Expired Study
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Atlanta, Georgia 30322


Purpose:

This is a randomized, double-blind, placebo-controlled, parallel-group forced up-titration study. Randomization will be stratified according to the patient's baseline serum sodium concentration (137-144 and <137 mmol/L). The dose of study drug will be increased to the next level on Day 15, and the total duration of the double-blind treatment period is 120 days.


Criteria:

- Men or women with chronic heart failure (NYHA Class IIIB and IV). - Women must be post-menopausal or surgically sterilized; they cannot be pregnant or nursing. - Age 21 to 80 years. - Chronic heart failure of at least 3 months duration. For 2 months prior to screening, patients must have had symptoms at rest or on minimal exertion for more than 50% of the time. For 2 weeks prior to screening, patients must have had symptoms at rest or on minimal exertion for more than 90% of the time. - Patients must be receiving a diuretic and an ACE inhibitor (or an angiotensin II receptor antagonist) for the treatment of heart failure. - Patients may be receiving digoxin, a beta-blocker or spironolactone


NCT ID:

NCT00032747


Primary Contact:

Study Director
ICD CSD
Sanofi-Aventis


Backup Contact:

N/A


Location Contact:

Atlanta, Georgia 30322
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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