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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 B

The 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

Page last updated: August 23, 2015

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