Clinical Trials Logo
  1. Home
  2. Hyponatremia
  3. NCT00264927

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

Hyponatremia Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Group, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion

Clinical Trial Summary

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 in patients with SIADH. To assess the safety and tolerability of SR121463B in patients with SIADH.

The double blind period is followed by an open label extension study with flexible doses of satavaptan.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00264927
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date May 2004
Completion date September 2007
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06037928 - Plasma Sodium and Sodium Administration in the ICU
Recruiting NCT04561531 - Efficacy and Safety of Bolus Comparing With Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia. N/A
Terminated NCT02012959 - Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia Phase 3
Recruiting NCT02936167 - Comparison of Ringer Lactate and Isotonic Acetate Solution as Perioperative Maintenance Fluid for Children N/A
Completed NCT00621348 - Maintenance Intravenous Fluids in Children Phase 3
Terminated NCT03703713 - Colloid Osmotic Pressure and Osmolality in Hyponatremia
Completed NCT02926989 - Intravenous Fluids in Hospitalised Children Phase 4
Terminated NCT02959411 - Tolvaptan for Advanced or Refractory Heart Failure Phase 4
Completed NCT02573077 - An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy
Withdrawn NCT02667977 - Reexamining Hypotonic Intravenous Fluid Use N/A
Terminated NCT01708811 - Hyponatremia and Myometrium Contractility. An Invitro Study N/A
Completed NCT01456533 - Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients N/A
Withdrawn NCT01326429 - Frequency and Origin of Dysnatremias in the Emergency Department N/A
Terminated NCT01227512 - Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia Phase 3
Recruiting NCT06013800 - Hyponatremia Volume Status Analysis by Point-of-care Ultrasound
Terminated NCT04020926 - Impact of Hyponatremia on Muscle Strength, Gait and Cognitive Function
Completed NCT02545101 - An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH N/A
Withdrawn NCT02442674 - A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia Phase 3
Terminated NCT02215148 - Pharmacokinetics and Clinical Response of Tolvaptan in Neurocritical Care Patients N/A
Recruiting NCT01748331 - The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia N/A