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

November 15, 2018 updated by: Kuhnil Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

215

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variation rate of Non HDL-C
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Variation rate of TG
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
Variation rate of Non HDL-C
Time Frame: 4 weeks
4 weeks
Variation rate of TC
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
Variation rate of LDL-C
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
Variation rate of VLDL-C
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
Variation rate of Apo A-I
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks
Variation rate of Apo B
Time Frame: 4 weeks, 8 weeks
4 weeks, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuhnil Pharmaceutical Co., Ltd.

Investigators

  • Study Director: kyungshun Shin, Dr, manager

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2016

Primary Completion (Actual)

May 16, 2017

Study Completion (Actual)

March 23, 2018

Study Registration Dates

First Submitted

March 23, 2018

First Submitted That Met QC Criteria

March 23, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

November 19, 2018

Last Update Submitted That Met QC Criteria

November 15, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-OA-8301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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