To Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia

November 29, 2021 updated by: JW Pharmaceutical

To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia

To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Multi-center, Randomized, Double-blinded, Active-controlled, Factorial Design Phase 3 Clinical Trial

Study Type

Interventional

Enrollment (Actual)

283

Phase

  • 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
    • Korea
      • Seoul, Korea, Korea, Republic of, 134-701
        • Gangdong Sacred Heart 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

Ages Eligible for Study

19 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with primary hypercholesterolemia

Exclusion Criteria:

  • The subject not meet the specified LDL-C level

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: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Livalo 2mg, Ezetrol 10mg
Pitavastatin 2mg, Ezetimibe 10mg
Drug: Livalo, Ezetrol
Pitavastatin+Ezetimibe Pitavastatin
Other Names:
  • Pitavastatin, Ezetimibe
Active Comparator: Livalo 2mg
Pitavastatin 2mg
Drug: Livalo, Ezetrol
Pitavastatin+Ezetimibe Pitavastatin
Other Names:
  • Pitavastatin, Ezetimibe
Experimental: Livalo 4mg, Ezetrol 10mg
Pitavastatin 4mg, Ezetimibe 10mg
Drug: Livalo, Ezetrol
Pitavastatin+Ezetimibe Pitavastatin
Other Names:
  • Pitavastatin, Ezetimibe
Active Comparator: Livalo 4mg
Pitavastatin 4mg
Drug: Livalo, Ezetrol
Pitavastatin+Ezetimibe Pitavastatin
Other Names:
  • Pitavastatin, Ezetimibe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% change in LDL-C level from baseline at Week 8
Time Frame: Week 8
change in LDL-C level
Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in LDL-C level from baseline at Week 4 and Week 8
Time Frame: Week 4 and Week 8
change in LDL-C level
Week 4 and Week 8

Collaborators and Investigators

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

Sponsor

JW Pharmaceutical

Investigators

  • Study Chair: dongryeong lee, Manager, +82-2-840-6982

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)

June 11, 2019

Primary Completion (Actual)

July 16, 2020

Study Completion (Actual)

October 12, 2020

Study Registration Dates

First Submitted

October 6, 2020

First Submitted That Met QC Criteria

October 12, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

December 1, 2021

Last Update Submitted That Met QC Criteria

November 29, 2021

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JWP-PTZ-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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