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

Tracking Information

First Received Date ^ICMJE

March 31, 2003

Last Updated Date

June 26, 2008

Start Date ^ICMJE

November 2002

Primary Completion Date

March 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in respiratory Visual analog Scale (VAS) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00057356 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Pilot Study Evaluating the Efficacy and Safety of YM087 in Patients With Decompensated Chronic Heart Failure

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Chronic Heart Failure

Intervention ^ICMJE

Drug: conivaptan
Drug: placebo

Study Arms / Comparison Groups

Experimental: Low dose
Experimental: Middle dose
Experimental: High dose

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

170

Completion Date

March 2004

Primary Completion Date

March 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00057356

Responsible Party

Sr Manager Clinical Trials Registry, Astellas Pharma US, Inc.

Study ID Numbers ^ICMJE

087-CL-071

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Use Central Contact

Astellas Pharma US, Inc.

Information Provided By

Astellas Pharma Inc

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP