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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00303498 |
The purpose of this Phase II study is to explore whether sitaxsentan sodium is effective in the treatment of subjects with Diastolic Heart Failure
Condition | Intervention | Phase |
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Ventricular Dysfunction, Left |
Drug: sitaxsentan sodium Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Exploratory Efficacy Study of Sitaxsentan Sodium to Improve Impaired Exercise Tolerance in Subjects With Diastolic Heart Failure |
Estimated Enrollment: | 150 |
Study Start Date: | March 2006 |
Study Completion Date: | June 2008 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: sitaxsentan sodium
100 mg (target dose) daily.
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2: Placebo Comparator |
Drug: Placebo
Placebo
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Michael R Zile, M.D. | Unaffiliated |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure ) |
Study ID Numbers: | B1321006, FDHF01 |
Study First Received: | March 16, 2006 |
Last Updated: | September 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00303498 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Ventricular Dysfunction, Left ECHO Normal Ejection Fraction |
Diastolic Heart Failure QOL Exercise Capacity |
Ventricular Dysfunction Heart Failure, Diastolic Heart Failure Heart Diseases Ventricular Dysfunction, Left |
Ventricular Dysfunction Heart Failure, Diastolic Heart Failure |
Heart Diseases Ventricular Dysfunction, Left Cardiovascular Diseases |