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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: JW Pharmaceutical
• Treatments: Pitavastatin

Criteria

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

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