NCT03482180

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
Last Updated

November 19, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

March 23, 2018

Last Update Submit

November 15, 2018

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (1)

  • Variation rate of Non HDL-C

    8 weeks

Secondary Outcomes (7)

  • Variation rate of TG

    4 weeks, 8 weeks

  • Variation rate of Non HDL-C

    4 weeks

  • Variation rate of TC

    4 weeks, 8 weeks

  • Variation rate of LDL-C

    4 weeks, 8 weeks

  • Variation rate of VLDL-C

    4 weeks, 8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Investigational Group- KI1106

EXPERIMENTAL

KI1106 tablet - daily administration

Drug: KI1106 4g, QD

Control Group - Atorvastatin

ACTIVE COMPARATOR

Atorvastatin Calcium 20mg - daily administration

Drug: Atorvastatin Calcium 20mg, QD

Interventions

KI1106 4g, QDDRUG

KI1106 4 Capsules

Investigational Group- KI1106
Atorvastatin Calcium 20mg, QDDRUG

Atorvastatin Calcium 20mg

Control Group - Atorvastatin

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • mg/dL\>TG≥200mg/dL and LDL-C\<110mg/dL for subjects who were taking statins for 4 weeks
  • Baseline Visit
  • mg/dL\>TG≥200mg/dL
  • LDL-C\<110mg/dL
  • Reduction of LDL-C comparing screening visit

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dyslipidemias

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • kyungshun Shin, Dr

    manager

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2018

First Posted

March 29, 2018

Study Start

May 4, 2016

Primary Completion

May 16, 2017

Study Completion

March 23, 2018

Last Updated

November 19, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share