Trial Outcomes & Findings for Comparison of Prasugrel and Clopidogrel in Very Elderly and Non-Elderly Patients With Stable Coronary Artery Disease (NCT NCT01107912)
NCT ID: NCT01107912
Last Updated: 2012-10-26
Results Overview
Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). Lower MPA values reflect stronger platelet inhibition, whereas higher MPA values reflect weaker inhibition.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
155 participants
Primary outcome timeframe
Baseline, 12 days
Results posted on
2012-10-26
Participant Flow
Participant milestones
| Measure |
5 mg Prasugrel (Elderly)
Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
10 mg Prasugrel (Elderly)
Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
|
75 mg Clopidogrel (Elderly)
Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
|
5 mg Prasugrel (Non-Elderly)
Non-elderly participants (≥45 to \<65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
|
10 mg Prasugrel (Non-Elderly)
Non-elderly participants (≥45 to \<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
75 mg Clopidogrel (Non-Elderly)
Non-elderly participants ( ≥45 to \<65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
73
|
0
|
0
|
0
|
82
|
0
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
73
|
0
|
0
|
0
|
82
|
0
|
|
Period 1
COMPLETED
|
72
|
0
|
0
|
0
|
79
|
0
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
0
|
0
|
3
|
0
|
|
Period 2
STARTED
|
0
|
36
|
36
|
41
|
0
|
38
|
|
Period 2
COMPLETED
|
0
|
36
|
35
|
41
|
0
|
38
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Period 3
STARTED
|
0
|
35
|
36
|
38
|
0
|
41
|
|
Period 3
COMPLETED
|
0
|
34
|
35
|
37
|
0
|
41
|
|
Period 3
NOT COMPLETED
|
0
|
1
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
5 mg Prasugrel (Elderly)
Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
10 mg Prasugrel (Elderly)
Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
|
75 mg Clopidogrel (Elderly)
Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
|
5 mg Prasugrel (Non-Elderly)
Non-elderly participants (≥45 to \<65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
|
10 mg Prasugrel (Non-Elderly)
Non-elderly participants (≥45 to \<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
75 mg Clopidogrel (Non-Elderly)
Non-elderly participants ( ≥45 to \<65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
|
|---|---|---|---|---|---|---|
|
Period 1
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Period 1
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 1
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Period 3
Adverse Event
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Period 3
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Comparison of Prasugrel and Clopidogrel in Very Elderly and Non-Elderly Patients With Stable Coronary Artery Disease
Baseline characteristics by cohort
| Measure |
Very Elderly, Drug Sequence ABC
n=36 Participants
Participants (≥75 years of age) in this arm received study drug sequence ABC. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
|
Very Elderly; Drug Sequence ACB
n=37 Participants
Participants (≥75 years of age) in this arm received study drug sequence ACB. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
|
Non-Elderly; Drug Sequence BAC
n=42 Participants
Participants (≥45 to \<65 years of age) in this arm received study drug sequence BAC. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
|
Non-Elderly; Drug Sequence BCA
n=40 Participants
Participants (≥45 to \<65 years of age) in this arm received study drug sequence BCA. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
79.02 years
STANDARD_DEVIATION 2.87 • n=5 Participants
|
78.74 years
STANDARD_DEVIATION 3.12 • n=7 Participants
|
57.11 years
STANDARD_DEVIATION 4.75 • n=5 Participants
|
55.46 years
STANDARD_DEVIATION 5.53 • n=4 Participants
|
66.94 years
STANDARD_DEVIATION 12.08 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
119 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
116 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
141 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
14 participants
n=4 Participants
|
39 participants
n=21 Participants
|
|
Region of Enrollment
Ireland
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
6 participants
n=4 Participants
|
19 participants
n=21 Participants
|
|
Region of Enrollment
Netherlands
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Region of Enrollment
Sweden
|
22 participants
n=5 Participants
|
23 participants
n=7 Participants
|
23 participants
n=5 Participants
|
19 participants
n=4 Participants
|
87 participants
n=21 Participants
|
|
Weight
|
88.49 kilograms (kg)
STANDARD_DEVIATION 10.92 • n=5 Participants
|
82.30 kilograms (kg)
STANDARD_DEVIATION 10.74 • n=7 Participants
|
92.85 kilograms (kg)
STANDARD_DEVIATION 20.01 • n=5 Participants
|
93.36 kilograms (kg)
STANDARD_DEVIATION 17.32 • n=4 Participants
|
89.45 kilograms (kg)
STANDARD_DEVIATION 16.01 • n=21 Participants
|
|
Tobacco Use Status at Baseline
Yes
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
13 participants
n=5 Participants
|
11 participants
n=4 Participants
|
29 participants
n=21 Participants
|
|
Tobacco Use Status at Baseline
No
|
32 participants
n=5 Participants
|
36 participants
n=7 Participants
|
29 participants
n=5 Participants
|
29 participants
n=4 Participants
|
126 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 daysPopulation: All randomized participants who continued in the study through the Day 12 visit, and who had at least 1 evaluable PD assessment at the Day 12 visit. Participants were analysed based on randomized treatment assignment, regardless of the study drug they took.
Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). Lower MPA values reflect stronger platelet inhibition, whereas higher MPA values reflect weaker inhibition.
Outcome measures
| Measure |
5 mg Prasugrel (Elderly)
n=72 Participants
Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
75 mg Clopidogrel (Elderly)
Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
|
10 mg Prasugrel (Non-Elderly)
n=79 Participants
Non-elderly participants (≥45 to \<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
5 mg Prasugrel (Non-Elderly)
Non-elderly participants (≥45 to \<65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
|
10 mg Prasugrel (Non-Elderly)
Non-elderly participants (≥45 to \<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
75 mg Clopidogrel (Non-Elderly)
Non-elderly participants ( ≥45 to \<65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
|
|---|---|---|---|---|---|---|
|
Change in Maximum Platelet Aggregation (MPA) to 20 Micromoles (μM) Adenosine Diphosphate (ADP) as Measured by Light Transmission Aggregometry (LTA) From Baseline to 12 Days of Therapy in the First Treatment Period
Baseline
|
78.00 percentage of aggregation
Interval 72.0 to 83.5
|
—
|
75.00 percentage of aggregation
Interval 71.0 to 83.0
|
—
|
—
|
—
|
|
Change in Maximum Platelet Aggregation (MPA) to 20 Micromoles (μM) Adenosine Diphosphate (ADP) as Measured by Light Transmission Aggregometry (LTA) From Baseline to 12 Days of Therapy in the First Treatment Period
Period 1 (12 days) (n=71, 79)
|
58.00 percentage of aggregation
Interval 50.0 to 65.0
|
—
|
46.00 percentage of aggregation
Interval 39.0 to 52.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 12Population: All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.
Vasodilator-associated stimulated phosphoprotein (VASP) phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition. A lower PRI reflects stronger inhibition of P2Y12, whereas a higher PRI reflects weaker inhibition of P2Y12.
Outcome measures
| Measure |
5 mg Prasugrel (Elderly)
n=72 Participants
Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
75 mg Clopidogrel (Elderly)
n=71 Participants
Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
|
10 mg Prasugrel (Non-Elderly)
n=70 Participants
Non-elderly participants (≥45 to \<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
5 mg Prasugrel (Non-Elderly)
n=78 Participants
Non-elderly participants (≥45 to \<65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
|
10 mg Prasugrel (Non-Elderly)
n=79 Participants
Non-elderly participants (≥45 to \<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
75 mg Clopidogrel (Non-Elderly)
n=79 Participants
Non-elderly participants ( ≥45 to \<65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
|
|---|---|---|---|---|---|---|
|
Change in Vasodilator-associated Stimulated Phosphoprotein (VASP) From Baseline to 12 Days of Therapy
Baseline (n=68, 66, 67, 71, 72, 72)
|
85.62 percentage platelet reactive index (PRI)
Standard Deviation 4.28
|
85.60 percentage platelet reactive index (PRI)
Standard Deviation 4.31
|
85.66 percentage platelet reactive index (PRI)
Standard Deviation 4.32
|
86.10 percentage platelet reactive index (PRI)
Standard Deviation 5.31
|
86.18 percentage platelet reactive index (PRI)
Standard Deviation 5.32
|
86.18 percentage platelet reactive index (PRI)
Standard Deviation 5.32
|
|
Change in Vasodilator-associated Stimulated Phosphoprotein (VASP) From Baseline to 12 Days of Therapy
Day 12 (n=67, 65, 67, 73, 74, 73)
|
44.30 percentage platelet reactive index (PRI)
Standard Deviation 18.87
|
54.95 percentage platelet reactive index (PRI)
Standard Deviation 18.86
|
22.66 percentage platelet reactive index (PRI)
Standard Deviation 11.90
|
54.72 percentage platelet reactive index (PRI)
Standard Deviation 18.67
|
27.74 percentage platelet reactive index (PRI)
Standard Deviation 15.84
|
54.53 percentage platelet reactive index (PRI)
Standard Deviation 21.82
|
SECONDARY outcome
Timeframe: Baseline, Day 12Population: All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.
The Accumetrics VerifyNow® P2Y12 assay measures platelet aggregation in whole blood and is reported in P2Y12 reaction units (PRU). PRU report the extent of P2Y12 receptor-mediated platelet aggregation calculated as a function of the rate and extent of platelet aggregation in the presence of adenosine phosphate ADP. A lower PRU reflects stronger inhibition of P2Y12, whereas a higher PRU reflects weaker inhibition of P2Y12.
Outcome measures
| Measure |
5 mg Prasugrel (Elderly)
n=72 Participants
Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
75 mg Clopidogrel (Elderly)
n=71 Participants
Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
|
10 mg Prasugrel (Non-Elderly)
n=70 Participants
Non-elderly participants (≥45 to \<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
5 mg Prasugrel (Non-Elderly)
n=78 Participants
Non-elderly participants (≥45 to \<65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
|
10 mg Prasugrel (Non-Elderly)
n=79 Participants
Non-elderly participants (≥45 to \<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
75 mg Clopidogrel (Non-Elderly)
n=79 Participants
Non-elderly participants ( ≥45 to \<65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
|
|---|---|---|---|---|---|---|
|
Change in VerifyNow P2Y12 Reaction Units (PRU) From Baseline to 12 Days of Therapy
Baseline
|
315.63 P2Y12 reaction units (PRU)
Standard Deviation 45.98
|
314.14 P2Y12 reaction units (PRU)
Standard Deviation 44.54
|
314.11 P2Y12 reaction units (PRU)
Standard Deviation 45.74
|
291.81 P2Y12 reaction units (PRU)
Standard Deviation 45.16
|
291.62 P2Y12 reaction units (PRU)
Standard Deviation 44.90
|
291.62 P2Y12 reaction units (PRU)
Standard Deviation 44.90
|
|
Change in VerifyNow P2Y12 Reaction Units (PRU) From Baseline to 12 Days of Therapy
Day 12 (n=71, 67, 69, 77, 79, 79)
|
175.52 P2Y12 reaction units (PRU)
Standard Deviation 57.19
|
212.33 P2Y12 reaction units (PRU)
Standard Deviation 69.65
|
84.13 P2Y12 reaction units (PRU)
Standard Deviation 47.72
|
177.01 P2Y12 reaction units (PRU)
Standard Deviation 67.29
|
85.46 P2Y12 reaction units (PRU)
Standard Deviation 60.24
|
181.22 P2Y12 reaction units (PRU)
Standard Deviation 71.80
|
SECONDARY outcome
Timeframe: Baseline up to 4 hours post-dosePopulation: All available PK sample data from all treated participants who contributed complete PK profiles.
A descriptive pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing prasugrel and clopidogrel active metabolite exposures to MPA in response to 20 µM ADP (by LTA) was conducted as originally intended; however, the graphic output from that analysis is not possible here. Therefore, the PK portion is presented here as AUC and the PD portion is presented in Secondary Outcome Measure #5. AUC was calculated through the last scheduled sampling time of 4 hours \[AUC (0-4)\] or through the sampling time of the last quantifiable concentration prior to 4 hours. AUC values were denoted AUC(0-tlast) in both instances.
