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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 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 72 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01129388
The ClinicalTrials.gov registry entry for NCT01129388 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01129388 reports 0 study locations.
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.
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