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

NCT00389779 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 849

Last updated 2014-03-18

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

Darusentan

Darusentan capsules administered orally once daily

DRUG

Guanfacine

Guanfacine capsules administered orally once daily

DRUG

Darusentan Placebo

Placebo to match darusentan administered orally once daily

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Denmark
  • France
  • Germany
  • New Zealand
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00389779 on ClinicalTrials.gov