Myogen starts phase 3 trial of darusentan for resistant hypertension

New York, June 5 - Myogen, Inc. said it has begun a phase 3 trial to evaluate darusentan in patients with resistant hypertension.

The primary objective of the trial, called Dorado, 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.

Myogen expects to enroll about 352 patients, who will receive one of three doses of darusentan (50, 100 or 300 mg qd) versus a placebo in a ratio of 7:7:7:11.

The treatment period is 14 weeks.

The primary endpoint of the trial is change from baseline to week 14 in trough sitting systolic blood pressure as compared to the placebo.

On completion, patients will be eligible to enroll in a long-term safety study. Patients will be treated and followed for safety for at least six months with a mean exposure expected to be in excess of one year.

Denver-based Myogen is planning a second international phase 3 trial, to start in the fourth quarter.

Darusentan is a non-sulfonamide, propanoic-acid class, type-A selective endothelin receptor antagonist being investigated in clinical trials as an add-on oral therapy for patients with resistant hypertension.

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