Status:
COMPLETED
A Diabetes Study to Treat A Population Previously Not at Target
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will assess if customizing the start dose of rosuvastatin appropriate for the degree of LDL-C reduction required, would achieve LDL-C target of ≤ 2.0 mmol/L quickly with either no titration...
Eligibility Criteria
Inclusion
- Diagnosis of Type 2 diabetes
- Previously treated with a commonly accepted start dose of a statin for the last 4 weeks prior to study entry
- Fasting LDL-C concentration of \> 2.0 mmol/L (and ≤ 5.0 mmol/L) (in the past 3 months)
- History of serum TG level of ≤ 4.6 mmol/l (in the past 3 months)
Exclusion
- If currently receiving therapy with any statin at a dose higher than listed
- Rosuvastatin (current use)
- Fibrates, niacin or resins that was not discontinued a minimum of 2 months prior to enrolment.
- Type 1 diabetes; glycated haemoglobin (HbA1c) \> 9.0%
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 1.5 × upper limit of normal (ULN) (in the past 2 months)
- Resting diastolic or systolic blood pressure of \> 95 mmHg or \> 180 mmHg, respectively (in the past 2 months)
- Unexplained serum creatine kinase (CK) level \> 3 × ULN (in the past 2 months).
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
598 Patients enrolled
Trial Details
Trial ID
NCT00747149
Start Date
May 1 2008
End Date
August 1 2009
Last Update
August 31 2011
Active Locations (84)
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1
Research Site
Calgary, Alberta, Canada
2
Research Site
Edmonton, Alberta, Canada
3
Research Site
Red Deer, Alberta, Canada
4
Research Site
Spruce Grove, Alberta, Canada