Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia
Information source: JW Pharmaceutical
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia With Type2DM
Intervention: Pitavastatin (Drug); Atorvastatin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: JW Pharmaceutical Official(s) and/or principal investigator(s): Ho Young Shon, MD, Principal Investigator, Affiliation: Endocrinology, Kangnam Saint Mary's Hospital
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
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Proportion of patients achieving LDL- C<100mg/dL
Secondary outcome: The change of LDL-C, TC, TG, HDL-C, Apo A1, Apo BThe change of hs-CRP 3 The change of fasting insulin The change of adiponectin The change of brachial ankle PWV Adverse events Any abnormal change of physical examination and Lab result
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
Minimum age: 25 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Additional Information
Starting date: April 2008
Last updated: April 2, 2013
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