Clinical trials: Hyponatremia
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
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
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.
Syndrome of Inappropriate ADH (SIADH) Secretion, Hyponatremia
Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
The study is designed to assess the efficacy of an investigational drug called SR121463B (vasopressin receptor antagonist) in the treatment of low levels of sodium in the blood associated with the Syndrome of Inappropriate…
- Trial name
- NCT00032734
- Testing
- satavaptan (SR121463B)
- Where
- 4 sites in Belgium, France and 2 more
- Volunteers
- 35 people
- Sponsor
- Sanofi
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
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
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 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.
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
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, 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
Syndrome of Inappropriate Antidiuretic Hormone Secretion
A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH
The objective of this study is to investigate the efficacy and safety of tolvaptan based on the change in serum sodium concentration following administration of tolvaptan oral tablets at 7.5 to 60 mg/day for up to 30 days in…
- Trial name
- NCT03048747
- Testing
- Tolvaptan Oral Tablet
- Where
- 6 sites in Japan
- Volunteers
- 16 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Hyponatremia
A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia
The purpose of this trial is to demonstrate that tolvaptan effectively and safely increases and maintains serum sodium concentrations in children and adolescent subjects with euvolemic or hypervolemic hyponatremia.
- Trial name
- NCT02442674
- Testing
- Tolvaptan
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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.
Hyponatremia
An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia
The objective of this trial was to provide 6 months of safety follow-up for children and adolescents with dilutional (euvolemic or hypervolemic) hyponatremia who had previously participated in a tolvaptan hyponatremia trial and…
- Trial name
- NCT02020278
- Testing
- Tolvaptan
- Where
- 23 sites in United States, Belgium and 6 more
- Volunteers
- 3 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Nocturia Due to Nocturnal Polyuria
Specified Drug Use-results Survey (Long-term Use) on MINIRINMELT® OD Tablet (Nocturia)
To investigate the incidence and risk factors of desmopressin-induced hyponatremia during long-term treatment (1 year [52 weeks]) of MINIRINMELT orally disintegrating (OD) tablets 25μg/50μg (drug) for nocturia caused by nocturnal…
- Trial name
- NOC01 (NCT04329975)
- Testing
- Desmopressin
- Where
- Japan
- Volunteers
- 1,087 people
- Sponsor
- Ferring Pharmaceuticals
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.
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
Study of IV YM087 to Assess Efficacy and Safety 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
- NCT00380575
- Testing
- YM087
- Where
- 47 sites in United States, Canada and 2 more
- Volunteers
- 84 people
- Sponsor
- Cumberland Pharmaceuticals
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