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NCT00687076 · ClinicalTrials.gov registry record · Phase 4
Effectiveness of Intensive Lipid Modification Medication in Preventing the Progression of Peripheral Arterial Disease (The ELIMIT Study)
A Phase 4 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 102
- Enrollment target
NCT00687076: Completed Phase 4 study, sponsored by Baylor College of Medicine.
NCT00687076 is a Phase 4 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 102 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00687076, a Phase 4 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 102 participants
- Enrollment target
Study Summary
Peripheral arterial disease (PAD) occurs when arteries become narrowed or hardened because of a build-up of plaque or fat deposits. PAD develops most often in arteries in the legs, which can result in reduced blood flow to the legs and feet, occasionally causing leg pain and fatigue. Early identification of PAD and treatment with lifestyle changes or medications can help to keep legs healthy and lower risk for heart attack and stroke, but endovascular or surgical procedures may be necessary for people with severe PAD. Even after endovascular intervention, PAD symptoms must be continually monitored to prevent the development and progression of blockages in the arteries. The best approach for monitoring symptoms is still undetermined. This study will compare the effectiveness of an intensive combination of lipid modifying medications versus standard lipid modifying medications in treating people with significant PAD who have had an endovascular intervention.
Primary Outcome
The primary outcome variable was the change in superficial femoral artery (SFA) wall volume over 24-months, as determined by MRI. The 24-month changes in SFA lumen and SFA total vessel volumes were also analyzed. Analysis details: A total of 102 patients were randomized. 87 patients completed baseline MRI. Between randomization and the baseline visit, 1 patient withdrew from the study, 8 patients opted out from baseline imaging, and 6 additional patients declined blood collection at baseline. T
Interventions
- DRUG Aspirin
- DRUG Ezetimibe
- BEHAVIORAL Standard care
- DRUG Niaspan
- DRUG Statin therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2004-04 |
| Est. Completion | 2010-12 |
| Phase | Phase 4 |
What the finished NCT00687076 record still lists
NCT00687076 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 5 interventions - of which Aspirin is the first listed.
NCT00687076 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00687076 about?
NCT00687076 is a clinical study titled "Effectiveness of Intensive Lipid Modification Medication in Preventing the Progression of Peripheral Arterial Disease (The ELIMIT Study)". Peripheral arterial disease (PAD) occurs when arteries become narrowed or hardened because of a build-up of plaque or fat deposits. PAD develops most often in arteries in the legs, which can result in reduced blood flow to the legs and feet, occasionally causing leg pain and fatigue. Early identific...
What is the current status of trial NCT00687076?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 102 participants. The study started on 2004-04. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00687076?
The interventions under investigation include: Aspirin (DRUG), Ezetimibe (DRUG), Standard care (BEHAVIORAL), Niaspan (DRUG), Statin therapy (DRUG).
Who is sponsoring clinical trial NCT00687076?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00687076's enrollment target sits among peer trials
102 764th of 2000 higher than 1,235 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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