HealthyPhase 1NCT01129375
Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Omeprazole 80 mg in Healthy Subjects
A Phase 1 study testing clopidogrel and omeprazole in people with Healthy, run by Sanofi at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- clopidogrel and omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to May 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Evidence of inherited disorder of coagulation/hemostasis functions
- Smoking more than 5 cigarettes or equivalent per day
- Abnormal hemostasis screen
- unability to abstain from intake of any drug affecting hemostasis throughout the whole study duration
- Any contraindication to clopidogrel and/or omeprazole
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: A Randomized, Placebo-controlled, Two-period, Two-treatment, Two Sequence, Cross-over Pharmacodynamic and Pharmacokinetic Interaction Study After 5-days Repeated Oral Doses of Clopidogrel (300 mg Loading Dose Followed by 75 mg/Day) Alone or Given Concomitantly With Omeprazole 80 mg/Day in Healthy Male and Female 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:
- Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone or concomitantly with omeprazole
Read the detailed description
The total study duration per subjects is 8 - 9 weeks broken down as follows:
- Screening: 2 to 21 days before the first dosing
- Period clopidogrel/placebo: 7 days including 5 days treatment
- Period clopidogrel/placebo + omeprazole: 12 days including 10 days treatment
- Washout between periods: at least 14 days after last dosing with respect to clopidogrel treatment
- End of study: 7 to 10 days after the last dosing
- Conditions
- Healthy
- Being tested
- clopidogrel, placebo, omeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrelDrug
Also called SR25990
Pharmaceutical form: tablet
Route of administration: oral
placeboDrug
Pharmaceutical form: matching tablet
Route of administration: oral
omeprazoleDrug
Pharmaceutical form: delayed-release capsule
Route of administration:oral
| Study group | Role | What they receive |
|---|---|---|
| Group clopidogrel - clopidogrel + omeprazole | Experimental | Period 1:
* Day 1: clopidogrel 300 mg loading dose
* Day 2 to Day 5: clopidogrel 75 mg, once daily
Period 2:
* Day -5 to Day -1: omeprazole 80 mg, once daily
* Day 1: clopidogrel 300 mg loading dose + omeprazole 80 mg concomitantly
* Day 2 to Day 5: clopidogrel 75 mg + omeprazole 80 mg concomitantly, once daily
Each intake is under fasted conditions Receives: Drug: clopidogrel; Drug: omeprazole |
| Group placebo - placebo + omeprazole | Placebo comparator | Period 1:
* Day 1: placebo loading dose
* Day 2 to Day 5: placebo, once daily
Period 2:
* Day -5 to Day -1: omeprazole 80 mg, once daily
* Day 1: placebo loading dose + omeprazole 80 mg concomitantly
* Day 2 to Day 5: placebo + omeprazole 80 mg concomitantly, once daily
Each intake is under fasted conditions Receives: Drug: placebo; Drug: omeprazole |
| Group clopidogrel + omeprazole - clopidogrel | Experimental | Period 1:
* Day -5 to Day -1: omeprazole 80 mg, once daily
* Day 1: clopidogrel 300 mg loading dose + omeprazole 80 mg concomitantly
* Day 2 to Day 5: clopidogrel 75 mg + omeprazole 80 mg concomitantly, once daily
Period 2:
* Day 1: clopidogrel 300 mg loading dose
* Day 2 to Day 5: clopidogrel 75 mg, once daily
Each intake is under fasted conditions Receives: Drug: clopidogrel; Drug: omeprazole |
| Group placebo + omeprazole placebo | Placebo comparator | Period 1:
* Day -5 to Day -1: omeprazole 80 mg, once daily
* Day 1: placebo loading dose + omeprazole 80 mg concomitantly
* Day 2 to Day 5: placebo + omeprazole 80 mg concomitantly, once daily
Period 2:
* Day 1: placebo loading dose
* Day 2 to Day 5: placebo, once daily
Each intake is under fasted conditions Receives: Drug: placebo; Drug: omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5µM after 5 days treatment
Measured: Day 5 of each period
Secondary outcomes (4)
Maximum platelet aggregation intensity (MAI) induced by ADP 20µM after 5 days treatment
Measured: Day 5 of each period
Platelet Reactivity Index - Vasodilatator-stimulated phosphoprotein test (PRI - VASP) after 5 days treatment
Measured: Day 5 of each period
Clopidogrel pharmacokinetic parameters (maximum plasma concentration (Cmax) and area under the plasma concentration curve (AUC0-24)) after 5 days treatment
Measured: Up to 24 hours postdose on Day 5 for each period
Clopidogrel active metabolite pharmacokinetic parameters (Cmax and AUC0- 24) after 5 days treatment
Measured: Up to 24 hours postdose on Day 5 for each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startFeb 2009
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- International Clinical Development Study Director, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129375
- Sponsor's protocol ID
- INT11146
- Status last verified
- Dec 2011
- First submitted
- 21 May 2010
- Last updated
- 15 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Angiolillo DJ, Gibson CM, Cheng S, Ollier C, Nicolas O, Bergougnan L, Perrin L, LaCreta FP, Hurbin F, Dubar M. Differential effects of omeprazole and pantoprazole on the pharmacodynamics and pharmacokinetics of clopidogrel in healthy subjects: randomized, placebo-controlled, crossover comparison studies. Clin Pharmacol Ther. 2011 Jan;89(1):65-74. doi: 10.1038/clpt.2010.219. Epub 2010 Sep 15.
