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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

Page last updated: August 23, 2015

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