Outcome measures
| Measure |
5 mg Prasugrel (Elderly)
n=71 Participant PK Profiles
Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
75 mg Clopidogrel (Elderly)
n=103 Participant PK Profiles
Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
|
10 mg Prasugrel (Non-Elderly)
n=101 Participant PK Profiles
Non-elderly participants (≥45 to \<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
5 mg Prasugrel (Non-Elderly)
n=114 Participant PK Profiles
Non-elderly participants (≥45 to \<65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
|
10 mg Prasugrel (Non-Elderly)
n=80 Participant PK Profiles
Non-elderly participants (≥45 to \<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
75 mg Clopidogrel (Non-Elderly)
n=118 Participant PK Profiles
Non-elderly participants ( ≥45 to \<65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
|
|---|---|---|---|---|---|---|
|
Active Metabolite Blood Levels to Drug Exposure as Measured by Pharmacokinetics (PK) Through 4 Hours After Dosing
|
18.9 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 43
|
13.0 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 62
|
41.2 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 35
|
16.1 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 54
|
36.7 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 49
|
11.8 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 68
|
SECONDARY outcome
Timeframe: Baseline, Day 12Population: All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.
Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.
Outcome measures
| Measure |
5 mg Prasugrel (Elderly)
n=72 Participants
Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
75 mg Clopidogrel (Elderly)
n=71 Participants
Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
|
10 mg Prasugrel (Non-Elderly)
n=70 Participants
Non-elderly participants (≥45 to \<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
5 mg Prasugrel (Non-Elderly)
n=78 Participants
Non-elderly participants (≥45 to \<65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
|
10 mg Prasugrel (Non-Elderly)
n=79 Participants
Non-elderly participants (≥45 to \<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
75 mg Clopidogrel (Non-Elderly)
n=79 Participants
Non-elderly participants ( ≥45 to \<65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) From Baseline at Day 12 of Therapy
Baseline
|
79.10 percentage of aggregation
Standard Deviation 9.73
|
79.11 percentage of aggregation
Standard Deviation 9.80
|
78.75 percentage of aggregation
Standard Deviation 9.53
|
76.61 percentage of aggregation
Standard Deviation 8.07
|
76.61 percentage of aggregation
Standard Deviation 8.02
|
76.61 percentage of aggregation
Standard Deviation 8.02
|
|
Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) From Baseline at Day 12 of Therapy
Day 12 (n=71, 70, 70, 78, 79, 79)
|
57.05 percentage of aggregation
Standard Deviation 13.98
|
63.08 percentage of aggregation
Standard Deviation 13.73
|
45.54 percentage of aggregation
Standard Deviation 11.07
|
56.83 percentage of aggregation
Standard Deviation 11.62
|
45.83 percentage of aggregation
Standard Deviation 11.82
|
59.09 percentage of aggregation
Standard Deviation 13.44
|
Adverse Events
5 mg Prasugrel (Elderly)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
10 mg Prasugrel (Elderly)
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
75 mg Clopidogrel (Elderly)
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
5 mg Prasugrel (Non-Elderly)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
10 mg Prasugrel (Non-Elderly)
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
75 mg Clopidogrel (Non-Elderly)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5 mg Prasugrel (Elderly)
n=73 participants at risk
Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
10 mg Prasugrel (Elderly)
n=71 participants at risk
Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
|
75 mg Clopidogrel (Elderly)
n=72 participants at risk
Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
|
5 mg Prasugrel (Non-Elderly)
n=79 participants at risk
Non-elderly participants (≥45 to \<65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
|
10 mg Prasugrel (Non-Elderly)
n=82 participants at risk
Non-elderly participants (≥45 to \<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
75 mg Clopidogrel (Non-Elderly)
n=79 participants at risk
Non-elderly participants ( ≥45 to \<65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/73
|
0.00%
0/71
|
1.4%
1/72 • Number of events 1
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/73
|
1.4%
1/71 • Number of events 1
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/73
|
1.4%
1/71 • Number of events 1
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/73
|
0.00%
0/71
|
1.4%
1/72 • Number of events 1
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Infections and infestations
Endocarditis
|
0.00%
0/73
|
1.4%
1/71 • Number of events 1
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
Other adverse events
| Measure |
5 mg Prasugrel (Elderly)
