A Clinical Trial to Evaluate the Efficacy and Safety of Pitavastatin/Fenofibrate in Complex-dyslipidemia

August 1, 2018 updated by: Hanlim Pharm. Co., Ltd.

A Multicenter, Randomized, Double-blinded, Parallel, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of Pitavastatin Versus Pitavastatin/Fenofibrate in Complex-dyslipidemia Patients

The purpose of this study is to evaluate the efficacy and safety of Pitavastatin versus Pitavastatin/Fenofibrate in complex-dyslipidemia patients.

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 purpose of this study is to demonstrate the efficacy of the Pitavastatin/Fenofibrate in complex-dyslipidemia patients by the reduction of non-HDL-Cholesterol levels compared with Pitavastatin.

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.
347

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

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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • High risk patient to Coronary Heart Disease

  • At visit 1(Screening)

    1. If treated with Pitavastatin 2mg monotherapy 4 weeks prior to this study : LDL-C<100mg/dL and 150mg/dL≤TG<500mg/dL, randomize without run-in period
    2. If non treated with Pitavastatin 2mg monotherapy 4 weeks prior to this study : LDL-C≥100mg/dL and 150mg/dL≤TG<500mg/dL, treatment of Pitavastatin 2mg for 4 weeks(run-in period)
  • LDL-C<100mg/dL and 150mg/dL≤TG<500mg/dL after 4 weeks of Pitavastatin 2mg monotherapy

Exclusion Criteria:

  • Subject with acute artery disease
  • Subject with congestive heart failure(NYHA class III~IV) or uncontrolled arrhythmia
  • Secondary or iatrogenic dyslipidemia caused by hypothyroidism, nephrotic syndrome etc.
  • AST or ALT > 2XULN, Serum Creatinine > 2.5mg/dL, Creatinine phosphokinase > 2XULN
  • Subject with gall bladder disease or pancreatitis
  • Uncontrolled hypertension
  • Endocrine or metabolic disease affected on serum lipid or liprotein
  • Subject with medical history of myopathy or rhabdomyolysis caused by Statin treatment, hereditary myopathy or family history
  • Not eligible to participate for the study at the discretion of investigator

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: TRIPLE

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: HL-PIF cap.160/2mg + Placebo
  • Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg
  • once a day
Drug: HL-PIF cap.160/2mg + Placebo
Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg
Other Names:
  • Fenofibrate 160mg/Pitavastatin Ca 2mg
ACTIVE_COMPARATOR: Livalo tab. 2mg + Placebo
  • Pitavastatin ca 2mg
  • once a day
Drug: Livalo tab. 2mg + Placebo
Pitavastatin ca 2mg
Other Names:
  • Pitavastatin Ca 2mg

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
Measure Description
Time Frame
The mean percentage change of Non-HDL Cholesterol
Time Frame: from baseline at week 8
Change rate of Non-HDL-C after 8 weeks compared to baseline (%)
from baseline at 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
Measure Description
Time Frame
The mean percentage change of Non-HDL Cholesterol
Time Frame: from baseline at week 4
Change rate of Non-HDL-C after 4 weeks compared to baseline (%)
from baseline at week 4
The mean percentage change of LDL-C
Time Frame: from baseline at week 4,8
Change rate of LDL-C after 4 and 8 weeks compared to baseline (%)
from baseline at week 4,8
The mean percentage change of HDL-C
Time Frame: from baseline at week 4,8
Change rate of HDL-C after 4 and 8 weeks compared to baseline (%)
from baseline at week 4,8
The mean percentage change of LDL-C/HDL-C
Time Frame: from baseline at week 4,8
Change rate of LDL-C/HDL-C after 4 and 8 weeks compared to baseline (%)
from baseline at week 4,8
The mean percentage change of TC/HDL-C
Time Frame: from baseline at week 4,8
Change rate of TC/HDL-C after 4 and 8 weeks compared to baseline (%)
from baseline at week 4,8
The mean percentage change of non-HDL-C/HDL-C
Time Frame: from baseline at week 4,8
Change rate of non-HDL-C/HDL-C after 4 and 8 weeks compared to baseline (%)
from baseline at week 4,8
The mean percentage change of VLDL-C
Time Frame: from baseline at week 4,8
Change rate of VLDL-C after 4 and 8 weeks compared to baseline (%)
from baseline at week 4,8
The mean percentage change of TG
Time Frame: from baseline at week 4,8
Change rate of TG after 4 and 8 weeks compared to baseline (%)
from baseline at week 4,8
The mean percentage change of TC
Time Frame: from baseline at week 4,8
Change rate of TC after 4 and 8 weeks compared to baseline (%)
from baseline at week 4,8
The mean percentage change of Apo Al
Time Frame: from baseline at week 4,8
Change rate of Apo Al after 4 and 8 weeks compared to baseline (%)
from baseline at week 4,8
The mean percentage change of Apo B
Time Frame: from baseline at week 4,8
Change rate of Apo B change after 4 and 8 weeks compared to baseline (%)
from baseline at week 4,8
The mean percentage change of Apo Al/Apo B
Time Frame: from baseline at week 4,8
Change rate of Apo Al/Apo B after 4 and 8 weeks compared to baseline (%)
from baseline at week 4,8
The mean percentage change of fibrinogen
Time Frame: from baseline at week 4,8
Change rate of fibrinogen after 4 and 8 weeks compared to baseline (%)
from baseline at week 4,8
The mean percentage change of hs-CRP
Time Frame: from baseline at week 4,8
Change rate of hs-CRP after 4 and 8 weeks compared to baseline (%)
from baseline at week 4,8
Achievement rate(%) of treatment goals after 4 weeks and 8 weeks
Time Frame: from baseline at week 4,8
LDL-C<100mg/dL & non-HDL-C <130mg/dL
from baseline at week 4,8

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.
Hanlim Pharm. Co., Ltd.

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: Ki-Bae Seung, The Catholic University of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

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.
November 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.
January 1, 2018

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.
May 1, 2018

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).
August 1, 2018

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.
August 1, 2018

First Posted (ACTUAL)

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.
August 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

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.
August 7, 2018

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.
August 1, 2018

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.
August 1, 2018

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.
  • HL-PIF-301

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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