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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 27 July 2020
Main ID:  EUCTR2012-003837-41-GB
Date of registration: 25/01/2013
Prospective Registration: Yes
Primary sponsor: Eli Lilly and Company
Public title: A Phase 3 study for the Efficacy and Safety Comparison of Prasugrel and Placebo in Pediatric Patients with Sickle Cell Disease
Scientific title: A Phase 3, Double-Blind, Randomized, Efficacy and Safety Comparison of Prasugrel and Placebo in Pediatric Patients with Sickle Cell Disease
Date of first enrolment: 15/04/2013
Target sample size: 220
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003837-41
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: Option to continue on into an open label study after completion of randomised, double blind study
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Belgium Brazil Canada Egypt France Ghana Italy Kenya
Lebanon Netherlands Oman Saudi Arabia Turkey United Arab Emirates United Kingdom United States
Contacts
Name: Clinical Trial Information   
Address:  N/A N/A
Telephone: N/A
Email: EU_Lilly_Clinical_Trials@lilly.com
Affiliation:  Eli Lilly
Name: Clinical Trial Information   
Address:  N/A N/A
Telephone: N/A
Email: EU_Lilly_Clinical_Trials@lilly.com
Affiliation:  Eli Lilly
Key inclusion & exclusion criteria
Inclusion criteria:
a. Have SCD (HbSS or HbS0 thalassemia)

b. Are patients with SCD who have had =2 episodes of VOC (vaso-occlusive crisis) in the past year

c. Have a body weight =12 kg and are =2 and <18 years of age, inclusive at the time of screening
Are the trial subjects under 18? yes
Number of subjects for this age range: 220
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
a. History of: TIA/ ischemic or hemorrhagic stroke, severe head trauma, intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm

b. History of abnormal or conditional (velocity in middle or anterior cerebral, or internal carotid artery =170 cm/sec) transcranial Doppler within the last year

c. History of, or are undergoing treatment with, chronic RBC transfusion therapy

d. Are at an increased risk for bleeding complications
e. Are receiving treatment with oral NSAIDs exceeding 4 days per week or intravenous NSAIDs exceeding 2 days per week



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Efficacy and Safety Comparison of Prasugrel and Placebo in Pediatric Patients with Sickle Cell Disease
MedDRA version: 16.0 Level: LLT Classification code 10040644 Term: Sickle cell disease System Organ Class: 100000004850
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Intervention(s)

Product Name: Prasugrel hydrochloride
Product Code: LY640315
Pharmaceutical Form: Tablet
INN or Proposed INN: PRASUGREL
CAS Number: 389574-19-0
Current Sponsor code: LY640315
Other descriptive name: PRASUGREL HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Prasugrel hydrochloride
Product Code: LY640315
Pharmaceutical Form: Tablet
INN or Proposed INN: PRASUGREL
CAS Number: 389574-19-0
Current Sponsor code: LY640315
Other descriptive name: PRASUGREL HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Prasugrel hydrochloride
Product Code: LY640315
Pharmaceutical Form: Tablet
INN or Proposed INN: PRASUGREL
CAS Number: 389574-19-0
Current Sponsor code: LY640315
Other descriptive name: PRASUGREL HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Prasugrel hydrochloride
Product Code: LY640315
Pharmaceutical Form: Tablet
INN or Proposed INN: PRASUGREL
CAS Number: 389574-19-0
Current Sponsor code: LY640315
Other descriptive name: PRASUGREL HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Prasugrel hydrochloride
Product Code: LY640315
Pharmaceutical Form: Tablet
INN or Proposed INN: PRASUGREL
CAS Number: 389574-19-0
Current Sponsor code: LY640315
Other descri
Primary Outcome(s)
Main Objective: The primary objective of this study is to assess the efficacy of prasugrel compared to placebo in pediatric patients with SCD as measured by reduction in the rate of VOC, which is a composite endpoint of painful crisis or acute chest syndrome, throughout the study.
Primary end point(s): The primary objective of this study is to test the hypothesis that prasugrel compared to placebo will reduce the rate of VOC, which is a composite endpoint of painful crisis or acute chest syndrome.
Secondary Objective: Major Secondary Efficacy Objectives
• Assess the efficacy of prasugrel compared to placebo in pediatric patients with SCD by assessment of the following key endpoints:
1. the reduction in the rate and intensity of sickle cell-related pain as recorded in patient pain diaries
2. the reduction in the rate of hospitalization for VOC

Safety Objectives:
• Assess the safety of prasugrel compared to placebo in pediatric patients with SCD.
Timepoint(s) of evaluation of this end point: 24 months
Secondary Outcome(s)
Secondary end point(s): Major secondary efficacy measures include:
• Rate and intensity of sickle cell-related pain as recorded in patient pain diaries

• Rate of hospitalization for VOC
Timepoint(s) of evaluation of this end point: 36 months (3 years)
Secondary ID(s)
H7T-MC-TADO
Source(s) of Monetary Support
Eli Lilly and Company
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 15/04/2013
Contact:
Results
Results available: Yes
Date Posted: 01/07/2016
Date Completed: 17/12/2015
URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-003837-41/results
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