Skip to main content
OpenTrials
Completed

NCT Number: NCT00640276

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia Dyslipidemias Glucose Metabolism Disorders Hyperinsulinism Hyperlipidemias Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital, Bundang-gu, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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

Treatment and study plan

Pitavastatin

Drug

Pitavastatin 2mg daily once

Other names: Livaro

Lifestyle Modification

Behavioral

conducting mainly exercises and diet

Primary outcomes

  1. A change of metabolic syndrome risk component

    Time frame: 48week

Secondary outcomes

  1. Changes of cardiometabolic profiles : lipid profiles, hs-CRP, adiponectin, HMW adiponectin

    Time frame: 48week

  2. Changes of abdominal visceral fat

    Time frame: 48week

  3. Changes of insulin resistance : OGTT(75g), HOMA

    Time frame: 48week

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

A Prospective Comparative Clinical Study to Identify Efficacy and Safety of Pitavastatin in Patients With a Metabolic Syndrome

Acronym: ProPit

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 21, 2008
Registry last updated
Mar 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.