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

Dyslipidaemia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654602
• Other study ID #: 4522IL/0091
• Secondary ID: D3560C00091
• Status: Completed
• Phase: Phase 3
• First received: April 3, 2008
• Last updated: May 27, 2009
• Start date: February 2002
• Est. completion date: November 2004

Study information

• Verified date: May 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research CouncilCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Israel: Israeli Health Ministry Pharmaceutical AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidaemia
• Dyslipidemias

Intervention

Drug:
• Rosuvastatin

Behavioral:
• Maintenance of specific diet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

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