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

NCT ID: NCT01386853

Last Updated: 2011-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-07-31

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.

Conditions

Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pitavastatin

Group Type: EXPERIMENTAL

Pitavastatin

Intervention Type: DRUG

2 mg QD

Atorvastatin

Group Type: ACTIVE_COMPARATOR

Atorvastatin

Intervention Type: DRUG

10 mg QD

Interventions

Pitavastatin

2 mg QD

Intervention Type: DRUG

Atorvastatin

10 mg QD

Intervention Type: DRUG

Other Intervention Names

Livalo; Lipitor

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tai Tien Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Development Department

Principal Investigators

Jaw-Wen Chen, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taipei, Taiwan

Locations

Changhua Christian Hospital

Chang-hua, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

Chang Gung Memorial Hospital-LinKou

Taipei, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Countries

Taiwan

Central Contacts

Jasmine Chao

Role: CONTACT

jasmine@tanabe.com.tw

+886-27423012

References

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.

Reference Type: DERIVED

PMID: 25027585 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24098467 (View on PubMed)

Other Identifiers

TATPITA20101005

Identifier Type: -

Identifier Source: org_study_id