Back to resultsSafety and Efficacy Study of Pitavastatin in Patient With a Metabolic Syndrome (ProPit)
Primary Purpose
Hypercholesterolemia, Metabolic Syndrome
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pitavastatin
Lifestyle Modification
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring pitavastatin, metabolic syndrome, metabolic syndrome risk score, hypercholesterolemia
Eligibility Criteria
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
Sites / Locations
- Seoul National University Bundang Hospital
- Hanyang Univ. Guri Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
T
C
Arm Description
Lifestyle modification + active drug(Pitavastatin)
Lifestyle Modification
Outcomes
Primary Outcome Measures
A change of metabolic syndrome risk component
Secondary Outcome Measures
Changes of cardiometabolic profiles : lipid profiles, hs-CRP, adiponectin, HMW adiponectin
Changes of abdominal visceral fat
Changes of insulin resistance : OGTT(75g), HOMA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00640276
Brief Title
Safety and Efficacy Study of Pitavastatin in Patient With a Metabolic Syndrome
Acronym
ProPit
Official Title
A Prospective Comparative Clinical Study to Identify Efficacy and Safety of Pitavastatin in Patients With a Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JW Pharmaceutical
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Metabolic Syndrome
Keywords
pitavastatin, metabolic syndrome, metabolic syndrome risk score, hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T
Arm Type
Active Comparator
Arm Description
Lifestyle modification + active drug(Pitavastatin)
Arm Title
C
Arm Type
Other
Arm Description
Lifestyle Modification
Intervention Type
Drug
Intervention Name(s)
pitavastatin
Other Intervention Name(s)
Livaro
Intervention Description
Pitavastatin 2mg daily once
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Modification
Intervention Description
conducting mainly exercises and diet
Primary Outcome Measure Information:
Title
A change of metabolic syndrome risk component
Time Frame
48week
Secondary Outcome Measure Information:
Title
Changes of cardiometabolic profiles : lipid profiles, hs-CRP, adiponectin, HMW adiponectin
Time Frame
48week
Title
Changes of abdominal visceral fat
Time Frame
48week
Title
Changes of insulin resistance : OGTT(75g), HOMA
Time Frame
48week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Beom Lee
Organizational Affiliation
Hanyang Univ. Guri Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hak Chul Jang
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Bundang-gu
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Hanyang Univ. Guri Hospital
City
Guri-si
State/Province
Gyeonggi-do
ZIP/Postal Code
471-701
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Pitavastatin in Patient With a Metabolic Syndrome
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