Efficacy and Safety Study of Pitavastatin and Atorvastatin in High Risk Hypercholesterolemic Patients
Information source: Tai Tien Pharmaceuticals Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperlipidemia
Intervention: Pitavastatin (Drug); Atorvastatin (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Tai Tien Pharmaceuticals Co., Ltd. Official(s) and/or principal investigator(s): Jaw-Wen Chen, M.D. Ph.D., Principal Investigator, Affiliation: Taipei Veterans General Hospital, Taipei, Taiwan
Overall contact: Jasmine Chao, Phone: +886-27423012, Email: jasmine@tanabe.com.tw
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The change of LDL-C
Secondary outcome: 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
Eligibility
Minimum age: 20 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Jasmine Chao, Phone: +886-27423012, Email: jasmine@tanabe.com.tw
Changhua Christian Hospital, Chang-hua, Taiwan; Not yet recruiting Chien-Hsun Hsia, M.D., Principal Investigator Lee-Shin Lin, M.D., Sub-Investigator
National Cheng Kung University Hospital, Tainan, Taiwan; Not yet recruiting Ping-Yen Liu, M.D. Ph.D., Principal 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., Sub-Investigator
Chang Gung Memorial Hospital-LinKou, Taipei, Taiwan; Not yet recruiting Ming-Shien Wen, M.D. Ph.D., Principal 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., Sub-Investigator
National Taiwan University Hospital, Taipei, Taiwan; Not yet recruiting Kuo-Liong Chien, M.D. Ph.D., Principal Investigator Chia-Lun Chao, M.D., Sub-Investigator Ta-Chen Su, M.D. Ph.D., Sub-Investigator Hung-Ju Lin, M.D., Sub-Investigator
Taipei Veterans General Hospital, Taipei, Taiwan; Not yet recruiting Tao-Cheng Wu, M.D. Ph.D., Principal Investigator Chin-Chou Huang, M.D., Sub-Investigator Liang-Yu Lin, M.D., Sub-Investigator Wen-Chung Yu, M.D., Sub-Investigator
Tri-Service General Hospital, Taipei, Taiwan
Additional Information
Starting date: July 2011
Last updated: June 30, 2011
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