Enrollment complete in Ph II Thelin trial
USA-based Encysive Pharmaceuticals has completed patient enrollment in a Phase II trial of Thelin (sitaxsentan sodium) in the treatment of diastolic heart failure, a type of congestive heart failure. Results from the study are expected in the middle of 2008.
The agent is being tested on approximately 150 DHF patients across 40 study centers. The primary efficacy objective of the study is change in treadmill exercise time at week 24 of treatment. A Data Safety Monitor Board has conducted two reviews of the Phase II trial with no recommended changes to the study plan, the firm noted.
DHF occurs when the heart is stiff and cannot relax after contracting. As a result, it cannot properly fill with blood, causing blood to back up in the left atrium and lung. Three million Americans have CHF and 500,000 new cases are diagnosed each year. Of these cases, DHF accounts for 40%-60%.
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