DORADO – A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Evaluate the Efficacy and Safety of Fixed Doses of Darusentan in Subjects with Resistant Systolic Hypertension Receiving Combination Therapy with Four or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311)

Myogen, inc.0 个研究点目标入组 350 人开始时间: 2006年7月11日最近更新: 2020年1月13日

适应症

试验速览

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•Subjects who are competent to provide written consent. Subjects with diabetes and/or chronic kidney disease must have a mean systolic blood pressure greater than or equal to 130 mmHg- All other subjects must have a mean systolic blood pressure greater than or equal to 140 mmHg- Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from four different classes of antihypertensive agents, including a diuretic- Female subjects of non-childbearing potential (post-menopausal for at least 2 years; surgically sterile).

•Average sitting systolic blood pressure greater than or equal to 180 mmHg or diastolic blood pressure greater than or equal to 110 mmHg- Serum ALT or AST greater than or equal to 2X ULN- Subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident (CVA) within 6 month; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia- Implanted pacemakers or implanted cardioverter defibrillator (ICD) - Symptomatic CHF requiring treatment- Hemodynamically significant valvular heart disease- Type I diabetes mellitus- Hemodialysis or peritoneal dialysis; or history of renal transplant- Diagnosis or recurrence of malignancy within the past 3 years- Sleep apnea, unless a recent sleep study demonstrates arterial oxygen saturation >90%, treated or untreated- Subjects who perform alternating shift or night work- Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening.

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