Clinical trials: Hyponatraemia
Congestive Heart Failure
DILIPO (DILutIonal HyPOnatremia)
Primary: To assess the efficacy of SR121463B in correcting hyponatremia in patients with dilutional hyponatremia other than SIADH or cirrhosis Secondary: To assess the long-term efficacy of SR121463B in maintaining normonatremia…
- Trial name
- NCT00274326
- Testing
- SR121463B
- Where
- 15 sites in United States, Argentina and 13 more
- Volunteers
- 150 people
- Sponsor
- Sanofi
Nocturia
Efficacy Study of VA106483 in Males With Nocturia.
To investigate the effect of VA106483 on nocturia related clinical outcomes compared to placebo.
- Trial name
- NCT01038843
- Testing
- VA106483
- Where
- 19 sites in United States
- Volunteers
- 152 people
- Sponsor
- Vantia Ltd
Ascites, Liver Cirrhosis
Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites
The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites and the correction of hyponatraemia when used concomitantly with a standard dose regimen of spironolactone.
- Trial name
- Hypo~CAT (NCT00501722)
- Testing
- satavaptan (SR121463B)
- Where
- 13 sites in United States, Argentina and 11 more
- Volunteers
- 110 people
- Sponsor
- Sanofi
Hyponatremia, Euvolemia
A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
The study will evaluate the effectiveness and safety of multiple dosing regimens of IV conivaptan in subjects with euvolemic or hypervolemic hyponatremia
- Conditions
- Hyponatremia, Euvolemia, Hypervolemia
- Trial name
- NCT00435591
- Testing
- Conivaptan
- Where
- 18 sites in United States, India and 1 more
- Volunteers
- 121 people
- Sponsor
- Cumberland Pharmaceuticals
Non-hypovolemic Non-acute Hyponatremia
Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia
This drug has been developed to treat Hyponatremia. The primary purpose of this study is to verify the efficacy and safety of seven-day repeated oral administration of tolvaptan at 15, 30, and 60 mg or placebo in patients with…
- Trial name
- NCT01507727
- Testing
- Tolvaptan
- Where
- 3 sites in China
- Volunteers
- 240 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hyponatremia, Acute Decompensated Heart Failure
Safety and Efficacy of Conivaptan in Hyponatremic Patients With Symptomatic Acute Decompensated Heart Failure (ADHF)
This study will evaluate the safety and effectiveness of Conivaptan, a vasopressin antagonist, in the treatment of hyponatremic subjects having symptomatic acute decompensated heart failure (ADHF).
- Trial name
- CONVERT-H (NCT00843986)
- Testing
- conivaptan
- Where
- 4 sites in India
- Volunteers
- 9 people
- Sponsor
- Cumberland Pharmaceuticals
Hyponatremia
Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia
Study of efficacy \& safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia
- Trial name
- NCT00492037
- Testing
- YM087 oral
- Where
- 29 sites in Belgium, Finland and 7 more
- Volunteers
- 83 people
- Sponsor
- Cumberland Pharmaceuticals
Hypervolemic and Euvolemic Hyponatremia
Samsca Post Marketing Surveillance Study
This Post-Marketing Surveillance will be conducted in accordance with the local regulation of New Drug Re-examination. The surveillance will be conducted for 6 years of the re-examination period (01Sep2011~31Aug2017).
- Trial name
- Samsca PMS (NCT02722863)
- Where
- 4 sites in South Korea
- Volunteers
- 908 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Antidiuretic Hormone, Inappropriate Secretion
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH
The purpose of this study is to confirm the safety of tolvaptan in patients with hyponatremia in syndrome of inappropriate antidiuretic hormone secretion (SIADH) in Japan
- Trial name
- NCT04790175
- Testing
- Tolvaptan (SAMSCA)
- Where
- Japan
- Volunteers
- 300 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Hyponatremia
Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
The study is designed to assess the efficacy and safety of multiple infusions of conivaptan in subjects with euvolemic or hypervolemic hyponatremia
- Trial name
- NCT00478192
- Testing
- Conivaptan
- Where
- 26 sites in United States, India
- Volunteers
- 50 people
- Sponsor
- Cumberland Pharmaceuticals
Hyponatremia, Inappropriate ADH Syndrome
A Phase III Study Evaluating the Efficacy and Safety of Satavaptan Versus Placebo in Patients With Dilutional Hyponatremia
The primary objective of this study is to assess the efficacy of satavaptan versus placebo in participants with dilutional hyponatremia due to SIADH.
