NCT00032747

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
338

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2001

Shorter than P25 for phase_2

Geographic Reach
3 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2002

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
Last Updated

June 17, 2008

Status Verified

June 1, 2008

First QC Date

March 29, 2002

Last Update Submit

June 16, 2008

Conditions

Chronic Heart Failure

Keywords

Chronic Heart FailureHeart Disease

Outcome Measures

Primary Outcomes (1)

  • Clinical status at day 120.

Secondary Outcomes (1)

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

Interventions

Vasopressin V2 Receptor AntagonistDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (9)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242-1081, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Brian LGH Heart Institute

Lincoln, Nebraska, 68510, United States

Location

The Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

MUSC/Division Cardiology

Charleston, South Carolina, 29425, United States

Location

Sanofi-aventis Administrative Office

Laval, Canada

Location

Sanofi-aventis Administrative Office

Guildford Surrey, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 29, 2002

First Posted

April 1, 2002

Study Start

August 1, 2001

Study Completion

February 1, 2003

Last Updated

June 17, 2008

Record last verified: 2008-06

Locations

US(7)GB(1)CA(1)