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| Sponsored by: |
Encysive Pharmaceuticals |
|---|---|
| Information provided by: | Encysive Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00303498 |
Purpose
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 |
|---|---|---|
|
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 |
|---|---|
| 1: Experimental |
Drug: sitaxsentan sodium
100 mg (target dose) daily.
|
| 2: Placebo Comparator |
Drug: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The subject provides written informed consent before the commencement of any study related procedure.
The subject has signs and symptoms of chronic HF assessed as NYHA Class II or III.
The subject has an LVEF >=50%.
The subject has a minimum exercise time of 120 seconds and a maximum of 720 seconds.
The subject has ECHO evidence of concentric remodeling and/or diastolic dysfunction.
Exclusion Criteria:
The subject has evidence of unstable cardiovascular disease including atrial fibrillation or unstable angina within the preceding 4 weeks prior to Screening.
The subject has amyloidosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis.
The subject has a history of myocardial infarction, coronary artery bypass graft surgery, or percutaneous intervention within the last 3 months.
The subject has clinically significant valvular heart disease.
The subject has a history of cerebrovascular accident or transient ischemic attack within the last 3 months.
The subject has liver disease and/or elevated liver enzymes defined as AST and/or ALT >= 1.5 times the upper limit of normal.
The subject has exercise tolerance limited by noncardiac causes (e.g., exercise-induced asthma, chronic obstructive pulmonary disease, malignancy, obesity, musculoskeletal disorder).
The subject has uncontrolled systemic hypertension.
The subject has chronic renal impairment or renal insufficiency.
Contacts and Locations
Show 30 Study Locations| Principal Investigator: | Michael R Zile, M.D. | Unaffiliated |
More Information
| Study ID Numbers: | FDHF01 |
| Study First Received: | March 16, 2006 |
| Last Updated: | July 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00303498 |
| 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 |
|
Cardiovascular Diseases |
