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NCT01129375 · ClinicalTrials.gov registry record · Phase 1

Interaction Study of Clopidogrel 300/75 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

NCT01129375 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 72 participants.

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The verdict

NCT01129375, 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 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 2009-02
Est. Completion 2009-05
Phase Phase 1

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT01129375

The ClinicalTrials.gov registry entry for NCT01129375 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.

NCT01129375 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01129375 about?

NCT01129375 is a clinical study titled "Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Omeprazole 80 mg 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 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 NCT01129375?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2009-02. Estimated completion is 2009-05.

What interventions are being tested in trial NCT01129375?

The interventions under investigation include: placebo (DRUG), clopidogrel (DRUG), omeprazole (DRUG).

Who is sponsoring clinical trial NCT01129375?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.