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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00330369
First Posted: May 26, 2006
Last Update Posted: March 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
  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 Drug: Darusentan Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Change from baseline in trough sitting systolic and diastolic blood pressure measured by sphygmomanometry [ Time Frame: Baseline to Week 14 ]

Secondary Outcome Measures:
  • Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure [ Time Frame: Baseline to Week 14 ]
  • Percentage of subjects to reach systolic blood pressure goal [ Time Frame: Week 14 ]
  • Change from baseline in estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline to Week 14 ]

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: 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
Drug: Darusentan Placebo
Placebo to match darusentan administered orally once daily
Experimental: Darusentan 50 mg
Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 50 mg administered orally once daily for 14 weeks
Drug: Darusentan
Darusentan administered orally once daily
Other Name: LU 135252
Drug: Darusentan Placebo
Placebo to match darusentan administered orally once daily
Experimental: Darusentan 100 mg
Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 100 mg administered orally once daily for 14 weeks
Drug: Darusentan
Darusentan administered orally once daily
Other Name: LU 135252
Drug: Darusentan Placebo
Placebo to match darusentan administered orally once daily
Experimental: Darusentan 300 mg
Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 300 mg administered orally once daily for 14 weeks
Drug: Darusentan
Darusentan administered orally once daily
Other Name: LU 135252
Drug: Darusentan Placebo
Placebo to match darusentan administered orally once daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 >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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330369


  Show 115 Study Locations
Sponsors and Collaborators
Gilead Sciences
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00330369     History of Changes
Other Study ID Numbers: DAR-311
First Submitted: May 24, 2006
First Posted: May 26, 2006
Last Update Posted: March 18, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Darusentan
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action