Baltimore, Maryland 21201

  • Chronic Heart Failure

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


Study is Available At:


Original ID:

DFI4510


NCT ID:

NCT00032747


Secondary ID:

SR121463B


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Sanofi-Aventis


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

338


Enrollment Type:

Actual


Overall Contact Information

Official Name:ICD CSD
Study Director
Sanofi-Aventis

Study Dates

Start Date:August 2001
Completion Date:February 2003
Completion Type:Actual
Verification Date:June 2008
Last Changed Date:June 16, 2008
First Received Date:March 29, 2002

Study Outcomes

Outcome Type:Primary Outcome
Measure:Clinical status at day 120.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:NYHA functional class, left ventricular ejection fraction, global assessment,serum sodium concentration.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Vasopressin V2 Receptor Antagonist

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Sanofi-Aventis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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