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

Tracking Information

First Received Date ^ICMJE

March 29, 2002

Last Updated Date

June 16, 2008

Start Date ^ICMJE

August 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Clinical status at day 120.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00032747 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

NYHA functional class, left ventricular ejection fraction, global assessment,serum sodium concentration.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

Condition ^ICMJE

Chronic Heart Failure

Intervention ^ICMJE

Drug: Vasopressin V2 Receptor Antagonist

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

338

Completion Date

February 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00032747

Responsible Party

ICD Study Director, sanofi-aventis

Study ID Numbers ^ICMJE

DFI4510, SR121463B

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

ICD CSD

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

June 2008

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