Primary HypercholesterolemiaPhase 3NCT02205606

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

A Phase 3 study testing HGP0816 5mg, HGP0816 10mg and HGP0816 20mg in people with Primary Hypercholesterolemia, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 19 years and older
Conditions the study is for: Primary Hypercholesterolemia
What is being tested?: HGP0816 5mg, HGP0816 10mg and HGP0816 20mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 412 participants
Where: 1 siteSouth Korea
Study dates: Jun 2014to Apr 2015
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

19 institutions including Seoul National University Hospital
Seoul

Other trials in South Korea

About this study

Official title: 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.

Conditions: Primary Hypercholesterolemia
Being tested: HGP0816 5mg, HGP0816 10mg, HGP0816 20mg, HCP1306 5/10mg, HCP1306 10/10mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HGP0816 5mgDrug
P.O.
HGP0816 10mgDrug
P.O.
HGP0816 20mgDrug
P.O.
HCP1306 5/10mgDrug
P.O.
HCP1306 10/10mgDrug
P.O.
HCP1306 20/10mgDrug
P.O.

Study groups in NCT02205606
Study group	Role	What they receive
HGP0816 5mg	Active comparator	Not described Receives: Drug: HGP0816 5mg
HGP0816 10mg	Active comparator	Not described Receives: Drug: HGP0816 10mg
HGP0816 20mg	Active comparator	Not described Receives: Drug: HGP0816 20mg
HCP1306 5/10mg	Experimental	Not described Receives: Drug: HCP1306 5/10mg
HCP1306 10/10mg	Experimental	Not described Receives: Drug: HCP1306 10/10mg
HCP1306 20/10mg	Experimental	Not described Receives: Drug: HCP1306 20/10mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent change from baseline to 8 week in LDL-Cholesterol
Measured: baseline and 8 week

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Apr 2015

First posted31 Jul 2014 (estimated)
Study startJun 2014
Primary completionFeb 2015
Study completionApr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Primary HypercholesterolemiaStudies of the same condition, open and under way.
More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 412 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02205606
Sponsor's protocol ID: HM-ROZE-301
Status last verified: Jul 2014
First submitted: 30 Jul 2014
Last updated: 22 Sep 2015
Results posted: No
Data monitoring committee: No

Publications

Rhee MY, Kim KJ, Kim SH, Yoon YW, Rha SW, Hong SJ, Kwak CH, Kim W, Nam CW, Park TH, Hong TJ, Park S, Ahn Y, Lee N, Jeon HK, Jeon DW, Han KR, Moon KW, Chae IH, Kim HY, Kim HS. Ezetimibe and Rosuvastatin Combination Treatment Can Reduce the Dose of Rosuvastatin Without Compromising Its Lipid-lowering Efficacy. Clin Ther. 2019 Dec;41(12):2571-2592. doi: 10.1016/j.clinthera.2019.10.010. Epub 2019 Nov 11.
PubMed 31727361

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
Polygenic Hypercholesterolaemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia

All Primary Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of HCP1306 Tablet in Patients With Primary Hypercholesterolemia
ClinicalTrials.gov ID: NCT02205606
Acronym / sponsor ID: HM-ROZE-301
Conditions: Primary Hypercholesterolemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 412 participants (actual)
Lead sponsor: Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Feb 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 31 Jul 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
HGP0816 5mg	Active comparator	Drug: HGP0816 5mg
HGP0816 10mg	Active comparator	Drug: HGP0816 10mg
HGP0816 20mg	Active comparator	Drug: HGP0816 20mg
HCP1306 5/10mg	Experimental	Drug: HCP1306 5/10mg
HCP1306 10/10mg	Experimental	Drug: HCP1306 10/10mg
HCP1306 20/10mg	Experimental	Drug: HCP1306 20/10mg

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HGP0816 5mgP.O.	Drug	HGP0816 5mg
HGP0816 10mgP.O.	Drug	HGP0816 10mg
HGP0816 20mgP.O.	Drug	HGP0816 20mg
HCP1306 5/10mgP.O.	Drug	HCP1306 5/10mg
HCP1306 10/10mgP.O.	Drug	HCP1306 10/10mg
HCP1306 20/10mgP.O.	Drug	HCP1306 20/10mg

Primary outcome

Percent change from baseline to 8 week in LDL-Cholesterol
Time frame: baseline and 8 week

5 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
Derived from this study: PubMed 31727361Rhee MY, Kim KJ, Kim SH, Yoon YW, Rha SW, Hong SJ, Kwak CH, Kim W, Nam CW, Park TH, Hong TJ, Park S, Ahn Y, Lee N, Jeon HK, Jeon DW, Han KR, Moon KW, Chae IH, Kim HY, Kim HS. Ezetimibe and Rosuvastatin Combination Treatment Can Reduce the Dose of Rosuvastatin Without Compromising Its Lipid-lowering Efficacy. Clin Ther. 2019 Dec;41(12):2571-2592. doi: 10.1016/j.clinthera.2019.10.010. Epub 2019 Nov 11.

Related trials for Primary Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
Polygenic Hypercholesterolaemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
RecruitingObservational study
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Primary Hypercholesterolaemia, Mixed Dyslipidemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hyo-soo Kim, MD, Ph.D. principal investigator

Seoul National University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HGP0816 5mg, HGP0816 10mg and HGP0816 20mg in people with Primary Hypercholesterolemia, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change from baseline to 8 week in LDL-Cholesterol (time frame: baseline and 8 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02205606, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2015.