MedTrace Logo

Effect of Ticagrelor vs. Placebo in the Reduction of Vaso-occlusive Crises in Pediatric Patients With Sickle Cell Disease

NCT03615924 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2021-04-09

Study results available
· View outcomes & findings →

Summary

The purpose of the study is to Evaluate the Effect of Ticagrelor versus Placebo in Reducing the Rate of Vaso-Occlusive Crises in Paediatric Patients with Sickle Cell Disease

Conditions

Interventions

DRUG

Ticagrelor

The double-blinded study drug dose will be weight dependent: * ≥12 to ≤24kg: Ticagrelor 15 mg, twice a day * \>24 to ≤48 kg: Ticagrelor 30 mg, twice a day * \>48 kg: Ticagrelor 45 mg, twice a day.

DRUG

Placebo

The double-blinded study drug dose will be weight dependent: * ≥12 to ≤24kg: Placebo to match ticagrelor 15 mg, twice a day * \>24 to ≤48 kg: Placebo to match ticagrelor 30 mg, twice a day * \>48 kg: Placebo to match ticagrelor 45 mg, twice a day.

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Anders Berggren, MD, PhD · AstraZeneca

  • Matthew Heeney, MD · Harvard Medical School (HMS and HSDM)

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
2018-09-26
Primary Completion
2020-08-13
Completion
2020-08-13
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • Egypt
  • Ghana
  • Greece
  • India
  • Italy
  • Kenya
  • Lebanon
  • South Africa
  • Spain
  • Tanzania
  • Turkey (Türkiye)
  • Uganda
  • 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 NCT03615924 on ClinicalTrials.gov