ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00942175
Recruitment Status : Completed
First Posted : July 20, 2009
Results First Posted : September 7, 2011
Last Update Posted : February 3, 2012
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Healthy
Interventions Drug: Clopidogrel
Drug: Clopidogrel and Lansoprazole
Drug: Clopidogrel and Dexlansoprazole
Drug: Clopidogrel and Omeprazole
Drug: Clopidogrel and Esomeprazole
Enrollment 160
Recruitment Details Participants enrolled at one site in the United States from 15 December 2009 to 08 July 2010.
Pre-assignment Details Healthy participants were enrolled in one of 4, once-daily (QD), proton pump inhibitor (PPI) treatment groups.
Arm/Group Title PPI Group 1 PPI Group 2 PPI Group 3 PPI Group 4
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
Started 40 40 40 40
Completed 38 36 38 38
Not Completed 2 4 2 2
Reason Not Completed
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
Arm/Group Title PPI Group 1 PPI Group 2 PPI Group 3 PPI Group 4 Total
Hide Arm/Group Description

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.

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 40 40 40 40 160
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 40 participants 40 participants 160 participants
32.8  (6.48) 35.7  (7.92) 34.0  (7.40) 33.3  (7.10) 33.9  (7.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 40 participants 40 participants 160 participants
Female
20
  50.0%
20
  50.0%
20
  50.0%
20
  50.0%
80
  50.0%
Male
20
  50.0%
20
  50.0%
20
  50.0%
20
  50.0%
80
  50.0%
1.Primary Outcome
Title Pharmacokinetic Parameter Peak Plasma Concentration (Cmax) of Clopidogrel’s Active Metabolite.
Hide Description Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time Frame Day 9 of each period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had valid parameter estimates for both regimens within a PPI group were included in the pharmacokinetics (PK) statistical analyses for this parameter.
Arm/Group Title PPI Group 1: Regimen A PPI Group 1: Regimen B PPI Group 2: Regimen A PPI Group 2: Regimen C PPI Group 3: Regimen A PPI Group 3: Regimen D PPI Group 4: Regimen A PPI Group 4: Regimen E
Hide Arm/Group Description:
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
Overall Number of Participants Analyzed 38 38 36 36 38 38 38 38
Mean (Standard Deviation)
Unit of Measure: ng/mL
39.14  (12.553) 30.01  (15.264) 38.85  (15.699) 29.33  (12.400) 38.25  (12.461) 22.55  (10.682) 40.98  (22.908) 24.69  (10.641)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PPI Group 1: Regimen A, PPI Group 1: Regimen B
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.7000
Confidence Interval (2-Sided) 90%
0.6106 to 0.8026
Estimation Comments The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PPI Group 2: Regimen A, PPI Group 2: Regimen C
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.7340
Confidence Interval (2-Sided) 90%
0.6516 to 0.8269
Estimation Comments The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PPI Group 3: Regimen A, PPI Group 3: Regimen D
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.5564
Confidence Interval (2-Sided) 90%
0.4877 to 0.6347
Estimation Comments The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PPI Group 4: Regimen A, PPI Group 4: Regimen E
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.6783
Confidence Interval (2-Sided) 90%
0.5063 to 0.9087
Estimation Comments The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.
2.Primary Outcome
Title 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.
Hide Description Area under the plasma concentration versus time curve (AUC(0-tlqc)) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).
Time Frame Day 9 of each period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had valid parameter estimates for both formulations within PPI groups were included in the PK statistical analyses for those parameters.
Arm/Group Title PPI Group 1: Regimen A PPI Group 1: Regimen B PPI Group 2: Regimen A PPI Group 2: Regimen C PPI Group 3: Regimen A PPI Group 3: Regimen D PPI Group 4: Regimen A PPI Group 4: Regimen E
Hide Arm/Group Description:
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
Overall Number of Participants Analyzed 38 38 36 36 38 38 38 38
Mean (Standard Deviation)
Unit of Measure: ng*hr/ML
41.69  (10.020) 36.42  (10.825) 41.25  (14.690) 37.75  (13.132) 37.78  (12.043) 26.28  (8.800) 42.35  (18.785) 31.23  (9.938)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PPI Group 1: Regimen A, PPI Group 1: Regimen B
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.8573
Confidence Interval (2-Sided) 90%
0.8020 to 0.9165
Estimation Comments The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PPI Group 2: Regimen A, PPI Group 2: Regimen C
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.9103
Confidence Interval (2-Sided) 90%
0.8567 to 0.9672
Estimation Comments The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PPI Group 3: Regimen A, PPI Group 3: Regimen D
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.6943
Confidence Interval (2-Sided) 90%
0.6438 to 0.7487
Estimation Comments The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PPI Group 4: Regimen A, PPI Group 4: Regimen E
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.8389
Confidence Interval (2-Sided) 90%
0.6440 to 1.0928
Estimation Comments The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.
