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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Hyperlipidemia	Drug: Pitavastatin; Drug: Atorvastatin	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	July 2011
Estimated Primary Completion Date :	March 2012
Estimated Study Completion Date :	July 2012

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Pitavastatin	Drug: Pitavastatin; 2 mg QD; Other Name: Livalo
Active Comparator: Atorvastatin	Drug: Atorvastatin; 10 mg QD; Other Name: Lipitor

Outcome Measures

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Primary Outcome Measures :

1. The change of LDL-C [ Time Frame: Baseline to 12 weeks ]

Secondary Outcome Measures :

1. 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 [ Time Frame: Baseline to 4 weeks and 12 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Contacts

Contact: Jasmine Chao	+886-27423012	jasmine@tanabe.com.tw

Locations

Taiwan
Changhua Christian Hospital	Not yet recruiting
Chang-hua, Taiwan
Principal Investigator: Chien-Hsun Hsia, M.D.
Sub-Investigator: Lee-Shin Lin, M.D.
National Cheng Kung University Hospital	Not yet recruiting
Tainan, Taiwan
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.
Chang Gung Memorial Hospital-LinKou	Not yet recruiting
Taipei, Taiwan
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.
National Taiwan University Hospital	Not yet recruiting
Taipei, Taiwan
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 Veterans General Hospital	Not yet recruiting
Taipei, Taiwan
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.
Tri-Service General Hospital
Taipei, Taiwan

Sponsors and Collaborators

Tai Tien Pharmaceuticals Co., Ltd.

Investigators

Principal Investigator:	Jaw-Wen Chen, M.D. Ph.D.	Taipei Veterans General Hospital, Taipei, Taiwan

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Manager, Development Department
ClinicalTrials.gov Identifier:	NCT01386853 History of Changes
Other Study ID Numbers:	TATPITA20101005
First Posted:	July 1, 2011
Last Update Posted:	July 1, 2011
Last Verified:	June 2011

Keywords provided by Tai Tien Pharmaceuticals Co., Ltd.:

Hyperlipidemia; Pitavastatin; Atorvastatin

Additional relevant MeSH terms:

Hyperlipidemias; Hyperlipoproteinemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Atorvastatin Calcium; Pitavastatin	Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors