to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia (SIPHON)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by JW Pharmaceutical
Sponsor:
Collaborators:
The Catholic Univ. of Korea Daejeon St. Marys Hostpial
The Catholic University of Korea
The Catholic University of Korea Yeouido St.Marys Hostpial
The Catholic University of Korea Uijeongbu St.Marys Hostpial
Kyunghee University Medical Center
Korea University Guro Hospitla
Dong-A University Hospital
Seoul National University Bundang Hospital
Samsung Medical Center
Seoul National University Hospital
Ajou University School of Medicine
Gangnam Severance Hospital
Severance Hospital
Youngnam University Medical Center
Ulsan University Hospital
Eulji University Hospital
Asan Medical Center
Chonnam National University Hospital
Chonbuk National University Hospital
Chungnam National University Hospital
Hanllym University Medical Center
Information provided by (Responsible Party):
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT02056847
First received: February 4, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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)


Condition Intervention Phase
HbA1c Level Associated With Lipid Compositions
Drug: Pitavastatin calcium 4mg
Drug: Pitavastatin calcium 2mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Open-label, Multi-centered Study to Evaluate the Safety and Efficacy of Pitavastatin in Patients With Impaired Fasting Glucose and Hyperlipidemia(Phase 4)

Resource links provided by NLM:


Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:
  • The change of HbA1c before and after taking LIVALO® [ Time Frame: 24 weeks after taking IP ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of diabetes [ Time Frame: within 1year after registration ] [ Designated as safety issue: Yes ]
    based; FPG ≥126mg/dL or to need taking diabetes medication

  • Incidence of total cardiovascular (TVR-MACE) events [ Time Frame: within 1 year after registration ] [ Designated as safety issue: Yes ]
  • The change of the lipid composition (T-chol, TG, LDL-C, HDL-C, ApoA1/ApoB) [ Time Frame: 24weeks and 1 year after registration ] [ Designated as safety issue: Yes ]
  • The changes of hs-CRP, Adiponectin, blood glucose and Insulin levels [ Time Frame: 24weeks and 1 year after registration ] [ Designated as safety issue: Yes ]
    The change of blood glucose and Insulin levels FPG(Fasting Plasma Glucose) Fasting Serum Insulin HOMA IR [fasting insulin(µIU/mL) X fasting glucose(mg/dL)]/405 HOMA β [360 X fasting insulin(µIU/mL)]/[fasting glucose(mg/dL)-63]


Estimated Enrollment: 318
Study Start Date: January 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pitavastatin calcium 4mg
Pitavastatin calcium (LIVALO®) 4mg, once a day
Drug: Pitavastatin calcium 4mg
taking once a day
Other Name: Pitavastatin calcium(LIVALO) 4mg
Active Comparator: Pitavastatin calcium 2mg
Pitavastatin calcium (LIVALO®) 2mg, once a day
Drug: Pitavastatin calcium 2mg
Taking once a day
Other Name: LIVALO 2mg

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patient who has familial hypercholesterolemia
  2. 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%)
  3. Patient who has received antidiabetic within 6weeks to the screening visit
  4. Patient who has been taking insulin continuously or to be needed in the future
  5. Patient who has a history of gastrectomy
  6. Patient who is suspected or diagnosed with malignant tumor within last 10 years
  7. Patient who has serious pancreatic disease or endocrine disorders
  8. Patient who currently takes Cyclosporine
  9. Patient who has a medical history of hypersensitivity to Pitavastatin calcium
  10. Patient who has suspected renal failure (serum creatinine ≥2.0 mg/dL)
  11. Patient who has suspected liver dysfunction (more than 2.5 times the upper limit of normal AST or ALT)
  12. Patient who has more than 3 times the upper limit of normal CPK
  13. Patient who is breastfeeding, pregnant or planning pregnancy
  14. Patient who deemed inappropriate as subject in the opinion of the Principal Investigator or Investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02056847

Contacts
Contact: HyoJeong Seo 82-2-840-6958 hjseo@jw-pharma.co.kr
Contact: SongHee Cho 82-2-840-918 20130594@jw-group.co.kr

Locations
Korea, Republic of
JW pharmaceutical Recruiting
Seoul, Korea, Republic of, 137-864
Contact: HyoJeong Seo    82-2-840-6958    hjseo@jw-pharma.co.kr   
Contact: SongHee Cho    82-2-840-6918    20130594@jw-pharma.co.kr   
Principal Investigator: SungHo Her, M.D., Ph.D.         
Principal Investigator: PumJoon Kim, M.D., Ph.D.         
Principal Investigator: WooBaek Chung, M.D., Ph.D.         
Principal Investigator: JongMin Lee, M.D., Ph.D.         
Principal Investigator: WooShik Kim, M.D., Ph.D.         
Principal Investigator: SeungWoon Rha, M.D., Ph.D.         
Principal Investigator: JongSung Park, M.D., Ph.D.         
Principal Investigator: DongJu Choi, M.D., Ph.D.         
Principal Investigator: HyeonCheol Gwon, M.D., Ph.D.         
Principal Investigator: HaeYoung Lee, M.D., Ph.D.         
Principal Investigator: SoYeon Choi, M.D., Ph.D.         
Principal Investigator: BumKee Hong, M.D., Ph.D.         
Principal Investigator: Namsik Chung, M.D., Ph.D.         
Principal Investigator: JongSeon Park, M.D., Ph.D.         
Principal Investigator: EunSeok Shin, M.D., Ph.D.         
Principal Investigator: KyungTae Jung, M.D., Ph.D.         
Principal Investigator: KiHoon Han, M.D., Ph.D.         
Principal Investigator: MyungHo Jeong, M.D., Ph.D.         
Principal Investigator: JeiKeon Chae, M.D., Ph.D.         
Principal Investigator: SiWan Choi, M.D., Ph.D.         
Principal Investigator: KyooRok Han, M.D., Ph.D.         
Sponsors and Collaborators
JW Pharmaceutical
The Catholic Univ. of Korea Daejeon St. Marys Hostpial
The Catholic University of Korea
The Catholic University of Korea Yeouido St.Marys Hostpial
The Catholic University of Korea Uijeongbu St.Marys Hostpial
Kyunghee University Medical Center
Korea University Guro Hospitla
Dong-A University Hospital
Seoul National University Bundang Hospital
Samsung Medical Center
Seoul National University Hospital
Ajou University School of Medicine
Gangnam Severance Hospital
Severance Hospital
Youngnam University Medical Center
Ulsan University Hospital
Eulji University Hospital
Asan Medical Center
Chonnam National University Hospital
Chonbuk National University Hospital
Chungnam National University Hospital
Hanllym University Medical Center
Investigators
Principal Investigator: NamSik Chung, M.D., Ph D. Severance Hospital
  More Information

No publications provided

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT02056847     History of Changes
Other Study ID Numbers: JW-PTV-713
Study First Received: February 4, 2014
Last Updated: February 4, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by JW Pharmaceutical:
Livalo, pitavastatin, hyperlipidemia, IFG

Additional relevant MeSH terms:
Calcium, Dietary
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pitavastatin
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014