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NCT01303445 · ClinicalTrials.gov registry record · Phase 1

Drug-drug Interaction Study of Aggrenox and Omeprazole in Normal Volunteers

A Phase 1 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 1
Development phase
60
Enrollment target

NCT01303445 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 60 participants.

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The verdict

NCT01303445, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target

Study Summary

The objective of the current study is to investigate if a drug-drug interaction occurs with the administration of omeprazole 80 mg q.d. at steady state on the pharmacokinetics of dipyridamole and the pharmacodynamics of ASA-induced platelet aggregation inhibition (components of Aggrenox®) when administered every 12 hours at steady state.

Interventions

  • DRUG Aggrenox alone
  • DRUG Aggrenox and omeprazole
  • DRUG Omeprazole alone

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2011-03
Phase Phase 1

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT01303445

The ClinicalTrials.gov registry entry for NCT01303445 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Aggrenox alone is the first listed.

NCT01303445 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01303445 about?

NCT01303445 is a clinical study titled "Drug-drug Interaction Study of Aggrenox and Omeprazole in Normal Volunteers". The objective of the current study is to investigate if a drug-drug interaction occurs with the administration of omeprazole 80 mg q.d. at steady state on the pharmacokinetics of dipyridamole and the pharmacodynamics of ASA-induced platelet aggregation inhibition (components of Aggrenox®) when admin...

What is the current status of trial NCT01303445?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2011-03.

What interventions are being tested in trial NCT01303445?

The interventions under investigation include: Aggrenox alone (DRUG), Aggrenox and omeprazole (DRUG), Omeprazole alone (DRUG).

Who is sponsoring clinical trial NCT01303445?

This trial is sponsored by Boehringer Ingelheim, which has 515 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.