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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00640276
Recruitment Status : Completed
First Posted : March 21, 2008
Last Update Posted : March 30, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Hypercholesterolemia Metabolic Syndrome Drug: pitavastatin Behavioral: Lifestyle Modification Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2008
Primary Completion Date : February 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. A change of metabolic syndrome risk component [ Time Frame: 48week ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT00640276     History of Changes
Other Study ID Numbers: CWP_PTV_706
First Posted: March 21, 2008    Key Record Dates
Last Update Posted: March 30, 2012
Last Verified: March 2012

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

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