Clinical trials: Sodium Depletion
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
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
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 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.
Liver Disease, Hyponatremia
Study to Compare Conivaptan in Subjects With Mild & Moderate Liver Impairment Versus Subjects With Normal Liver Function
A study to compare a 48-hour continuous infusion of conivaptan in subjects with mild and moderate liver impairment versus subjects with normal liver function
- Trial name
- NCT00851227
- Testing
- conivaptan hydrochloride
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Cumberland Pharmaceuticals
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
Euvolemic Hyponatremia
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects With Euvolemic Hyponatremia
The purpose of this study is to evaluate the safety and tolerability of oral lixivaptan capsules in subjects with Euvolemic Hyponatremia.
- Trial name
- NCT00876798
- Testing
- Lixivaptan
- Where
- 90 sites in United States, Belgium and 6 more
- Volunteers
- 206 people
- Sponsor
- CardioKine Inc.
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
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 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
Hyponatremia, Syndrome of Inappropriate ADH (SIADH) Secretion
An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy
This observational, prospective, non-interventional study will include cancer patients who need a treatment for hyponatraemia secondary to SIADH.
- Conditions
- Hyponatremia, Syndrome of Inappropriate ADH (SIADH) Secretion, Cancer
- Trial name
- ASSERT (NCT02573077)
- Where
- 20 sites in Italy
- Volunteers
- 69 people
- Sponsor
- Otsuka Pharmaceutical Europe Ltd
Hyponatremia
THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
The purpose of this study is to determine the safety and efficacy of lixivaptan in the treatment of hyponatremia in patients with congestive heart failure.
- Trial name
- NCT00578695
- Testing
- lixivaptan
- Where
- 287 sites in United States, Argentina and 13 more
- Volunteers
- 652 people
- Sponsor
- CardioKine Inc.
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
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
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, Syndrome of Inappropriate ADH (SIADH) Secretion
An Observational Study to Describe the Adherence to the SEOM Algorithm for the Treatment of Hyponatraemia in Spain
In 2014, the Spanish Sociedad Española de Oncología Médica (SEOM) algorithm for the treatment of hyponatraemia secondary to to syndrome of inappropriate antidiuretic hormone (SIADH) in oncology patients was developed.
- Trial name
- ALGA (NCT02548845)
- Where
- 4 sites in Spain
- Volunteers
- 70 people
- Sponsor
- Otsuka Pharmaceutical Europe Ltd
Hyponatremia, Syndrome of Inappropriate ADH (SIADH) Secretion
An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH
This is a retrospective chart review non-interventional study designed to collect real world data on the use and outcomes of tolvaptan for the treatment of patients with hyponatraemia secondary to syndrome of inappropriate…
- Trial name
- SAMPLE (NCT02545101)
- Where
- 7 sites in Germany, Spain
- Volunteers
- 100 people
- Sponsor
- Otsuka Pharmaceutical Europe Ltd
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.
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
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