3.Primary Outcome
Title Pharmacodynamic Parameter Platelet Reactivity Index (PRI) From Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation State (Flow Cytometry).
Hide Description PRI is the platelet reactivity index from VASP phosphorylation state (flow cytometry).
Time Frame 24-hour post Day 9 dose in each period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had valid parameter estimates for both regimens within a PPI group were included in the pharmacodynamics (PD) statistical analyses for this parameter.
Arm/Group Title PPI Group 1: Regimen A PPI Group 1: Regimen B PPI Group 2: Regimen A PPI Group 2: Regimen C PPI Group 3: Regimen A PPI Group 3: Regimen D PPI Group 4: Regimen A PPI Group 4: Regimen E
Hide Arm/Group Description:
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
Overall Number of Participants Analyzed 38 38 36 36 38 38 38 38
Mean (Standard Deviation)
Unit of Measure: percent inhibition
42.3  (14.61) 46.4  (16.44) 41.3  (15.45) 43.0  (16.47) 47.9  (15.70) 59.1  (17.87) 46.5  (17.28) 58.0  (14.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PPI Group 1: Regimen A, PPI Group 1: Regimen B
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.1016
Confidence Interval (2-Sided) 90%
0.0348 to 8.1684
Estimation Comments Included only participants with complete data for both regimens. Values are least squares mean difference.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PPI Group 2: Regimen A, PPI Group 2: Regimen C
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.0474
Confidence Interval (2-Sided) 90%
-0.8555 to 4.9503
Estimation Comments Included only participants with complete data for both regimens. Values are least squares mean difference.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PPI Group 3: Regimen A, PPI Group 3: Regimen D
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.0407
Confidence Interval (2-Sided) 90%
6.5219 to 15.5595
Estimation Comments Included only participants with complete data for both regimens. Values are least squares mean difference.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PPI Group 4: Regimen A, PPI Group 4: Regimen E
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.4437
Confidence Interval (2-Sided) 90%
7.1791 to 15.7083
Estimation Comments Included only participants with complete data for both regimens. Values are least squares mean difference.
4.Primary Outcome
Title Pharmacodynamic Parameter Maximum Platelet Aggregation (MPA) From Aggregometry (Turbidimetric) With 5 µM Adenosine Diphosphate.
Hide Description Maximum platelet aggregation (MPA) from aggregometry (turbidimetric) with 5 µM adenosine diphosphate.
Time Frame 24-hour post Day 9 dose in each period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had valid parameter estimates for both formulations within PPI groups were included in the PD statistical analyses for those parameters.
Arm/Group Title PPI Group 1: Regimen A PPI Group 1: Regimen B PPI Group 2: Regimen A PPI Group 2: Regimen C PPI Group 3: Regimen A PPI Group 3: Regimen D PPI Group 4: Regimen A PPI Group 4: Regimen E
Hide Arm/Group Description:
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
Overall Number of Participants Analyzed 38 38 36 36 37 37 38 38
Mean (Standard Deviation)
Unit of Measure: percentage of MPA
28.1  (6.76) 30.8  (9.35) 34.6  (14.23) 36.2  (16.87) 34.2  (12.32) 42.5  (14.74) 29.3  (10.41) 38.2  (17.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PPI Group 1: Regimen A, PPI Group 1: Regimen B
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments From ANOVA models in which the least-square means between two regimens are compared.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PPI Group 2: Regimen A, PPI Group 2: Regimen C
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.445
Comments From ANOVA models in which the least-square means between two regimens are compared.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PPI Group 3: Regimen A, PPI Group 3: Regimen D
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments From ANOVA models in which the least-square means between two regimens are compared.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PPI Group 4: Regimen A, PPI Group 4: Regimen E
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments From ANOVA models in which the least-square means between two regimens are compared.
Method ANOVA
Comments [Not Specified]
5.Primary Outcome
Title Pharmacodynamic Parameter MPA From Aggregometry (Turbidimetric) With 20 µM Adenosine Diphosphate.
Hide Description MPA from aggregometry (turbidimetric) with 20 µM adenosine diphosphate.
Time Frame 24-hour post Day 9 dose in each period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had valid parameter estimates for both formulations within PPI groups were included in the PK and PD statistical analyses for those parameters.
