22 completed. 22 Phase 3, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 22 | Completed 22 |
| Phase 2 | 3 | Completed 3 |
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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation lixivaptan, Placebo - Hyponatremia | Phase 3 | Completed | CardioKine Inc. | 652 | 2007-01-01 | 2011-06-28 |
| Maintenance Intravenous Fluids in Children Isotonic fluid, Hypotonic fluid - Hyponatremia | Phase 3 | Completed | All India Institute of Medical Sciences | 167 | 2006-09-01 | 2011-08-10 |
| Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion SR121463B - Inappropriate ADH Syndrome, Hyponatremia | Phase 3 | Completed | Sanofi | 57 | 2005-07-01 | 2009-01-21 |
| DILIPO (DILutIonal HyPOnatremia) SR121463B - Congestive Heart Failure | Phase 3 | Completed | Sanofi | 150 | 2005-05-01 | 2008-09-15 |
| Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion SR121463B - Inappropriate ADH Syndrome, Hyponatremia | Phase 3 | Completed | Sanofi | 77 | 2004-05-01 | 2008-12-10 |
| International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia Tolvaptan - Hyponatremia | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 111 | 2004-05-01 | 2016-01-21 |
| 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 |
| Study of Ascending Levels of Tolvaptan in Hyponatremia Tolvaptan, Placebo - Hyponatremia | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 243 | 2003-11-01 | 2026-07-13 |
| "SALT Trial" Study of Ascending Levels of Tolvaptan in Hyponatremia tolvaptan, placebo matching tolvaptan - Hyponatremias, Water Intoxication | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 205 | 2003-04-01 | 2026-07-13 |
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Inappropriate ADH Syndrome (7) · Diabetes Insipidus (4) · Edema (4) · Fibrosis (3) · Heart Failure (3) · Water-Electrolyte Imbalance (2) · Hepatic Encephalopathy (1) · Hypernatremia (1) · Water Intoxication (1)
Metabolic Diseases (22) · Nutritional and Metabolic Diseases (22) · Water-Electrolyte Imbalance (20) · Endocrine System Diseases (9) · Pituitary Diseases (9) · Brain Diseases (8) · Central Nervous System Diseases (8) · Nervous System Diseases (8) · Hypothalamic Diseases (7) · Pathological Conditions, Signs and Symptoms (7) · Female Urogenital Diseases (4) · Female Urogenital Diseases and Pregnancy Complications (4) · Kidney Diseases (4) · Male Urogenital Diseases (4) · Signs and Symptoms (4)
Tolvaptan (5) · conivaptan (4) · Sodium Chloride (3) · empagliflozin (3) · satavaptan (3) · Glucose (2) · lixivaptan (2) · Hypotonic Solutions (1) · Isotonic Solutions (1) · Saline Solution (1) · Tablets (1)
Cumberland Pharmaceuticals (4) · Otsuka Pharmaceutical Development & Commercialization, Inc. (4) · Sanofi (3) · University Hospital, Basel, Switzerland (3) · CardioKine Inc. (2) · All India Institute of Medical Sciences (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) · The Hospital for Sick Children (1)
United States (11) · Canada (8) · Germany (6) · Belgium (5) · Switzerland (5) · India (4) · Israel (4) · Poland (4) · Argentina (3) · Hungary (3) · South Africa (3) · Spain (3) · Australia (2) · Brazil (2) · Chile (2)
Art Wheeler, MD (4) · 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) · Mirjam Christ-Crain, Prof., MD (1) · Nestor Molfino, 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)