Heart Failure Clinical Trial

Safety Study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT).

Summary

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

338

Study ID:

NCT00032747

Recruitment Status:

Completed

Sponsor:

Sanofi

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There are 7 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Emory University
Atlanta Georgia, 30322, United States
University of Iowa Hospital and Clinics
Iowa City Iowa, 52242, United States
University of Maryland School of Medicine
Baltimore Maryland, 21201, United States
Brian LGH Heart Institute
Lincoln Nebraska, 68510, United States
The Lindner Clinical Trial Center
Cincinnati Ohio, 45219, United States
MUSC/Division Cardiology
Charleston South Carolina, 29425, United States
Sanofi-aventis Administrative Office
Laval , , Canada
Sanofi-aventis Administrative Office
Guildford Surrey , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

338

Study ID:

NCT00032747

Recruitment Status:

Completed

Sponsor:


Sanofi

How clear is this clinincal trial information?

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