Back to results48-wk Open Label Phase IIIb to Evaluate Efficacy and Safety
Primary Purpose
Dyslipidaemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rosuvastatin
Maintenance of specific diet
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidaemia focused on measuring cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor
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 lipid levels above the limits defined in the protocol.
- Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
Sites / Locations
Outcomes
Primary Outcome Measures
Reduction in low density lipoprotein cholesterol levels
Secondary Outcome Measures
Reduction in low density lipoprotein cholesterol levels
Safety: adverse events & abnormal laboratory markers
Maintenance of lowered low density lipoprotein cholesterol level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00654602
Brief Title
48-wk Open Label Phase IIIb to Evaluate Efficacy and Safety
Official Title
A 48 Week, Open Label, Non-Comparative, Multicentre, Phase IIIb Study to Evaluate the Efficacy and Safety of the Lipid-Regulating Agent Rosuvastatin in the Treatment of Subjects With Fredrickson Type IIa and Type IIb Dyslipidaemia, Including Heterozygous Familial Hypercholesterolaemia.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 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 efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with dyslipidaemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidaemia
Keywords
cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Type
Behavioral
Intervention Name(s)
Maintenance of specific diet
Primary Outcome Measure Information:
Title
Reduction in low density lipoprotein cholesterol levels
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Reduction in low density lipoprotein cholesterol levels
Time Frame
24 & 48 weeks
Title
Safety: adverse events & abnormal laboratory markers
Time Frame
4 weekly until week 12 then 12 weekly thereafter.
Title
Maintenance of lowered low density lipoprotein cholesterol level
Time Frame
Between week 12-48
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 lipid levels above the limits defined in the protocol.
Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Evan Stein
Organizational Affiliation
Metabolic & Athersclerotic research centre, 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
48-wk Open Label Phase IIIb to Evaluate Efficacy and Safety
We'll reach out to this number within 24 hrs