Back to results

Evaluating the Efficacy and Safety of HCP1105 in Combined Hyperlipidemic Patients With High Risk for CHD

Primary Purpose

Hyperlipidemias

Status

Unknown status

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

HCP1105

HGP0816

Placebo of HCP1105

Placebo of HGP0816

About this trial

This is an interventional treatment trial for Hyperlipidemias

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age 19≤
Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

History of clinically significant hypersensitivity reaction with HMG-CoA reductase inhibitor and Omega-3
Subject who has active liver disease and severe liver failure(Continuous elevation of AST,ALT level with unspecified cause or AST, ALT level exceeds more than three times of maximum upper range.)

Sites / Locations

Euljii General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

experimental sequence

comparative sequence

Arm Description

Run-in period → Treatment period HGP0816 20mg 1tab HCP1105 4capsues +Placebo of HGP0816

Run-in period → Treatment period HGP0816 20mg 1tab Placebo of HCP1105 4capsues +HGP0816 20mg

Outcomes

Primary Outcome Measures

Mean rate of change of non-HDL-C (%) from baseline

Secondary Outcome Measures

Mean rate of change of HDL-C (%) from baseline

Mean rate of change of LDL-C (%) from baseline

Mean rate of change of Triglyceride (%) from baseline

Mean rate of change of Total cholesterol (%) from baseline

Mean rate of change of Total apo A1 (%) from baseline

Mean rate of change of Total apo B (%) from baseline

Mean rate of change of Lipoprotein(a) (%) from baseline

Mean rate of change of hs-CRP (%) from baseline

Rate of the subjects who meet the target level of treatment

target level (Non-HDL-C<130mg/dL)

Full Information

NCT ID

NCT02551172

First Posted

September 11, 2015

Last Updated

September 15, 2015

Sponsor

Hanmi Pharmaceutical Company Limited

1. Study Identification

Unique Protocol Identification Number

NCT02551172

Brief Title

Evaluating the Efficacy and Safety of HCP1105 in Combined Hyperlipidemic Patients With High Risk for CHD

Official Title

An Efficacy and Safety Study of HCP1105 Capsule in Combined Hyperlipidemic Patients With High Risk for Coronary Heart Disease (CHD): A Randomized,Double-blind, Multicenter, Phase 3 Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

January 2016 (Anticipated)

Study Completion Date

February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hanmi Pharmaceutical Company Limited

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To investigate the efficacy and safety after administration of HCP1105 in hyperlipidemic patients with high risk for CHD.

Detailed Description

An efficacy and safety study of HCP1105 Capsule in combined hyperlipidemic patients with high risk for Coronary Heart Disease(CHD): A randomized,double-blind, multicenter, phase 3 study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperlipidemias

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

experimental sequence

Arm Type

Experimental

Arm Description

Run-in period → Treatment period HGP0816 20mg 1tab HCP1105 4capsues +Placebo of HGP0816

Arm Title

comparative sequence

Arm Type

Placebo Comparator

Arm Description

Run-in period → Treatment period HGP0816 20mg 1tab Placebo of HCP1105 4capsues +HGP0816 20mg

Intervention Type

Drug

Intervention Name(s)

HCP1105

Intervention Description

Rosuvastatin + Omega-3-acids ethyl esters

Intervention Type

Drug

Intervention Name(s)

HGP0816

Intervention Description

Rosuvastatin

Intervention Type

Drug

Intervention Name(s)

Placebo of HCP1105

Intervention Description

Soybean Oil

Intervention Type

Drug

Intervention Name(s)

Placebo of HGP0816

Intervention Description

Exclusion of Rosuvastatin in HGP0816

Primary Outcome Measure Information:

Title

Mean rate of change of non-HDL-C (%) from baseline

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Mean rate of change of HDL-C (%) from baseline

Time Frame

4, 8, 12 weeks

Title

Mean rate of change of LDL-C (%) from baseline

Time Frame

4, 8, 12 weeks

Title

Mean rate of change of Triglyceride (%) from baseline

Time Frame

4, 8, 12 weeks

Title

Mean rate of change of Total cholesterol (%) from baseline

Time Frame

4, 8, 12 weeks

Title

Mean rate of change of Total apo A1 (%) from baseline

Time Frame

4, 8, 12 weeks

Title

Mean rate of change of Total apo B (%) from baseline

Time Frame

4, 8, 12 weeks

Title

Mean rate of change of Lipoprotein(a) (%) from baseline

Time Frame

4, 8, 12 weeks

Title

Mean rate of change of hs-CRP (%) from baseline

Time Frame

4, 8, 12 weeks

Title

Rate of the subjects who meet the target level of treatment

Description

target level (Non-HDL-C<130mg/dL)

Time Frame

4, 8, 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age 19≤ Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing Exclusion Criteria: History of clinically significant hypersensitivity reaction with HMG-CoA reductase inhibitor and Omega-3 Subject who has active liver disease and severe liver failure(Continuous elevation of AST,ALT level with unspecified cause or AST, ALT level exceeds more than three times of maximum upper range.)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chang-Hee Jung

Phone

02-3010-3246

chjung0204@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jung-yeol Park, M.D., Ph.D.

Organizational Affiliation

Asan Medecal Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Euljii General Hospital

City

Seoul

ZIP/Postal Code

139-711

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin-Young Jang

Phone

+82-2-970-8216

erica_37@naver.com

First Name & Middle Initial & Last Name & Degree

Kyung Ah Han, M.D., Ph.D.

12. IPD Sharing Statement

Learn more about this trial

Evaluating the Efficacy and Safety of HCP1105 in Combined Hyperlipidemic Patients With High Risk for CHD

We'll reach out to this number within 24 hrs