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A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD)

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: NCT01794000
Recruitment Status : Terminated (The study is being terminated for lack of efficacy.)
First Posted : February 18, 2013
Results First Posted : July 27, 2016
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Sickle Cell Disease
Interventions Drug: Prasugrel
Drug: Placebo
Enrollment 341
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prasugrel Placebo
Hide Arm/Group Description Participants (Pts.) will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily. Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
Period Title: Double-Blind Phase (DBP)
Started 171 170
Received at Least One Dose of Drug 170 170
Discontinued During Double Blind Phase 169 166
Completed 2 4
Not Completed 169 166
Reason Not Completed
Adverse Event             5             2
Death             1             2
Entry Criteria Not Met             2             0
Parent/Caregiver Decision             5             2
Physician Decision             2             0
Sponsor Decision             148             149
Withdrawal by Subject             6             11
Period Title: Open-Label Extension Phase (OLE)
Started 3 [1] 0 [2]
Completed 0 0
Not Completed 3 0
Reason Not Completed
Sponsor Decision             3             0
[1]
Pts. who had not permanently discontinued study drug and concluded DBP were eligible to enter OLE
[2]
Placebo arm was not applicable to Open-Label Extension Phase
Arm/Group Title Prasugrel Placebo Total
Hide Arm/Group Description Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily. Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group. Total of all reporting groups
Overall Number of Baseline Participants 171 170 341
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 171 participants 170 participants 341 participants
10.606  (4.334) 10.580  (4.349) 10.593  (4.335)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171 participants 170 participants 341 participants
Female
87
  50.9%
86
  50.6%
173
  50.7%
Male
84
  49.1%
84
  49.4%
168
  49.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171 participants 170 participants 341 participants
Hispanic or Latino
2
   1.2%
1
   0.6%
3
   0.9%
Not Hispanic or Latino
94
  55.0%
98
  57.6%
192
  56.3%
Unknown or Not Reported
75
  43.9%
71
  41.8%
146
  42.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171 participants 170 participants 341 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
113
  66.1%
109
  64.1%
222
  65.1%
White
58
  33.9%
58
  34.1%
116
  34.0%
More than one race
0
   0.0%
2
   1.2%
2
   0.6%
Unknown or Not Reported
0
   0.0%
1
   0.6%
1
   0.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 171 participants 170 participants 341 participants
United States 23 25 48
Egypt 23 22 45
United Kingdom 5 4 9
Ghana 29 28 57
Kenya 47 44 91
Oman 2 4 6
Lebanon 8 8 16
Saudi Arabia 1 0 1
Canada 4 4 8
Turkey 20 22 42
Belgium 1 2 3
Brazil 1 0 1
Italy 7 7 14
Hydroxyurea Use at Baseline  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 171 participants 170 participants 341 participants
Yes 77 76 153
No 94 94 188
1.Primary Outcome
Title Number of Vaso-Occlusive Crisis (VOC) Events Per Participant Per Year (Rate of VOC)
Hide Description The VOC is a composite endpoint of painful crisis or acute chest syndrome. Events that occurred within 7 days from the prior event onset date were not counted as a new episode. Data collected through the primary completion date reported below.
Time Frame Randomization through 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Prasugrel Placebo
Hide Arm/Group Description:
Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
Overall Number of Participants Analyzed 171 170
Measure Type: Number
Unit of Measure: Number of Events per Participant-Year
2.295 2.767
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Placebo
Comments The time to a recurrent episode of VOC was analyzed using Andersen-Gill model. A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .117
Comments [Not Specified]
Method Andersen-Gill model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.66 to 1.05
Estimation Comments The rate ratio and 2-sided 95% Confidence Interval (CI) were estimated from the Andersen-Gill model.
2.Secondary Outcome
Title Monthly Rate of Days With Pain
Hide Description Monthly rate of days with pain was measured through participant diaries using a modified version of the Faces Pain Scale-Revised (FPS-R). Each day participants selected the face on the scale that reflected their worst pain related to sickle cell disease (SCD) on that day. This pain scale contains six faces corresponding to the pain intensity of 0, 2, 4, 6, 8 or 10, in which 0 denotes no pain and 10 denotes the worst pain possible. Any day the participant selected a face other than face 0 was considered a day with pain. Monthly rate of days with pain was calculated for each participant by summing the number of days reported with any pain divided by the number of non-missing diary entries completed in the month. A month was defined as 4 weeks (28 days).The monthly rate was set to missing if there were more than 14 missing entries for the FPS-R in a specific month. Data collected through the primary completion date are present below.
