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

Phase 2
Completed
Conditions
Chronic Heart Failure
Interventions
Drug: placebo
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

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
GroupInterventionDescription
1placebo-
2conivaptanLow dose
4conivaptanHigh dose
3conivaptanMiddle dose
Primary Outcome Measures
NameTimeMethod
Change from baseline in respiratory Visual analog Scale (VAS)48 hours
Secondary Outcome Measures
NameTimeMethod
Change from baseline in global VAS48 hours
Total urine output vs. baseline72 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

Scroll for more (16 remaining)
The Heart Center, P.C.
🇺🇸Huntsville, Alabama, United States

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