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NCT00116831 · ClinicalTrials.gov registry record · Phase 3
Rosiglitazone Versus a Sulfonylurea On Progression Of Atherosclerosis In Patients With Heart Disease And Type 2 Diabetes
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 672
- Enrollment target
NCT00116831: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00116831 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 672 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00116831, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 672 participants
- Enrollment target
Study Summary
The purpose of this study is to test the safety and effectiveness of rosiglitazone against a sulfonylurea in reducing or slowing the development of atherosclerosis in the blood vessels of the heart.
Primary Outcome
The primary efficacy endpoint was change in PAV (defined as total atheroma volume divided by total vessel volume x 100) within a 40 mm segment in non-intervened coronary arteries from Baseline to Month 18, based upon Intravascular Ultrasound (IVUS) assessment.
Interventions
- DRUG Glipizide
- DRUG rosiglitazone maleate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 672 participants |
| Start Date | 2005-01 |
| Est. Completion | 2008-08 |
| Phase | Phase 3 |
What the finished NCT00116831 record still lists
NCT00116831 is an interventional study that assigns participants to a tested intervention. The registered 672 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 (13% lower).
The record links to 0 conditions, and to 2 interventions - of which Glipizide is the first listed.
NCT00116831 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00116831 about?
NCT00116831 is a clinical study titled "Rosiglitazone Versus a Sulfonylurea On Progression Of Atherosclerosis In Patients With Heart Disease And Type 2 Diabetes". The purpose of this study is to test the safety and effectiveness of rosiglitazone against a sulfonylurea in reducing or slowing the development of atherosclerosis in the blood vessels of the heart.
What is the current status of trial NCT00116831?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 672 participants. The study started on 2005-01. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00116831?
The interventions under investigation include: Glipizide (DRUG), rosiglitazone maleate (DRUG).
Who is sponsoring clinical trial NCT00116831?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00116831's enrollment target sits among peer trials
672 544th of 2000 higher than 1,457 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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