Time Frame Randomization through 9 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who are 7 years or older and have both baseline and at least one post-baseline monthly outcome measure in any month. This is the Sickle cell population in which content validity has been established for the FPS-R.
Arm/Group Title Prasugrel Placebo
Hide Arm/Group Description:
Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
Overall Number of Participants Analyzed 127 127
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of Days in a Month
17.457  (1.558) 17.699  (1.551)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .912
Comments Mixed Model Repeated Measures (MMRM) included fixed effects of treatment, baseline value of the pain-diary outcome measure, hydroxyurea use, age group, time and treatment-by-time interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value -0.242
Confidence Interval (2-Sided) 95%
-4.564 to 4.079
Estimation Comments The Least Square (LS) Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.
3.Secondary Outcome
Title Monthly Mean in Faces Pain Scale-Revised Score
Hide Description Each day participants selected the face on the FPS-R scale that reflected their worst pain related to sickle cell disease (SCD) on that day. Monthly mean in FPS-R score was calculated for each participant by summing the FPS-R score divided by the number of non-missing diary entries completed in the month. This pain scale contains six faces corresponding to the pain intensity of 0, 2, 4, 6, 8 or 10, in which 0 denotes no pain and 10 denotes the worst pain possible. A month was defined as 4 weeks (28 days). The monthly mean in FPS-R score was set to missing if there were more than 14 missing entries for the FPS-R in a specific month. Data collected through the primary completion date are presented below.
Time Frame Randomization through 9 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who are 7 years or older and have both baseline and at least one post-baseline monthly outcome measure in any month. This is the Sickle cell population in which content validity has been established for the FPS-R.
Arm/Group Title Prasugrel Placebo
Hide Arm/Group Description:
Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
Overall Number of Participants Analyzed 127 127
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
0.7116  (0.0757) 0.6148  (0.0753)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .365
Comments MMRM model included fixed effects of treatment, baseline value of the pain-diary outcome measure, hydroxyurea use, age group, time and treatment-by-time interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 0.0968
Confidence Interval (2-Sided) 95%
-0.1132 to 0.3068
Estimation Comments The LS Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.
4.Secondary Outcome
Title Number of Painful Crisis Events Per Participant Per Year (Rate of Painful Crisis)
Hide Description A painful crisis is defined as an onset of moderate to severe pain that lasts at least 2 hours for which there is no explanation other than vaso-occlusion and which requires therapy with oral or parenteral opioids, ketorolac, or other analgesics prescribed by a health care provider (HCP) in a medical setting such as a hospital, clinic, emergency room visit, or telephone management. The painful crisis that occurred within 7 days from the prior event onset date was not counted as a new episode. Data collected through the primary completion date are presented below.
Time Frame Randomization through 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Prasugrel Placebo
Hide Arm/Group Description:
Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
Overall Number of Participants Analyzed 171 170
Measure Type: Number
Unit of Measure: Number of Events per Participant-Year
2.239 2.720
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .109
Comments The time to a recurrent episode of painful crisis was analyzed using Andersen-Gill model.
Method Andersen-Gill Model
Comments A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.65 to 1.04
Estimation Comments The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.
5.Secondary Outcome
Title Number of Hospitalizations for VOC Per Participant Per Year (Rate of Hospitalizations)
Hide Description Hospitalization that occurred within 7 days of the prior event onset date were not counted as a new episode. Data collected through the primary completion date are presented below.
Time Frame Randomization through 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Prasugrel Placebo
Hide Arm/Group Description:
Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
Overall Number of Participants Analyzed 171 170
Measure Type: Number
Unit of Measure: Number of Events per Participant-Year
1.064 1.126
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .759
Comments The time to a recurrent episode of hospitalization was analyzed using Andersen-Gill model.
Method Andersen-Gill model
Comments A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.65 to 1.37
Estimation Comments The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.
6.Secondary Outcome
Title Number of Acute Chest Syndrome Per Participant Per Year (Rate of Acute Chest Syndrome)
Hide Description Acute chest syndrome was defined as an acute illness characterized by fever and/or respiratory symptoms, accompanied by a new pulmonary infiltrate on a chest X-ray. Acute chest syndrome that occurred within 7 days of the prior event onset date was not counted as a new episode. Data collected through the primary completion date are presented below.
