Multicenter, Randomized, Double-Blind, Placebo Controlled, Efficacy Study on the Effects of Tolvaptan on Left Ventricular Dilatation in Congestive Heart Failure Patients

This study has been completed.

Sponsor:

Information provided by:

Otsuka Pharmaceutical Development & Commercialization, Inc.

ClinicalTrials.gov Identifier:

NCT00043758

First received: August 13, 2002

Last updated: June 23, 2005

Last verified: June 2005

History of Changes

Purpose

The purpose of this study is to study the effects of tolvaptan on the size and function of the left heart chamber (ventricle) in patients with congestive heart failure (CHF)

Condition	Intervention	Phase
Congestive Heart Failure	Drug: Tolvaptan	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Tolvaptan

U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Estimated Enrollment:	170
Study Start Date:	July 2002
Estimated Study Completion Date:	July 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

History of congestive heart failure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043758

Show 40 Study Locations

Sponsors and Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

More Information

No publications provided by Otsuka Pharmaceutical Development & Commercialization, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Udelson JE, McGrew FA, Flores E, Ibrahim H, Katz S, Koshkarian G, O'Brien T, Kronenberg MW, Zimmer C, Orlandi C, Konstam MA. Multicenter, randomized, double-blind, placebo-controlled study on the effect of oral tolvaptan on left ventricular dilation and function in patients with heart failure and systolic dysfunction. J Am Coll Cardiol. 2007 Jun 5;49(22):2151-9. Epub 2007 May 18.

ClinicalTrials.gov Identifier:	NCT00043758 History of Changes
Other Study ID Numbers:	156-01-232
Study First Received:	August 13, 2002
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

CHF

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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