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.
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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
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.
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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.