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Completed

NCT Number: NCT00330369

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CIMEL, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Darusentan

Drug

Darusentan administered orally once daily

Other names: LU 135252

Darusentan Placebo

Drug

Placebo to match darusentan administered orally once daily

Primary outcomes

  1. Change from baseline in trough sitting systolic and diastolic blood pressure measured by sphygmomanometry

    Time frame: Baseline to Week 14

Secondary outcomes

  1. Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure

    Time frame: Baseline to Week 14

  2. Percentage of subjects to reach systolic blood pressure goal

    Time frame: Week 14

  3. Change from baseline in estimated glomerular filtration rate (eGFR)

    Time frame: Baseline to Week 14

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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)

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 26, 2006
Registry last updated
Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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