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

Hyperlipidemia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01386853
• Other study ID #: TATPITA20101005
• Status: Not yet recruiting
• Phase: Phase 3
• First received: June 29, 2011
• Last updated: June 30, 2011
• Start date: July 2011
• Est. completion date: July 2012

Study information

• Verified date: June 2011
• Source: Tai Tien Pharmaceuticals Co., Ltd.
• Contact: Jasmine Chao
• Phone: +886-27423012
• Email: jasmine[@]tanabe.com.tw
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• Pitavastatin
2 mg QD
• Atorvastatin
10 mg QD

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Chang-hua
Taiwan	National Cheng Kung University Hospital	Tainan
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

Sponsors (1)

Lead Sponsor	Collaborator
Tai Tien Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of LDL-C		Baseline to 12 weeks	No
Secondary	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	No