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The aim of this study is to determine if there is a pharmacological interaction between clopidogrel and different types of proton pump inhibitors (PPIs), and if the extent of this possible interaction would change over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | lansoprazole 60 mg + clopidogrel 300 mg/ 75 mg |
|
| 2 | Experimental | omeprazole 80 mg + clopidogrel 300/75 mg |
|
| 3 | Experimental | esomeprazole 40 mg + clopidogrel 300/75 mg |
|
| 4 | Experimental | clopidogrel 300/75 mg alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lansoprazole | Drug | 60 mg (2x30-mg capsule), once daily |
| |
| omeprazole |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the PK profile of clopidogrel active metabolite by assessing the inhibition of platelet aggregation (mIPA). | Baseline | |
| Assess the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the PK profile of clopidogrel active metabolite by assessing the inhibition of platelet aggregation (mIPA). | Day 2 | |
| Assess the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the PK profile of clopidogrel active metabolite by assessing the inhibition of platelet aggregation (mIPA). | Day 6 | |
| Assess the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the PK profile of clopidogrel active metabolite by assessing the inhibition of platelet aggregation (mIPA). | Day 15 | |
| Assess the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the PK profile of clopidogrel active metabolite by assessing the inhibition of platelet aggregation (mIPA). | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the PK profile of clopidogrel active metabolite by assessing the AUC, AUC 0-t and Cmax after the loading dose of clopidogrel (Day 1) and AUC 0-t, ss and Css, max. | Days 5,14, 29 | |
| Evaluate the safety and tolerability of clopidogrel given concomittantly with esomeprazole, omeprazole or lansoprazole by assessment of adverse events and calculation of change from baseline for clinical laboratory tests, vital signs and pECG. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelli Craven, MD | Quintiles, Inc. | Principal Investigator |
| Ken Price | AstraZeneca | Study Director |
| Mirjana Kujacic | AstraZeneca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24677117 | Derived | 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. |
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| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| D009853 | Omeprazole |
| D064098 | Esomeprazole |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Drug |
80 mg (2x40-mg capsule), once daily |
|
| esomeprazole | Drug | 40 mg (1x40-mg capsule), once daily |
|
| clopidogrel | Drug | 300 mg loading dose on Day 1 then 75 mg daily for 28 days |
|
| Every in-house day |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |