Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01129388 · ClinicalTrials.gov registry record · Phase 1
Interaction Study of Clopidogrel 300/75 mg Given Alone or With Omeprazole 80 mg 12 Hours Apart in Healthy Subjects
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT01129388: Completed Phase 1 study, sponsored by Sanofi.
NCT01129388 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01129388, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study Summary
Primary objective: * Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given either alone in the morning, or in association with omeprazole 80 mg/day in the evening at a 12-hours interval in healthy male and female subjects Secondary Objectives: * Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone alone in the morning, or in association with omeprazole in the evening at a 12-hours interval
Interventions
- DRUG Placebo
- DRUG clopidogrel
- DRUG omeprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2009-03 |
| Est. Completion | 2009-05 |
| Phase | Phase 1 |
What the finished NCT01129388 record still lists
NCT01129388 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01129388 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01129388 about?
NCT01129388 is a clinical study titled "Interaction Study of Clopidogrel 300/75 mg Given Alone or With Omeprazole 80 mg 12 Hours Apart in Healthy Subjects". Primary objective: * Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given either alone in the morning, or in association with omeprazole 80 mg/day in the evening at a 12-hours interval in healthy ...
What is the current status of trial NCT01129388?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2009-03. Estimated completion is 2009-05.
What interventions are being tested in trial NCT01129388?
The interventions under investigation include: Placebo (DRUG), clopidogrel (DRUG), omeprazole (DRUG).
Who is sponsoring clinical trial NCT01129388?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01129388's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02359253 · 72 participants · NA
Robot Aided Rehabilitation - Intervention
- NCT02962661 · 72 participants · Phase 1
Donor Bone Marrow Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients With Cardiomyopathy Caused by Anthracyclines
- NCT03113643 · 72 participants · Phase 1
SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- NCT03187535 · 72 participants · NA
Effect of TEAS on PONV After Spinal Surgery
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia