A Study of the Effects of Multiple Doses of Dexlansoprazole, Lansoprazole, Omeprazole or Esomeprazole on the Pharmacokinetics and Pharmacodynamics of Clopidogrel in Healthy Participants.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00942175
First received: July 16, 2009
Last updated: February 1, 2012
Last verified: February 2012
Results First Received: May 31, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy
Interventions: Drug: Clopidogrel
Drug: Clopidogrel and Lansoprazole
Drug: Clopidogrel and Dexlansoprazole
Drug: Clopidogrel and Omeprazole
Drug: Clopidogrel and Esomeprazole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants enrolled at one site in the United States from 15 December 2009 to 08 July 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Healthy participants were enrolled in one of 4, once-daily (QD), proton pump inhibitor (PPI) treatment groups.

Reporting Groups
  Description
PPI Group 1

Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.

Regimen B: Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.

PPI Group 2

Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.

Regimen C: Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.

PPI Group 3

Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.

Regimen D: Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.

PPI Group 4

Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.

Regimen E: Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.


Participant Flow:   Overall Study
    PPI Group 1     PPI Group 2     PPI Group 3     PPI Group 4  
STARTED     40     40     40     40  
COMPLETED     38     36     38     38  
NOT COMPLETED     2     4     2     2  
Adverse Event                 2                 1                 0                 0  
Protocol Violation                 0                 1                 2                 0  
Pregnancy                 0                 0                 0                 1  
Elevated Alanine Amino Transferase                 0                 0                 0                 1  
Low Platelet Count                 0                 2                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PPI Group 1

Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.

Regimen B: Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.

PPI Group 2

Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.

Regimen C: Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.

PPI Group 3

Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.

Regimen D: Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.

PPI Group 4

Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.

Regimen E: Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.

Total Total of all reporting groups

Baseline Measures
    PPI Group 1     PPI Group 2     PPI Group 3     PPI Group 4     Total  
Number of Participants  
[units: participants]
  40     40     40     40     160  
Age  
[units: years]
Mean ± Standard Deviation
  32.8  ± 6.48     35.7  ± 7.92     34.0  ± 7.40     33.3  ± 7.10     33.9  ± 7.26  
Gender  
[units: participants]
         
Female     20     20     20     20     80  
Male     20     20     20     20     80  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pharmacokinetic Parameter Peak Plasma Concentration (Cmax) of Clopidogrel’s Active Metabolite.   [ Time Frame: Day 9 of each period ]

2.  Primary:   Pharmacokinetic Parameter Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]) of Clopidogrel’s Active Metabolite.   [ Time Frame: Day 9 of each period ]

3.  Primary:   Pharmacodynamic Parameter Platelet Reactivity Index (PRI) From Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation State (Flow Cytometry).   [ Time Frame: 24-hour post Day 9 dose in each period. ]

4.  Primary:   Pharmacodynamic Parameter Maximum Platelet Aggregation (MPA) From Aggregometry (Turbidimetric) With 5 µM Adenosine Diphosphate.   [ Time Frame: 24-hour post Day 9 dose in each period. ]

5.  Primary:   Pharmacodynamic Parameter MPA From Aggregometry (Turbidimetric) With 20 µM Adenosine Diphosphate.   [ Time Frame: 24-hour post Day 9 dose in each period. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


No publications provided by Takeda

Publications automatically indexed to this study:

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00942175     History of Changes
Other Study ID Numbers: TAK-390MR_101, U1111-1112-6792
Study First Received: July 16, 2009
Results First Received: May 31, 2011
Last Updated: February 1, 2012
Health Authority: United States: Food and Drug Administration