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

March 28, 2012 updated by: JW Pharmaceutical

A Prospective Comparative Clinical Study to Identify Efficacy and Safety of Pitavastatin in Patients 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

187

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Bundang-gu, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
      • Guri-si, Gyeonggi-do, Korea, Republic of, 471-701
        • Hanyang Univ. Guri Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: T
Lifestyle modification + active drug(Pitavastatin)
Drug: pitavastatin
Pitavastatin 2mg daily once
Other Names:
  • Livaro
Other: C
Lifestyle Modification
Behavioral: Lifestyle Modification
conducting mainly exercises and diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A change of metabolic syndrome risk component
Time Frame: 48week
48week

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes of cardiometabolic profiles : lipid profiles, hs-CRP, adiponectin, HMW adiponectin
Time Frame: 48week
48week
Changes of abdominal visceral fat
Time Frame: 48week
48week
Changes of insulin resistance : OGTT(75g), HOMA
Time Frame: 48week
48week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Investigators

  • Study Chair: Chang Beom Lee, Hanyang Univ. Guri Hospital
  • Study Chair: Hak Chul Jang, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

March 18, 2008

First Submitted That Met QC Criteria

March 20, 2008

First Posted (Estimate)

March 21, 2008

Study Record Updates

Last Update Posted (Estimate)

March 30, 2012

Last Update Submitted That Met QC Criteria

March 28, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CWP_PTV_706

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metabolic Syndrome

Clinical Trials on pitavastatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe