Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Dorado program designed to evaluate the safety and efficacy of darusentan for reducing SBP and DBP
Subscribe to our email newsletter
Gilead Sciences, a biopharmaceutical company, has reported that DAR-311, a Phase III clinical trial evaluating the company’s endothelin receptor antagonist darusentan for the treatment of resistant hypertension, met its co-primary efficacy endpoints of change from baseline to week 14 in trough sitting systolic blood pressure and trough sitting diastolic blood pressure.
Dorado is one of two ongoing Phase III clinical trials evaluating the safety, efficacy and tolerability of darusentan as an add-on treatment for resistant hypertension, defined as the failure to achieve goal blood pressure while adhering to full doses of an appropriate three-drug regimen that includes a diuretic. The second study, DAR-312 (Dorado-AC), is approximately 90% enrolled and is expected to be completed by the end of 2009.
In the DAR-311 study, reductions in mean trough sitting systolic blood pressure (SBP) from baseline of 8.6mmHg, 16.5mmHg, 18.1mmHg and 18.1mmHg were observed for the placebo, darusentan 50mg, 100mg and 300mg groups, respectively, after 14 weeks of treatment, said Gilead.
Reductions in mean trough sitting diastolic blood pressure (DBP) from baseline of 5.3mmHg, 10.1mmHg, 9.9mmHg and 10.7mmHg were observed for the placebo, darusentan 50mg, 100mg and 300mg groups, respectively, after 14 weeks of treatment. These results were statistically significant for all darusentan groups (p<0.001), the company said.
The Dorado program is designed to evaluate the safety and efficacy of darusentan for reducing SBP and DBP in resistant hypertension patients currently treated with full doses of three or more antihypertensive medications, one of which is a diuretic.
Norbert Bischofberger, chief scientific officer of Gilead, said: In this study, more than half of the patients treated with darusentan achieved goal blood pressure, as compared to approximately one quarter of patients receiving placebo. We look forward to presenting full results from this study and to completing our second Phase III study, which will further characterize darusentan’s safety and efficacy profile.