Clinical Trial to Evaluate the Efficacy and Safety of CKD-391

January 26, 2016 updated by: Chong Kun Dang Pharmaceutical

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, Factorial Design, Phase III Clinical Trial To Evaluate the Efficacy and Safety of Atorvastatin+Ezetimibe Combination Therapy and Atorvastatin Monotherapy in Patients With Primary Hypercholesterolemia

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Factorial Design, Phase III Clinical Trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-391 once daily for 8 weeks in patients with primary hypercholesterolemia. Furthermore, the extension study for additional 12 weeks is designed to confirm long term safety of CKD-391.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
385

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • The Catholic University of Korea Seoul St. Mary's Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult, at least 19 years of age.
  • Hyperlipidemia patient of LDL-C≤250 mg/dl and TG ≤400 mg/dl
  • Patients requiring anti-dyslipidemia drug therapy [based on the NCEP ATP III(2002)]
  • Drug compliance during Run-in period ≥70%
  • Patients must willing to the study and signed an informed consent

Exclusion Criteria:

  • Patients with myopathy included rhabdomyolysis or CPK level≥2xULN
  • Patients with acute arterial disease
  • Patients with renal dysfunction or Serum creatinine level ≥2x ULN
  • Patients with liver dysfunction or ALT, AST level > 2xULN
  • Patients with medical history within 6 months prior to screening visit (Heart failure, uncontrolled arrhythmia, drug and alcohol abuse history, gastrointestinal disease or surgery, anticoagulation disease)
  • Patient with uncontrolled disease (diabetes mellitus as HbA1c level of > 9.0%, hypertension as SBP≥180mmHg or DBP≥110mmHg, hypothyroidism as TSH≥1.5xULN)
  • Patients who have a history or presence of active malignancy within 5 years
  • Patients with difficulty of stop taking lipid-lowering agents during run-in period.
  • Patients who have taken another investigational drug within 4 weeks prior to screening visit.

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Atorvastatin10mg, Ezetimibe10mg
Atorvastatin10mg, Ezetimibe10mg will be administered (Duration 8 weeks)
Drug: Atorvastatin10mg, Ezetimibe10mg
Atorvastatin10mg, Ezetimibe 10mg (Duration: 8weeks)
Other Names:
  • CKD-391
Active Comparator: Atorvastatin10mg, Ezetimibe placebo
Atorvastatin10mg, placebo will be administered (Duration 8 weeks)
Drug: Atorvastatin10mg, Ezetimibe placebo
Atorvastatin10mg, Ezetimibe placebo(Duration: 8 weeks)
Other Names:
  • Lipitor
Experimental: Atorvastatin20mg, Ezetimibe10mg
Atorvastatin20mg, Ezetimibe10mg will be administered (Duration 8 weeks)
Drug: Atorvastatin20mg, Ezetimibe10mg
Atorvastatin20mg, Ezetimibe 10mg (Duration: 8weeks)
Other Names:
  • CKD-391
Active Comparator: Atorvastatin20mg, Ezetimibe placebo
Atorvastatin20mg, placebo will be administered (Duration 8 weeks)
Drug: Atorvastatin20mg, Ezetimibe placebo
Atorvastatin20mg, Ezetimibe placebo(Duration: 8weeks)
Other Names:
  • Lipitor
Experimental: Atorvastatin40mg, Ezetimibe10mg
Atorvastatin40mg, Ezetimibe10mg will be administered (Duration 8 weeks)
Drug: Atorvastatin40mg, Ezetimibe10mg
Atorvastatin40mg, Ezetimibe 10mg (Duration: 8weeks)
Other Names:
  • CKD-391
Active Comparator: Atorvastatin40mg, Ezetimibe placebo
Atorvastatin40mg, placebo will be administered (Duration 8 weeks)
Drug: Atorvastatin40mg, Ezetimibe placebo
Atorvastatin40mg, Ezetimibe placebo(Duration: 8weeks)
Other Names:
  • Lipitor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change form baseline in LDL-C
Time Frame: up to week 8
up to week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change form baseline in LDL-C
Time Frame: up to week 20
up to week 20
Change form baseline in Total cholesterol
Time Frame: up to week 20
up to week 20
Change form baseline in Triglyceride
Time Frame: up to week 20
up to week 20
Change form baseline in HDL-C
Time Frame: up to week 20
up to week 20
Change form baseline in Non-HDL-C
Time Frame: up to week 20
up to week 20
Change form baseline in LDL-C/HDL-C ratio
Time Frame: up to week 20
up to week 20
Change form baseline in TC/HDL-C ratio
Time Frame: up to week 20
up to week 20
Change form baseline in Non-HDL-C/HDL-C ratio
Time Frame: up to week 20
up to week 20
Change form baseline in Apo-B ratio
Time Frame: up to week 20
up to week 20
Change form baseline in Apo-B
Time Frame: up to week 20
up to week 20
Change form baseline in Apo-A1
Time Frame: up to week 20
up to week 20
Change form baseline in Apo-B/Apo-A1 ratio
Time Frame: up to week 20
up to week 20

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Evaluate safety of CKD-391 from adverse events, laboratory test results, physical examination, vital signs.
Time Frame: up to week 20
up to week 20

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chong Kun Dang Pharmaceutical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ho-Jung Yoon, PhD, The Catholic University of Korea

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 152PDL14025

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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