Primary HypercholesterolemiaPhase 3NCT04643093
Compare the Efficacy and Safety of 1PC111 With Pitavastatin and Ezetimibe in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
A Phase 3 study testing Pitavastatin, Ezetimibe and 1PC111 in people with Primary Hypercholesterolemia and Mixed Dyslipidemias, run by Orient Pharma Co., Ltd. at 34 sites in 3 countries.
Trial summary
The study is to evaluate whether the efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients with primary hypercholesterolemia or mixed dyslipidemia in the 12 week treatment period. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Primary Hypercholesterolemia, Mixed Dyslipidemias
- What is being tested?
- Pitavastatin, Ezetimibe and 1PC111
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 34 sitesin 3 countries
- Study dates
- 1 Aug 2020to 5 Oct 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary hypercholesterolemia or mixed dyslipidemia
- Subject meeting All of the following diagnoses at Baseline visit:
- TG≦350 mg/dL
- ALT and AST≦ 2.5 times of upper limit of normal (ULN) with no acute liver disease
- Creatine kinase (CK) concentration≦2 times of UL N
- Creatinine≦1.5 mg/dL
- Subject who is willing and able to provide inform ed consent
Who cannot join
- Female who is or intends to be pregnant or breast feeding, or has childbearing potential but without effective contraception.
- Subject with documented HIV
- Subject with uncontrolled hypothyroidism according to the investigator's judgment
- Subject with unstable cardiovascular disease (CVD), including but not limited to congestive heart failure (CHF) defined as New York Heart Association class III or IV, unstable angina, unstable arrhythmia according to the investigator's judgment
- Subject with unstable hepatic or biliary disorders, including but not limited to acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, liver cancer, jaundice , and chronic hepatitis B or C under antiviral therapy
- Subject with the following medical histories:
Show all 13Show fewer
- History of malignancy, exceptions made for the following malignancies: a)those determined to be cured or in remission for ≥ 5 years, b) curatively resected basal cell or squamous cell skin cancers, c) cervical cancer in situ, or resected colonic polyps
- Acute coronary syndrome with or without cardiac catheterization within the past 9 months
- Therapeutic cardiac catheterization (due to reasons other than acute coronary syndrome) within the past 6 months
- Any unstable comorbidities or clinical conditions , including laboratory abnormalities which could lead to unacceptable risk to subject or confound data interpretation , per investigatiors judgment
- Use any lipid lowering agent within 6 weeks prior to initiating the study treatment ( recheck this criterion at Day 1)
- Use cyclosporine within 6 weeks prior to initiating the study treatment (recheck this criterion at Day 1)
- Use any investigational product within 6 weeks prior to initiating the study treatment ( recheck this criterion at Day 1)
Trial locations and contacts
34 sites in 3 countries.
34 sites in 3 countries
Taiwan23 sites
Changhua Christian Hospital
Changhua
Chiayi Christian Hospital
Chiayi City
E-Da Hospital
Kaohsiung City
Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F.
Kaohsiung City
Kaohsiung Medical University Hospital
Kaohsiung City
Kaohsiung Veterans General Hospital
Kaohsiung City
China Medical University Hospital
Taichung
Chung Shan Medical University Hospital
Taichung
Kuang Tien General Hospital
Taichung
Taichung Veterans General Hospital
Taichung
Chi Mei Medical Center
Tainan
National Cheng Kung University Hospital
Tainan
Tainan Municipal Hospital (Managed By Show Chwan Medical Care Corporation)
Tainan
Cathay General Hospital
Taipei
Cheng Hsin General Hospital
Taipei
Far Eastern Memorial Hospital
Taipei
National Taiwan University Hospital
Taipei
Shin Kong Wu Ho-Su Memorial Hospital
Taipei
Taipei Medical University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Tamsui Mackay Memorial Hospital
Taipei
Tri-Service General Hospital
Taipei
Chang Gung Medical Foundation- LinKuo Branch
Taoyuan
New Zealand7 sites
Southern Clinical Trials - Waitemata Ltd.
Auckland
Southern Clinical Trials Totara
Auckland
Southern Clinical Trials Group Ltd
Christchurch
Lakeland Clinical Trials Waikato
Hamilton
Southern Clinical Trials Tasman
Nelson
Lakeland Clinical Trials Rotorua
Rotorua
Culloden Research Ltd.
Tauranga
Australia4 sites
Paratus Clinical Research Western Sydney
Blacktown
Northern Beaches Clinical Research
Brookvale
Emeritus Research
Camberwell
Paratus Clinical Research Central Coast
Kanwal
About this study
Official title: Orient Pharma Co., Ltd.
The study is to evaluate whether the efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients with primary hypercholesterolemia or mixed dyslipidemia in the 12 week treatment period.
