Back to resultsIIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin
Primary Purpose
Fredrickson Type IIa & Type IIb Dyslipidaemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rosuvastatin
Simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Fredrickson Type IIa & Type IIb Dyslipidaemia focused on measuring Cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor, Simvastatin, Zocor, Renal, kidney
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Rosuvastatin
Simvastatin
Outcomes
Primary Outcome Measures
Development of Proteinuria
Secondary Outcome Measures
Renal effects of rosuvastatin and simvastatin
Low density lipoproteins cholesterol levels
Safety: adverse events & abnormal laboratory markers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00654446
Brief Title
IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin
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 Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fredrickson Type IIa & Type IIb Dyslipidaemia
Keywords
Cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor, Simvastatin, Zocor, Renal, kidney
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
442 (false)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Rosuvastatin
Arm Title
2
Arm Type
Active Comparator
Arm Description
Simvastatin
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
Zocor
Primary Outcome Measure Information:
Title
Development of Proteinuria
Time Frame
2 weekly
Secondary Outcome Measure Information:
Title
Renal effects of rosuvastatin and simvastatin
Time Frame
2 weekly
Title
Low density lipoproteins cholesterol levels
Time Frame
2 weekly
Title
Safety: adverse events & abnormal laboratory markers
Time Frame
2 weekly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan Stein
Organizational Affiliation
Metabolic & Athersclerotic research centre, Cincinatti, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Russell Esterline
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin
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