n=73 participants at risk
Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
10 mg Prasugrel (Elderly)
n=71 participants at risk
Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
|
75 mg Clopidogrel (Elderly)
n=72 participants at risk
Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
|
5 mg Prasugrel (Non-Elderly)
n=79 participants at risk
Non-elderly participants (≥45 to \<65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
|
10 mg Prasugrel (Non-Elderly)
n=82 participants at risk
Non-elderly participants (≥45 to \<65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
|
75 mg Clopidogrel (Non-Elderly)
n=79 participants at risk
Non-elderly participants ( ≥45 to \<65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/73
|
1.4%
1/71 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
1.4%
1/73 • Number of events 1
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/73
|
0.00%
0/71
|
1.4%
1/72 • Number of events 1
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
1.3%
1/79 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/73
|
0.00%
0/71
|
1.4%
1/72 • Number of events 1
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Cardiac disorders
Palpitations
|
0.00%
0/73
|
1.4%
1/71 • Number of events 1
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
1.3%
1/79 • Number of events 1
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/73
|
0.00%
0/71
|
1.4%
1/72 • Number of events 1
|
0.00%
0/79
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/73
|
1.4%
1/71 • Number of events 1
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
1/73 • Number of events 1
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/73
|
0.00%
0/71
|
1.4%
1/72 • Number of events 1
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/73
|
0.00%
0/71
|
1.4%
1/72 • Number of events 1
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Gastrointestinal disorders
Faeces discoloured
|
1.4%
1/73 • Number of events 1
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/73
|
2.8%
2/71 • Number of events 2
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/73
|
1.4%
1/71 • Number of events 1
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/73
|
2.8%
2/71 • Number of events 2
|
1.4%
1/72 • Number of events 1
|
1.3%
1/79 • Number of events 1
|
2.4%
2/82 • Number of events 2
|
0.00%
0/79
|
|
General disorders
Chest pain
|
0.00%
0/73
|
0.00%
0/71
|
1.4%
1/72 • Number of events 1
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
General disorders
Fatigue
|
0.00%
0/73
|
2.8%
2/71 • Number of events 2
|
2.8%
2/72 • Number of events 2
|
0.00%
0/79
|
0.00%
0/82
|
1.3%
1/79 • Number of events 1
|
|
General disorders
Inflammation
|
0.00%
0/73
|
0.00%
0/71
|
1.4%
1/72 • Number of events 1
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/73
|
0.00%
0/71
|
1.4%
1/72 • Number of events 1
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
General disorders
Oedema peripheral
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
1.3%
1/79 • Number of events 1
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
General disorders
Pain
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
1.3%
1/79 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/73
|
0.00%
0/71
|
1.4%
1/72 • Number of events 1
|
1.3%
1/79 • Number of events 1
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
1/73 • Number of events 1
|
0.00%
0/71
|
0.00%
0/72
|
3.8%
3/79 • Number of events 3
|
2.4%
2/82 • Number of events 2
|
5.1%
4/79 • Number of events 4
|
|
Infections and infestations
Pyelonephritis
|
1.4%
1/73 • Number of events 1
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
1.3%
1/79 • Number of events 1
|
0.00%
0/82
|
1.3%
1/79 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/73
|
0.00%
0/71
|
1.4%
1/72 • Number of events 1
|
0.00%
0/79
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/73 • Number of events 1
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Injury, poisoning and procedural complications
Contusion
|
6.8%
5/73 • Number of events 6
|
12.7%
9/71 • Number of events 12
|
5.6%
4/72 • Number of events 9
|
1.3%
1/79 • Number of events 1
|
7.3%
6/82 • Number of events 6
|
5.1%
4/79 • Number of events 4
|
|
Injury, poisoning and procedural complications
Ear abrasion
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
Injury, poisoning and procedural complications
Wound
|
1.4%
1/73 • Number of events 1
|
0.00%
0/71
|
1.4%
1/72 • Number of events 2
|
0.00%
0/79
|
0.00%
0/82
|
2.5%
2/79 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/73
|
1.4%
1/71 • Number of events 1
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
Investigations
Bleeding time prolonged
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/73
|
1.4%
1/71 • Number of events 1
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
1.3%
1/79 • Number of events 1
|
0.00%
0/82
|
2.5%
2/79 • Number of events 2
|
|
Investigations
Blood creatinine
|
0.00%
0/73
|
1.4%
1/71 • Number of events 1
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Investigations
Blood potassium decreased
