Status:
COMPLETED
DISCOVERY Asia - Crestor in Type IIa and IIb Hypercholesteremia
Lead Sponsor:
AstraZeneca
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This clinical trial is being performed to investigate the effect of 12 weeks treatment with rosuvastatin and atorvastatin in bringing subjects to their established EAS LDL-C target goal.
Eligibility Criteria
Inclusion
- Visit 1:
- Written informed consent to participate in the trial (Appendix B)
- Male or female subjects, age \> 18 years
- Primary hypercholesterolaemia with CV risk \> 20%/10yrs, type 2 diabetes, a history of CHD or other established atherosclerotic disease (definition given in Appendix L).
- Subjects may be lipid-lowering therapy-naïve, but have completed 6-weeks dietary counselling before this visit OR Subjects may be treated with the 'start' dose of other lipid lowering therapy, which is ineffective, ie. The subject has not met LDL-C treatment goals.
- Subjects willing to follow all study procedures including attendance at clinics for scheduled study visits, fasting prior to blood draws and compliance with study treatment regimen
- Visit 2:
- Subjects switched from start dose of a lipid lowering therapy (commonly accepted start dose) will have fasting LDL-C levels \> 3.1 mmol (120 mg/dl)
- Newly treated subjects, after a six-weeks dietary counselling, will have fasting LDL-C levels \> 3.5 mmol/L (135 mg/dL)
- Fasting triglycerides £ 4.52 mmol/L (400 mg/dL)
- Switched patients must stop current lipid lowering treatment at randomisation (Visit 2)
Exclusion
- Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
- Documented secondary hypercholesterolaemia of any cause other than named in inclusion criteria 3
- History of serious adverse effect or hypersensitivity reactions to other HMG-CoA reductase inhibitors, in particular any history of myopathy
- Unstable angina within three months prior to inclusion in the study
- Active liver disease or hepatic dysfunction as defined by elevations of AST or ALT ³ 1.5 times the ULN. In this case, a second determination of hepatic tests will be performed after one week. If the dysfunction is confirmed, the subject must not be included in the study
- Known uncontrolled diabetes
- Uncontrolled hypertension defined as either resting diastolic blood pressure of \> 95mmHg or resting systolic blood pressure of \> 200 mmHg
- Unexplained serum CK \> 3 times ULN (eg not due to recent trauma, intramuscular injections, heavy exercise etc)
- Serum creatinine \> 220 µmol/L (2.5mg/dL)
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2007
Estimated Enrollment :
1362 Patients enrolled
Trial Details
Trial ID
NCT00241488
Start Date
June 1 2003
End Date
February 1 2007
Last Update
February 7 2008
Active Locations (34)
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1
Beijing, China
2
Ching Qing, China
3
Guangzhou, China
4
Harbin, China