- Conditions
- Primary Hypercholesterolemia, Mixed Dyslipidemias
- Being tested
- Pitavastatin, Ezetimibe, 1PC111
- Keywords
- Primary Hypercholesterolemia, Mixed Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitavastatinDrug
Pitavastatin, QD
EzetimibeDrug
Ezetimibe, QD
1PC111Drug
1PC111, QD
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin | Active comparator | Pitavastatin Receives: Drug: Pitavastatin |
| Ezetimibe | Active comparator | Ezetimibe Receives: Drug: Ezetimibe |
| 1PC111 | Experimental | 1PC111 Receives: Drug: 1PC111 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients
Measured: 12 week treatment period
Secondary outcomes (1)
The efficacy and safety profile of 1PC111 , pitavastatin and ezetimibe during the treatment period and 2 week follow up period.
Measured: 12 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start1 Aug 2020
- Primary completion19 Aug 2021
- Study completion5 Oct 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.
- 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
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orient Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643093
- Sponsor's protocol ID
- OP-1PC111-301
- Status last verified
- May 2022
- First submitted
- 22 Nov 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chou MT, McGirr A, Jong GP, Chao TH, Lee IT, Huang CY, Chen CP, Hsieh CH, Lu CH, Sheu WH. Effect of 1PC111, a Fixed-dose Combination of Pitavastatin and Ezetimibe, Versus Pitavastatin or Ezetimibe Monotherapy on Lipid Profiles in Patients With Hypercholesterolemia or Mixed Dyslipidemia: A Randomized, Double-blind, Multicenter, Phase III Study. Clin Ther. 2022 Oct;44(10):1272-1281. doi: 10.1016/j.clinthera.2022.08.006. Epub 2022 Aug 25.
PubMed 36030106
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orient Pharma Co., Ltd.
- ClinicalTrials.gov ID
- NCT04643093
- Acronym / sponsor ID
- OP-1PC111-301
- Conditions
- Primary Hypercholesterolemia, Mixed Dyslipidemias
- Keywords
- Primary Hypercholesterolemia, Mixed Dyslipidemias
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Orient Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 19 Aug 2021 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 24 Nov 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 study is to evaluate whether the efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients with primary hypercholesterolemia or mixed dyslipidemia in the 12 week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin | Active comparator | Drug: PitavastatinPitavastatin |
| Ezetimibe | Active comparator | Drug: EzetimibeEzetimibe |
| 1PC111 | Experimental | Drug: 1PC1111PC111 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Primary hypercholesterolemia or mixed dyslipidemia
- Subject meeting All of the following diagnoses at Baseline visit:
- Subject who is willing and able to provide inform ed consent
Key exclusion criteria (13 listed)
- Female who is or intends to be pregnant or breast feeding, or has childbearing potential but without effective contraception.
- Subject with documented HIV
- Subject with uncontrolled hypothyroidism according to the investigator's judgment
- Subject with unstable cardiovascular disease (CVD), including but not limited to congestive heart failure (CHF) defined as New York Heart Association class III or IV, unstable angina, unstable arrhythmia according to the investigator's judgment
- Subject with unstable hepatic or biliary disorders, including but not limited to acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, liver cancer, jaundice , and chronic hepatitis B or C under antiviral therapy
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 |
|---|---|---|
| PitavastatinPitavastatin, QD | Drug | Pitavastatin |
| EzetimibeEzetimibe, QD | Drug | Ezetimibe |
| 1PC1111PC111, QD | Drug | 1PC111 |
Primary outcome
The efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients
Time frame: 12 week treatment period
1 secondary outcome
The efficacy and safety profile of 1PC111 , pitavastatin and ezetimibe during the treatment period and 2 week follow up period.
Time frame: 12 week treatment period
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 18 May 2022.
- Derived from this study: PubMed 36030106Chou MT, McGirr A, Jong GP, Chao TH, Lee IT, Huang CY, Chen CP, Hsieh CH, Lu CH, Sheu WH. Effect of 1PC111, a Fixed-dose Combination of Pitavastatin and Ezetimibe, Versus Pitavastatin or Ezetimibe Monotherapy on Lipid Profiles in Patients With Hypercholesterolemia or Mixed Dyslipidemia: A Randomized, Double-blind, Multicenter, Phase III Study. Clin Ther. 2022 Oct;44(10):1272-1281. doi: 10.1016/j.clinthera.2022.08.006. Epub 2022 Aug 25.
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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.
34 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pitavastatin, Ezetimibe and 1PC111 in people with Primary Hypercholesterolemia and Mixed Dyslipidemias, run by Orient Pharma Co., Ltd. at 34 sites in 3 countries.
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 7 inclusion and 13 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 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Taiwan, New Zealand, Australia. 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?
The efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients (time frame: 12 week treatment period). 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 NCT04643093, 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 18 May 2022.