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Status:

COMPLETED

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

Lead Sponsor:

Gilead Sciences

Conditions:

Hypertension

Eligibility:

All Genders

35-80 years

Phase:

PHASE3

Brief Summary

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 Administr...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2009

    Estimated Enrollment :

    849 Patients enrolled

    Trial Details

    Trial ID

    NCT00389779

    Start Date

    September 1 2006

    End Date

    August 1 2009

    Last Update

    March 18 2014

    Active Locations (147)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 37 (147 locations)

    1

    Alabama Internal Medicine, PC

    Birmingham, Alabama, United States, 35235

    2

    Greystone Medical Research, LLC

    Birmingham, Alabama, United States, 35242

    3

    The Heart Center, PC

    Huntsville, Alabama, United States, 35801

    4

    Mulberry Medical Associates, PC

    Montgomery, Alabama, United States, 36106