HyperlipidemiasPhase 3NCT02551172
Evaluating the Efficacy and Safety of HCP1105 in Combined Hyperlipidemic Patients With High Risk for CHD
A Phase 3 study testing HCP1105 and HGP0816 in people with Hyperlipidemias, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
To investigate the efficacy and safety after administration of HCP1105 in hyperlipidemic patients with high risk for CHD. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- HCP1105 and HGP0816
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Feb 2016
- 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
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Euljii General Hospital
Seoul, Seoul, 139-711
Jin-Young Jang, +82-2-970-8216, erica_37@naver.com
Kyung Ah Han, M.D., Ph.D.
About this study
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
To investigate the efficacy and safety after administration of HCP1105 in hyperlipidemic patients with high risk for CHD.
Read the 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.
- Conditions
- Hyperlipidemias
- Being tested
- HCP1105, HGP0816, Placebo of HCP1105, Placebo of HGP0816
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCP1105Drug
Rosuvastatin + Omega-3-acids ethyl esters
HGP0816Drug
Rosuvastatin
Placebo of HCP1105Drug
Soybean Oil
Placebo of HGP0816Drug
Exclusion of Rosuvastatin in HGP0816
| Study group | Role | What they receive |
|---|---|---|
| experimental sequence | Experimental | Run-in period → Treatment period HGP0816 20mg 1tab HCP1105 4capsues +Placebo of HGP0816 Receives: Drug: HCP1105; Drug: HGP0816; Drug: Placebo of HGP0816 |
| comparative sequence | Placebo comparator | Run-in period → Treatment period HGP0816 20mg 1tab Placebo of HCP1105 4capsues +HGP0816 20mg Receives: Drug: HGP0816; Drug: Placebo of HCP1105 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean rate of change of non-HDL-C (%) from baseline
Measured: 12 weeks
Secondary outcomes (9)
Mean rate of change of HDL-C (%) from baseline
Measured: 4, 8, 12 weeks
Mean rate of change of LDL-C (%) from baseline
Measured: 4, 8, 12 weeks
Mean rate of change of Triglyceride (%) from baseline
Measured: 4, 8, 12 weeks
Mean rate of change of Total cholesterol (%) from baseline
Measured: 4, 8, 12 weeks
Mean rate of change of Total apo A1 (%) from baseline
Measured: 4, 8, 12 weeks
Mean rate of change of Total apo B (%) from baseline
Measured: 4, 8, 12 weeks
Mean rate of change of Lipoprotein(a) (%) from baseline
Measured: 4, 8, 12 weeks
Mean rate of change of hs-CRP (%) from baseline
Measured: 4, 8, 12 weeks
Rate of the subjects who meet the target level of treatment
target level (Non-HDL-C<130mg/dL)
Measured: 4, 8, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startOct 2014
- Primary completionJan 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies 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
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jung-yeol Park, M.D., Ph.D., Principal investigator, Asan Medecal Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551172
- Sponsor's protocol ID
- HM-ROMA-301
- Status last verified
- Sep 2015
- First submitted
- 11 Sep 2015
- Last updated
- 16 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02551172
- Acronym / sponsor ID
- HM-ROMA-301
- Conditions
- Hyperlipidemias
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 16 Sep 2015 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental sequence | Experimental | Drug: HCP1105, Drug: HGP0816, Drug: Placebo of HGP0816Run-in period → Treatment period HGP0816 20mg 1tab HCP1105 4capsues +Placebo of HGP0816 |
| comparative sequence | Placebo comparator | Drug: HGP0816, Drug: Placebo of HCP1105Run-in period → Treatment period HGP0816 20mg 1tab Placebo of HCP1105 4capsues +HGP0816 20mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.)
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 |
|---|---|---|
| HCP1105Rosuvastatin + Omega-3-acids ethyl esters | Drug | experimental sequence |
| HGP0816Rosuvastatin | Drug | comparative sequence, experimental sequence |
| Placebo of HCP1105Soybean Oil | Drug | comparative sequence |
| Placebo of HGP0816Exclusion of Rosuvastatin in HGP0816 | Drug | experimental sequence |
Primary outcome
Mean rate of change of non-HDL-C (%) from baseline
Time frame: 12 weeks
9 secondary outcomes
Mean rate of change of HDL-C (%) from baseline
Time frame: 4, 8, 12 weeks
Mean rate of change of LDL-C (%) from baseline
Time frame: 4, 8, 12 weeks
Mean rate of change of Triglyceride (%) from baseline
Time frame: 4, 8, 12 weeks
Mean rate of change of Total cholesterol (%) from baseline
Time frame: 4, 8, 12 weeks
Mean rate of change of Total apo A1 (%) from baseline
Time frame: 4, 8, 12 weeks
Mean rate of change of Total apo B (%) from baseline
Time frame: 4, 8, 12 weeks
Mean rate of change of Lipoprotein(a) (%) from baseline
Time frame: 4, 8, 12 weeks
Mean rate of change of hs-CRP (%) from baseline
Time frame: 4, 8, 12 weeks
Rate of the subjects who meet the target level of treatment
Time frame: 4, 8, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2015.
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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.
Jung-yeol Park, M.D., Ph.D. principal investigator
Asan Medecal Center
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 HCP1105 and HGP0816 in people with Hyperlipidemias, 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang-Hee Jung (02-3010-3246, chjung0204@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean rate of change of non-HDL-C (%) from baseline (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2015.