NCT00640276

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2008

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 30, 2012

Status Verified

March 1, 2012

Enrollment Period

2.8 years

First QC Date

March 18, 2008

Last Update Submit

March 28, 2012

Conditions

HypercholesterolemiaMetabolic Syndrome

Keywords

pitavastatinmetabolic syndromemetabolic syndrome risk scorehypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • A change of metabolic syndrome risk component

    48week

Secondary Outcomes (3)

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

    48week

  • Changes of abdominal visceral fat

    48week

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

    48week

Study Arms (2)

T

ACTIVE COMPARATOR

Lifestyle modification + active drug(Pitavastatin)

Drug: pitavastatin

C

OTHER

Lifestyle Modification

Behavioral: Lifestyle Modification

Interventions

pitavastatinDRUG

Pitavastatin 2mg daily once

Also known as: Livaro
T
Lifestyle ModificationBEHAVIORAL

conducting mainly exercises and diet

C

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Bundang Hospital

Bundang-gu, Gyeonggi-do, 463-707, South Korea

Location

Hanyang Univ. Guri Hospital

Guri-si, Gyeonggi-do, 471-701, South Korea

Location

MeSH Terms

Conditions

HypercholesterolemiaMetabolic Syndrome

Interventions

pitavastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism Disorders

Study Officials

  • Chang Beom Lee

    Hanyang Univ. Guri Hospital

    STUDY CHAIR

  • Hak Chul Jang

    Seoul National University Bundang Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2008

First Posted

March 21, 2008

Study Start

April 1, 2008

Primary Completion

February 1, 2011

Study Completion

June 1, 2011

Last Updated

March 30, 2012

Record last verified: 2012-03

Locations

KR(2)