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

August 18, 2005
May 2, 2012
December 2004
December 2006   (final data collection date for primary outcome measure)
Change in heart pressures (PCWP) at 3 to 8 hours post-dose
Change in heart pressures (PCWP) at 3 to 8 hours post-dose.
Complete list of historical versions of study NCT00132886 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure
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

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.).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Heart Failure, Congestive
Drug: tolvaptan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
December 2006
December 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Romania
 
NCT00132886
156-04-247
Not Provided
Not Provided
Otsuka Pharmaceutical Development & Commercialization, Inc.
Not Provided
Study Chair: James Udelson, MD Cardiovascular Clinical Studies and Tufts/New England Medical Center
Otsuka Pharmaceutical Development & Commercialization, Inc.
May 2012

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