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CompletedNCT00364026Updated Jan 18, 2007

A Clinical Study to Evaluate the Effects of Darusentan on Safety and Efficacy in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Blood Pressure Lowering Drugs

A Phase 2 interventional study of darusentan in Hypertension, sponsored by Gilead Sciences. Completed. Open to participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2007-01-18.

Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Allocation
Randomized
Ages
35 Years to 85 Years
Sex
All
01

Study summary

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 blood pressure lowering drugs, including a diuretic.

02

Conditions studied

03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

Browse Hypertension studies →

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects who are competent to provide written consent
  • Aged 35 to 85 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 childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the time of Randomization.

Exclusion criteria

Exclusion Criteria:

  • Average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg at Screening
  • Serum ALT or AST >2X ULN
  • Subjects who have experienced myocardial infarction, unstable angina, or a cerebrovascular accident (CVA) within 6 month of the Screening Visit; or sick sinus syndrome or second or third degree atrioventricular block, chronic atrial fibrillation or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia
  • Implanted cardioverter defibrillator (ICD) that has fired for any arrhythmia within 3 months of Screening or implanted pacemakers
  • Symptomatic CHF requiring treatment
  • Hemodynamically significant valvular heart disease
  • Hemodialysis or peritoneal dialysis; or history of renal transplant
  • Diagnosis or recurrence of malignancy within the past 3 years
  • Sleep apnea
  • Subjects who perform alternating shift or night work
  • Subjects who have participated in a clinical study involving another investigational drug or device within 1 month of the Screening Visit
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double

Interventions

  • Drugdarusentan
06

What researchers measure

Primary outcomes

  1. Co-primary efficacy measures are changes in trough sitting systolic BP from baseline through Weeks 8 and 10.

Secondary outcomes

  1. Secondary efficacy measurements are change in trough sitting diastolic BP from baseline to study Week 10; change in mean 24-hour systolic BP, as measured by ABPM; and the percent of subjects who reached systolic BP goal after 10 weeks of treatment.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00364026
Lead sponsor
Gilead Sciences
First posted
Aug 15, 2006
Start date
Jun 2004
Completion
Jul 2005
Last update
Jan 18, 2007
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2006. You cannot join it, but the record below documents what was studied.

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