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NCT01144338 · ClinicalTrials.gov registry record · Phase 3
Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 14,752
- Enrollment target
NCT01144338: Completed Phase 3 study, sponsored by AstraZeneca.
NCT01144338 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 14,752 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1813% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01144338, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 14,752 participants
- Enrollment target
Study Summary
This study will compare the impact of including exenatide once weekly in addition to usual care vs. usual care without exenatide on major cardiovascular outcomes as measured by the primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction (MI), or nonfatal stroke.
Primary Outcome
The primary efficacy outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results. The primary efficacy endpoint is the same as the primary safety endpoint, and the statistical analysis tests the superiority of exenatide against the placebo.
Interventions
- DRUG Placebo
- DRUG Exenatide Once Weekly
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14,752 participants |
| Start Date | 2010-06-18 |
| Est. Completion | 2017-04-24 |
| Phase | Phase 3 |
What the finished NCT01144338 record still lists
NCT01144338 is an interventional study that assigns participants to a tested intervention. Its 14,752 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1813% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01144338 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01144338 about?
NCT01144338 is a clinical study titled "Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus". This study will compare the impact of including exenatide once weekly in addition to usual care vs. usual care without exenatide on major cardiovascular outcomes as measured by the primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction (MI), or nonfatal stroke.
What is the current status of trial NCT01144338?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 14,752 participants. The study started on 2010-06-18. Estimated completion is 2017-04-24.
What interventions are being tested in trial NCT01144338?
The interventions under investigation include: Placebo (DRUG), Exenatide Once Weekly (DRUG).
Who is sponsoring clinical trial NCT01144338?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01144338's enrollment target sits among peer trials
14,752 15th of 2000 higher than 1,986 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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