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

JW Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia; Metabolic Syndrome

Treatments: Behavioral: Lifestyle Modification; Drug: pitavastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00640276

CWP_PTV_706

Details and patient eligibility

About

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.

Enrollment: 187 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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187 participants in 2 patient groups

T

Active Comparator group

Description:

Lifestyle modification + active drug(Pitavastatin)

Treatment:

Drug: pitavastatin

C

Other group

Description:

Lifestyle Modification

Treatment:

Behavioral: Lifestyle Modification