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Clopidogrel Bioequivalence Study in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02185534
Recruitment Status : Completed
First Posted : July 9, 2014
Results First Posted : November 30, 2015
Last Update Posted : June 22, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Bioequivalence, AUC, Cmax, Pharmacokinetics
Intervention Drug: Clopidogrel
Enrollment 144
Recruitment Details Participants recruited at PAREXEL Early Phase Clinical Unit Berlin, Germany between August 2014 and September 2014.
Pre-assignment Details 84 participants recruited; 144 screened, 60 excluded (59 did not meet inclusion criteria and 1 refused participation)
Arm/Group Title First European, Then Japanese, Then US Clopidogrel First European, Then US, Then Japanese Clopidogrel First Japanese, Then European, Then US Clopidogrel First Japanese, Then US, Then European Clopidogrel First US, Then European, Then Japanese Clopidogrel First US, Then Japanese, Then European Clopidogrel
Hide Arm/Group Description

A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA

- test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3

A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3 A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi-Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3 A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3 A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1, a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3 A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
Period Title: First Period
Started 14 14 14 14 14 14
Completed 14 14 14 13 14 14
Not Completed 0 0 0 1 0 0
Reason Not Completed
Withdrawal by Subject             0             0             0             1             0             0
Period Title: First Washout Period
Started 14 14 14 13 14 14
Completed 13 14 14 13 13 13
Not Completed 1 0 0 0 1 1
Reason Not Completed
Withdrawal by Subject             1             0             0             0             1             0
Protocol Violation             0             0             0             0             0             1
Period Title: Second Period
Started 13 14 14 13 13 13
Completed 13 14 14 13 13 13
Not Completed 0 0 0 0 0 0
Period Title: Second Washout Period
Started 13 14 14 13 13 13
Completed 13 14 14 13 13 13
Not Completed 0 0 0 0 0 0
Period Title: Third Period
Started 13 14 14 13 13 13
Completed 13 14 14 13 13 13
Not Completed 0 0 0 0 0 0
Arm/Group Title First European, Then Japanese, Then US Clopidogrel First European, Then US, Then Japanese Clopidogrel First Japanese, Then European, Then US Clopidogrel First Japanese, Then US, Then European Clopidogrel First US, Then European, Then Japanese Clopidogrel First US, Then Japanese, Then European Clopidogrel Total
Hide Arm/Group Description

