A Clinical Study to Evaluate the Effects of Darusentan on Safety and Efficacy in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Blood Pressure Lowering Drugs

Gilead Sciences

Status and phase

Completed

Phase 2

Conditions

Hypertension

Treatments

Drug: darusentan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00364026

Protocol DAR-201

Details and patient eligibility

About

This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the U.S. Food and Drug Administration (FDA) for use in the United States, which means that a doctor cannot prescribe this drug. The purpose of this study is to determine if darusentan is effective in reducing systolic blood pressure in subjects with resistant systolic hypertension, despite treatment with full doses of three or more blood pressure lowering drugs, including a diuretic.

Sex

All

Ages

35 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects who are competent to provide written consent
Aged 35 to 85 years
Subjects with diabetes and/or chronic kidney disease must have a mean systolic blood pressure ≥130 mmHg
All other subjects must have a mean systolic blood pressure ≥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 childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the time of Randomization.

Exclusion criteria

Average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg at Screening
Serum ALT or AST >2X ULN
Subjects who have experienced myocardial infarction, unstable angina, or a cerebrovascular accident (CVA) within 6 month of the Screening Visit; or sick sinus syndrome or second or third degree atrioventricular block, chronic atrial fibrillation or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia
Implanted cardioverter defibrillator (ICD) that has fired for any arrhythmia within 3 months of Screening or implanted pacemakers
Symptomatic CHF requiring treatment
Hemodynamically significant valvular heart disease
Hemodialysis or peritoneal dialysis; or history of renal transplant
Diagnosis or recurrence of malignancy within the past 3 years
Sleep apnea
Subjects who perform alternating shift or night work
Subjects who have participated in a clinical study involving another investigational drug or device within 1 month of the Screening Visit