Study to Compare the Effects of Two Dosages of Tolvaptan in Congestive Heart Failure Patients

June 23, 2005 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

Multi-Center, Double-Blind Study to Compare the Effects of 30mg Qd Versus 15 Mg Bid of Tolvaptan in Congestive Heart Failure Patients

Patients with congestive heart failure will be assessed for safety and clinical effects of Tolvaptan 30 mg every day versus 15 mg twice a day over a period of 7 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Bakersfield, California, United States
        • Central Cardiology Medical Clinic
      • San Diego, California, United States
        • University of California-San Diego
    • Florida
      • Miami, Florida, United States
        • University of Miami/Jackson Memorial Hospital
    • Louisiana
      • Slidell, Louisiana, United States
        • Medical Research Institute
    • Maine
      • Auburn, Maine, United States
        • Androscoggin Cardiology Associates
    • Missouri
      • Kansas City, Missouri, United States
        • University of Missouri-Kansas City School of Medicine
      • St. Louis, Missouri, United States
        • Saint Louis University
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • Cardiology of Oklahoma
    • South Carolina
      • Charleston, South Carolina, United States
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

History of CHF

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion

December 7, 2022

Study Completion

September 1, 2002

Study Registration Dates

First Submitted

August 13, 2002

First Submitted That Met QC Criteria

August 13, 2002

First Posted (Estimate)

August 14, 2002

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

September 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 156-01-231

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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