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Completed

NCT Number: NCT00389779

DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant Hypertension

This is a randomized, double-blind, placebo- and active-controlled study of a new experimental drug called darusentan. Darusentan is not currently approved by the United States Food and Drug Administration (FDA), which means that a doctor cannot prescribe this drug. The purpose of this study is to determine if darusentan is effective in reducing systolic and diastolic hypertension despite treatment with full doses of three or more antihypertensive drugs, including a diuretic. Subjects will be randomized to darusentan (optimized dose), an active comparator, or placebo, administered orally. The treatment period for this trial is 14 weeks.

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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

Hospital Italiano Regional del Sur, Bahía Blanca, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

SELECTED 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 an average sitting systolic blood pressure greater than or equal to 130 mmHg;
  • All other subjects must have an average sitting systolic blood pressure greater than or equal to 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 least 2 years or surgically sterile).

SELECTED EXCLUSION CRITERIA:

  • Average sitting systolic and diastolic blood pressure greater than or equal to 180 mmHg and 110 mmHg, respectively;
  • Subjects treated with a central alpha-2 agonist and/or imidazoline receptor agonist;
  • Left ventricular dysfunction;
  • Serum ALT or AST greater than 2 times the Upper Limit of Normal;
  • Subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachycardia, recurrent ventricular tachycardia, or symptomatic bradycardia;
  • Implanted pacemakers or cardioverter defibrillator;
  • Symptomatic congestive heart failure requiring treatment;
  • Hemodynamically significant valvular heart disease;
  • Hemodialysis or peritoneal dialysis, or history of renal transplant;
  • Type I diabetes mellitus;
  • Diagnosis or recurrence of malignancy within the past 3 years;
  • Sleep apnea, unless a recent sleep study demonstrated arterial oxygenation saturation greater than or equal to 90%, treated or untreated;
  • 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 capsules administered orally once daily

Other names: LU 135252

Guanfacine

Drug

Guanfacine capsules administered orally once daily

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. Percentage of subjects reaching systolic blood pressure goal after 14 weeks of treatment

    Time frame: Week 14

  2. Change from baseline in mean 24-hour systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM)

    Time frame: Baseline to 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

A Phase 3 Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-center, Parallel Group Study to Evaluate the Safety and Efficacy of Darusentan in Subjects With Resistant Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine or Placebo (Protocol DAR-312)

Acronym: Darusentan

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Oct 19, 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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