Safety and Efficacy Study of Pitavastatin in Patient With a Metabolic Syndrome

Phase 4

Completed

• Conditions: Hypercholesterolemia; Metabolic Syndrome
• Interventions: Behavioral: Lifestyle Modification; Drug: pitavastatin

• Registration Number: NCT00640276
• Lead Sponsor: JW Pharmaceutical

Brief Summary

We will identify the influence of long-term treatment of Pitavastatin compared to non-treatment control group on the metabolic syndrome by evaluation of a change of metabolic syndrome component score. And we will additionally observe the changes of CVD risk factors like lipid profile, abdominal fat, insulin resistance and so on.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-20
• Study First Posted: 2008-03-21
• Study Start: 2008-04
• Primary Completion: 2011-02
• Study Completion: 2011-06
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-28
• Last Update Posted: 2012-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

• Patients aged between 18 and 75

• Patients with LDL ≥ 100mg/dL

• Patients with metabolic syndrome

  1. IFG: Fasting glucose ≥ 100mg/dL

  2. Abdominal Obesity: Waist circumference: men≥90cm,women≥85cm

  3. 1 or more of the following

     1. Triglyceride ≥ 150mg/dL
     2. HDL-C: men < 40mg/dL, women < 50mg/dL
     3. Blood pressure: SBP ≥ 130mmHg or DBP ≥ 85mmHg or subject receiving anti-hypertensive treatment

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Exclusion Criteria

• uncontrolled hypertension (DBP ≥ 95mmHg)
• taking diabetic drugs or with HbA1c > 8%
• LDL ≥ 190mg/dL or Triglyceride ≥ 400mg/dL
• coronary heart disease or other diseases caused by artherosclerosis
• malignancy within 6 months
• Serum creatinine ≥ 2.0mg/dL
• ALT or AST ≥ ULN*2.5
• CPK ≥ ULN*2
• hypothyroidism

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	Lifestyle Modification	Lifestyle Modification
T	pitavastatin	Lifestyle modification + active drug(Pitavastatin)

Primary Outcome Measures

Name	Time	Method
A change of metabolic syndrome risk component	48week

Secondary Outcome Measures

Name	Time	Method
Changes of insulin resistance : OGTT(75g), HOMA	48week
Changes of abdominal visceral fat	48week
Changes of cardiometabolic profiles : lipid profiles, hs-CRP, adiponectin, HMW adiponectin	48week

Trial Locations

Locations (2)

Seoul National University Bundang Hospital; 🇰🇷 Bundang-gu, Gyeonggi-do, Korea, Republic of

Hanyang Univ. Guri Hospital; 🇰🇷 Guri-si, Gyeonggi-do, Korea, Republic of