hyponatremia in Patients With Heart Failure Tolvaptan, Placebo - Heart Failure With Hyponatremia | Phase 4 | Terminated | Korea Otsuka Pharmaceutical Co., Ltd. | 58 | 2012-12-01 | 2017-06-14 |
| Tolvaptan for Hyponatremia in Cirrhotic Patients With Ascites Tolvaptan, placebo - Hyponatremia, Ascites | Phase 4 | Unknown | Konkuk University Medical Center | 105 | 2012-11-01 | 2012-10-30 |
| The Use of Tolvaptan to Prevent Renal Dysfunction in High Risk Patients With Heart Failure-Pilot Study Tolvaptan, placebo - Heart Failure | Phase 4 | Withdrawn | University of Michigan | 2012-08-01 | 2015-12-11 | |
| Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites Tolvaptan, Placebo - Hyponatremia and Extracellular Fluid in Cirrhotic | Phase 4 | Terminated | Korea Otsuka Pharmaceutical Co., Ltd. | 74 | 2012-04-01 | 2022-03-04 |
| Tolvaptan to Reduce Length of Stay in Hospitalized Patients With Cirrhosis and Hyponatremia Tolvaptan, Placebo, Hepatic Encephalopathy Assessment - Hyponatremia | Phase 4 | Terminated | NYU Langone Health | 2 | 2012-03-01 | 2017-12-11 |
| Tolvaptan for Ascites in Cirrhotic Patients Tolvaptan - Ascites, Cirrhosis | Phase 4 | Completed | University of Florida | 10 | 2012-03-01 | 2015-07-27 |
| Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients Tolvaptan, Placebo of tolvaptan - Heart Failure | Phase 4 | Completed | Otsuka Pharmaceutical Co., Ltd. | 100 | 2011-09-01 | 2019-10-22 |
| Tolvaptan in Hyponatremic Cancer Patients Tolvaptan, Placebo - Advanced Cancers | Phase 4 | Completed | M.D. Anderson Cancer Center | 52 | 2011-05-01 | 2020-09-23 |
| Pilot Study of Using Copeptin to Predict Response to Tolvaptan tolvaptan - Cardiovascular Diseases, Heart Diseases | Phase 4 | Completed | University of North Carolina, Chapel Hill | 21 | 2011-04-01 | 2017-05-17 |
Heart Failure (7) · Hyponatremia (6) · Diabetes Insipidus (3) · Ascites (2) · Polycystic Kidney, Autosomal Dominant (2) · Cardiovascular Diseases (1) · Edema (1) · Fibrosis (1) · Heart Diseases (1) · Liver Cirrhosis (1)
Korea Otsuka Pharmaceutical Co., Ltd. (3) · University of North Carolina, Chapel Hill (2) · Cardiology Research UBC (1) · Konkuk University Medical Center (1) · Lisbet Brandi (1) · M.D. Anderson Cancer Center (1) · NYU Langone Health (1) · Northwestern University (1) · Otsuka Pharmaceutical Co., Ltd. (1) · The Christ Hospital (1) · University of Calgary (1) · University of Florida (1) · University of Michigan (1) · University of Southern California (1) · Vanderbilt University (1)
United States (10) · South Korea (4) · Canada (2) · Denmark (1) · Japan (1)
Kirkwood F Adams, MD (2) · Abdulla K. Salahudeen, MD (1) · Barry E Bleske, Pharm. D. (1) · Dongju Choi, MD (1) · Eugene S Chung, MD (1) · Gary L Robertson, MD (1) · Jonathan Howlett, MD (1) · June Sung Lee, MD, PhD (1) · Lisbet Brandi, MD DMSc MHM (1) · Samuel Sigal, MD (1) · Sean Virani, MD, MSc, MPH, FRCPC (1) · Tien Ng, PharmD (1) · Uri Elkayam, MD (1) · Zachary L Cox, PharmD (1)