IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin

Fredrickson Type IIa & Type IIb Dyslipidaemia Clinical Trial

Official title:

A 6-wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study, Which Describes the Renal Effects of the Lipid-Regulating Agents Rosuvastatin and Simvastatin in the Treatment of Sub's With Fredrickson Type IIa & Type IIb Dyslipidaemia, Inc. Heterozygous Familial Hypercholesterolaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654446
• Other study ID #: 4522IL/0099
• Status: Completed
• Phase: Phase 3
• First received: April 3, 2008
• Last updated: March 13, 2009
• Start date: September 2002
• Est. completion date: April 2004

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: 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 AgencySouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effects on the kidney of rosuvastatin and simvastatin in subjects with Fredrickson Type IIa & Type IIb Dyslipidaemia

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: April 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 creatine levels above the limits defined in the protocol or +4 proteinuria during dietary lead in period.

• Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Fredrickson Type IIa & Type IIb Dyslipidaemia

Intervention

Drug:
• Rosuvastatin

• Simvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of Proteinuria		2 weekly	No
Secondary	Renal effects of rosuvastatin and simvastatin		2 weekly	No
Secondary	Low density lipoproteins cholesterol levels		2 weekly	No
Secondary	Safety: adverse events & abnormal laboratory markers		2 weekly	Yes