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OpenTrials
Completed

NCT Number: NCT03482180

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

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

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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KI1106 4g, QD

Drug

KI1106 4 Capsules

Atorvastatin Calcium 20mg, QD

Drug

Atorvastatin Calcium 20mg

Primary outcomes

  1. Variation rate of Non HDL-C

    Time frame: 8 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kuhnil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 29, 2018
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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