Status:
COMPLETED
DORADO - Fixed Doses of Darusentan as Compared to Placebo in Resistant Hypertension
Lead Sponsor:
Gilead Sciences
Conditions:
Hypertension
Eligibility:
All Genders
35-80 years
Phase:
PHASE3
Brief Summary
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 tha...
Eligibility Criteria
Inclusion
- Subjects who are competent to provide written consent
- Aged 35 to 80 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 non-childbearing potential (i.e., post-menopausal for at lest 2 years; surgically sterile)
Exclusion
- Average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg
- Serum ALT or AST \>2 x the upper limit of the normal range (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 congestive heart failure 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 greater than or equal to 90%
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT00330369
Start Date
June 1 2006
End Date
January 1 2009
Last Update
March 18 2014
Active Locations (115)
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1
UAB Hypertension Program
Birmingham, Alabama, United States, 35294
2
Comprehensive Heart Failure Center
Mobile, Alabama, United States, 36608
3
Canyon Clinical Research
Tucson, Arizona, United States, 85712
4
Chrishard Medical Group
Inglewood, California, United States, 90301