Time Frame Randomization through 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Prasugrel Placebo
Hide Arm/Group Description:
Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
Overall Number of Participants Analyzed 171 170
Measure Type: Number
Unit of Measure: Number of Events per Participant-Year
0.112 0.115
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .916
Comments The time to a recurrent episode of acute chest syndrome was analyzed using Andersen-Gill model.
Method Andersen-Gill model
Comments A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.48 to 1.93
Estimation Comments The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.
7.Secondary Outcome
Title Number of Red Blood Cell (RBC) Transfusions Due to Sickle Cell Disease (SCD) Per Participant Per Year (Rate of RBC Transfusions)
Hide Description RBC transfusions that occurred within 7 days of the prior event onset date were not counted as a new episode. Data collected through the primary completion date are presented below.
Time Frame Randomization through 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Prasugrel Placebo
Hide Arm/Group Description:
Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
Overall Number of Participants Analyzed 171 170
Measure Type: Number
Unit of Measure: Number of Events per Participant-Year
0.497 0.420
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .544
Comments The time to a recurrent episode of RBC transfusion was analyzed using Andersen-Gill model.
Method Andersen-Gill model
Comments A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.71 to 1.91
Estimation Comments The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.
8.Secondary Outcome
Title Monthly Rate of Days of Analgesic Use
Hide Description Monthly rate of days of analgesic use was measured through participant diaries and was calculated for each participant by summing the number of days they reported analgesic use divided by the number of diary entries completed in the month. A month was defined as 4 weeks (28 days). The monthly rate was set to missing if there were more than 14 missing entries for analgesic use in a specific month. Data collected through the primary completion date are presented below.
Time Frame Randomization through 9 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who are 4 years or older and have baseline and at least one post-baseline monthly outcome measure in any month. Diaries were only provided to participants 4 years and older.
Arm/Group Title Prasugrel Placebo
Hide Arm/Group Description:
Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
Overall Number of Participants Analyzed 153 153
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of Days in a Month
24.270  (2.290) 22.757  (2.337)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .602
Comments The MMRM model included the fixed effects of treatment, the baseline value of the pain-diary measure, hydroxyurea use, age group, time and treatment-by-time interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 1.513
Confidence Interval (2-Sided) 95%
-4.186 to 7.213
Estimation Comments The Least Square Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.
9.Secondary Outcome
Title Quarterly Rate of School Absence Due to Sickle Cell Pain
Hide Description Quarterly rate of school absence due to sickle cell pain was measured through participant diaries and was calculated for each participant by summing the number of days with school absence due to sickle cell pain divided by the number of school dates in the quarter. A quarter was defined as 12 weeks. The quarterly rate was set to missing if there were more than 6 weeks of missing diary entries during a specific quarter. Data collected through the primary completion date are presented below.
Time Frame Randomization through 9 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized participants who are 4 years or older and have both baseline and at least one post-baseline quarterly outcome measure in any quarter. Diaries were only provided to participants 4 years and older.
Arm/Group Title Prasugrel Placebo
Hide Arm/Group Description:
Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
Overall Number of Participants Analyzed 105 115
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of Days in a Quarter
11.527  (1.525) 10.255  (1.466)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .459
Comments The MMRM model included the fixed effects of treatment, the baseline value of the pain-diary measure, hydroxyurea use, age group, time and treatment-by-time interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 1.272
Confidence Interval (2-Sided) 95%
-2.109 to 4.652
Estimation Comments The LS Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.
10.Secondary Outcome
Title Time to First Transient Ischemic Attack (TIA)/Ischemic Stroke
Hide Description [Not Specified]
Time Frame Randomization through 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
No participants had a TIA or ischemic stroke at time of analysis.
Arm/Group Title Prasugrel Placebo
Hide Arm/Group Description:
Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Number of Days Hospitalized for VOC
Hide Description The total length of hospitalization in days for VOC was calculated for each participant. Data collected through the primary completion date are presented below.
Time Frame Randomization through 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who were hospitalized for VOC.
Arm/Group Title Prasugrel Placebo
Hide Arm/Group Description:
Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
Overall Number of Participants Analyzed 69 76
Least Squares Mean (Standard Error)
Unit of Measure: Days
12.9  (1.72) 12.0  (1.63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .662
Comments The ANCOVA model included the factors of treatment, hydroxyurea use, age group, and length of follow-up.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
-3.31 to 5.19
Estimation Comments The LS Mean difference of prasugrel minus placebo and 2-sided 95% CI were estimated from the ANCOVA model.