A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA

- test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3

A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3 A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi-Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3 A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3 A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1, a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3 A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3 Total of all reporting groups
Overall Number of Baseline Participants 14 14 14 14 14 14 84
Hide Baseline Analysis Population Description
The overall number of baseline participants is 84, as it comprised all randomized subjects, although one subject withdrew consent prior to the first dose. Thus the safety population includes 83 subjects only.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 14 participants 14 participants 14 participants 14 participants 84 participants
33  (9) 37  (11) 36  (10) 35  (8) 34  (9) 36  (11) 35  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 14 participants 14 participants 14 participants 14 participants 84 participants
Female
7
  50.0%
7
  50.0%
8
  57.1%
7
  50.0%
4
  28.6%
4
  28.6%
37
  44.0%
Male
7
  50.0%
7
  50.0%
6
  42.9%
7
  50.0%
10
  71.4%
10
  71.4%
47
  56.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 14 participants 14 participants 14 participants 14 participants 84 participants
Black or African American 1 0 0 0 0 0 1
White 13 14 13 14 12 13 79
Other 0 0 1 0 2 1 4
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 14 participants 14 participants 14 participants 14 participants 84 participants
Hispanic or Latino 0 0 0 0 2 1 3
Not Hispanic or Latino 14 14 14 14 12 13 81
BMI (Body Mass Index)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 14 participants 14 participants 14 participants 14 participants 14 participants 14 participants 84 participants
23.7  (3.1) 24.7  (3.5) 23.4  (2.9) 24.1  (2.7) 23.0  (3.1) 23.9  (3.1) 23.8  (3.0)
1.Primary Outcome
Title Pharmacokinetics of Clopidogrel by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))
Hide Description Comparison of the pharmacokinetic profile in terms of plasma concentration-time curve from time zero extrapolated to infinity, AUC(0-inf), of clopidogrel sourced in Europe and Japan.
Time Frame 0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic population consisted of 79 subjects, i.e. all subjects in the safety population for whom AUC(0-last) and Cmax could be calculated for clopidogrel for the test treatment (European) and at least one of the reference treatments (Japanese, US). AUC(0-inf) could not be reliably calculated for many of these subjects.
Arm/Group Title European Clopidogrel Tablets, 75 mg Japanese Clopidogrel Tablets, 75 mg US Clopidogrel Tablets, 75 mg
Hide Arm/Group Description:
Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
Overall Number of Participants Analyzed 41 45 38
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
1.05
(139.0%)
0.992
(117.9%)
1.09
(106.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection European Clopidogrel Tablets, 75 mg, Japanese Clopidogrel Tablets, 75 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 104.43
Confidence Interval (2-Sided) 90%
92.27 to 118.19
Estimation Comments Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection European Clopidogrel Tablets, 75 mg, US Clopidogrel Tablets, 75 mg
Comments The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25
Type of Statistical Test Non-Inferiority or Equivalence
Comments Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 97.19
Confidence Interval (2-Sided) 90%
81.12 to 116.45
Estimation Comments Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel
2.Primary Outcome
Title Pharmacokinetics of Clopidogrel by Assessment of Observed Maximum Plasma Concentration (Cmax)
Hide Description Comparison of the pharmacokinetic profile in terms of observed maximum plasma concentration, taken directly from the individual concentration-time curve, Cmax, of clopidogrel sourced in Europe and the US.
Time Frame 0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic population consisted of 79 subjects, i.e. all subjects in the safety population for whom AUC(0-last) and Cmax could be calculated for clopidogrel for the test treatment (European) and at least one of the reference treatments (Japanese, US)
Arm/Group Title European Clopidogrel Tablets, 75 mg Japanese Clopidogrel Tablets, 75 mg US Clopidogrel Tablets, 75 mg
Hide Arm/Group Description:
Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
Overall Number of Participants Analyzed 79 79 79
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
0.551
(122.6%)
0.511
(150.6%)
0.521
(122.4%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection European Clopidogrel Tablets, 75 mg, Japanese Clopidogrel Tablets, 75 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 108.06
Confidence Interval (2-Sided) 90%
95.46 to 122.33
Estimation Comments Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection European Clopidogrel Tablets, 75 mg, US Clopidogrel Tablets, 75 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 105.79
Confidence Interval (2-Sided) 90%
95.22 to 117.53
Estimation Comments Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel
3.Secondary Outcome
Title Pharmacokinetics of Clopidogrel by Assessment of Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-last))
Hide Description Comparison of the pharmacokinetic profile in terms of the area under the plasma concentration-curve from time zero to the time of last quantifiable clopidogrel or SR26334 concentration, AUC(0-last), of clopidogrel sourced in Europe and the US.
Time Frame 0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic population consisted of 79 subjects, i.e. all subjects in the safety population for whom AUC(0-last) and Cmax could be calculated for clopidogrel for the test treatment (European) and at least one of the reference treatments (Japanese, US)
Arm/Group Title European Clopidogrel Tablets, 75 mg Japanese Clopidogrel Tablets, 75 mg US Clopidogrel Tablets, 75 mg
Hide Arm/Group Description:
Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
Overall Number of Participants Analyzed 79 79 79
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*ng/mL
0.705
(114.8%)
0.751
(116.5%)
0.767
(107.1%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection European Clopidogrel Tablets, 75 mg, Japanese Clopidogrel Tablets, 75 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 93.94
Confidence Interval (2-Sided) 90%
87.12 to 101.29
Estimation Comments Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection European Clopidogrel Tablets, 75 mg, US Clopidogrel Tablets, 75 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 92.03
Confidence Interval (2-Sided) 90%
84.91 to 99.75
Estimation Comments Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel
Time Frame From screening until follow-up, i.e. up to 7 weeks after the first dose.
Adverse Event Reporting Description

Adverse events (AEs) were assigned to the treatment after which they occurred:

Treatment A: AEs starting at the time of /after dosing of European clopidogrel tablets Treatment B: AEs starting at the time of / after dosing of Japanese clopidogrel tablets Treatment C: AEs starting at the time of / after dosing of US clopidogrel tablets

 
Arm/Group Title European Clopidogrel Tablets, 75 mg Japanese Clopidogrel Tablets, 75 mg US Clopidogrel Tablets, 75 mg Total Number of Participants
Hide Arm/Group Description Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test) Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference) Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference) total number of subjects exposed to any treatment
All-Cause Mortality
European Clopidogrel Tablets, 75 mg Japanese Clopidogrel Tablets, 75 mg US Clopidogrel Tablets, 75 mg Total Number of Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
European Clopidogrel Tablets, 75 mg Japanese Clopidogrel Tablets, 75 mg US Clopidogrel Tablets, 75 mg Total Number of Participants
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/81 (0.00%)      0/80 (0.00%)      0/82 (0.00%)      0/83 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
European Clopidogrel Tablets, 75 mg Japanese Clopidogrel Tablets, 75 mg US Clopidogrel Tablets, 75 mg Total Number of Participants
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/81 (23.46%)      18/80 (22.50%)      22/82 (26.83%)      38/83 (45.78%)    
Ear and labyrinth disorders         
Tinnitus * 1  0/81 (0.00%)  0 0/80 (0.00%)  0 1/82 (1.22%)  1 1/83 (1.20%)  1
Gastrointestinal disorders         
Abdominal Pain * 1  1/81 (1.23%)  1 1/80 (1.25%)  1 1/82 (1.22%)  1 3/83 (3.61%)  3
Diarrhoea * 1  0/81 (0.00%)  0 1/2 (50.00%)  2 2/2 (100.00%)  2 3/4 (75.00%)  4
Nausea * 1  0/81 (0.00%)  0 0/80 (0.00%)  0 2/82 (2.44%)  2 2/83 (2.41%)  2
Vomiting * 1  0/81 (0.00%)  0 0/80 (0.00%)  0 1/82 (1.22%)  1 1/83 (1.20%)  1
General disorders         
Catheter Site Pain * 1 [1]  0/81 (0.00%)  0 2/80 (2.50%)  2 0/82 (0.00%)  0 2/83 (2.41%)  2
Catheter Site Inflammation * 1 [1]  0/81 (0.00%)  0 0/80 (0.00%)  0 1/82 (1.22%)  1 1/83 (1.20%)  1
Fatigue * 1 [2]  1/81 (1.23%)  1 0/80 (0.00%)  0 0/82 (0.00%)  0 1/83 (1.20%)  1
Infections and infestations         
Nasopharyngitis * 1  0/81 (0.00%)  0 0/80 (0.00%)  0 2/82 (2.44%)  2 2/83 (2.41%)  2
Injury, poisoning and procedural complications         
Contusion * 1  1/81 (1.23%)  1 0/80 (0.00%)  0 1/82 (1.22%)  1 2/83 (2.41%)  2
Nervous system disorders         
Headache * 1  16/81 (19.75%)  19 15/80 (18.75%)  17 16/82 (19.51%)  20 29/83 (34.94%)  56
Dizziness * 1  0/81 (0.00%)  0 1/80 (1.25%)  1 3/82 (3.66%)  3 4/83 (4.82%)  4
Presyncope * 1  0/81 (0.00%)  0 1/80 (1.25%)  1 0/82 (0.00%)  0 1/83 (1.20%)  1
Respiratory, thoracic and mediastinal disorders         
Cough * 1  1/81 (1.23%)  1 0/80 (0.00%)  0 0/82 (0.00%)  0 1/83 (1.20%)  1
Dysphonia * 1  0/81 (0.00%)  0 0/80 (0.00%)  0 1/82 (1.22%)  1 1/83 (1.20%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 17.0.
[1]
includes Administration Site Conditions
[2]
includes Administrations Site Conditions
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.
If a publication (e.g., in a scientific journal) based on the results of this study is envisaged, approval from AstraZeneca will be obtained and a draft manuscript will be submitted to AstraZeneca for scrutiny and comment. The choice of conduit will be mutually agreed on by the Principal Investigator and AstraZeneca.
Results Point of Contact
Name/Title: Brilinta Global Clinical Leader
Organization: AstraZeneca
Phone: +46 31 776 1000
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02185534     History of Changes
Other Study ID Numbers: D5130C00131
First Submitted: July 4, 2014
First Posted: July 9, 2014
Results First Submitted: September 18, 2015
Results First Posted: November 30, 2015
Last Update Posted: June 22, 2016