Status:
COMPLETED
Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia
Lead Sponsor:
JW Pharmaceutical
Conditions:
Hypercholesterolemia With Type2DM
Eligibility:
All Genders
25-75 years
Phase:
PHASE4
Brief Summary
A randomized, open label, dose titration study to evaluate the efficacy and safety of Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia
Detailed Description
To evaluate the effect of pitavastatin compared to atorvastatin on the change of Lipid profiles, ApoA1, ApoB, adiponectin and baPWV as a marker of atherosclerosis in Type 2DM .
Eligibility Criteria
Inclusion
- Age: 25yrs\~75yrs
- Fasting TG \<400mg/dL, LDL-C ≥130mg/dL
- 3months \> Diagnosed Type2 DM, With OAD, HbA1c ≤ 10.0% or First Diagnosed Type2 DM, 6.5%≤HbA1c≤10.0%
Exclusion
- Type1 DM, Gestational diabetes
- Patient need to treat with Insulin
- Patient with operational treatment for severe diabetic complication
- Uncontrolled Hypothyroidism
- Unstable angina, MI, transient ischemic attack(TIA), Stroke, PCI, Heart Failure within 3 months (NYHA class4)
- Severe Hypertension (SBP ≥ 180 or DBP ≥ 110mmHg)
- Renal disorder (Serum creatinine ≥ 2.0mg/dL)
- Hepatic disorder (AST or ALT ≥ 2.5 X UNL)
- Creatinine Kinase \> 2.5 X UNL
- Gravida or lactation phase
- Administration of Atorvastatin, Rosuvastatin, Pitavastatin
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT00889226
Start Date
April 1 2008
End Date
January 1 2010
Last Update
September 17 2019
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