Expired Study
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Fort Lauderdale, Florida 33308


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)


Criteria:

History of congestive heart failure


Study is Available At:


Original ID:

156-01-232


NCT ID:

NCT00043758


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Otsuka Pharmaceutical Development & Commercialization, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

170


Enrollment Type:


Study Dates

Start Date:July 2002
Completion Date:July 2004
Verification Date:June 2005
Last Changed Date:June 23, 2005
First Received Date:August 13, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Tolvaptan

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Otsuka Pharmaceutical Development & Commercialization, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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