CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 440 enrolled
Drug / intervention
Hydroxyurea (Moderate Dose) +1 moredrug
Likely dose
Hydroxyurea (Moderate Dose) 20 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02560935
NCT02560935Phase 3Completed
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Primary Prevention of Stroke in Children With Sickle Cell Disease in Sub-Saharan Africa II

Vanderbilt University Medical Center·interventional·Posted Sep 25, 2015·Updated Aug 3, 2020

In Brief

A Phase 3 clinical trial evaluating Hydroxyurea (Moderate Dose) and Hydroxyurea (Low Dose) for Sickle Cell Disease and Stroke. Completed, enrolled 440 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSickle Cell Disease, Stroke
CountriesNigeria
CollaboratorsAminu Kano Teaching Hospital, Murtala Muhammed Specialist Hospital, National Institute of Neurological Disorders and Stroke (NINDS), Barau Dikko Teaching Hospital/Kaduna State University

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 25, 2015
Enrollment StartJul 19, 2016
Primary CompletionMar 3, 2020
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 10.8 years ago

Interventions

Hydroxyurea (Moderate Dose)drug

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

Hydroxyurea (Low Dose)drug

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.