Myogen has announced the initiation of DORADO (DAR-311), an international Phase III clinical trial to evaluate darusentan in patients with resistant hypertension (RHTN). Myogen currently plans to initiate a second international Phase III clinical trial, DAR-312, for the same indication in the fourth quarter of this year. Contemporary clinical guidelines define RHTN as "the failure to achieve goal blood pressure in patients who are adhering to full doses of an appropriate three-drug regimen that includes a diuretic."
The primary objective of DORADO, a randomized, double-blind, placebo-controlled parallel group trial, is to determine if darusentan is effective in reducing systolic blood pressure in resistant hypertension patients currently treated with full doses of four or more antihypertensive medications, one of which is a diuretic. Patients are eligible for enrollment in this trial if they have a systolic blood pressure greater than or equal to 140 mmHg and no other compelling conditions.