Clinical trials: Hyponatraemia
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
Hyponatremias, Water Intoxication
"SALT Trial" Study of Ascending Levels of Tolvaptan in Hyponatremia
This study's purpose is 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 treatment.
- Conditions
- Hyponatremias, Water Intoxication, Inappropriate ADH Syndrome, Water-Electrolyte Imbalances
- Trial name
- NCT00072683
- Testing
- tolvaptan
- Where
- 23 sites in United States
- Volunteers
- 205 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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
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 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.
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
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.
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
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.
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.
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
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
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
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.
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
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
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.
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.
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
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