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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2004

Intervention(s) in this Clinical Trial

• Drug: Rosuvastatin
• Drug: Simvastatin

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Rosuvastatin
• Active Comparator: 2
  • Simvastatin

Primary Measures

• Development of Proteinuria
  • Time Frame: 2 weekly
    Safety Issue?: No

Secondary Measures

• Renal effects of rosuvastatin and simvastatin
  • Time Frame: 2 weekly
    Safety Issue?: No
• Low density lipoproteins cholesterol levels
  • Time Frame: 2 weekly
    Safety Issue?: No
• Safety: adverse events & abnormal laboratory markers
  • Time Frame: 2 weekly
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Evan Stein Principal Investigator Metabolic & Athersclerotic research centre, Cincinatti, USA  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00654446

Study ID Number: 4522IL/0099

ClinicalTrials.gov Identifier: NCT00654446

Health Authority: United States: Food and Drug Administration