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Primary Prevention of Stroke in Children With SCD in Sub-Saharan Africa II

NCT02560935 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2020-08-03

No results posted yet for this study

Summary

The overall goal of this proposal is to conduct a partial double-blind randomized Phase III clinical trial for primary stroke prevention in children with sickle cell anemia (SCA) in sub-Saharan Africa.

Conditions

Interventions

DRUG

Hydroxyurea (Moderate Dose)

The study intervention will include moderate dose hydroxyurea therapy at 20 mg/kg/day (range 17.5 - 26 mg/kg/day) for 36 months.

DRUG

Hydroxyurea (Low Dose)

The study intervention will include random allocation to low dose hydroxyurea therapy at 10 mg/kg/day (range 7 - 15 mg/kg/day) for 36 months.

Sponsors & Collaborators

  • Aminu Kano Teaching Hospital

    collaborator OTHER

  • Murtala Muhammed Specialist Hospital

    collaborator OTHER

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Barau Dikko Teaching Hospital/Kaduna State University

    collaborator UNKNOWN

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Michael R. DeBaun, MD, MPH · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-19
Primary Completion
2020-03-03
Completion
2020-03-03

Countries

  • Nigeria

Study Locations

More Related Trials

Entities

Diseases

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 NCT02560935 on ClinicalTrials.gov