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NCT00353574 · ClinicalTrials.gov registry record · Phase 3

DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension

A Phase 3 study, sponsored by Gilead Sciences.

Terminated
Registry status
Phase 3
Development phase
282
Enrollment target

NCT00353574: Clinical Trial Phase 3 study, sponsored by Gilead Sciences.

NCT00353574 is a Phase 3 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 282 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00353574, a Phase 3 study, was terminated before completion, sponsored by Gilead Sciences.

TERMINATED
Registry status
Phase 3
Development phase
282 participants
Enrollment target

Study Summary

This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the United States (U.S.) Food and Drug Administration (FDA) for use in the U.S., which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan in subjects with resistant systolic hypertension despite treatment with full doses of three or more antihypertensive medications, including a diuretic.

Interventions

  • DRUG Darusentan

Trial Details

FieldValue
Enrollment Target 282 participants
Start Date 2006-09
Est. Completion 2010-04
Phase Phase 3
Gilead Sciences

504 total trials

Why NCT00353574 stopped before completion

NCT00353574 is an interventional study that assigns participants to a tested intervention. The registered 282 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower).

The record links to 0 conditions, and to 1 intervention - of which Darusentan is the first listed.

NCT00353574 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00353574 about?

NCT00353574 is a clinical study titled "DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension". This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the United States (U.S.) Food and Drug Administration (FDA) for use in the U.S., which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term...

What is the current status of trial NCT00353574?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 282 participants. The study started on 2006-09. Estimated completion is 2010-04.

What interventions are being tested in trial NCT00353574?

The interventions under investigation include: Darusentan (DRUG).

Who is sponsoring clinical trial NCT00353574?

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

How this trial's enrollment target compares

Where NCT00353574's enrollment target sits among peer trials

282 1194th of 2000 higher than 807 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00353574, the US trial registry maintained by the National Library of Medicine. NCT00353574 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.