PubMed 20844485
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Two-period, Two-treatment, Two Sequence, Cross-over Pharmacodynamic and Pharmacokinetic Interaction Study After 5-days Repeated Oral Doses of Clopidogrel (300 mg Loading Dose Followed by 75 mg/Day) Alone or Given Concomitantly With Omeprazole 80 mg/Day in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT01129375
- Acronym / sponsor ID
- INT11146
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Feb 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The total study duration per subjects is 8 - 9 weeks broken down as follows:
- Screening: 2 to 21 days before the first dosing
- Period clopidogrel/placebo: 7 days including 5 days treatment
- Period clopidogrel/placebo + omeprazole: 12 days including 10 days treatment
- Washout between periods: at least 14 days after last dosing with respect to clopidogrel treatment
- End of study: 7 to 10 days after the last dosing
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group clopidogrel - clopidogrel + omeprazole | Experimental | Drug: clopidogrel, Drug: omeprazolePeriod 1: * Day 1: clopidogrel 300 mg loading dose * Day 2 to Day 5: clopidogrel 75 mg, once daily Period 2: * Day -5 to Day -1: omeprazole 80 mg, once daily * Day 1: clopidogrel 300 mg loading dose + omeprazole 80 mg concomitantly * Day 2 to Day 5: clopidogrel 75 mg + omeprazole 80 mg concomitantly, once daily Each intake is under fasted conditions |
| Group placebo - placebo + omeprazole | Placebo comparator | Drug: placebo, Drug: omeprazolePeriod 1: * Day 1: placebo loading dose * Day 2 to Day 5: placebo, once daily Period 2: * Day -5 to Day -1: omeprazole 80 mg, once daily * Day 1: placebo loading dose + omeprazole 80 mg concomitantly * Day 2 to Day 5: placebo + omeprazole 80 mg concomitantly, once daily Each intake is under fasted conditions |
| Group clopidogrel + omeprazole - clopidogrel | Experimental | Drug: clopidogrel, Drug: omeprazolePeriod 1: * Day -5 to Day -1: omeprazole 80 mg, once daily * Day 1: clopidogrel 300 mg loading dose + omeprazole 80 mg concomitantly * Day 2 to Day 5: clopidogrel 75 mg + omeprazole 80 mg concomitantly, once daily Period 2: * Day 1: clopidogrel 300 mg loading dose * Day 2 to Day 5: clopidogrel 75 mg, once daily Each intake is under fasted conditions |
| Group placebo + omeprazole placebo | Placebo comparator | Drug: placebo, Drug: omeprazolePeriod 1: * Day -5 to Day -1: omeprazole 80 mg, once daily * Day 1: placebo loading dose + omeprazole 80 mg concomitantly * Day 2 to Day 5: placebo + omeprazole 80 mg concomitantly, once daily Period 2: * Day 1: placebo loading dose * Day 2 to Day 5: placebo, once daily Each intake is under fasted conditions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Evidence of inherited disorder of coagulation/hemostasis functions
- Smoking more than 5 cigarettes or equivalent per day
- Abnormal hemostasis screen
- unability to abstain from intake of any drug affecting hemostasis throughout the whole study duration
- Any contraindication to clopidogrel and/or omeprazole
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clopidogrelAlso: SR25990Pharmaceutical form: tablet Route of administration: oral | Drug | Group clopidogrel + omeprazole - clopidogrel, Group clopidogrel - clopidogrel + omeprazole |
| placeboPharmaceutical form: matching tablet Route of administration: oral | Drug | Group placebo + omeprazole placebo, Group placebo - placebo + omeprazole |
| omeprazolePharmaceutical form: delayed-release capsule Route of administration:oral | Drug | Group clopidogrel + omeprazole - clopidogrel, Group clopidogrel - clopidogrel + omeprazole, Group placebo + omeprazole placebo, Group placebo - placebo + omeprazole |
Primary outcome
Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5µM after 5 days treatment
Time frame: Day 5 of each period
4 secondary outcomes
Maximum platelet aggregation intensity (MAI) induced by ADP 20µM after 5 days treatment
Time frame: Day 5 of each period
Platelet Reactivity Index - Vasodilatator-stimulated phosphoprotein test (PRI - VASP) after 5 days treatment
Time frame: Day 5 of each period
Clopidogrel pharmacokinetic parameters (maximum plasma concentration (Cmax) and area under the plasma concentration curve (AUC0-24)) after 5 days treatment
Time frame: Up to 24 hours postdose on Day 5 for each period
Clopidogrel active metabolite pharmacokinetic parameters (Cmax and AUC0- 24) after 5 days treatment
Time frame: Up to 24 hours postdose on Day 5 for each period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2011.
- Results publication: PubMed 20844485Angiolillo DJ, Gibson CM, Cheng S, Ollier C, Nicolas O, Bergougnan L, Perrin L, LaCreta FP, Hurbin F, Dubar M. Differential effects of omeprazole and pantoprazole on the pharmacodynamics and pharmacokinetics of clopidogrel in healthy subjects: randomized, placebo-controlled, crossover comparison studies. Clin Pharmacol Ther. 2011 Jan;89(1):65-74. doi: 10.1038/clpt.2010.219. Epub 2010 Sep 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
International Clinical Development Study Director study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing clopidogrel and omeprazole in people with Healthy, run by Sanofi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5µM after 5 days treatment (time frame: Day 5 of each period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01129375, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2011.