Who is sponsoring NCT00355615?

NCT00355615 is sponsored by AstraZeneca.

What condition does NCT00355615 study?

NCT00355615 studies Familial Hypercholesterolemia.

What drugs are being tested in NCT00355615?

Interventions: Rosuvastatin, Placebo.

What is the status of NCT00355615?

NCT00355615 is currently COMPLETED.

Last reviewed 2011-08-29 · How we verify

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

NCT00355615 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	COMPLETED
Enrolment	173
Start date	2006-07
Completion	2008-07

Conditions

Familial Hypercholesterolemia

Interventions

Rosuvastatin
Placebo

Primary outcomes

Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase — 12 weeks
Percent change in low-density lipoprotein cholesterol (LDL-C) = (final value - Baseline value)/Baseline value \* 100

Countries

United States, Canada, Netherlands, Norway, Spain