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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00057356
First received: March 31, 2003
Last updated: June 26, 2008
Last verified: June 2008
History of Changes
  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
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:

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

Further study details as provided by Astellas Pharma Inc:

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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00057356

  Show 26 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma US, Inc.
  More Information

No publications provided

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
Study First Received: March 31, 2003
Last Updated: June 26, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Chronic Heart Failure
YM078

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013