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

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ClinicalTrials.gov Identifier: NCT02056847
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : March 8, 2018
Sponsor:
Collaborators:
The Catholic University of Korea
Kyunghee University Medical Center
Korea University Guro Hospital
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
Yeungnam University Hospital
Ulsan University Hospital
Eulji University Hospital
Asan Medical Center
Chonnam National University Hospital
Chonbuk National University Hospital
Chungnam National University Hospital
Hallym University Medical Center
Information provided by (Responsible Party):
JW Pharmaceutical

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)


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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 313 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Actual Study Start Date : September 2013
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. The change of HbA1c before and after taking LIVALO® [ Time Frame: 24 weeks after taking IP ]

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

  2. Incidence of total cardiovascular (TVR-MACE) events [ Time Frame: within 1 year after registration ]
  3. The change of the lipid composition (T-chol, TG, LDL-C, HDL-C, ApoA1/ApoB) [ Time Frame: 24weeks and 1 year after registration ]
  4. The changes of hs-CRP, Adiponectin, blood glucose and Insulin levels [ Time Frame: 24weeks and 1 year after registration ]
    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]



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056847


Locations
Korea, Republic of
JW pharmaceutical
Seoul, Korea, Republic of, 137-864
Sponsors and Collaborators
JW Pharmaceutical
The Catholic University of Korea
Kyunghee University Medical Center
Korea University Guro Hospital
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
Yeungnam University Hospital
Ulsan University Hospital
Eulji University Hospital
Asan Medical Center
Chonnam National University Hospital
Chonbuk National University Hospital
Chungnam National University Hospital
Hallym University Medical Center
Investigators
Principal Investigator: NamSik Chung, M.D., Ph D. Severance Hospital

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT02056847     History of Changes
Other Study ID Numbers: JW-PTV-713
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2017

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

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