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DORADO - Fixed Doses of Darusentan as Compared to Placebo in Resistant Hypertension | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

DORADO - A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Evaluate the Efficacy and Safety of Fixed Doses of Darusentan in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311)

NCT00330369•Gilead Sciences

View on ClinicalTrials.gov

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.

Eligibility

Age

35 - 80 years

Sex

ALL

Healthy Volunteers

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%
+2 more criteria

Locations (115)

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 D.C., District of Columbia, United States

Key Dates

Start Date

June 1, 2006

Primary Completion Date

January 1, 2009

Completion Date

January 1, 2009

Last Updated

March 18, 2014

Enrollment

352

ACTUAL participants

Conditions

Hypertension

Interventions

Darusentan

DRUG

Darusentan Placebo

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITING

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

NCT07480265

Hypertension (HTN)Hyperhomocysteinemia+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

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