NCT02056847

Brief Summary

Primary Objective : To evaluate that there is no different effect on HbA1c between routine lipid lowering therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic patients with impaired fasting glucose (IFG). H0: µT-µC ≥ 0.4 vs H1: µT-µC \< 0.4 µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the control drug (Pitavastatin 2 MG)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
313

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

March 8, 2018

Status Verified

March 1, 2017

Enrollment Period

3.7 years

First QC Date

February 4, 2014

Last Update Submit

March 6, 2018

Conditions

HbA1c Level Associated With Lipid Compositions

Keywords

Livalo, pitavastatin, hyperlipidemia, IFG

Outcome Measures

Primary Outcomes (1)

  • The change of HbA1c before and after taking LIVALO®

    24 weeks after taking IP

Secondary Outcomes (4)

  • Incidence of diabetes

    within 1year after registration

  • Incidence of total cardiovascular (TVR-MACE) events

    within 1 year after registration

  • The change of the lipid composition (T-chol, TG, LDL-C, HDL-C, ApoA1/ApoB)

    24weeks and 1 year after registration

  • The changes of hs-CRP, Adiponectin, blood glucose and Insulin levels

    24weeks and 1 year after registration

Study Arms (2)

Pitavastatin calcium 4mg

ACTIVE COMPARATOR

Pitavastatin calcium (LIVALO®) 4mg, once a day

Drug: Pitavastatin calcium 4mg

Pitavastatin calcium 2mg

ACTIVE COMPARATOR

Pitavastatin calcium (LIVALO®) 2mg, once a day

Drug: Pitavastatin calcium 2mg

Interventions

Pitavastatin calcium 4mgDRUG

taking once a day

Also known as: Pitavastatin calcium(LIVALO) 4mg
Pitavastatin calcium 4mg
Pitavastatin calcium 2mgDRUG

Taking once a day

Also known as: LIVALO 2mg
Pitavastatin calcium 2mg

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and Female patients who are more than 20 years old or 70 years old or less.
  • Patient who voluntarily sign on written informed consent form
  • Patient who LDL-C ≥ 100mg/dl or was diagnosed with hyperlipidemia
  • Patient who was suspected with Imparied Fasting Glucose (IFG) and satisfy FPG level ≥ 100mg/dL and \< 126mg/dL when FPG measured twice.

You may not qualify if:

  • Patient who has familial hypercholesterolemia
  • Patient who has been diagnosed with Type1, Type2 DM or secondary DM(diabetes mellitus) at the screening visit (Diagnostic criteria of DM: HbA1c≥ 6.5%)
  • Patient who has received antidiabetic within 6weeks to the screening visit
  • Patient who has been taking insulin continuously or to be needed in the future
  • Patient who has a history of gastrectomy
  • Patient who is suspected or diagnosed with malignant tumor within last 10 years
  • Patient who has serious pancreatic disease or endocrine disorders
  • Patient who currently takes Cyclosporine
  • Patient who has a medical history of hypersensitivity to Pitavastatin calcium
  • Patient who has suspected renal failure (serum creatinine ≥2.0 mg/dL)
  • Patient who has suspected liver dysfunction (more than 2.5 times the upper limit of normal AST or ALT)
  • Patient who has more than 3 times the upper limit of normal CPK
  • Patient who is breastfeeding, pregnant or planning pregnancy
  • Patient who deemed inappropriate as subject in the opinion of the Principal Investigator or Investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JW pharmaceutical

Seoul, 137-864, South Korea

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

pitavastatin

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • NamSik Chung, M.D., Ph D.

    Severance Hospital

    PRINCIPAL INVESTIGATOR

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

February 4, 2014

First Posted

February 6, 2014

Study Start

September 1, 2013

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

March 8, 2018

Record last verified: 2017-03

Locations

KR(1)