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

This study has been completed.
Information provided by:
Cumberland Pharmaceuticals Identifier:
First received: March 31, 2003
Last updated: April 30, 2014
Last verified: April 2014

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.

Condition Intervention Phase
Chronic Heart Failure
Drug: conivaptan
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Dose-ranging Pilot Study Evaluating the Efficacy and Safety of YM087 in Patients With Decompensated Chronic Heart Failure

Resource links provided by NLM:

Further study details as provided by Cumberland Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in respiratory Visual analog Scale (VAS) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in global VAS [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Total urine output vs. baseline [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Enrollment: 170
Study Start Date: November 2002
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: placebo
Experimental: 2
Low dose
Drug: conivaptan
Other Names:
  • Vaprisol
  • YM087
Experimental: 3
Middle dose
Drug: conivaptan
Other Names:
  • Vaprisol
  • YM087
Experimental: 4
High dose
Drug: conivaptan
Other Names:
  • Vaprisol
  • YM087


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00057356

  Show 26 Study Locations
Sponsors and Collaborators
Cumberland Pharmaceuticals
Study Director: Art Wheeler, MD Cumberland Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: Sr Manager Clinical Trials Registry, Astellas Pharma US, Inc. Identifier: NCT00057356     History of Changes
Other Study ID Numbers: 087-CL-071
Study First Received: March 31, 2003
Last Updated: April 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cumberland Pharmaceuticals:
Chronic Heart Failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases processed this record on October 02, 2015