ABC
1Main
2Brand Name
3Generic Namedarusentan
4IndicationResistant Hypertension. 7 million drug-treated hypertensive patients on 3+ drug regimens. 2-3m in the US are resistant or uncontrolled. - GILD #s.
5SafetyPeripheral Edema 7-12%.
6Clinical Trials
7Phase III - Study 311 - placebo-controlled study - 53% enrolled as of 4/2008
8Patients who are resistant to 3 full doses of antihypertensives including a diuretic.
9Will ammend protocol to reduce # of HTN drugs from 4 to 3.
10
11Phase III - Study 312 - active comparator - n=770 - 17% enrolled as of 4/2008
12First patients enroll 6/30/07
13Darusentan vs guanfasine vs placebo 3:3:1
14
15Phase II - Published in J of Clinical Hypertension 2007