Safety and Efficacy Study of YM087 (Conivaptan) in Patients With Acute Decompensated Heart Failure

Phase 2

Completed

• Conditions: Chronic Heart Failure
• Interventions: Drug: placebo; Drug: conivaptan

• Registration Number: NCT00057356
• Lead Sponsor: Cumberland Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2003-03-31
• Study First Submitted QC: 2003-03-31
• Study First Posted: 2003-04-01
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-30
• Last Update Posted: 2014-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	placebo	-
2	conivaptan	Low dose
4	conivaptan	High dose
3	conivaptan	Middle dose

Primary Outcome Measures

Name	Time	Method
Change from baseline in respiratory Visual analog Scale (VAS)	48 hours

Secondary Outcome Measures

Name	Time	Method
Change from baseline in global VAS	48 hours
Total urine output vs. baseline	72 hours

Trial Locations

Locations (26)

The Heart Center, P.C.; 🇺🇸 Huntsville, Alabama, United States

LA County/USC Medical Center; 🇺🇸 Los Angeles, California, United States

San Joaquin Cardiology; 🇺🇸 Manteca, California, United States

Apex Research Institute; 🇺🇸 Santa Ana, California, United States

The Greater Fort Lauderdale Heart Group Research; 🇺🇸 Fort Lauderdale, Florida, United States

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

U. Miami, Jackson Mem'l Medical Center; 🇺🇸 Miami, Florida, United States

Discovery Medical Research Group; 🇺🇸 Ocala, Florida, United States

Rush-Presbyterian St. Luke's Medical Center; 🇺🇸 Chicago, Illinois, United States

Louisiana State University Medical Center School of Medicine; 🇺🇸 New Orleans, Louisiana, United States

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