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DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension

NCT00389675 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 661

Last updated 2014-01-06

No results posted yet for this study

Summary

This is a double-blind, active-controlled, long-term study of a new experimental drug called darusentan. Darusentan in 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 evaluate the long-term safety of darusentan (optimized dose) as compared to an active control, administered orally.

Conditions

Interventions

DRUG

Darusentan

Darusentan capsules at a dose of 50, 100, or 300 mg administered orally once daily

DRUG

Guanfacine

Guanfacine 1 mg capsules 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
2007-05-31
Primary Completion
2010-02-28
Completion
2010-05-31

Countries

  • United States
  • Argentina
  • Australia
  • Brazil

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 NCT00389675 on ClinicalTrials.gov