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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Tai Tien Pharmaceuticals Co., Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tai Tien Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01386853
First received: June 29, 2011
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Hyperlipidemia
Drug: Pitavastatin
Drug: Atorvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Tai Tien Pharmaceuticals Co., Ltd.:

Primary Outcome Measures:
  • The change of LDL-C [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]

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 [ Time Frame: Baseline to 4 weeks and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pitavastatin Drug: Pitavastatin
2 mg QD
Other Name: Livalo
Active Comparator: Atorvastatin Drug: Atorvastatin
10 mg QD
Other Name: Lipitor

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386853

Contacts
Contact: Jasmine Chao +886-27423012 jasmine@tanabe.com.tw

Locations
Taiwan
Changhua Christian Hospital Not yet recruiting
Chang-hua, Taiwan
Principal Investigator: Chien-Hsun Hsia, M.D.         
Sub-Investigator: Lee-Shin Lin, M.D.         
National Cheng Kung University Hospital Not yet recruiting
Tainan, Taiwan
Principal Investigator: Ping-Yen Liu, M.D. Ph.D.         
Sub-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.         
Chang Gung Memorial Hospital-LinKou Not yet recruiting
Taipei, Taiwan
Principal Investigator: Ming-Shien Wen, M.D. Ph.D.         
Sub-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.         
Taipei Veterans General Hospital Not yet recruiting
Taipei, Taiwan
Principal Investigator: Tao-Cheng Wu, M.D. Ph.D.         
Sub-Investigator: Chin-Chou Huang, M.D.         
Sub-Investigator: Liang-Yu Lin, M.D.         
Sub-Investigator: Wen-Chung Yu, M.D.         
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan
Principal Investigator: Kuo-Liong Chien, M.D. Ph.D.         
Sub-Investigator: Chia-Lun Chao, M.D.         
Sub-Investigator: Ta-Chen Su, M.D. Ph.D.         
Sub-Investigator: Hung-Ju Lin, M.D.         
Tri-Service General Hospital
Taipei, Taiwan
Sponsors and Collaborators
Tai Tien Pharmaceuticals Co., Ltd.
Investigators
Principal Investigator: Jaw-Wen Chen, M.D. Ph.D. Taipei Veterans General Hospital, Taipei, Taiwan
  More Information

No publications provided by Tai Tien Pharmaceuticals Co., Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Manager, Development Department
ClinicalTrials.gov Identifier: NCT01386853     History of Changes
Other Study ID Numbers: TATPITA20101005
Study First Received: June 29, 2011
Last Updated: June 30, 2011
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by Tai Tien Pharmaceuticals Co., Ltd.:
Hyperlipidemia
Pitavastatin
Atorvastatin

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Pitavastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014