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

Sponsored by:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00330369

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: darusentan (LU 135252) and placebo	Phase III

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	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)

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

The co-primary efficacy measures are change from baseline in trough sitting systolic and diastolic blood pressure measured by sphygmomanometry [ Time Frame: Week 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary efficacy measurements are (i) change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure, (ii) percent of subjects to reach systolic blood pressure goal, and (iii) change from baseline in eGFR [ Time Frame: Week 14 ] [ Designated as safety issue: No ]

Estimated Enrollment:	352
Study Start Date:	June 2006
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: darusentan (LU 135252) and placebo 3 tablets QD, PO
2: Experimental 50 mg	Drug: darusentan (LU 135252) and placebo 3 tablets QD, PO
3: Experimental 100 mg	Drug: darusentan (LU 135252) and placebo 3 tablets QD, PO
4: Experimental 300 mg	Drug: darusentan (LU 135252) and placebo 3 tablets QD, PO

Eligibility

Ages Eligible for Study:	35 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 >2X 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 CHF 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330369

Show 115 Study Locations

Sponsors and Collaborators

Gilead Sciences

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Gilead Sciences, Inc ( Kathleen DeHaven )
Study ID Numbers:	DAR-311
Study First Received:	May 24, 2006
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00330369
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009