Efficacy and Safety Study of Pitavastatin and Atorvastatin in High Risk Hypercholesterolemic Patients

A 12-week, Randomized, Multicenter, Double-blind, Active-controlled, Non-inferiority Study to Compare the Efficacy and Safety of Pitavastatin and Atorvastatin in High Risk Hypercholesterolemic Patients

This is a 12-week, randomized, multicenter, double-blind, active-controlled, non-inferiority study (TATPITA20101005) to compare the efficacy and safety of pitavastatin (Livalo®) and atorvastatin (Lipitor®) in high risk hypercholesterolemic patients.

Study Overview

• Status: Unknown
• Conditions: Hyperlipidemia
• Intervention / Treatment: Drug: Pitavastatin; Drug: Atorvastatin

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jasmine Chao; Phone Number: +886-27423012; Email: jasmine@tanabe.com.tw

Study Locations

• Taiwan
  • Chang-hua, Taiwan
    • Changhua Christian Hospital
    • Principal Investigator: Chien-Hsun Hsia, M.D.
    • Sub-Investigator: Lee-Shin Lin, M.D.
  • Tainan, Taiwan
    • National Cheng Kung University Hospital
    • Principal Investigator: Ping-Yen Liu, M.D. Ph.D.
    • Sub-Investigator: Po-Sheng Chen, M.D.
    • Sub-Investigator: Ju-Yi Chen, M.D.
    • Sub-Investigator: Wei-Ting Li, M.D.
    • Sub-Investigator: Yen-Wen Liu, M.D.
    • Sub-Investigator: Cheng-Han Lee, M.D.
    • Sub-Investigator: Wei-Chuan Tsai, M.D.
    • Sub-Investigator: Yi-Heng Li, M.D.
    • Sub-Investigator: Chih-Chan Lin, M.D.
    • Sub-Investigator: Shih-Hung Chan, M.D.
    • Sub-Investigator: Ting-Hsing Chao, M.D.
  • Taipei, Taiwan
    • Tri-Service General Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital
    • Principal Investigator: Kuo-Liong Chien, M.D. Ph.D.
    • Sub-Investigator: Chia-Lun Chao, M.D.
    • Sub-Investigator: Ta-Chen Su, M.D. Ph.D.
    • Sub-Investigator: Hung-Ju Lin, M.D.
  • Taipei, Taiwan
    • Taipei Veterans General Hospital
    • Principal Investigator: Tao-Cheng Wu, M.D. Ph.D.
    • Sub-Investigator: Chin-Chou Huang, M.D.
    • Sub-Investigator: Liang-Yu Lin, M.D.
    • Sub-Investigator: Wen-Chung Yu, M.D.
  • Taipei, Taiwan
    • Chang Gung Memorial Hospital-Linkou
    • Principal Investigator: Ming-Shien Wen, M.D. Ph.D.
    • Sub-Investigator: Kuo-Chun Hung, M.D.
    • Sub-Investigator: I-Chang Hsieh, M.D.
    • Sub-Investigator: Chao-Yung Wang, M.D.
    • Sub-Investigator: Chun-Chi Chen, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient aged ≥ 20 years old and < 75 years old.
• Patient who was eligible and able to participate in the study and accepts to enter the study by signing written informed consent.
• Patient with fasting LDL-C > 100 mg/dL. The concentration of LDL-C is obtained from laboratory examination.
• Patient with at least one of the following description (NCEP ATP III guideline).
• Female patient with child-bearing potential must take reliable contraception method(s) during the participation of the study.

Exclusion Criteria:

• Patient who has participated in other investigational studies within 3 months.
• Patient took medication and natural health foods known to alter blood lipid profiles within 4 weeks.
• Patient is taking any medication or food that is prohibited by the study.
• Patient taking Amiodarone will be excluded from this study (due to long half life of this medication).
• Patient is diagnosed with type 1 DM or has been using insulin/insulin analog medication.
• Patient with a history of multiple drug allergies or with a known allergy to HMG-CoA reductase inhibitors.
• Patient with TG > 400 mg/dL.
• Excessive obesity defined as BMI above 35 kg/m2.
• Cerebral vascular disease (including cerebrovascular hemorrhage or ischemia, transient ischemic attack) diagnosed within 3 months.
• Myocardial infarction, heart failure (NYHA class III or IV), gross cardiac enlargement (cardiothoracic ratio > 0.5), significant heart block or cardiac arrhythmias within 3 months; history of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardia, pacemaker or implantable cardiac device were not eligible for this study.
• Patient with advanced renal disorder (Serum creatinine levels ≥ 2 mg/dL and BUN ≥ 25 mg/dL).
• Patient with advanced hepatic disorder (AST or ALT level ≥ 100 IU/L)
• Patient with CK level > 5 × ULRR at any time point between Visit 1 and Visit 2.
• Patient with poorly controlled diabetes mellitus (HbA1c > 9.0%) or patient with severe hypertension (> 180 mmHg for systolic or > 120 mmHg in diastolic blood pressure).
• Patient with hypothyroidism, hereditary muscular disorders, family history of the above or history of drug-induced myopathy.
• Patient has significant alcohol consumption (> 65 mL pure alcohol) within 48 hours before Visit 2.
• Any major surgery within 3 months prior to Visit 2.
• Female patient who is lactating, being pregnant or plans to become pregnant.
• Patient with conditions judged by the investigator as unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Atorvastatin	Drug: Atorvastatin; 10 mg QD; Other Names: Lipitor
Experimental: Pitavastatin	Drug: Pitavastatin; 2 mg QD; Other Names: Livalo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change of LDL-C	Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients achieving LDL-C < 100 mg/dL; the changes of HDL-C, TG, non-HDL-C, Apo A1 and Apo B, fasting plasma glucose, fasting insulin level, insulin resistance by the HOMA-IR, HbA1c, free fatty acid, and ADMA	Baseline to 4 weeks and 12 weeks

Collaborators and Investigators

• Sponsor: Tai Tien Pharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Jaw-Wen Chen, M.D. Ph.D., Taipei Veterans General Hospital, Taipei, Taiwan

Publications and helpful links

General Publications

• Lin LY, Huang CC, Chen JS, Wu TC, Leu HB, Huang PH, Chang TT, Lin SJ, Chen JW. Effects of pitavastatin versus atorvastatin on the peripheral endothelial progenitor cells and vascular endothelial growth factor in high-risk patients: a pilot prospective, double-blind, randomized study. Cardiovasc Diabetol. 2014 Jul 16;13:111. doi: 10.1186/s12933-014-0111-1.
• Liu PY, Lin LY, Lin HJ, Hsia CH, Hung YR, Yeh HI, Wu TC, Chen JY, Chien KL, Chen JW. Pitavastatin and Atorvastatin double-blind randomized comPArative study among hiGh-risk patients, including thOse with Type 2 diabetes mellitus, in Taiwan (PAPAGO-T Study). PLoS One. 2013 Oct 1;8(10):e76298. doi: 10.1371/journal.pone.0076298. eCollection 2013. Erratum In: PLoS One. 2014;9(11):e114175.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): March 1, 2012
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: June 29, 2011
• First Submitted That Met QC Criteria: June 30, 2011
• First Posted (Estimate): July 1, 2011

Study Record Updates

• Last Update Posted (Estimate): July 1, 2011
• Last Update Submitted That Met QC Criteria: June 30, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Hyperlipidemia; Atorvastatin; Pitavastatin
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Pitavastatin
• Other Study ID Numbers: TATPITA20101005