NCT01123824 is a Phase 1 clinical trial of CLOPIDOGREL in Healthy, sponsored by Sanofi.

Who is sponsoring NCT01123824?

NCT01123824 is sponsored by Sanofi.

What drugs are being tested in NCT01123824?

Interventions in NCT01123824: CLOPIDOGREL, placebo.

Is NCT01123824 still recruiting?

NCT01123824 is currently completed. Last updated 14 December 2011.

Last reviewed 2011-12-14 · How we verify

NCT01123824

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Double-blind, Double-dummy, Two Period, Two Treatment Cross-over Pharmacodynamic and Pharmacokinetic Study of Clopidogrel Given as 5-day Repeated Oral Doses (300 mg Loading Dose Followed by 75 mg/Day and 600 mg Loading Dose Followed by 150 mg/Day) in 4 Different Groups of CYP2C19 Genotyped Healthy Male and Female Subjects

Completed Phase 1 Last updated 14 December 2011

What this trial tests

Phase 1 trial testing CLOPIDOGREL in Healthy in 40 participants. Completed in 1 August 2009.

Timeline

1 April 2009

Primary endpoint
1 August 2009

1 August 2009

Quick facts

Lead sponsor	Sanofi
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	40
Start date	1 April 2009
Primary completion	1 August 2009
Estimated completion	1 August 2009
Sites	1 location across Germany

Drugs / interventions tested

CLOPIDOGREL (clopidogrel) — full drug profile →
placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Sanofi — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5 µM after 5 days treatment
Time frame: Day 5 of each period

Sponsor's own description

Primary Objective: * Investigate the possible role of the CYP2C19 genotype in Adenosine diphosphate (ADP)-induced platelet aggregation after administration of a standard dose regimen of clopidogrel (300 mg loading dose followed by 75 mg/day for 4 days) in healthy male and female subjects Secondary Objectives: * Assess the pharmacodynamic activity of a higher dose regimen of clopidogrel (600 mg loading dose followed by 150 mg/day for 4 days) * Compare the pharmacokinetic profiles of clopidogrel active metabolite between the selected groups of genotyped subjects and the 2 dose regimen

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effect of proton pump inhibitors on platelet inhibition activity of clopidogrel in Chinese patients with percutaneous coronary intervention.
Kwan J, Htun WW, Huang Y, Ko W, et al · · 2011 · cited 11× · PMID 21796254 · DOI 10.2147/vhrm.s22273

Verify or expand the search:

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Other Sanofi trials

Trials by the same sponsor.

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NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01123824 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanofi
Last refreshed: 14 December 2011

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01123824.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing