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IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin

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ClinicalTrials.gov Identifier: NCT00654446
Recruitment Status : Completed
First Posted : April 8, 2008
Last Update Posted : March 16, 2009
Information provided by:

Brief 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

Condition or disease Intervention/treatment Phase
Fredrickson Type IIa & Type IIb Dyslipidaemia Drug: Rosuvastatin Drug: Simvastatin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 442 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2002
Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: Rosuvastatin
Other Name: Crestor
Active Comparator: 2
Drug: Simvastatin
Other Name: Zocor

Primary Outcome Measures :
  1. Development of Proteinuria [ Time Frame: 2 weekly ]

Secondary Outcome Measures :
  1. Renal effects of rosuvastatin and simvastatin [ Time Frame: 2 weekly ]
  2. Low density lipoproteins cholesterol levels [ Time Frame: 2 weekly ]
  3. Safety: adverse events & abnormal laboratory markers [ Time Frame: 2 weekly ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654446

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

Responsible Party: Michael Cressman - Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00654446     History of Changes
Other Study ID Numbers: 4522IL/0099
First Posted: April 8, 2008    Key Record Dates
Last Update Posted: March 16, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
low density lipoproteins

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Lipid Regulating Agents
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors