Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure

This study has been completed.

Sponsor:

Information provided by:

Otsuka Pharmaceutical Development & Commercialization, Inc.

ClinicalTrials.gov Identifier:

NCT00132886

First received: August 18, 2005

Last updated: May 2, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 18, 2005

Last Updated Date

May 2, 2012

Start Date ^ICMJE

December 2004

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in heart pressures (PCWP) at 3 to 8 hours post-dose

Original Primary Outcome Measures ^ICMJE

Change in heart pressures (PCWP) at 3 to 8 hours post-dose.

Change History

Complete list of historical versions of study NCT00132886 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in heart function measurements (CI, SVR, PVR, RAP) at 3 to 8 hours post-dose
Change in urine output and free water clearance
Change from baseline in urine osmolality
Cmax, tmax, and AUC 12h of tolvaptan in plasma
Adverse events, vital signs and clinical labs

Original Secondary Outcome Measures ^ICMJE

Change in heart function measurements (CI, SVR, PVR, RAP) at 3 to 8 hours post-dose.
Change in urine output and free water clearance.
Change from baseline in urine osmolality.
Cmax, tmax, and AUC 12h of tolvaptan in plasma
Adverse events, vital signs and clinical labs

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure

Official Title ^ICMJE

Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Single Oral Tolvaptan Tablets on Hemodynamic Parameters in Subjects With Heart Failure

Brief Summary

This study will look at how a single dose of study medication (tolvaptan) versus an inactive sugar pill (placebo) effect pressures in the heart in patients with congestive heart failure. Higher than normal pressures can be related to symptoms of heart failure (shortness of breath, fatigue, etc.).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Heart Failure, Congestive

Intervention ^ICMJE

Drug: tolvaptan

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

140

Completion Date

December 2006

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosed with Class III or IV heart failure for at least 3 months
Left ventricular ejection fraction less than or equal to 40%
Currently being treated for heart failure with standard therapies for at least one month

Exclusion Criteria:

Women who are pregnant or breastfeeding
Inability to take oral medications
Uncontrolled hypertension, bradyarrhythmias or tachyarrhythmias
Hypertrophic obstructive cardiomyopathy
Severe obstructive pulmonary disease
Significant renal impairment
Significant uncorrected valvular or congenital heart disease

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, Romania

Administrative Information

NCT Number ^ICMJE

NCT00132886

Other Study ID Numbers ^ICMJE

156-04-247

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

James Udelson, MD

Cardiovascular Clinical Studies and Tufts/New England Medical Center

Information Provided By

Otsuka Pharmaceutical Development & Commercialization, Inc.

Verification Date

May 2012

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

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