DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant Hypertension | NCT00389779 | Trialant

DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant Hypertension | NCT00389779 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: SELECTED INCLUSION CRITERIA:

Subjects who are competent to provide written consent;

Aged 35 to 80 years;

Subjects with diabetes and/or chronic kidney disease must have an average sitting systolic blood pressure greater than or equal to 130 mmHg;

All other subjects must have an average sitting systolic blood pressure greater than or equal to 140 mmHg;

Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic;

Female subjects of non-childbearing potential (i.e., post-menopausal for at least 2 years or surgically sterile).

SELECTED EXCLUSION CRITERIA:

Average sitting systolic and diastolic blood pressure greater than or equal to 180 mmHg and 110 mmHg, respectively;

Subjects treated with a central alpha-2 agonist and/or imidazoline receptor agonist;

Left ventricular dysfunction;

Serum ALT or AST greater than 2 times the Upper Limit of Normal;

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;

Implanted pacemakers or cardioverter defibrillator;

Symptomatic congestive heart failure requiring treatment;

Hemodynamically significant valvular heart disease;

Hemodialysis or peritoneal dialysis, or history of renal transplant;

Type I diabetes mellitus;

Diagnosis or recurrence of malignancy within the past 3 years;

Sleep apnea, unless a recent sleep study demonstrated arterial oxygenation saturation greater than or equal to 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