12.Secondary Outcome
Title Time From Randomization to First and Second VOC
Hide Description Data collected through the primary completion date are presented below.
Time Frame Randomization to First VOC and Second VOC respectively (up to 24 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Prasugrel Placebo
Hide Arm/Group Description:
Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
Overall Number of Participants Analyzed 171 170
Median (95% Confidence Interval)
Unit of Measure: Days
Time from Randomization to the First VOC
90.0
(71.0 to 151.0)
87.0
(65.0 to 106.0)
Time from Randomization to the Second VOC
338.0 [1] 
(240.0 to NA)
238.0
(177.0 to 300.0)
[1]
Upper limit of 95% Confidence Interval could not be calculated due to limited data
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Placebo
Comments Time from Randomization to the First VOC
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .317
Comments [Not Specified]
Method Log Rank
Comments A stratified log-rank test were performed with hydroxyurea use and age group as the stratification factors.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Prasugrel, Placebo
Comments Time from Randomization to the Second VOC
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .133
Comments [Not Specified]
Method Log Rank
Comments A stratified log-rank test were performed with hydroxyurea use and age group as the stratification factors.
13.Secondary Outcome
Title Percentage of Participants With Hemorrhagic Events Requiring Medical Intervention
Hide Description Medical intervention was defined as any medical evaluation resulting in therapy or further investigation, as determined by a trained medical professional. Data collected from the first dose of study medication through 10 days after last dose of study medication during the double blind study period are presented below.
Time Frame First Dose through 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of drug.
Arm/Group Title Prasugrel Placebo
Hide Arm/Group Description:
Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
Overall Number of Participants Analyzed 170 170
Measure Type: Number
Unit of Measure: Percentage of Participants
6.5 4.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .638
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame Adverse events reported below reflect the entire study safety information through the supplemental data base lock (the study completion date).
Adverse Event Reporting Description All randomized participants who received at least one dose of drug.
 
Arm/Group Title Prasugrel - Double Blind Phase Placebo - Double Blind Phase Prasugrel - Open Label Phase
Hide Arm/Group Description Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily. Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group. Participants who continued to meet eligibility criteria, who were not permanently discontinued from study drug, and who concluded their participation in 24 months of double blind treatment were to be considered eligible to enter the open label phase.
All-Cause Mortality
Prasugrel - Double Blind Phase Placebo - Double Blind Phase Prasugrel - Open Label Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Prasugrel - Double Blind Phase Placebo - Double Blind Phase Prasugrel - Open Label Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   100/170 (58.82%)      106/170 (62.35%)      0/3 (0.00%)    
Blood and lymphatic system disorders       
Anaemia  1  17/170 (10.00%)  34 20/170 (11.76%)  23 0/3 (0.00%)  0
Haemolysis  1  3/170 (1.76%)  3 3/170 (1.76%)  3 0/3 (0.00%)  0
Hypersplenism  1  3/170 (1.76%)  4 1/170 (0.59%)  1 0/3 (0.00%)  0
Intravascular haemolysis  1  1/170 (0.59%)  1 2/170 (1.18%)  3 0/3 (0.00%)  0
Sickle cell anaemia with crisis  1  75/170 (44.12%)  187 83/170 (48.82%)  202 0/3 (0.00%)  0
Splenic infarction  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Thrombocytopenia  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Thrombotic thrombocytopenic purpura  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Cardiac disorders       
Cardiac failure  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Tachycardia  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Ear and labyrinth disorders       
Vertigo  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Endocrine disorders       
Inappropriate antidiuretic hormone secretion  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Eye disorders       
Disorder of orbit  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  0/170 (0.00%)  0 1/170 (0.59%)  3 0/3 (0.00%)  0
Abdominal pain upper  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Constipation  1  1/170 (0.59%)  1 1/170 (0.59%)  1 0/3 (0.00%)  0
Diarrhoea  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Enteritis  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Gastritis  1  1/170 (0.59%)  1 2/170 (1.18%)  2 0/3 (0.00%)  0
Gingival bleeding  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Vomiting  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
General disorders       
Chest pain  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Multi-organ failure  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Non-cardiac chest pain  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Pain  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Pyrexia  1  2/170 (1.18%)  2 5/170 (2.94%)  6 0/3 (0.00%)  0
Hepatobiliary disorders       
Cholelithiasis  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Hepatic sequestration  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Hyperbilirubinaemia  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Immune system disorders       
Anaphylactic reaction  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Infections and infestations       
Abscess limb  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Acinetobacter bacteraemia  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Acute sinusitis  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Adenovirus infection  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Arthritis bacterial  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Atypical pneumonia  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Bacterial infection  1  1/170 (0.59%)  1 1/170 (0.59%)  1 0/3 (0.00%)  0
Bronchitis  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Cellulitis  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Cellulitis orbital  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Corona virus infection  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Enterovirus infection  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Gastroenteritis  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Hepatitis a  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Hepatitis c  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Influenza  1  0/170 (0.00%)  0 3/170 (1.76%)  3 0/3 (0.00%)  0
Lower respiratory tract infection  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Malaria  1  11/170 (6.47%)  12 11/170 (6.47%)  14 0/3 (0.00%)  0
Mastoiditis  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Nasopharyngitis  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Osteomyelitis  1  1/170 (0.59%)  1 2/170 (1.18%)  2 0/3 (0.00%)  0
Osteomyelitis acute  1  2/170 (1.18%)  3 0/170 (0.00%)  0 0/3 (0.00%)  0
Osteomyelitis chronic  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Otitis media  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Parvovirus b19 infection  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Pharyngitis  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Pharyngitis streptococcal  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Pilonidal cyst  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Plasmodium falciparum infection  1  6/170 (3.53%)  7 4/170 (2.35%)  4 0/3 (0.00%)  0
Pneumonia  1  6/170 (3.53%)  6 7/170 (4.12%)  7 0/3 (0.00%)  0
Pneumonia streptococcal  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Pyomyositis  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Respiratory syncytial virus bronchiolitis  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Respiratory syncytial virus infection  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Respiratory tract infection  1  2/170 (1.18%)  2 0/170 (0.00%)  0 0/3 (0.00%)  0
Sepsis  1  1/170 (0.59%)  1 4/170 (2.35%)  4 0/3 (0.00%)  0
Septic shock  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Sinusitis  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Staphylococcal sepsis  1  0/170 (0.00%)  0 2/170 (1.18%)  2 0/3 (0.00%)  0
Tonsillitis  1  2/170 (1.18%)  2 4/170 (2.35%)  4 0/3 (0.00%)  0
Tooth abscess  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Tooth infection  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Upper respiratory tract infection  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Urinary tract infection  1  2/170 (1.18%)  2 2/170 (1.18%)  2 0/3 (0.00%)  0
Viral infection  1  1/170 (0.59%)  1 2/170 (1.18%)  2 0/3 (0.00%)  0
Viral tonsillitis  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Viral upper respiratory tract infection  1  0/170 (0.00%)  0 2/170 (1.18%)  2 0/3 (0.00%)  0
Injury, poisoning and procedural complications       
Contusion  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Fall  1  1/170 (0.59%)  1 1/170 (0.59%)  1 0/3 (0.00%)  0
Hand fracture  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Humerus fracture  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Lower limb fracture  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Thermal burn  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Investigations       
Haemoglobin decreased  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Platelet count decreased  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Platelet count increased  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Serum ferritin increased  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Hypoglycaemia  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Dactylitis  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Musculoskeletal chest pain  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Pain in extremity  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Nervous system disorders       
Haemorrhage intracranial  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Headache  1  1/170 (0.59%)  1 1/170 (0.59%)  1 0/3 (0.00%)  0
Ruptured cerebral aneurysm  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Psychiatric disorders       
Suicidal ideation  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Renal and urinary disorders       
Acute kidney injury  1  0/170 (0.00%)  0 1/170 (0.59%)  1 0/3 (0.00%)  0
Renal papillary necrosis  1  1/170 (0.59%)  2 0/170 (0.00%)  0 0/3 (0.00%)  0
Reproductive system and breast disorders       
Amenorrhoea  1  1/87 (1.15%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Priapism  1  0/170 (0.00%)  0 2/84 (2.38%)  3 0/3 (0.00%)  0
Thrombosis corpora cavernosa  1  0/170 (0.00%)  0 1/84 (1.19%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Acute chest syndrome  1  15/170 (8.82%)  16 14/170 (8.24%)  16 0/3 (0.00%)  0
Asthma  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Epistaxis  1  2/170 (1.18%)  2 1/170 (0.59%)  1 0/3 (0.00%)  0
Lung disorder  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Pleural effusion  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Pneumothorax  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Pulmonary hypertension  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders       
Ecchymosis  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Purpura  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Surgical and medical procedures       
Nail operation  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Selective abortion  1  1/87 (1.15%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Vascular disorders       
Deep vein thrombosis  1  1/170 (0.59%)  1 0/170 (0.00%)  0 0/3 (0.00%)  0
Haematoma  1  2/170 (1.18%)  2 1/170 (0.59%)  1 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Prasugrel - Double Blind Phase Placebo - Double Blind Phase Prasugrel - Open Label Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   148/170 (87.06%)      154/170 (90.59%)      1/3 (33.33%)    
Blood and lymphatic system disorders       
Anaemia  1  6/170 (3.53%)  8 11/170 (6.47%)  13 0/3 (0.00%)  0
Sickle cell anaemia with crisis  1  90/170 (52.94%)  223 102/170 (60.00%)  272 1/3 (33.33%)  1
Gastrointestinal disorders       
Abdominal pain  1  17/170 (10.00%)  23 20/170 (11.76%)  28 0/3 (0.00%)  0
Abdominal pain upper  1  3/170 (1.76%)  3 11/170 (6.47%)  14 0/3 (0.00%)  0
Constipation  1  9/170 (5.29%)  10 12/170 (7.06%)  16 0/3 (0.00%)  0
Diarrhoea  1  6/170 (3.53%)  8 11/170 (6.47%)  12 0/3 (0.00%)  0
Gastritis  1  10/170 (5.88%)  13 10/170 (5.88%)  19 0/3 (0.00%)  0
Vomiting  1  7/170 (4.12%)  11 12/170 (7.06%)  19 0/3 (0.00%)  0
General disorders       
Nodule  1  0/170 (0.00%)  0 0/170 (0.00%)  0 1/3 (33.33%)  1
Pain  1  18/170 (10.59%)  31 19/170 (11.18%)  30 0/3 (0.00%)  0
Pyrexia  1  35/170 (20.59%)  54 43/170 (25.29%)  69 1/3 (33.33%)  1
Infections and infestations       
Malaria  1  33/170 (19.41%)  62 33/170 (19.41%)  53 0/3 (0.00%)  0
Nasopharyngitis  1  15/170 (8.82%)  19 18/170 (10.59%)  34 0/3 (0.00%)  0
Pharyngitis  1  4/170 (2.35%)  4 10/170 (5.88%)  11 0/3 (0.00%)  0
Rhinitis  1  11/170 (6.47%)  12 7/170 (4.12%)  10 0/3 (0.00%)  0
Tonsillitis  1  20/170 (11.76%)  26 24/170 (14.12%)  31 0/3 (0.00%)  0
Upper respiratory tract infection  1  44/170 (25.88%)  76 37/170 (21.76%)  69 0/3 (0.00%)  0
Urinary tract infection  1  17/170 (10.00%)  26 17/170 (10.00%)  17 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  8/170 (4.71%)  11 10/170 (5.88%)  11 0/3 (0.00%)  0
Back pain  1  20/170 (11.76%)  32 29/170 (17.06%)  54 0/3 (0.00%)  0
Pain in extremity  1  28/170 (16.47%)  45 47/170 (27.65%)  84 0/3 (0.00%)  0
Nervous system disorders       
Headache  1  25/170 (14.71%)  32 29/170 (17.06%)  43 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough  1  14/170 (8.24%)  19 17/170 (10.00%)  19 1/3 (33.33%)  1
Epistaxis  1  23/170 (13.53%)  48 21/170 (12.35%)  29 0/3 (0.00%)  0
Oropharyngeal pain  1  9/170 (5.29%)  13 8/170 (4.71%)  8 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
The study was stopped following Submission Database Lock, the topline information indicated that the primary and secondary efficacy endpoints were not met.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01794000    
Other Study ID Numbers: 13038
H7T-MC-TADO ( Other Identifier: Eli Lilly and Company )
2012-003837-41 ( EudraCT Number )
First Submitted: February 14, 2013
First Posted: February 18, 2013
Results First Submitted: June 15, 2016
Results First Posted: July 27, 2016
Last Update Posted: September 25, 2019