Main
|
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:
|
22 August 2016 |
Main ID: |
EUCTR2012-003837-41-BE |
Date of registration:
|
02/04/2013 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
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:
|
28/06/2013 |
Target sample size:
|
200 |
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: no
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
|
Jamaica
|
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: 200 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: 17.0
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 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 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 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 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
|
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 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.
|
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 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)
|
2012-003837-41-GB
|
H7T-MC-TADO
|
Source(s) of Monetary Support
|
Eli Lilly and Company
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|