13 completed, 4 withdrawn, 3 terminated, 1 unknown. 7 Phase 3, 5 Phase 1, 4 Phase 4, 3 Phase 2, 2 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 7 | Completed 4, Terminated 2, Withdrawn 1 |
| Phase 1 | 5 | Completed 5 |
| Phase 4 | 4 | Completed 2, Terminated 1, Withdrawn 1 |
| Phase 2 | 3 | Completed 2, Withdrawn 1 |
| Not applicable | 2 | Unknown 1, Withdrawn 1 |
Follow conivaptan: new trials by email Literature Review of conivaptan trials Research Report on conivaptan
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 |
|---|---|---|---|---|---|---|
| Conivaptan for the Reduction of Cerebral Edema in Intracerebral Hemorrhage- A Safety and Tolerability Study Conivaptan - Cerebral Hemorrhage, Cerebral Edema | Phase 1 | Completed | Jesse Corry | 7 | 2017-03-22 | 2020-04-17 |
| Study of Stroke Related Edema Treatments Conivaptan, Hypertonic saline, Mannitol - Acute Cerebrovascular Accident, Cerebral Edema | Phase 2 | Withdrawn | University of Florida | 2015-09-01 | 2016-12-14 | |
| Effects on Exercise Hemodynamics of Vasopressin Blockade by Conivaptan Infusion in Heart Failure Patients Conivaptan, Placebo (Dextrose) - Heart Failure | Phase 4 | Completed | Finn Gustafsson | 20 | 2013-12-01 | 2015-06-17 |
| A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic Hyponatremia Conivaptan hydrochloride, Placebo - Hyponatremia | Phase 3 | Terminated | Cumberland Pharmaceuticals | 4 | 2012-02-01 | 2016-03-01 |
| A Study to Assess the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan conivaptan hydrochloride - Liver Disease | Phase 1 | Completed | Cumberland Pharmaceuticals | 17 | 2011-04-01 | 2014-05-02 |
| Study of the Safety and Efficacy of Conivaptan (Vaprisol®) to Raise Serum Sodium Levels in Patients With Severe Traumatic Brain Injury Conivaptan (Vaprisol) - Severe Traumatic Brain Injury | Phase 1 | Completed | University of Washington | 10 | 2009-08-01 | 2010-09-10 |
| Comparing the Effects of Conivaptan and Diuretics on Plasma Neurohormones and Renal Blood Flow in Patients With Chronic Congestive Heart Failure Conivaptan, Furosemide, Conivaptan and furosemide - Heart Failure | Not applicable | Unknown | Hennepin County Medical Center, Minneapolis | 8 | 2009-07-01 | 2009-06-18 |
| Safety and Efficacy of Conivaptan in Hyponatremic Patients With Symptomatic Acute Decompensated Heart Failure (ADHF) conivaptan, placebo - Hyponatremia, Acute Decompensated Heart Failure | Phase 3 | Terminated | Cumberland Pharmaceuticals | 9 | 2009-04-01 | 2014-05-15 |
| Study to Compare Conivaptan Pharmacokinetics in Subjects With Mild & Moderate Kidney Function Impairment to Subjects With Normal Kidney Function conivaptan hydrochloride - Kidney Diseases, Hyponatremia | Phase 1 | Completed | Cumberland Pharmaceuticals | 25 | 2009-04-01 | 2014-05-02 |
| Study to Compare Conivaptan in Subjects With Mild & Moderate Liver Impairment Versus Subjects With Normal Liver Function conivaptan hydrochloride - Liver Disease, Hyponatremia | Phase 1 | Completed | Cumberland Pharmaceuticals | 26 | 2009-02-01 | 2014-05-02 |
| Body Volume Regulation in Pulmonary Arterial Hypertension With Right Ventricular Failure Spironolactone and conivaptan - Right Heart Failure, Pulmonary Hypertension | Not applicable | Withdrawn | University of Colorado, Denver | 2009-01-01 | 2013-01-28 | |
| Diuretic and Renal Effects of Vaprisol When Administered Along With Furosemide and Nesiritide Continuous Infusion Conivaptan, Placebo - Heart Failure | Phase 4 | Withdrawn | Albert Einstein Healthcare Network | 2008-10-01 | 2011-06-23 | |
| Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients Conivaptan - Hyponatremia | Phase 4 | Terminated | Northwestern University | 6 | 2008-08-01 | 2022-03-28 |
| Safety and Efficacy of Conivaptan for the Correction of Hyponatremia in Neurological Patients Conivaptan, D5 - Hyponatremia | Phase 3 | Withdrawn | Columbia University | 2008-05-01 | 2015-03-06 | |
| A Study to Assess the Safety and Effects of Intravenous (IV) Conivaptan on the Hepatic Hemodynamic Response in Cirrhotic Patients conivaptan, Placebo - Liver Cirrhosis | Phase 2 | Completed | Cumberland Pharmaceuticals | 20 | 2007-12-01 | 2014-05-15 |
| Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia Conivaptan, Placebo - Hyponatremia | Phase 3 | Completed | Cumberland Pharmaceuticals | 50 | 2007-04-01 | 2014-05-15 |
| A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia Conivaptan, placebo - Hyponatremia, Euvolemia | Phase 4 | Completed | Cumberland Pharmaceuticals | 121 | 2007-01-01 | 2014-05-15 |
| An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia conivaptan - Hyponatremia | Phase 3 | Completed | Cumberland Pharmaceuticals | 251 | 2004-02-01 | 2014-05-02 |
| Safety and Efficacy Study of YM087 (Conivaptan) in Patients With Acute Decompensated Heart Failure conivaptan, placebo - Chronic Heart Failure | Phase 2 | Completed | Cumberland Pharmaceuticals | 170 | 2002-11-01 | 2014-05-02 |
| Study of IV YM087 to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia YM087 - Hyponatremia | Phase 3 | Completed | Cumberland Pharmaceuticals | 84 | 2000-08-01 | 2014-05-02 |
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Hyponatremia (11) · Heart Failure (4) · Edema (3) · Brain Edema (2) · Diabetes Insipidus (2) · Liver Diseases (2) · Stroke (2) · Brain Injuries, Traumatic (1) · Cerebral Hemorrhage (1) · Hypertension, Portal (1) · Hypertension, Pulmonary (1) · Kidney Diseases (1) · Liver Cirrhosis (1) · Trauma, Nervous System (1)
Cumberland Pharmaceuticals (12) · Albert Einstein Healthcare Network (1) · Columbia University (1) · Finn Gustafsson (1) · Hennepin County Medical Center, Minneapolis (1) · Jesse Corry (1) · Northwestern University (1) · University of Colorado, Denver (1) · University of Florida (1) · University of Washington (1)
United States (14) · India (3) · Israel (3) · South Africa (2) · Spain (2) · Belgium (1) · Canada (1) · Colombia (1) · Denmark (1) · Finland (1) · France (1) · Germany (1) · Italy (1) · Netherlands (1) · Poland (1)
Art Wheeler, MD (12) · Andrew M Naidech, MD, MSPH (1) · Darshak H Karia, MD (1) · Finn Gustafsson, MD, PhD, DMSci (1) · Jesse J Corry, MD (1) · Louise Balling, MD (1) · Michael F Waters, MD (1) · Miriam Treggiari, MD (1) · Shweta Bansal, MD (1) · Stephan A. Mayer, MD (1) · Steven R Goldsmith, MD (1) · Vishnumurthy Shushuthra Hedna, MD (1)