At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 20 enrolled
Drug / intervention
Rosuvastatin 20mg +1 moredrug
Likely dose
Rosuvastatin 20mgfrom 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.
A Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (Aged 6 to <18 Years) With Homozygous Familial Hypercholesterolemia (HoFH)
In Brief
A Phase 3 clinical trial evaluating Rosuvastatin 20mg and Placebo for Homozygous Familial Hypercholesterolemia (HoFH). Completed, enrolled 20 participants across 9 sites in 7 countries.
Detailed Summary
The purpose of the study is to establish the efficacy, safety and tolerability of rosuvastatin in children and adolescents with homozygous familial hypercholesterolemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Canada, Denmark, Israel, Malaysia, Netherlands, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 2014
Enrollment StartNov 2014
Primary CompletionJul 2015
TodayJul 2026
First PostedAug 27, 2014
Enrollment StartNov 1, 2014
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.8 years ago
Interventions
Rosuvastatin 20mgdrug
Active drug will be taken taken orally, QD, either in the morning or in the evening
Placebodrug
Will be taken taken orally, QD, either in the morning or in the evening