CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 173 enrolled
Drug / intervention
Rosuvastatin +1 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Aged 10–17 years
  • ✓Diagnosed with heterozygous familial hypercholesterolemia (HeFH)
  • ✓Female participants must be at least 1 year post-menarche
Key exclusion· 2
  • ✕History of reaction/intolerance to rosuvastatin or other statin drugs
  • ✕Certain medical conditions and abnormal lab test results (details not provided in raw criteria)

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

Search/NCT00355615
NCT00355615Phase 3Completed
CompareCT.gov

A Phase IIIb, Efficacy, and Safety Study of Rosuvastatin in Children 10-17 Years of Age With Heterozygous Familial Hypercholesterolemia: a 12-week, Double-blind, Randomized, Multicenter, Placebo-controlled Study With a 40-week, Open-label, Follow-up

AstraZeneca·interventional·Posted Jul 24, 2006·Updated Aug 31, 2011

In Brief

A Phase 3 clinical trial evaluating Rosuvastatin and Placebo for Familial Hypercholesterolemia. Completed, enrolled 173 participants across 20 sites in 5 countries.

Detailed Summary

The primary objective of this study is to determine the efficacy of once-daily rosuvastatin in reducing LDL-C in children and adolescents aged 10-17 years with HeFH from baseline (Day 0) to the end of the 12-week double-blind treatment period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFamilial Hypercholesterolemia
CountriesCanada, Netherlands, Norway, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 24, 2006
Enrollment StartJul 1, 2006
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 19.9 years ago

Interventions

Rosuvastatindrug

oral

Placebodrug

oral