22 completed, 6 terminated, 2 withdrawn, 1 recruiting. 32 Phase 3, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 32 | Completed 22, Terminated 6, Withdrawn 2, Recruiting 1, Unknown 1 |
| Phase 2 | 4 | Completed 3, Unknown 1 |
Follow Hyponatremia: new trials by email Literature Review of Hyponatremia trials Research Report on Hyponatremia
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 |
|---|---|---|---|---|---|---|
| Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia DDAVP, Standard hyponatremia treatment - Hyponatremia | Phase 3 | Recruiting | Assistance Publique - Hôpitaux de Paris | 260 | 2024-12-17 | 2025-05-23 |
| Effects of the SGLT2-inhibitor Empagliflozin on Patients With Chronic SIADH - the SANDx Study Empagliflozin 25mg, Placebo - SIAD - Syndrome of Inappropriate Antidiuresis, Hyponatremia | Phase 2 / Phase 3 | Completed | University Hospital, Basel, Switzerland | 17 | 2017-12-15 | 2021-12-13 |
| Effects of the SGLT2-inhibitor Empagliflozin on Patients With SIADH - the SAND Study Empagliflozin, Placebo - SIADH | Phase 2 / Phase 3 | Completed | University Hospital, Basel, Switzerland | 88 | 2016-09-05 | 2019-06-13 |
| 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 |
| Effects of Empagliflozin an SGLT2-Inhibitor on Healthy Volunteers With Induced Hypotonic Hyponatremia - the DIVE Study Induced hypotonic hyponatremia - SIAD model, Empagliflozin 25mg Tbl, Placebo P-Tablet - Inappropriate ADH Syndrome | Phase 2 / Phase 3 | Completed | University Hospital, Basel, Switzerland | 15 | 2016-03-01 | 2016-08-10 |
| 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and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia Tolvaptan, Placebo - Hyponatremia | Phase 3 | Withdrawn | Otsuka Pharmaceutical Development & Commercialization, Inc. | 2015-11-01 | 2017-07-31 | |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 |
| Use of Isotonic Solutions Versus Hypotonic Solutions for Preventing Hospital Acquired Hyponatremia 0.3% Saline in 3.3% dextrose, 0.45% Saline in 5% dextrose, 0.9% Saline in 5% dextrose - Hyponatremia | Phase 3 | Completed | Instituto Tecnologico y de Estudios Superiores de Monterey | 161 | 2013-07-01 | 2016-12-16 |
| 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 |
| 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 |
| Variation in Natremia Using Two Different Maintenance Intravenous Fluids in Postsurgical Hospitalized Children 0.45% NaCl/dextrose 5%, 0.3% NaCl/dextrose 5% - Hyponatremia | Phase 3 | Completed | Hospital General de Niños Pedro de Elizalde | 78 | 2010-12-01 | 2017-03-03 |
| Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia tolvaptan, Fluid Restriction - Hyponatremia, Dilutional Hyponatremia | Phase 3 | Terminated | Otsuka Pharmaceutical Development & Commercialization, Inc. | 124 | 2010-10-01 | 2014-10-30 |
| 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 |
| A Phase III Study Evaluating the Efficacy and Safety of Satavaptan Versus Placebo in Patients With Dilutional Hyponatremia Satavaptan, placebo - Hyponatremia, Inappropriate ADH Syndrome | Phase 3 | Terminated | Sanofi | 2 | 2008-07-01 | 2016-05-26 |
| 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 | |
| Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic Hyponatremia lixivaptan, placebo - Hyponatremia With Normal Extracellular Fluid Volume | Phase 3 | Completed | CardioKine Inc. | 106 | 2008-04-01 | 2011-06-28 |
| Hypotonic Versus Isotonic Parenteral (HIP) Fluid Trial 0.9% NaCl, 0.45%NaCl - Hyponatremia, Hypernatremia | Phase 3 | Completed | Hamilton Health Sciences Corporation | 258 | 2008-03-01 | 2015-04-29 |
| 0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Hospitalized Children Hypotonic (0.45% NaCl/5% dextrose) IV maintenance fluids, Isotonic (0.9% NaCl/5% dextrose) IV maintenance fluids - Hyponatremia | Phase 3 | Completed | The Hospital for Sick Children | 110 | 2007-12-01 | 2013-08-26 |
| Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic Patients Tolvaptan, Placebo - Hyponatremia | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 57 | 2007-08-01 | 2011-04-28 |
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Inappropriate ADH Syndrome (9) · Edema (5) · Diabetes Insipidus (4) · Water-Electrolyte Imbalance (4) · Fibrosis (3) · Heart Failure (3) · Metabolic Diseases (3) · Hepatic Encephalopathy (1) · Hypernatremia (1) · Trauma, Nervous System (1) · Water Intoxication (1)
Nutritional and Metabolic Diseases (32) · Metabolic Diseases (29) · Water-Electrolyte Imbalance (28) · Endocrine System Diseases (11) · Nervous System Diseases (11) · Pituitary Diseases (11) · Brain Diseases (10) · Central Nervous System Diseases (10) · Hypothalamic Diseases (9) · Pathological Conditions, Signs and Symptoms (8) · Signs and Symptoms (5) · Female Urogenital Diseases (4) · Female Urogenital Diseases and Pregnancy Complications (4) · Kidney Diseases (4) · Male Urogenital Diseases (4)
Tolvaptan (10) · conivaptan (7) · satavaptan (4) · Sodium Chloride (3) · empagliflozin (3) · Glucose (2) · lixivaptan (2) · Deamino Arginine Vasopressin (1) · Hypotonic Solutions (1) · Isotonic Solutions (1) · Saline Solution (1) · Tablets (1)
Otsuka Pharmaceutical Development & Commercialization, Inc. (8) · Cumberland Pharmaceuticals (6) · Sanofi (4) · University Hospital, Basel, Switzerland (3) · CardioKine Inc. (2) · All India Institute of Medical Sciences (1) · Assistance Publique - Hôpitaux de Paris (1) · Columbia University (1) · Hamilton Health Sciences Corporation (1) · Hospital General de Niños Pedro de Elizalde (1) · Hunter Holmes Mcguire Veteran Affairs Medical Center (1) · Instituto Tecnologico y de Estudios Superiores de Monterey (1) · Jiangsu HengRui Medicine Co., Ltd. (1) · The Hospital for Sick Children (1)
United States (17) · Canada (8) · Germany (7) · Belgium (6) · India (5) · Switzerland (5) · Israel (4) · Italy (4) · Poland (4) · Spain (4) · Argentina (3) · France (3) · Hungary (3) · Romania (3) · South Africa (3)
Art Wheeler, MD (6) · Ann Dandurand, MD (2) · Claudia Montserrat Flores Robles, MD (1) · Daniel Ter-Minassian, MD (1) · Denis Geary, MD (1) · Frank Czerwiec, MD, PhD (1) · Jasmohan S Bajaj, MD (1) · Joseph Verbalis, MD (1) · Karen Choong, MB, BCh, MSc (1) · Manuela Dicembrino, md (1) · Mirjam Christ-Crain, Prof. (1) · Mirjam Christ-Crain, Prof. Dr. MD (1)
PMID 17105757, PMID 22027579, PMID 25151571, PMID 20185637, PMID 20668885, PMID 21199833, PMID 22007013, PMID 25751673, PMID 34412521, PMID 36396331, PMID 37098131, PMID 42522233
2015 (1), 2017 (1)