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NCT00501059 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
A Phase 3 study of Moderate Risk of CVD, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 12,546
- Enrollment target
- 20
- Study locations
NCT00501059: Completed Phase 3 study of Moderate Risk of CVD, sponsored by Bayer.
NCT00501059 is a Phase 3 study of Moderate Risk of CVD that has completed, run by Bayer. The registered enrollment target is 12,546 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1527% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00501059, a Phase 3 study of Moderate Risk of CVD, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 12,546 participants
- Enrollment target
- 20
- Study locations
Study Summary
The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied but to a lesser extent in patients with moderate levels of cardiovascular risk. The current study is designed to prove the efficacy and tolerability of 100 mg enteric-coated Aspirin versus placebo in the prevention of cardiovascular disease (CVD) events, which include fatal and nonfatal myocardial infarction, fatal and nonfatal stroke and CV death, in a population with no history of known CVD who are at moderate risk of major CHD events (approximately 10-20% 10 year CHD risk). This corresponds to a patient population mean 10-year CVD risk of approximately 30%. Subjects are treated in a standard care setting and may receive treatment for the underlying risk factors as defined by the treating physician. Outcome events will be adjudicated by an Endpoint Adjudication Committee and the study will be monitored by an independent Data Safety Monitoring Board.
Primary Outcome
The primary efficacy endpoint was a composite outcome consisting of the first occurrence of confirmed MI, stroke, cardiovascular death, UA, TIA. The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Aspirin (Acetylsalicylic acid, BAYE4465)
Study Locations (20)
California
- - Fremont
- - Huntington Park
- - Los Angeles
- - Rancho Cucamonga
- - Rolling Hills Estates
- Helping Hands Clinical Trials - Santa Ana
Florida
- Medical Research Trust - Boynton Beach
- - Gainesville
- - Hialeah
- Medical Research Centers of South Florida, Inc. - Hollywood
- Office of Dr.Larry Levinson, DO - Hollywood
- - Kissimmee
Alabama
- - Birmingham
- - Graysville
- - Pell City
Arizona
- - Phoenix
- - Scottsdale
- - Tucson
Arkansas
- - Hot Springs
Delaware
- - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12,546 participants |
| Start Date | 2007-07-05 |
| Est. Completion | 2016-11-15 |
| Phase | Phase 3 |
What the finished NCT00501059 record still lists
NCT00501059 is an interventional study that assigns participants to a tested intervention. Its 12,546 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 (1527% higher).
The record links to 1 condition, with Moderate Risk of CVD appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00501059 names 20 study sites across 6 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT00501059 about?
NCT00501059 is a clinical study titled "A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease". The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied but to a lesser extent in patients with moderate levels of cardiovascular risk. The current study is designed to prove the efficacy and tolerability of 100 mg enteric-coated Aspirin versus...
What is the current status of trial NCT00501059?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 12,546 participants. The study started on 2007-07-05. Estimated completion is 2016-11-15.
What conditions does trial NCT00501059 study?
This clinical trial studies the following conditions: Moderate Risk of CVD.
What interventions are being tested in trial NCT00501059?
The interventions under investigation include: Placebo (DRUG), Aspirin (Acetylsalicylic acid, BAYE4465) (DRUG).
Who is sponsoring clinical trial NCT00501059?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00501059 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00501059's enrollment target sits among peer trials
12,546 20th of 2000 higher than 1,981 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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