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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00057356
First Posted: April 1, 2003
Last Update Posted: May 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cumberland Pharmaceuticals
  Purpose
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: Quadruple (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
IV
Experimental: 2
Low dose
Drug: conivaptan
IV
Other Names:
  • Vaprisol
  • YM087
Experimental: 3
Middle dose
Drug: conivaptan
IV
Other Names:
  • Vaprisol
  • YM087
Experimental: 4
High dose
Drug: conivaptan
IV
Other Names:
  • Vaprisol
  • YM087

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057356


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

Responsible Party: Sr Manager Clinical Trials Registry, Astellas Pharma US, Inc.
ClinicalTrials.gov Identifier: NCT00057356     History of Changes
Other Study ID Numbers: 087-CL-071
First Submitted: March 31, 2003
First Posted: April 1, 2003
Last Update Posted: May 2, 2014
Last Verified: April 2014

Keywords provided by Cumberland Pharmaceuticals:
Chronic Heart Failure
YM078

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Conivaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs