Safety and Efficacy Study of Pitavastatin in Patient With a Metabolic Syndrome
NCT ID: NCT00640276
Last Updated: 2012-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
187 participants
INTERVENTIONAL
2008-04-30
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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T
Lifestyle modification + active drug(Pitavastatin)
pitavastatin
Pitavastatin 2mg daily once
C
Lifestyle Modification
Lifestyle Modification
conducting mainly exercises and diet
Interventions
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pitavastatin
Pitavastatin 2mg daily once
Lifestyle Modification
conducting mainly exercises and diet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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JW Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Chang Beom Lee
Role: STUDY_CHAIR
Hanyang Univ. Guri Hospital
Hak Chul Jang
Role: STUDY_CHAIR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Bundang-gu, Gyeonggi-do, South Korea
Hanyang Univ. Guri Hospital
Guri-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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CWP_PTV_706
Identifier Type: -
Identifier Source: org_study_id