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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure

Drug Information available for: Darusentan

U.S. FDA Resources

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 ]

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

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Weber MA, Black H, Bakris G, Krum H, Linas S, Weiss R, Linseman JV, Wiens BL, Warren MS, Lindholm LH. A selective endothelin-receptor antagonist to reduce blood pressure in patients with treatment-resistant hypertension: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Oct 24;374(9699):1423-31. Epub 2009 Sep 11.

Responsible Party:	Kathleen DeHaven, Gilead Sciences, Inc
ClinicalTrials.gov Identifier:	NCT00330369 History of Changes
Other Study ID Numbers:	DAR-311
Study First Received:	May 24, 2006
Last Updated:	October 2, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012