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
1.3%
1/79 • Number of events 1
|
|
Investigations
Blood urea
|
0.00%
0/73
|
1.4%
1/71 • Number of events 1
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Investigations
Blood urine present
|
0.00%
0/73
|
1.4%
1/71 • Number of events 2
|
1.4%
1/72 • Number of events 1
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Investigations
Cardiac enzymes increased
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
1.3%
1/79 • Number of events 1
|
0.00%
0/82
|
0.00%
0/79
|
|
Investigations
Eosinophil count increased
|
0.00%
0/73
|
1.4%
1/71 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
1.3%
1/79 • Number of events 1
|
0.00%
0/82
|
1.3%
1/79 • Number of events 1
|
|
Investigations
Haematocrit decreased
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
1.3%
1/79 • Number of events 1
|
0.00%
0/82
|
0.00%
0/79
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
1.3%
1/79 • Number of events 1
|
0.00%
0/82
|
0.00%
0/79
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/73
|
0.00%
0/71
|
1.4%
1/72 • Number of events 1
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
1.3%
1/79 • Number of events 1
|
0.00%
0/82
|
0.00%
0/79
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/73
|
1.4%
1/71 • Number of events 1
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
2/73 • Number of events 2
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/73
|
0.00%
0/71
|
1.4%
1/72 • Number of events 1
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/73
|
0.00%
0/71
|
1.4%
1/72 • Number of events 1
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/73
|
1.4%
1/71 • Number of events 1
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Nervous system disorders
Dizziness
|
0.00%
0/73
|
1.4%
1/71 • Number of events 1
|
1.4%
1/72 • Number of events 1
|
1.3%
1/79 • Number of events 1
|
3.7%
3/82 • Number of events 3
|
0.00%
0/79
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
Nervous system disorders
Headache
|
1.4%
1/73 • Number of events 1
|
2.8%
2/71 • Number of events 3
|
1.4%
1/72 • Number of events 1
|
1.3%
1/79 • Number of events 1
|
3.7%
3/82 • Number of events 3
|
0.00%
0/79
|
|
Nervous system disorders
Migraine
|
0.00%
0/73
|
1.4%
1/71 • Number of events 1
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Nervous system disorders
Presyncope
|
1.4%
1/73 • Number of events 1
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
Nervous system disorders
Sciatica
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
1.3%
1/79 • Number of events 1
|
0.00%
0/82
|
0.00%
0/79
|
|
Psychiatric disorders
Restlessness
|
1.4%
1/73 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/73
|
1.4%
1/71 • Number of events 4
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
1.3%
1/79 • Number of events 1
|
1.2%
1/82 • Number of events 1
|
0.00%
0/79
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/73
|
0.00%
0/71
|
1.4%
1/72 • Number of events 1
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.4%
1/73 • Number of events 1
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
1.3%
1/79 • Number of events 2
|
0.00%
0/82
|
0.00%
0/79
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/73
|
1.4%
1/71 • Number of events 1
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/73 • Number of events 1
|
0.00%
0/71
|
1.4%
1/72 • Number of events 1
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
1.4%
1/73 • Number of events 1
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.7%
2/73 • Number of events 2
|
0.00%
0/71
|
0.00%
0/72
|
1.3%
1/79 • Number of events 1
|
6.1%
5/82 • Number of events 5
|
1.3%
1/79 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.4%
1/73 • Number of events 1
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
1.3%
1/79 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/73
|
0.00%
0/71
|
1.4%
1/72 • Number of events 1
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.7%
2/73 • Number of events 2
|
4.2%
3/71 • Number of events 6
|
1.4%
1/72 • Number of events 1
|
2.5%
2/79 • Number of events 2
|
4.9%
4/82 • Number of events 6
|
3.8%
3/79 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.4%
1/73 • Number of events 1
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
1.3%
1/79 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/73
|
0.00%
0/71
|
1.4%
1/72 • Number of events 3
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/73
|
0.00%
0/71
|
1.4%
1/72 • Number of events 1
|
0.00%
0/79
|
0.00%
0/82
|
0.00%
0/79
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/73
|
0.00%
0/71
|
0.00%
0/72
|
1.3%
1/79 • Number of events 1
|
1.2%
1/82 • Number of events 2
|
0.00%
0/79
|
|
Vascular disorders
Haematoma
|
1.4%
1/73 • Number of events 1
|
12.7%
9/71 • Number of events 10
|
2.8%
2/72 • Number of events 4
|
6.3%
5/79 • Number of events 6
|
11.0%
9/82 • Number of events 10
|
3.8%
3/79 • Number of events 5
|
|
Vascular disorders
Hypertension
|
1.4%
1/73 • Number of events 1
|
0.00%
0/71
|
0.00%
0/72
|
0.00%
0/79
|
0.00%
0/82
|
1.3%
1/79 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60