Status:
TERMINATED
A Phase III Study Evaluating the Efficacy and Safety of Satavaptan Versus Placebo in Patients With Dilutional Hyponatremia
Lead Sponsor:
Sanofi
Conditions:
Hyponatremia
Inappropriate ADH Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to assess the efficacy of satavaptan versus placebo in participants with dilutional hyponatremia due to SIADH. Secondary objectives are to assess the safety of ...
Eligibility Criteria
Inclusion
- Participants with symptomatic syndrome of inappropriate antidiuretic hormone secretion (SIADH) with chronic hyponatremia
Exclusion
- Presence of clinical signs of hypovolemia (e.g. orthostatic decreases in blood pressure and increase in pulse rate, dry mucus membranes, decreased skin turgor)
- Presence of clinical signs of hypervolemia (e.g. generalized edema, jugular venous extension)
- Participants with adrenocortical insufficiency
- Participants with hypothyroidism
- Participants with known causes of transient SIADH
- Participants with psychogenic polydipsia or beer potomania
- Concomitant use of thiazide diuretics during the study
- Presence of uncontrolled diabetes with fasting blood glucose ≥200 mg/dL (≥11.09 mmol/L) at time of screening
- Participants with impaired hepatic function or liver cirrhosis (Child-Pugh A-C)
- Pregnant or breast-feeding women
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00728091
Start Date
July 1 2008
End Date
December 1 2008
Last Update
May 26 2016
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807