IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin

Verified by: AstraZeneca, March 2009
First Received: April 3, 2008 | Last Updated: March 13, 2009 | Phase: Phase 3 | Start Date: September 2002
Overall Status: Completed | Estimated Enrollment: 442
  • …
  • Tell a FriendPrint

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...

Brief Summary

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

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

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

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00654446