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

This study has been completed.
Sponsor:
Information provided by:
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00057356
First received: March 31, 2003
Last updated: April 30, 2014
Last verified: April 2014
  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:


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
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
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 ClinicalTrials.gov identifier: NCT00057356

  Show 26 Study Locations
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
Study Director: Art Wheeler, MD Cumberland Pharmaceuticals 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: April 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cumberland Pharmaceuticals:
Chronic Heart Failure
YM078

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014