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

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ClinicalTrials.gov Identifier: NCT00057356
Recruitment Status : Completed
First Posted : April 1, 2003
Last Update Posted : May 2, 2014
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Drug: conivaptan Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
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
Study Start Date : November 2002
Actual Primary Completion Date : March 2004
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change from baseline in respiratory Visual analog Scale (VAS) [ Time Frame: 48 hours ]

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


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.

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.

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 Posted: April 1, 2003    Key Record Dates
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