A Phase 3 Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-center, Parallel Group Study to Evaluate the Safety and Efficacy of Darusentan in Subjects with Resistant Hypertension Receiving Combination Therapy with Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine or Placebo (Protocol DAR-312)

Myogen, Inc.0 个研究点目标入组 800 人开始时间: 2006年10月18日最近更新: 2020年1月13日

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•1) Subjects who are competent to provide written consent; 2) Subjects with diabetes and/or chronic kidney disease must have an average sitting systolic blood pressure greater than or equal to 130 mmHg; 3) All other subjects must have an average sitting systolic blood pressure greater than or equal to 140 mmHg; 4) Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic; 5) Female subjects must be of non-childbearing potential (post-menopausal for at least 2 years or surgically sterile).

•1) Average sitting systolic and diastolic blood pressure greater than or equal to 180 mmHg and 110 mmHg, respectively; 2) Subjects treated with a central alpha-2 agonist and/or imidazoline receptor agonist; 3) Left ventricular dysfunction; 4) Serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) greater than 2 times the Upper Limit of Normal; 5) Subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachycardia, recurrent ventricular tachycardia, or symptomatic bradycardia; 6) Implanted pacemakers or cardioverter defibrillator; 7) Symptomatic CHF requiring treatment; 8) Hemodynamically significant valvular heart disease; 9) Hemodialysis or peritoneal dialysis, or history of renal transplant; 10) Type I diabetes mellitus; 11) Diagnosis or recurrence of malignancy within the past 3 years; 12) Sleep apnea, unless a recent sleep study demonstrated arterial oxygenation saturation greater than 90%, treated or untreated; 13) Subjects who perform alternating shift or night work; 14) Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening.

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