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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00640276
First received: March 18, 2008
Last updated: March 28, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Metabolic Syndrome
 Drug: pitavastatin
Behavioral: Lifestyle Modification
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Comparative Clinical Study to Identify Efficacy and Safety of Pitavastatin in Patients With a Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:
  • A change of metabolic syndrome risk component [ Time Frame: 48week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes of cardiometabolic profiles : lipid profiles, hs-CRP, adiponectin, HMW adiponectin [ Time Frame: 48week ] [ Designated as safety issue: No ]
  • Changes of abdominal visceral fat [ Time Frame: 48week ] [ Designated as safety issue: No ]
  • Changes of insulin resistance : OGTT(75g), HOMA [ Time Frame: 48week ] [ Designated as safety issue: Yes ]

Enrollment: 187
Study Start Date: April 2008
Study Completion Date: June 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: T
Lifestyle modification + active drug(Pitavastatin)
 Drug: pitavastatin
Pitavastatin 2mg daily once
Other Name: Livaro
C
Lifestyle Modification
 Behavioral: Lifestyle Modification
conducting mainly exercises and diet

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640276

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Bundang-gu, Gyeonggi-do, Korea, Republic of, 463-707
Hanyang Univ. Guri Hospital
Guri-si, Gyeonggi-do, Korea, Republic of, 471-701
Sponsors and Collaborators
JW Pharmaceutical
Investigators
Study Chair: Chang Beom Lee Hanyang Univ. Guri Hospital
Study Chair: Hak Chul Jang Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT00640276     History of Changes
Other Study ID Numbers: CWP_PTV_706
Study First Received: March 18, 2008
Last Updated: March 28, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by JW Pharmaceutical:
pitavastatin
metabolic syndrome
metabolic syndrome risk score
hypercholesterolemia

Additional relevant MeSH terms:
Hypercholesterolemia
Metabolic Syndrome X
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Pitavastatin
 Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013