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Hyponatremia clinical trials

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NCT ID: NCT00264914 Completed - Hyponatremia Clinical Trials

Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion

SIADH Safety
Start date: July 2005
Phase: Phase 3
Study type: Interventional

To determine the long-term safety and tolerability of SR121463B in patients with syndrome of inappropriate antidiuretic secretion (SIADH). To assess the long-term efficacy of SR121463B in maintaining normal levels of serum sodium in patients with SIADH. Long term safety is evaluated further in an open label extension study with flexible doses of satavaptan.

NCT ID: NCT00201994 Completed - Hyponatremia Clinical Trials

"SALT-2 Trial" Study of Ascending Levels of Tolvaptan in Hyponatremia

Start date: November 2003
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT00156572 Terminated - Clinical trials for Bronchopulmonary Dysplasia

Management of Hyponatremia in Preterm Infants on Diuretics

Start date: April 2005
Phase: Phase 3
Study type: Interventional

Hydrochlorothiazide and spironolactone are diuretics that are commonly in preterm infants with bronchopulmonary dysplasia (BPD). Hyponatremia (low blood salt) is a common side effect. It is uncertain whether the best way to treat the hyponatremia is by oral salt supplementation or restricting fluid intake. Our hypothesis is that fluid restricted infants will be better able to preserve the beneficial effects of diuretics on the lungs. The study will include very low birth weight infants (VLBW) 400-1500g from Hermann Memorial Children's Hospital NICU or LBJ General Hospital NICU with BPD. They will be enrolled and randomly assigned to either the salt supplementation group or the fluid restriction group once they become hyponatremic (defined as serum Na <130). The study intervention will take place for four weeks. The primary outcome will be assessed by comparing the patient's initial oxygen and breathing machine requirements with those at the end of the four-week study period.

NCT ID: NCT00072683 Completed - Clinical trials for Inappropriate ADH Syndrome

“SALT Trial” Study of Ascending Levels of Tolvaptan in Hyponatremia

Start date: April 2003
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT00032734 Completed - Hyponatremia Clinical Trials

Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion

Start date: June 2001
Phase: Phase 2
Study type: Interventional

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 Antidiuretic Hormone Secretion (SIADH). This double blind period study is followed by 2 open label extension studies with flexible doses of satavaptan.