Clinical trials: Hyponatremia
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.
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
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.
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.
Arterial Hypertension, Diabetes
Cicletanine in Hypertension With Diabetes: Added Magnesium Preserves Potassium and Sodium
Cicletanine, which has been approved and launched for hypertension in France and Germany, has promise beyond hypertension in critically-unmet needs such as diabetes.
- Conditions
- Arterial Hypertension, Diabetes, Hypokalemia, Hyponatremia
- Trial name
- CHAMP (NCT02709031)
- Testing
- Cicletanine + magnesium, Cicletanine
- Volunteers
- 24 people
- Sponsor
- Navitas Pharma
Hyponatremia
Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic Patients
Demonstrate an improvement in the composite scores of validated neurocognitive tests in elderly subjects with chronic sub-clinical (i.e., asymptomatic) hyponatremia.
- Trial name
- INSIGHT (NCT00550459)
- Testing
- Tolvaptan
- Where
- 12 sites in United States
- Volunteers
- 57 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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
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
An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia
This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion.
- Trial name
- NCT00379847
- Testing
- conivaptan
- Where
- 28 sites in United States, Israel and 1 more
- Volunteers
- 251 people
- Sponsor
- Cumberland Pharmaceuticals
Inappropriate ADH Syndrome, Hyponatremia
Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
To assess the efficacy of SR121463B in correcting hyponatremia in patients with syndrome of inappropriate antidiuretic secretion (SIADH).To assess the long-term efficacy of SR121463B in maintaining normal levels of serum sodium…
- Trial name
- SIADH (NCT00264927)
- Testing
- SR121463B
- Where
- 11 sites in United States, Belgium and 9 more
- Volunteers
- 77 people
- Sponsor
- Sanofi
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.
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
SIADH, Non-SIADH Hyponatremia
Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice
A Drug Utilisation Survey is performed to monitor and document the drug utilisation patterns of Samsca in routine medical practice.
- Conditions
- SIADH, Non-SIADH Hyponatremia, Non-Hyponatremia
- Trial name
- NCT01228682
- Testing
- Tolvaptan
- Where
- 47 sites in Denmark, Germany and 5 more
- Volunteers
- 200 people
- Sponsor
- Otsuka Frankfurt Research Institute GmbH
Hyponatremia With Normal Extracellular Fluid Volume
Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic Hyponatremia
The present study is designed to confirm and extend the observation from previous studies that lixivaptan therapy corrects hyponatremia, in euvolemic subject, including subjects with SIADH.
- Trial name
- NCT00660959
- Testing
- lixivaptan
- Where
- 71 sites in United States, Belgium and 4 more
- Volunteers
- 106 people
- Sponsor
- CardioKine Inc.
CHRONIC HYPONATREMIA
Phase 2a Study for PK/PD of nC-001
CHRONIC EUVOLEMIC HYPONATREMIA
- Trial name
- NCT06798675
- Testing
- nC-001
- Volunteers
- 24 people
- Sponsor
- nephCentric
Hyponatremia With Normal Extracellular Fluid Volume, Hyponatremia With Excess Extracellular Fluid Volume
International, Multicenter Study of a Twenty-eight Week, Open-label, Titrated Oral Lixivaptan Administration in Patients With Chronic Hyponatremia: Extension to Studies CK-LX3401, 3405, and 3430
To evaluate the overall safety and continued efficacy of oral lixivaptan capsules in subjects with euvolemic and hypervolemic hyponatremia
- Trial name
- NCT01056848
- Where
- 6 sites in United States
- Volunteers
- 135 people
- Sponsor
- CardioKine Inc.
Inappropriate ADH Syndrome, Hyponatremia
Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
To determine the long-term safety and tolerability of SR121463B in patients with syndrome of inappropriate antidiuretic secretion (SIADH).
- Trial name
- SIADH Safety (NCT00264914)
- Testing
- SR121463B
- Where
- 11 sites in United States, Australia and 9 more
- Volunteers
- 57 people
- Sponsor
- Sanofi
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
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.
Hyponatremia and Extracellular Fluid in Cirrhotic
Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites
This study is to evaluate the efficacy of a 2-week course of tolvaptan in improving serum sodium and the excretion of extracellular fluid in liver cirrhotic patients with ascites and hyponatremia
- Trial name
- ECF (NCT01552590)
- Testing
- Tolvaptan
- Where
- 3 sites in South Korea
- Volunteers
- 74 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.