IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00654446
First received: April 3, 2008
Last updated: March 13, 2009
Last verified: March 2009
  Purpose

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


Condition Intervention Phase
Fredrickson Type IIa & Type IIb Dyslipidaemia
Drug: Rosuvastatin
Drug: Simvastatin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Development of Proteinuria [ Time Frame: 2 weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Renal effects of rosuvastatin and simvastatin [ Time Frame: 2 weekly ] [ Designated as safety issue: No ]
  • Low density lipoproteins cholesterol levels [ Time Frame: 2 weekly ] [ Designated as safety issue: No ]
  • Safety: adverse events & abnormal laboratory markers [ Time Frame: 2 weekly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 442
Study Start Date: September 2002
Study Completion Date: April 2004
Arms Assigned Interventions
Experimental: 1
Rosuvastatin
Drug: Rosuvastatin
Other Name: Crestor
Active Comparator: 2
Simvastatin
Drug: Simvastatin
Other Name: Zocor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654446

Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Evan Stein Metabolic & Athersclerotic research centre, Cincinatti, USA
Study Director: Russell Esterline AstraZeneca
  More Information

No publications provided

Responsible Party: Michael Cressman - Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00654446     History of Changes
Other Study ID Numbers: 4522IL/0099
Study First Received: April 3, 2008
Last Updated: March 13, 2009
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Israeli Health Ministry Pharmaceutical Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
South Africa: Medicines Control Council

Keywords provided by AstraZeneca:
Cholesterol
low density lipoproteins
dyslipidaemia
Rosuvastatin
Crestor
Simvastatin
Zocor
Renal
kidney

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Simvastatin
Rosuvastatin
Lipid Regulating Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014