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

NCT01386853 | Unknown Phase 3

• 1 other identifier: TATPITA20101005
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

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.

Conditions

Hyperlipidemia

Keywords

Hyperlipidemia; Pitavastatin; Atorvastatin

Outcome Measures

Primary Outcomes (1)

• The change of LDL-C

  Baseline to 12 weeks

Secondary Outcomes (1)

• 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

Study Arms (2)

Pitavastatin

EXPERIMENTAL

Drug: Pitavastatin

Atorvastatin

ACTIVE COMPARATOR

Drug: Atorvastatin

Interventions

Pitavastatin DRUG

2 mg QD

Also known as: Livalo

Pitavastatin

Atorvastatin DRUG

10 mg QD

Also known as: Lipitor

Atorvastatin

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tai Tien Pharmaceuticals Co., Ltd.: lead

Study Sites (6)

Changhua Christian Hospital

Chang-hua, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Chang Gung Memorial Hospital-LinKou

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

Related Publications (2)

• Lin LY, Huang CC, Chen JS, Wu TC, Leu HB, Huang PH, Chang TT, Lin SJ, Chen JW. Effects of pitavastatin versus atorvastatin on the peripheral endothelial progenitor cells and vascular endothelial growth factor in high-risk patients: a pilot prospective, double-blind, randomized study. Cardiovasc Diabetol. 2014 Jul 16;13:111. doi: 10.1186/s12933-014-0111-1.

  PMID: 25027585 DERIVED

• Liu PY, Lin LY, Lin HJ, Hsia CH, Hung YR, Yeh HI, Wu TC, Chen JY, Chien KL, Chen JW. Pitavastatin and Atorvastatin double-blind randomized comPArative study among hiGh-risk patients, including thOse with Type 2 diabetes mellitus, in Taiwan (PAPAGO-T Study). PLoS One. 2013 Oct 1;8(10):e76298. doi: 10.1371/journal.pone.0076298. eCollection 2013.

  PMID: 24098467 DERIVED

MeSH Terms

Conditions

Hyperlipidemias

Interventions

pitavastatin; Atorvastatin

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Jaw-Wen Chen, M.D. Ph.D.

  Taipei Veterans General Hospital, Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasmine Chao

CONTACT

+886-27423012; jasmine@tanabe.com.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 1, 2011
• Study Start: July 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 1, 2011

Record last verified: 2011-06

Locations

TW (6)