MedDataX Logo

An Interaction Study to Evaluate the Effect of Esomeprazole/Acetylsalicylic Acid on the Metabolism and Effect of Clopidogrel

NCT ID: NCT01210339

Last Updated: 2011-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary purpose of this study is to assess whether esomeprazole 20 mg/Acetyl Salicylic Acid (ASA) 81 mg affect the metabolism of clopidogrel.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Treatment A (Clopidogrel 9 days), at least 14 days wash-out, Treatment B (Clopidogrel 4 days followed by Clopidogrel + Esomeprazole/ASA 5 days)

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

Clopidogrel

Esomeprazole/ASA

Intervention Type DRUG

20 mg/81 mg once daily for five days (Day 5-9)

2

Treatment B (Clopidogrel 4 days followed by Clopidogrel + Esomeprazole/ASA 5 days), at least 14 days wash-out, Treatment A (Clopidogrel 9 days)

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

Clopidogrel

Esomeprazole/ASA

Intervention Type DRUG

20 mg/81 mg once daily for five days (Day 5-9)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clopidogrel

Clopidogrel

Intervention Type DRUG

Esomeprazole/ASA

20 mg/81 mg once daily for five days (Day 5-9)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Axanum

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male (aged between 18 and 45 years inclusive) or female (aged between 18 and 55 years inclusive) healthy volunteers
* Female healthy volunteers must be of non-childbearing potential or be of childbearing potential, be non-lactating and have a negative pregnancy test during the pre-entry visit and be using 1 clinically accepted method of contraception
* Have a body mass index between 19 and 30 kg/m2 inclusive
* No clinically significant abnormal findings at the physical examination as judged by the investigator

Exclusion Criteria

* Any clinically significant abnormalities in laboratory screening results as judged by investigator
* Platelet count \<150 x 10\^9/L on Day -1 or any other conditions that would increase the risk of bleeding
* Previous bone marrow transplant
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter Nagy, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Uppsala, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

Andersson T, Nagy P, Niazi M, Nylander S, Galbraith H, Ranjan S, Wallentin L. Effect of esomeprazole with/without acetylsalicylic acid, omeprazole and lansoprazole on pharmacokinetics and pharmacodynamics of clopidogrel in healthy volunteers. Am J Cardiovasc Drugs. 2014 Jun;14(3):217-27. doi: 10.1007/s40256-014-0073-4.

Reference Type DERIVED
PMID: 24677117 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D961FC00010

Identifier Type: -

Identifier Source: org_study_id