Arm/Group Title PPI Group 1: Regimen A PPI Group 1: Regimen B PPI Group 2: Regimen A PPI Group 2: Regimen C PPI Group 3: Regimen A PPI Group 3: Regimen D PPI Group 4: Regimen A PPI Group 4: Regimen E
Hide Arm/Group Description:
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
Overall Number of Participants Analyzed 38 38 36 36 37 37 38 38
Mean (Standard Deviation)
Unit of Measure: percentage of MPA
36.7  (9.11) 41.6  (12.65) 43.1  (13.24) 46.3  (16.93) 43.5  (14.00) 53.5  (13.75) 39.3  (13.22) 47.9  (15.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PPI Group 1: Regimen A, PPI Group 1: Regimen B
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments From ANOVA models in which the least-square means between two regimens are compared.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PPI Group 2: Regimen A, PPI Group 2: Regimen C
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.148
Comments From ANOVA models in which the least-square means between two regimens are compared.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PPI Group 3: Regimen A, PPI Group 3: Regimen D
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments From ANOVA models in which the least-square means between two regimens are compared.
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PPI Group 4: Regimen A, PPI Group 4: Regimen E
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments From ANOVA models in which the least-square means between two regimens are compared.
Method ANOVA
Comments [Not Specified]
Time Frame Treatment-emergent adverse events are adverse events that started or worsened after the first dose of study drug and within 30 days after the last dose of study drug.
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study drug.
 
Arm/Group Title PPI Group 1: Regimen A PPI Group 1: Regimen B PPI Group 2: Regimen A PPI Group 2: Regimen C PPI Group 3: Regimen A PPI Group 3: Regimen D PPI Group 4: Regimen A PPI Group 4: Regimen E
Hide Arm/Group Description Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days. Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days. Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days. Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days. Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days. Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days. Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days. Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
All-Cause Mortality
PPI Group 1: Regimen A PPI Group 1: Regimen B PPI Group 2: Regimen A PPI Group 2: Regimen C PPI Group 3: Regimen A PPI Group 3: Regimen D PPI Group 4: Regimen A PPI Group 4: Regimen E
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PPI Group 1: Regimen A PPI Group 1: Regimen B PPI Group 2: Regimen A PPI Group 2: Regimen C PPI Group 3: Regimen A PPI Group 3: Regimen D PPI Group 4: Regimen A PPI Group 4: Regimen E
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%)   1/40 (2.50%)   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%) 
Investigations                 
Serum sickness-like reaction  1  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PPI Group 1: Regimen A PPI Group 1: Regimen B PPI Group 2: Regimen A PPI Group 2: Regimen C PPI Group 3: Regimen A PPI Group 3: Regimen D PPI Group 4: Regimen A PPI Group 4: Regimen E
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/39 (33.33%)   16/39 (41.03%)   19/39 (48.72%)   16/38 (42.11%)   14/40 (35.00%)   11/38 (28.95%)   17/39 (43.59%)   15/39 (38.46%) 
Eye disorders                 
Ocular hyperaemia  1  0/39 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  2/38 (5.26%)  0/40 (0.00%)  0/38 (0.00%)  1/39 (2.56%)  0/39 (0.00%) 
Lacrimation increased  1  0/39 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  2/40 (5.00%)  0/38 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Gastrointestinal disorders                 
Abdominal pain upper  1  0/39 (0.00%)  2/39 (5.13%)  1/39 (2.56%)  1/38 (2.63%)  0/40 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  2/39 (5.13%) 
Nausea  1  3/39 (7.69%)  3/39 (7.69%)  5/39 (12.82%)  1/38 (2.63%)  1/40 (2.50%)  0/38 (0.00%)  0/39 (0.00%)  1/39 (2.56%) 
Abdominal pain lower  1  0/39 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  2/38 (5.26%)  1/40 (2.50%)  1/38 (2.63%)  3/39 (7.69%)  0/39 (0.00%) 
Constipation  1  1/39 (2.56%)  0/39 (0.00%)  2/39 (5.13%)  1/38 (2.63%)  1/40 (2.50%)  1/38 (2.63%)  1/39 (2.56%)  2/39 (5.13%) 
Toothache  1  0/39 (0.00%)  1/39 (2.56%)  1/39 (2.56%)  2/38 (5.26%)  0/40 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Abdominal pain  1  0/39 (0.00%)  1/39 (2.56%)  0/39 (0.00%)  2/38 (5.26%)  2/40 (5.00%)  1/38 (2.63%)  3/39 (7.69%)  1/39 (2.56%) 
Abdominal distension  1  0/39 (0.00%)  1/39 (2.56%)  1/39 (2.56%)  1/38 (2.63%)  0/40 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  2/39 (5.13%) 
General disorders                 
Feeling Hot  1  2/39 (5.13%)  1/39 (2.56%)  0/39 (0.00%)  0/38 (0.00%)  0/40 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Vessel puncture site pain  1  0/39 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/38 (0.00%)  0/40 (0.00%)  2/38 (5.26%)  0/39 (0.00%)  0/39 (0.00%) 
Infections and infestations                 
Upper respiratory tract infection  1  0/39 (0.00%)  2/39 (5.13%)  1/39 (2.56%)  0/38 (0.00%)  1/40 (2.50%)  0/38 (0.00%)  0/39 (0.00%)  1/39 (2.56%) 
Musculoskeletal and connective tissue disorders                 
Back pain  1  3/39 (7.69%)  1/39 (2.56%)  0/39 (0.00%)  1/38 (2.63%)  2/40 (5.00%)  1/38 (2.63%)  2/39 (5.13%)  0/39 (0.00%) 
Arthralgia  1  0/39 (0.00%)  0/39 (0.00%)  2/39 (5.13%)  0/38 (0.00%)  0/40 (0.00%)  1/38 (2.63%)  0/39 (0.00%)  1/39 (2.56%) 
Myalgia  1  1/39 (2.56%)  0/39 (0.00%)  1/39 (2.56%)  0/38 (0.00%)  0/40 (0.00%)  0/38 (0.00%)  1/39 (2.56%)  2/39 (5.13%) 
Pain in extremity  1  1/39 (2.56%)  0/39 (0.00%)  0/39 (0.00%)  1/38 (2.63%)  1/40 (2.50%)  0/38 (0.00%)  0/39 (0.00%)  4/39 (10.26%) 
Nervous system disorders                 
Headache  1  3/39 (7.69%)  4/39 (10.26%)  5/39 (12.82%)  7/38 (18.42%)  2/40 (5.00%)  6/38 (15.79%)  6/39 (15.38%)  4/39 (10.26%) 
Dizziness  1  1/39 (2.56%)  1/39 (2.56%)  0/39 (0.00%)  3/38 (7.89%)  1/40 (2.50%)  0/38 (0.00%)  2/39 (5.13%)  2/39 (5.13%) 
Somnolence  1  1/39 (2.56%)  1/39 (2.56%)  2/39 (5.13%)  1/38 (2.63%)  1/40 (2.50%)  2/38 (5.26%)  0/39 (0.00%)  0/39 (0.00%) 
Psychiatric disorders                 
Anxiety  1  1/39 (2.56%)  0/39 (0.00%)  1/39 (2.56%)  1/38 (2.63%)  0/40 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  2/39 (5.13%) 
Reproductive system and breast disorders                 
Menorrhagia  1  0/39 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  1/38 (2.63%)  1/40 (2.50%)  0/38 (0.00%)  2/39 (5.13%)  0/39 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Epistaxis  1  1/39 (2.56%)  0/39 (0.00%)  2/39 (5.13%)  1/38 (2.63%)  2/40 (5.00%)  0/38 (0.00%)  3/39 (7.69%)  2/39 (5.13%) 
Oropharyngeal pain  1  1/39 (2.56%)  1/39 (2.56%)  0/39 (0.00%)  2/38 (5.26%)  0/40 (0.00%)  0/38 (0.00%)  1/39 (2.56%)  0/39 (0.00%) 
Skin and subcutaneous tissue disorders                 
Ecchymosis  1  3/39 (7.69%)  1/39 (2.56%)  3/39 (7.69%)  3/38 (7.89%)  4/40 (10.00%)  2/38 (5.26%)  2/39 (5.13%)  0/39 (0.00%) 
Pruritus generalized  1  2/39 (5.13%)  1/39 (2.56%)  0/39 (0.00%)  1/38 (2.63%)  1/40 (2.50%)  1/38 (2.63%)  2/39 (5.13%)  1/39 (2.56%) 
Acne  1  0/39 (0.00%)  1/39 (2.56%)  1/39 (2.56%)  2/38 (5.26%)  0/40 (0.00%)  0/38 (0.00%)  1/39 (2.56%)  1/39 (2.56%) 
Pruritus  1  1/39 (2.56%)  0/39 (0.00%)  4/39 (10.26%)  0/38 (0.00%)  1/40 (2.50%)  0/38 (0.00%)  1/39 (2.56%)  0/39 (0.00%) 
Rash papular  1  1/39 (2.56%)  1/39 (2.56%)  2/39 (5.13%)  0/38 (0.00%)  0/40 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
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.
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights therefrom or any data, information or materials obtained or generated in the performance of it’s obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda’s sole discretion.
Results Point of Contact
Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00942175     History of Changes
Other Study ID Numbers: TAK-390MR_101
U1111-1112-6792 ( Registry Identifier: WHO )
First Submitted: July 16, 2009
First Posted: July 20, 2009
Results First Submitted: May 31, 2011
Results First Posted: September 7, 2011
Last Update Posted: February 3, 2012