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NCT00768300 · ClinicalTrials.gov registry record · Phase 3
(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF
A Phase 3 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 494
- Enrollment target
NCT00768300 is a Phase 3 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 494 participants.
The verdict
NCT00768300, a Phase 3 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 494 participants
- Enrollment target
Study Summary
The ARTEMIS-IPF study was conducted to determine if ambrisentan was effective in delaying disease progression and death in participants with idiopathic pulmonary fibrosis (IPF), to evaluate its safety, and to evaluate its effect on development of pulmonary hypertension, quality of life, and dyspnea (shortness of breath) symptoms in this participant population. Participants were randomized in a 2:1 ratio to receive ambrisentan or placebo, respectively. Participation in the study was to be up to 4 years, depending on how long it would take to enroll participants and observe study events. After randomization, visits to the clinic took place every 3 months, and laboratory procedures were performed every month.
Interventions
- DRUG Placebo
- DRUG Ambrisentan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 494 participants |
| Start Date | 2008-12 |
| Est. Completion | 2011-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00768300
The ClinicalTrials.gov registry entry for NCT00768300 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 494 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 Placebo is the first listed.
NCT00768300 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00768300 about?
NCT00768300 is a clinical study titled "(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF". The ARTEMIS-IPF study was conducted to determine if ambrisentan was effective in delaying disease progression and death in participants with idiopathic pulmonary fibrosis (IPF), to evaluate its safety, and to evaluate its effect on development of pulmonary hypertension, quality of life, and dyspnea ...
What is the current status of trial NCT00768300?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 494 participants. The study started on 2008-12. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00768300?
The interventions under investigation include: Placebo (DRUG), Ambrisentan (DRUG).
Who is sponsoring clinical trial NCT00768300?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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