Status:
COMPLETED
Safety and Efficacy Study of Pitavastatin in Patient With a Metabolic Syndrome
Lead Sponsor:
JW Pharmaceutical
Conditions:
Hypercholesterolemia
Metabolic Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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....
Eligibility Criteria
Inclusion
- Patients aged between 18 and 75
- Patients with LDL ≥ 100mg/dL
- Patients with metabolic syndrome
- IFG: Fasting glucose ≥ 100mg/dL
- Abdominal Obesity: Waist circumference: men≥90cm,women≥85cm
- 1 or more of the following
- Triglyceride ≥ 150mg/dL
- HDL-C: men \< 40mg/dL, women \< 50mg/dL
- Blood pressure: SBP ≥ 130mmHg or DBP ≥ 85mmHg or subject receiving anti-hypertensive treatment
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT00640276
Start Date
April 1 2008
End Date
June 1 2011
Last Update
March 30 2012
Active Locations (2)
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1
Seoul National University Bundang Hospital
Bundang-gu, Gyeonggi-do, South Korea, 463-707
2
Hanyang Univ. Guri Hospital
Guri-si, Gyeonggi-do, South Korea, 471-701