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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

347

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

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
Intervention / Treatment
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

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

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

Hanlim Pharm. Co., Ltd.

Investigators

  • 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)

November 1, 2015

Primary Completion (ACTUAL)

January 1, 2018

Study Completion (ACTUAL)

May 1, 2018

Study Registration Dates

First Submitted

August 1, 2018

First Submitted That Met QC Criteria

August 1, 2018

First Posted (ACTUAL)

August 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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