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NCT01129414 · ClinicalTrials.gov registry record · Phase 1

Interaction Study of Clopidogrel 600/150 mg Given Alone or Concomitantly With Omeprazole 80 mg in Healthy Subjects

A Phase 1 study, sponsored by Sanofi.

Completed
Registry status
Phase 1
Development phase
72
Enrollment target

NCT01129414: Completed Phase 1 study, sponsored by Sanofi.

NCT01129414 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.

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The verdict

NCT01129414, 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 (600 mg loading dose followed by 4 days 150 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with omeprazole 80 mg/day compared to given alone in healthy male and female subjects Secondary Objective: * Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone or concomitantly with omeprazole

Interventions

  • DRUG Placebo
  • DRUG Clopidogrel
  • DRUG Omeprazole

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2009-06
Est. Completion 2009-08
Phase Phase 1
Sanofi

713 total trials

What the finished NCT01129414 record still lists

NCT01129414 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.

NCT01129414 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01129414 about?

NCT01129414 is a clinical study titled "Interaction Study of Clopidogrel 600/150 mg Given Alone or Concomitantly With Omeprazole 80 mg in Healthy Subjects". Primary objective: * Assess the effects of clopidogrel (600 mg loading dose followed by 4 days 150 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with omeprazole 80 mg/day compared to given alone in healthy male and female subjects Secondary Objective:...

What is the current status of trial NCT01129414?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2009-06. Estimated completion is 2009-08.

What interventions are being tested in trial NCT01129414?

The interventions under investigation include: Placebo (DRUG), Clopidogrel (DRUG), Omeprazole (DRUG).

Who is sponsoring clinical trial NCT01129414?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01129414'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

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Source: ClinicalTrials.gov NCT01129414, the US trial registry maintained by the National Library of Medicine. NCT01129414 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.