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NCT01129427 · ClinicalTrials.gov registry record · Phase 1

Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Pantoprazole 80 mg in Healthy Subjects

A Phase 1 study, sponsored by Sanofi.

Completed
Registry status
Phase 1
Development phase
66
Enrollment target

NCT01129427 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 66 participants.

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The verdict

NCT01129427, a Phase 1 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 1
Development phase
66 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 pantoprazole 80 mg/day compared to given alone in healthy male subjects * Compare the pharmacokinetic profiles of clopidogrel active metabolite when clopidogrel is given either alone or concomitantly with pantoprazole Secondary Objective: * Compare the pharmacokinetic profiles of clopidogrel when clopidogrel is given either alone or concomitantly with pantoprazole

Interventions

  • DRUG Placebo
  • DRUG Clopidogrel
  • DRUG Pantoprazole

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2009-08
Est. Completion 2009-11
Phase Phase 1

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT01129427

The ClinicalTrials.gov registry entry for NCT01129427 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 66 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.

NCT01129427 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01129427 about?

NCT01129427 is a clinical study titled "Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Pantoprazole 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 pantoprazole 80 mg/day compared to given alone in healthy male subjects * Compare the pharmacokinetic p...

What is the current status of trial NCT01129427?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2009-08. Estimated completion is 2009-11.

What interventions are being tested in trial NCT01129427?

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

Who is sponsoring clinical trial NCT01129427?

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

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.