48-wk Open Label Phase IIIb to Evaluate Efficacy and Safety

A 48 Week, Open Label, Non-Comparative, Multicentre, Phase IIIb Study to Evaluate the Efficacy and Safety of the Lipid-Regulating Agent Rosuvastatin in the Treatment of Subjects With Fredrickson Type IIa and Type IIb Dyslipidaemia, Including Heterozygous Familial Hypercholesterolaemia.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00654602

Enrollment

1500

Registered

2008-04-08

Start date

2002-02-28

Completion date

2004-11-30

Last updated

2009-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidaemia

Keywords

cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor

Brief summary

The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with dyslipidaemia.

Interventions

DRUGRosuvastatin

BEHAVIORALMaintenance of specific diet

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Fasting low density lipoprotein level as defined by the protocol. * Fasting triglyceride level as defined by the protocol.

Exclusion criteria

* The use of lipid lowering drugs or dietary supplements after Visit 1. * Active arterial disease eg Unstable angina, or recent arterial surgery. * Blood lipid levels above the limits defined in the protocol. * Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

Design outcomes

Primary

Measure	Time frame
Reduction in low density lipoprotein cholesterol levels	12 weeks

Secondary

Measure	Time frame
Reduction in low density lipoprotein cholesterol levels	24 & 48 weeks
Safety: adverse events & abnormal laboratory markers	4 weekly until week 12 then 12 weekly thereafter.
Maintenance of lowered low density lipoprotein cholesterol level	Between week 12-48

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026