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Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00132886
First Posted: August 22, 2005
Last Update Posted: May 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
  Purpose
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.).

Condition Intervention Phase
Heart Failure, Congestive Drug: tolvaptan Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in heart pressures (PCWP) at 3 to 8 hours post-dose

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 140
Study Start Date: December 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132886


  Show 31 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
Study Chair: James Udelson, MD Cardiovascular Clinical Studies and Tufts/New England Medical Center
  More Information
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