Status:
COMPLETED
Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 n...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2006
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00132886
Start Date
December 1 2004
End Date
December 1 2006
Last Update
May 3 2012
Active Locations (31)
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1
Oracle Research, A Div of the Heart Center
Huntsville, Alabama, United States, 35801
2
Merced Heart Associates
Merced, California, United States, 95340
3
Olive View-UCLA Medical Center
Sylmar, California, United States, 91324
4
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316