Safety and Efficacy Study of Pitavastatin in Patient With... | NCT00640276

Studies
Safety and Efficacy Study of Pitavastatin in Patient With a Metabolic Syndrome

NCT00640276

Sponsor

JW Pharmaceutical

Status

Completed

Last Update Posted

Mar 30, 2012Estimated

Enrollment

187Actual

Phase

Phase 4

Conditions

Hypercholesterolemia
Metabolic Syndrome

Interventions

pitavastatin
Lifestyle Modification

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Feb 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Mar 18, 2008

First Submission Date that Met QC Criteria

Mar 20, 2008

First Posted Date

Mar 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2012

Last Update Posted Date

Mar 30, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

187Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
T	Active Comparator	Lifestyle modification + active drug(Pitavastatin)	Drug: pitavastatin
C	Other	Lifestyle Modification	Behavioral: Lifestyle Modification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pitavastatin	Drug	Pitavastatin 2mg daily once	T	Livaro

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chang Beom Lee	Hanyang Univ. Guri Hospital	Study Chair
Hak Chul Jang	Seoul National University Bundang Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Bundang-gu	Gyeonggi-do	463-707	South Korea
Hanyang Univ. Guri Hospital

Condition Browse Module

MeSH Terms

ID	Term
D006937	Hypercholesterolemia
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided