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

Sponsor

Tai Tien Pharmaceuticals Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01386853

Collaborator

(none)

200

Enrollment

Locations

Arms

Duration (Months)

33.3

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2011

Anticipated Primary Completion Date :

Mar 1, 2012

Anticipated Study Completion Date :

Jul 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Pitavastatin

Drug: Pitavastatin

2 mg QD

Other Names:

Livalo

Active Comparator: Atorvastatin

Drug: Atorvastatin

10 mg QD

Other Names:

Lipitor

Outcome Measures

Primary Outcome Measures

The change of LDL-C [Baseline to 12 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	Changhua Christian Hospital	Chang-hua	Taiwan
2	National Cheng Kung University Hospital	Tainan	Taiwan
3	Chang Gung Memorial Hospital-LinKou	Taipei	Taiwan
4	National Taiwan University Hospital	Taipei	Taiwan
5	Taipei Veterans General Hospital	Taipei	Taiwan
6	Tri-Service General Hospital	Taipei	Taiwan