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CompletedNCT04511000Updated Aug 12, 2020

Clinical Trial to to Compare of the Efficacy and Safety of Lipilou® 20 mg and Lipilou® 10 mg

A Phase 4 interventional study of Lipilou®(generic atorvastatin drug) 20 mg and Lipilou®(generic atorvastatin drug) 10 mg in Hypercholesterolemia, sponsored by Chong Kun Dang Pharmaceutical. Completed at 10 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-08-12.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Oct 2017, registered Aug 2020).
Phase
Phase 4
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

This study was designed to compare the mean percent change of LDL-C between Lipilou® 10mg and 20mg group after 12 weeks of treatment.

02

Conditions studied

  • Hypercholesterolemia
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 110 are open to participants now.

This study's enrollment of 250 is above the median of 100 across 992 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who had hypercholesterolemia with high risk, according to the 2015 Korean guidelines for managing dyslipidemia.

Exclusion criteria

Exclusion Criteria:

  • Patients with uncontrolled diabetes mellitus, uncontrolled hypertension, thyroid dysfunction.
  • Patients who are legally unable to participate in clinical trials or who are unable to participate in clinical trials based on investigator's decision.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
250 participants (actual)

Study arms

  • Experimental
    Experimental group

    Drug: Lipilou®(generic atorvastatin drug) 20 mg

  • Active comparator
    Comparator group

    Drug: Lipilou®(generic atorvastatin drug) 10 mg

Interventions

  • DrugLipilou®(generic atorvastatin drug) 20 mg

    Patients assigned to experimental group are treated with Lipilou® 20 mg

  • DrugLipilou®(generic atorvastatin drug) 10 mg

    Patients assigned to comparator group are treated with Lipilou® 10 mg

06

What researchers measure

Primary outcomes

  1. Change rate in LDL-C

    compare experimental group with comparator group

    Time frame: 12 weeks of treatment

07

Study locations

10 sites
  • Korea University Ansan Hospital
    Ansan, Korea, Republic of
  • Sejong General Hospital
    Bucheon, Korea, Republic of
  • Dong-A University Hospital
    Busan, Korea, Republic of
  • Inje University Ilsan Paik Hospital
    Goyang, Korea, Republic of
  • Myongji Hospital
    Goyang, Korea, Republic of
  • Seoul National University Bundang Hospital
    Seongnam, Korea, Republic of
  • Korea University Guro Hospital
    Seoul, Korea, Republic of
  • Ulsan University Hospital
    Ulsan, Korea, Republic of
  • Wonju Severance Christian Hospital
    Wŏnju, Korea, Republic of
  • Pusan National University Yangsan Hospital
    Yangsan, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04511000
Lead sponsor
Chong Kun Dang Pharmaceutical
Responsible party
Sponsor
First posted
Aug 12, 2020
Start date
Oct 11, 2017
Primary completion
May 20, 2019
Completion
May 20, 2019
Last update
Aug 12, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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