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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00330369
First received: May 24, 2006
Last updated: February 19, 2014
Last verified: February 2014

May 24, 2006
February 19, 2014
June 2006
January 2009   (final data collection date for primary outcome measure)
Change from baseline in trough sitting systolic and diastolic blood pressure measured by sphygmomanometry [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]
The primary efficacy measure is change from baseline in trough sitting systolic blood pressure measured by sphygmomanometry
Complete list of historical versions of study NCT00330369 on ClinicalTrials.gov Archive Site
  • Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]
  • Percentage of subjects to reach systolic blood pressure goal [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
  • Change from baseline in estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]
  • Secondary efficacy measurements are change from baseline in trough sitting diastolic blood pressure measured by sphygmomanometry
  • mean 24-hour systolic and diastolic blood pressure as measured by ambulatory blood pressure monitoring
  • the percent of subjects who reach systolic blood pressure goal
  • and estimated glomerular filtration rate (eGFR)
Not Provided
Not Provided
 
DORADO - Fixed Doses of Darusentan as Compared to Placebo in Resistant Hypertension
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
  • Drug: Darusentan
    Darusentan administered orally once daily
    Other Name: LU 135252
  • Drug: Darusentan Placebo
    Placebo to match darusentan administered orally once daily
  • 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
    Intervention: Drug: Darusentan Placebo
  • 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
    Interventions:
    • Drug: Darusentan
    • Drug: Darusentan Placebo
  • 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
    Interventions:
    • Drug: Darusentan
    • Drug: Darusentan Placebo
  • 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
    Interventions:
    • Drug: Darusentan
    • Drug: Darusentan Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
352
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
35 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Canada,   Denmark,   France,   Germany,   Italy,   Spain,   Sweden,   United Kingdom
 
NCT00330369
DAR-311
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Not Provided
Gilead Sciences
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP