Primary HypercholesterolemiaPhase 3NCT04652349

Efficacy and Safety of HGP1910 and HCP1903 in Patients With Primary Hypercholesterolemia

A Phase 3 study testing HGP1910, HCP1903 and HGP1909 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

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Trial summary

The purpose of this study is to investigate the safety and clinical efficacy of HGP1910 and HCP1903 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?: HGP1910, HCP1903 and HGP1909
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 279 participants
Where: 1 siteSouth Korea
Study dates: 6 Jul 2020to 14 Jan 2021
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

Participants aged ≥ 19 years
Participants who have voluntarily given written consent to participate in this clinical trial
Participants with LDL-C ≤ 250mg/dL and TG < 500mg/dL at Visit 1
Participants with LDL-C ≤ 250mg/dL, TG < 500 mg/dL and satisfied criteria according to cardiovascular risk category at Visit 2 (after at least 4 weeks of TLC)

Who cannot join

Patients with active liver disease and severe liver impairment
Patients with severe renal failure (eGFR < 30 mL/min/1.73 m2 at Visit 1)
Patients with type I diabetes or uncontrolled type 2 diabetes
Patients with acute hypertension or uncontrolled hypertension (sitSBP ≥ 180 mmHg or sitDBP ≥ 110 mmHg at Visit 1)
Patients with symptomatic orthostatic hypotension
Patients with NYHA class III~IV heart failure, CCSA class III~IV angina, ventricular arrhythmia, severe hemorrhagic or ischemic cerebrovascular diseases, transient ischemic attacks (TIAs), acute coronary syndrome or a history of angioplasty, percutaneous coronary intervention, or coronary artery bypass surgery within six months before Visit 1.
Patients who were diagnosed with a malignant tumor within five years before Visit.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Asan Medical Center
Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Double-Blinded, Multi-center, Phase 3 Study to Evaluate Efficacy and Safety of HGP1910 and HCP1903 in Patients With Primary Hypercholesterolemia

The purpose of this study is to investigate the safety and clinical efficacy of HGP1910 and HCP1903 in patients with primary hypercholesterolemia

Conditions: Primary Hypercholesterolemia
Being tested: HGP1910, HCP1903, HGP1909, HGP1911

What participants receive

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

HGP1910Drug
Take it once daily for 8 weeks orally.
HCP1903Drug
Take it once daily for 8 weeks orally.
HGP1909Drug
Take it once daily for 8 weeks orally.
HGP1911Drug
Take it once daily for 8 weeks orally.

Study groups in NCT04652349
Study group	Role	What they receive
HGP1910	Experimental	Not described Receives: Drug: HGP1910
HCP1903	Experimental	Not described Receives: Drug: HCP1903
HGP1909	Active comparator	Not described Receives: Drug: HGP1909
HGP1911	Active comparator	Not described Receives: Drug: HGP1911

What is being measured

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

Percentage change(%) from baseline in LDL-C at week 8
Measured: baseline, 8 weeks

Secondary outcomes (4)

Percentage change(%) from baseline in LDL-C at week 4
Measured: baseline, 4 weeks
Percentage change(%) from baseline in LDL-C, TC, HDL-C, non-HDL-C
Measured: baseline, 4 weeks, 8 weeks
Percentage change(%) from baseline in Apo A1, Apo B, lipoprotein (a)
Measured: baseline, 4 weeks, 8 weeks
Proportion of subjects achieving LDL-C treatment goals by cardiovascular Risk Category
Measured: baseline, 4 weeks, 8 weeks

Timeline

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

6 Jul 202014 Jan 2021

First posted3 Dec 2020
Study start6 Jul 2020
Primary completion17 Dec 2020
Study completion14 Jan 2021

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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 279 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04652349
Sponsor's protocol ID: HM-ROZE-302
Status last verified: Mar 2021
First submitted: 26 Nov 2020
Last updated: 5 Mar 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Lee SA, Kim W, Hong TJ, Ahn Y, Kim MH, Hong SJ, Kim BS, Kim SY, Chae IH, Kim BJ, Rhee MY, Shin JH, Kang TS, Cho JM, Kim JS, Lee CW. Effects of Fixed-dose Combination of Low-intensity Rosuvastatin and Ezetimibe Versus Moderate-intensity Rosuvastatin Monotherapy on Lipid Profiles in Patients With Hypercholesterolemia: A Randomized, Double-blind, Multicenter, Phase III Study. Clin Ther. 2021 Sep;43(9):1573-1589. doi: 10.1016/j.clinthera.2021.07.016. Epub 2021 Aug 21.
PubMed 34429197

