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NCT00542178 · ClinicalTrials.gov registry record · Phase 3
Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study)
A Phase 3 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 3
- Development phase
- 3,472
- Enrollment target
NCT00542178: Completed Phase 3 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT00542178 is a Phase 3 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 3,472 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (350% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00542178, a Phase 3 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,472 participants
- Enrollment target
Study Summary
Diabetic retinopathy (DR) is an eye disease that can occur in people with diabetes and can cause poor vision or blindness. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study is examining the effect of various treatments on cardiovascular disease in people with diabetes. This current study will examine the effects of the ACCORD treatments on the progression of DR in people participating in the ACCORD study.
Primary Outcome
Diabetic retinopathy status was defined according to the eye with the highest level on the ETDRS Final Severity Scale for Persons, as follows: no diabetic retinopathy, a level of less than 20; mild diabetic retinopathy, a level of 20; moderate nonproliferative diabetic retinopathy (NPDR), a level above 20 but less than 53; severe diabetic retinopathy, a level of 53 but less than 60; and proliferative diabetic retinopathy (PDR), a level of 60 or higher.
Interventions
- DRUG Fenofibrate
- DRUG Hypoglycemic Agents
- DRUG Standard glycemia control
- DRUG Intensive BP treatment
- DRUG Standard BP control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,472 participants |
| Start Date | 2003-10 |
| Est. Completion | 2009-12 |
| Phase | Phase 3 |
What the finished NCT00542178 record still lists
NCT00542178 is an interventional study that assigns participants to a tested intervention. Its 3,472 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (350% higher).
The record links to 0 conditions, and to 5 interventions - of which Fenofibrate is the first listed.
NCT00542178 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00542178 about?
NCT00542178 is a clinical study titled "Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study)". Diabetic retinopathy (DR) is an eye disease that can occur in people with diabetes and can cause poor vision or blindness. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study is examining the effect of various treatments on cardiovascular disease in people with diabetes. This curren...
What is the current status of trial NCT00542178?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,472 participants. The study started on 2003-10. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00542178?
The interventions under investigation include: Fenofibrate (DRUG), Hypoglycemic Agents (DRUG), Standard glycemia control (DRUG), Intensive BP treatment (DRUG), Standard BP control (DRUG).
Who is sponsoring clinical trial NCT00542178?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00542178's enrollment target sits among peer trials
3,472 70th of 2000 higher than 1,931 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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