- Trial name
- AQUARIST1 (NCT00728091)
- Testing
- Satavaptan
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Sanofi
Hyponatremia
A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic Hyponatremia
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of intravenous conivaptan in pediatric subjects with abnormally low concentration of sodium in blood.
- Trial name
- NCT01451411
- Testing
- Conivaptan hydrochloride
- Where
- 3 sites in United States, Colombia
- Volunteers
- 4 people
- Sponsor
- Cumberland Pharmaceuticals
Hyponatremia
Study of Ascending Levels of Tolvaptan in Hyponatremia
The purpose of this study was to determine whether tolvaptan can safely and effectively return the body's balance of sodium and water toward normal and to characterize and quantify the potential clinical benefits of this…
- Trial name
- SALT2 (NCT00201994)
- Testing
- Tolvaptan
- Where
- Germany
- Volunteers
- 243 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Kidney Diseases, Hyponatremia
Study to Compare Conivaptan Pharmacokinetics in Subjects With Mild & Moderate Kidney Function Impairment to Subjects With Normal Kidney Function
A study to compare a conivaptan PK in subjects with mild or moderate kidney function impairment to subjects with normal kidney function after a 48-hour continuous infusion of conivaptan.
- Trial name
- NCT00887627
- Testing
- conivaptan hydrochloride
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Cumberland Pharmaceuticals
Hypervolemic Hyponatremia
International, Multicenter, Open-Label and Randomized Withdrawal Study of Oral Lixivaptan in Heart Failure Patients With Chronic Hyponatremia
To demonstrate that after 12 weeks of open-label lixivaptan treatment, serum sodium is maintained in hyponatremic patients continuing to receive lixivaptan compared to placebo during the 4 week double blind treatment period.
- Trial name
- NCT00876876
- Testing
- Lixivaptan
- Volunteers
- 300 people
- Sponsor
- CardioKine Inc.
Hypovolemic Hyponatremia
A Phase 2 Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia
This is a randomized, double-blind, multicenter, placebo-controlled (standard therapy + placebo), phase 2 efficacy and safety study of the Tolvaptan tablets in treatment of patients with non-hypovolemic non-acute hyponatremia…
- Trial name
- NCT00664014
- Testing
- Tolvaptan
- Where
- 13 sites in China
- Volunteers
- 241 people
- Sponsor
- Otsuka Beijing Research Institute
Hyponatremia
Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia
The purpose of this trial was to demonstrate that tolvaptan effectively and safely increases and maintains serum sodium concentrations in children and adolescent participants with euvolemic or hypervolemic hyponatremia.
- Trial name
- NCT02012959
- Testing
- Tolvaptan
- Where
- 7 sites in United States, Italy and 1 more
- Volunteers
- 9 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Hyponatremia, Dilutional Hyponatremia
Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia
The purpose of this study is to determine if hospitalized patients with symptomatic hyponatremia treated with tolvaptan are in the hospital for less time than patients treated with fluid restriction.
- Conditions
- Hyponatremia, Dilutional Hyponatremia, Inappropriate ADH Syndrome
- Trial name
- SALACIA (NCT01227512)
- Testing
- tolvaptan, Fluid Restriction
- Where
- 56 sites in United States
- Volunteers
- 124 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Hyponatremia
International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia
This study will assess the safety of long-term tolvaptan use in patients previously enrolled in shorter-term Phase 3 studies and gather information on the natural history of hyponatremia in the context of tolvaptan therapy and…
- Trial name
- NCT02449044
- Testing
- Tolvaptan
- Volunteers
- 111 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Euvolemic Hyponatremia, Hypervolemic Hyponatremia
Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia
The registry is a multi-center, prospective, observational study designed to collect data in patients with euvolemic and hypervolemic hyponatremia in the hospital setting in the USA and hyponatremia secondary to syndrome of…
- Trial name
- HN Registry (NCT01240668)
- Where
- 79 sites in United States, Germany and 1 more
- Volunteers
- 5,028 people
- Sponsor
- Otsuka America Pharmaceutical