DORADO - Fixed Doses of Darusentan as Compared to Placebo in Resistant Hypertension

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Darusentan; Drug: Darusentan Placebo

• Registration Number: NCT00330369
• Lead Sponsor: Gilead Sciences

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 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 antihypertensive drugs, including a diuretic.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-05-24
• Study First Submitted QC: 2006-05-24
• Study First Posted: 2006-05-26
• Study Start: 2006-06
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Disposition First Submitted: 2014-01-03
• Disposition First Submitted QC: 2014-01-03
• Status Verified: 2014-02
• Disposition First Posted: 2014-02-04
• Last Update Submitted: 2014-02-19
• Last Update Posted: 2014-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

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 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Darusentan 100 mg	Darusentan Placebo	Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 100 mg administered orally once daily for 14 weeks
Darusentan Placebo	Darusentan Placebo	Placebo to match darusentan for 2-week placebo run-in period, followed by placebo to match darusentan administered orally once daily for 14 weeks
Darusentan 50 mg	Darusentan Placebo	Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 50 mg administered orally once daily for 14 weeks
Darusentan 300 mg	Darusentan	Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 300 mg administered orally once daily for 14 weeks
Darusentan 300 mg	Darusentan Placebo	Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 300 mg administered orally once daily for 14 weeks
Darusentan 50 mg	Darusentan	Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 50 mg administered orally once daily for 14 weeks
Darusentan 100 mg	Darusentan	Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 100 mg administered orally once daily for 14 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in trough sitting systolic and diastolic blood pressure measured by sphygmomanometry	Baseline to Week 14

Secondary Outcome Measures

Name	Time	Method
Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure	Baseline to Week 14
Percentage of subjects to reach systolic blood pressure goal	Week 14
Change from baseline in estimated glomerular filtration rate (eGFR)	Baseline to Week 14

Trial Locations

Locations (114)

UAB Hypertension Program; 🇺🇸 Birmingham, Alabama, United States

Comprehensive Heart Failure Center; 🇺🇸 Mobile, Alabama, United States

Canyon Clinical Research; 🇺🇸 Tucson, Arizona, United States

Chrishard Medical Group; 🇺🇸 Inglewood, California, United States

VA Medical Center - WLA; 🇺🇸 Los Angeles, California, United States

Sacramento Heart and Vascular; 🇺🇸 Sacramento, California, United States

Apex Research Institute; 🇺🇸 Santa Ana, California, United States

Complete Renal Care; 🇺🇸 Denver, Colorado, United States

Connecticut Clinical Research, LLC; 🇺🇸 Bridgeport, Connecticut, United States

MedStar Diabetes Institute at Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

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