At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 9 enrolled
Drug / intervention
Rosuvastatin 20mgdrug
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.
An Open-Label Long-Term Extension to the 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 for Homozygous Familial Hypercholesterolemia (HoFH). Completed, enrolled 9 participants across 6 sites in 6 countries.
Detailed Summary
The purpose of the study is to evaluate the safety of Rosuvastatin in Children and Adolescents with Homozygous Familial Hypercholesterolemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Canada, Denmark, Israel, Malaysia, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartJun 2015
Primary CompletionNov 2016
TodayJul 2026
First PostedMay 5, 2015
Enrollment StartJun 6, 2015
Primary CompletionNov 17, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.2 years ago
Interventions
Rosuvastatin 20mgdrug
Active drug 1 or 2 tablets will be taken taken orally, QD, either in the morning or in the evening