A Randomized, Double-blind, Placebo-controlled, Dose-ranging Pilot Study Evaluating the Efficacy and Safety of YM087 in Patients With Decompensated Chronic Heart Failure

Cumberland Pharmaceuticals26 sites in 1 country170 target enrollmentNovember 2002

ConditionsChronic Heart Failure

Interventionsconivaptan placebo

Drugsconivaptan placebo

Overview

Phase: Phase 2
Intervention: conivaptan
Conditions: Chronic Heart Failure
Sponsor: Cumberland Pharmaceuticals
Enrollment: 170
Locations: 26
Primary Endpoint: Change from baseline in respiratory Visual analog Scale (VAS)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, double-blind, placebo-controlled, dose ranging pilot study to examine the effects of conivaptan in patients with acute decompensated heart failure.

Registry

clinicaltrials.gov

Start Date

November 2002

End Date

March 2004

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cumberland Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

•Patients may be male or female age 18 years or older.
•Women must be post-menopausal or surgically sterile.
•Patients must have chronic heart failure of at least 2 months duration and be hospitalized for the treatment of worsening heart failure. The primary manifestation of worsening heart failure must be worsening dyspnea.