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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00032747
First received: March 29, 2002
Last updated: June 16, 2008
Last verified: June 2008
History of Changes

March 29, 2002
June 16, 2008
August 2001
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Clinical status at day 120.
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Complete list of historical versions of study NCT00032747 on ClinicalTrials.gov Archive Site
NYHA functional class, left ventricular ejection fraction, global assessment,serum sodium concentration.
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Safety Study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT).
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Effects of Vasopressin V2 Receptor Antagonist on Clinical Improvement in Patients With Severe Chronic Heart Failure

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Chronic Heart Failure
Drug: Vasopressin V2 Receptor Antagonist
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
338
February 2003
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  • 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   United Kingdom
 
NCT00032747
DFI4510, SR121463B
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP