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

NCT01794000 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 341

Last updated 2019-09-25

Study results available
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Summary

The main purpose of the study is to evaluate the efficacy and safety of the study drug known as prasugrel for the reduction of Vaso-Occlusive Crisis events in pediatric participants with sickle cell disease. The study will also investigate reduction in daily pain in children who have sickle cell disease.

Conditions

Interventions

DRUG

Prasugrel

Administered orally

DRUG

Placebo

Administered orally

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-07-31
Completion
2015-12-31

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • Egypt
  • Ghana
  • Italy
  • Kenya
  • Lebanon
  • Oman
  • Saudi Arabia
  • Turkey (Türkiye)
  • United Arab Emirates
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01794000 on ClinicalTrials.gov