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 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blinded, Multi-center, Phase 3 Study to Evaluate Efficacy and Safety of HGP1910 and HCP1903 in Patients With Primary Hypercholesterolemia
ClinicalTrials.gov ID: NCT04652349
Acronym / sponsor ID: HM-ROZE-302
Conditions: Primary Hypercholesterolemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 279 participants (actual)
Lead sponsor: Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
Study start: 6 Jul 2020 (actual)
Primary completion: 17 Dec 2020 (actual)
Study completion: 14 Jan 2021 (actual)
First posted: 3 Dec 2020 (actual)
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 investigate the safety and clinical efficacy of HGP1910 and HCP1903 in patients with primary hypercholesterolemia

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
HGP1910	Experimental	Drug: HGP1910
HCP1903	Experimental	Drug: HCP1903
HGP1909	Active comparator	Drug: HGP1909
HGP1911	Active comparator	Drug: HGP1911

Who may qualify

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

Key inclusion criteria (4 listed)

Participants aged ≥ 19 years
Participants who have voluntarily given written consent to participate in this clinical trial
Participants with LDL-C ≤ 250mg/dL and TG < 500mg/dL at Visit 1
Participants with LDL-C ≤ 250mg/dL, TG < 500 mg/dL and satisfied criteria according to cardiovascular risk category at Visit 2 (after at least 4 weeks of TLC)

Key exclusion criteria (7 listed)

Patients with active liver disease and severe liver impairment
Patients with severe renal failure (eGFR < 30 mL/min/1.73 m2 at Visit 1)
Patients with type I diabetes or uncontrolled type 2 diabetes
Patients with acute hypertension or uncontrolled hypertension (sitSBP ≥ 180 mmHg or sitDBP ≥ 110 mmHg at Visit 1)
Patients with symptomatic orthostatic hypotension

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
HGP1910Take it once daily for 8 weeks orally.	Drug	HGP1910
HCP1903Take it once daily for 8 weeks orally.	Drug	HCP1903
HGP1909Take it once daily for 8 weeks orally.	Drug	HGP1909
HGP1911Take it once daily for 8 weeks orally.	Drug	HGP1911

Primary outcome

Percentage change(%) from baseline in LDL-C at week 8
Time frame: baseline, 8 weeks

4 secondary outcomes

Percentage change(%) from baseline in LDL-C at week 4
Time frame: baseline, 4 weeks
Percentage change(%) from baseline in LDL-C, TC, HDL-C, non-HDL-C
Time frame: baseline, 4 weeks, 8 weeks
Percentage change(%) from baseline in Apo A1, Apo B, lipoprotein (a)
Time frame: baseline, 4 weeks, 8 weeks
Proportion of subjects achieving LDL-C treatment goals by cardiovascular Risk Category
Time frame: baseline, 4 weeks, 8 weeks

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 5 Mar 2021.
Derived from this study: PubMed 34429197Lee SA, Kim W, Hong TJ, Ahn Y, Kim MH, Hong SJ, Kim BS, Kim SY, Chae IH, Kim BJ, Rhee MY, Shin JH, Kang TS, Cho JM, Kim JS, Lee CW. Effects of Fixed-dose Combination of Low-intensity Rosuvastatin and Ezetimibe Versus Moderate-intensity Rosuvastatin Monotherapy on Lipid Profiles in Patients With Hypercholesterolemia: A Randomized, Double-blind, Multicenter, Phase III Study. Clin Ther. 2021 Sep;43(9):1573-1589. doi: 10.1016/j.clinthera.2021.07.016. Epub 2021 Aug 21.

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.

The record lists no contact. Use the official record to reach the sponsor.

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 HGP1910, HCP1903 and HGP1909 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 5 Mar 2021. 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?

Percentage change(%) from baseline in LDL-C at week 8 (time frame: baseline, 8 weeks). 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 NCT04652349, 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 5 Mar 2021.