Hyponatremia Clinical Trial
— AQUARIST1Official title:
A Double-Blind, Randomized, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of Two Doses of Satavaptan (SR121463B) Versus Placebo in Patients With Dilutional Hyponatremia Due to the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
Verified date | March 2009 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The primary objective of this study is to assess the efficacy of satavaptan versus placebo
in patients with dilutional hyponatremia due to SIADH.
Secondary objectives are to assess the safety of satavaptan, the maintenance of effect, and
the clinical benefit in these patients.
Status | Terminated |
Enrollment | 2 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with symptomatic syndrome of inappropriate antidiuretic hormone secretion (SIADH) with chronic hyponatremia Exclusion Criteria: - 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) - Patients with adrenocortical insufficiency - Patients with hypothyroidism - Patients with known causes of transient SIADH - Patients 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 - Patients 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 patient's potential participation in a clinical trial. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Sanofi-Aventis Administrative Office | Bridgewater | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | serum sodium change from baseline | At Day 5 pre-dose | No | |
Secondary | responder rate | At Day 5 pre-dose | No | |
Secondary | presence and intensity of clinical symptoms related to hyponatremia | At each scheduled visit | No | |
Secondary | change from baseline in cognitive function | At Day 5 and 30 | No |
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