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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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Change from baseline in global VAS [ Time Frame: 48 hours ]
  • Total urine output vs. baseline [ Time Frame: 72 hours ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by Cumberland Pharmaceuticals:
Chronic Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs processed this record on June 23, 2017