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NCT00389675 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Gilead Sciences.

Terminated
Registry status
Phase 3
Development phase
661
Enrollment target

NCT00389675 is a Phase 3 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 661 participants.

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The verdict

NCT00389675, a Phase 3 study, was terminated before completion, sponsored by Gilead Sciences.

TERMINATED
Registry status
Phase 3
Development phase
661 participants
Enrollment target

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.

Interventions

  • DRUG Guanfacine
  • DRUG Darusentan

Trial Details

FieldValue
Enrollment Target 661 participants
Start Date 2007-05
Est. Completion 2010-05
Phase Phase 3

Sponsor

Gilead Sciences

504 total trials

What the Registry Record Tells You About NCT00389675

The ClinicalTrials.gov registry entry for NCT00389675 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 661 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Guanfacine is the first listed.

NCT00389675 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00389675 about?

NCT00389675 is a clinical study titled "DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension". 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 lo...

What is the current status of trial NCT00389675?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 661 participants. The study started on 2007-05. Estimated completion is 2010-05.

What interventions are being tested in trial NCT00389675?

The interventions under investigation include: Guanfacine (DRUG), Darusentan (DRUG).

Who is sponsoring clinical trial NCT00389675?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.