Efficacy/Safety of HCP1306 Tablet Versus HGP0816 Tablet in Patients With Primary Hypercholesterolemia

September 21, 2015 updated by: Hanmi Pharmaceutical Company Limited

A Randomized, Double-Blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of HCP1306 Tablet in Patients With Primary Hypercholesterolemia

The purpose of this study is to evaluate efficacy and safety of HCP1306 in patients with primary hypercholesterolemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

412

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
      • Seoul, Korea, Republic of
        • 19 institutions including Seoul National University 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged over 19 years
  • Signed informed consent
  • At visit 1, LDL-C ≤ 250mg/dL and Triglyceride < 400 mg/dL
  • After 4 weeks more TLC, At visit2, LDL-C ≤ 250mg/dL, Triglyceride < 400 mg/dL and satisfied criteria according to Risk of cardiovascular disease

Exclusion Criteria:

  • Current or past history of hypersensitivity to HMG-CoA reductase inhibitors and component of Ezetimibe
  • Has an active liver disease and severe liver disorder (continous elevation of AST, ALT level or exceeds more than 3 times of normal upper limit)
  • Has a severe renal failure and kidney injury (Creatinine level exceeds more than 2 times of normal upper limit)
  • CK level exceeds more than 5 times of normal upper limit
  • Uncontrolled hypertension patient (SBP≥ 180 mmHg or DBP ≥ 110 mmHg)
  • Uncontrolled diabetes mellitus patient (HbA1c ≥ 9%)
  • Uncontrolled malfunctional thyroidism (or at pre-visit 2, TSH level exceeds more than 1.5 times of normal upper limit)

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HGP0816 5mg
Drug: HGP0816 5mg
P.O.
Active Comparator: HGP0816 10mg
Drug: HGP0816 10mg
P.O.
Active Comparator: HGP0816 20mg
Drug: HGP0816 20mg
P.O.
Experimental: HCP1306 5/10mg
Drug: HCP1306 5/10mg
P.O.
Experimental: HCP1306 10/10mg
Drug: HCP1306 10/10mg
P.O.
Experimental: HCP1306 20/10mg
Drug: HCP1306 20/10mg
P.O.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline to 8 week in LDL-Cholesterol
Time Frame: baseline and 8 week
baseline and 8 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline to 4 week in LDL-Cholesterol
Time Frame: baseline and 4 week
baseline and 4 week
Percentage of patients reaching treatment goals according to NCEP ATP III Guideline
Time Frame: week 4, week 8
week 4, week 8
Percent change from baseline to 4 week and 8 week in TC
Time Frame: week 4, week 8
week 4, week 8
Percent change from baseline to 4 week and 8 week in HDL-C
Time Frame: week 4, week 8
week 4, week 8
Percent change from baseline to 4 week and 8 week in TG
Time Frame: week 4, week 8
week 4, week 8

Collaborators and Investigators

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

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: Hyo-soo Kim, MD, Ph.D., Seoul National University Hospital

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

June 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

July 30, 2014

First Submitted That Met QC Criteria

July 30, 2014

First Posted (Estimate)

July 31, 2014

Study Record Updates

Last Update Posted (Estimate)

September 22, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-ROZE-301

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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