DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant Hypertension

Exclusion Criteria

• •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 ALT or 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 congestive heart failure 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 or equal to 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