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Multi-national, randomized, double-blind, parallel group, placebo-controlled study to evaluate the effects of an investigational product on safety and efficacy in subjects with resistant systolic hypertension receiving combination therapy with three or more antihypertensive drugs, including a diuretic
Sponsor: Myogen
Study Drug: Darusentan or LU 135252
Protocol: CV181013
Phase 3
CRO: ICON
Site #:
Investigator #:
CRA:
Central Lab:
IRB:
Subjects / Sites: Subjects per Site
IVRS (Integrated Voice Response System)
Study Design:
IC
35-85
SBP > 140 (or > 130 for DM or CRF)
GFR equal/greater than 30
EC
Secondary HTN
BMI > 43
MI, CVA PTCA, CABG within 6 months
CHF Requiring Rx
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