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Evaluate the Efficacy and Safety of KI1106 in Patients Whose TG Level is Not Adequately Controlled With Atorvastatin Calcium Monotherapy While LDL-C is Properly Controlled

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482180
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Kuhnil Pharmaceutical Co., Ltd.

Brief Summary:
To examine variation rate of Non-HDL with KI1106 comparison Atorvastatin monotherapy.

Condition or disease Intervention/treatment Phase
Dyslipidemias Drug: KI1106 4g, QD Drug: Atorvastatin Calcium 20mg, QD Phase 3

Detailed Description:
Randomly assigned to two groups (KI1106 or Atorvastatin monotherapy) after 4 weeks run-in period and prescribed KI1106 or Atorvastatin for 8 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Parallel Phase III Study to Evaluate the Efficacy and Safety of KI1106 in Patients Whose TG Level is Not Adequately Controlled With Atorvastatin Calcium Monotherapy While LDL-C is Properly Controlled
Actual Study Start Date : May 4, 2016
Actual Primary Completion Date : May 16, 2017
Actual Study Completion Date : March 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Experimental: Investigational Group- KI1106
KI1106 tablet - daily administration
Drug: KI1106 4g, QD
KI1106 4 Capsules

Active Comparator: Control Group - Atorvastatin
Atorvastatin Calcium 20mg - daily administration
Drug: Atorvastatin Calcium 20mg, QD
Atorvastatin Calcium 20mg




Primary Outcome Measures :
  1. Variation rate of Non HDL-C [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Variation rate of TG [ Time Frame: 4 weeks, 8 weeks ]
  2. Variation rate of Non HDL-C [ Time Frame: 4 weeks ]
  3. Variation rate of TC [ Time Frame: 4 weeks, 8 weeks ]
  4. Variation rate of LDL-C [ Time Frame: 4 weeks, 8 weeks ]
  5. Variation rate of VLDL-C [ Time Frame: 4 weeks, 8 weeks ]
  6. Variation rate of Apo A-I [ Time Frame: 4 weeks, 8 weeks ]
  7. Variation rate of Apo B [ Time Frame: 4 weeks, 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Screening Visit

    • Age: 20-80
    • High risk for cardiovascular disease according to NCEP APT III
    • TG≥300mg/dL and 160mg/dL>LDL-C≥100mg/dL for subjects who were not taking statins for 4 weeks
    • 500mg/dL>TG≥200mg/dL and LDL-C<110mg/dL for subjects who were taking statins for 4 weeks
  • Baseline Visit

    • 500mg/dL>TG≥200mg/dL
    • LDL-C<110mg/dL
    • Reduction of LDL-C comparing screening visit

Exclusion criteria:

  • The patient has histories of acute artery disease within 3 months
  • The patient has histories of operation revasculariation or aneurysm within 6 months
  • The patient has histories of unexplained myalgia or diagnosed myalgia or rhabdomyolysis
  • The patient has histories of effect able disease to the procedure and clinical trial result

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): NCT03482180


Sponsors and Collaborators
Kuhnil Pharmaceutical Co., Ltd.
Investigators
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Study Director: kyungshun Shin, Dr manager

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Responsible Party: Kuhnil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03482180    
Other Study ID Numbers: 12-OA-8301
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Calcium, Dietary
Atorvastatin
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors