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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04643093




Registration number
NCT04643093
Ethics application status
Date submitted
22/11/2020
Date registered
24/11/2020
Date last updated
18/05/2022

Titles & IDs
Public title
Compare the Efficacy and Safety of 1PC111 With Pitavastatin and Ezetimibe in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Scientific title
Orient Pharma Co., Ltd.
Secondary ID [1] 0 0
OP-1PC111-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Hypercholesterolemia 0 0
Mixed Dyslipidemias 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pitavastatin
Treatment: Drugs - Ezetimibe
Treatment: Drugs - 1PC111

Active comparator: Pitavastatin - Pitavastatin

Active comparator: Ezetimibe - Ezetimibe

Experimental: 1PC111 - 1PC111


Treatment: Drugs: Pitavastatin
Pitavastatin, QD

Treatment: Drugs: Ezetimibe
Ezetimibe, QD

Treatment: Drugs: 1PC111
1PC111, QD
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients
Timepoint [1] 0 0
12 week treatment period
Secondary outcome [1] 0 0
The efficacy and safety profile of 1PC111 , pitavastatin and ezetimibe during the treatment period and 2 week follow up period.
Timepoint [1] 0 0
12 week treatment period

Eligibility
Key inclusion criteria
1. Primary hypercholesterolemia or mixed dyslipidemia
2. 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
3. Subject who is willing and able to provide inform ed consent
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Female who is or intends to be pregnant or breast feeding, or has childbearing potential but without effective contraception.
2. Subject with documented HIV
3. Subject with uncontrolled hypothyroidism according to the investigator's judgment
4. 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
5. 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
6. Subject with the following medical histories:

* 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
7. Any unstable comorbidities or clinical conditions , including laboratory abnormalities which could lead to unacceptable risk to subject or confound data interpretation , per investigatiors judgment
8. Use any lipid lowering agent within 6 weeks prior to initiating the study treatment ( recheck this criterion at Day 1)
9. Use cyclosporine within 6 weeks prior to initiating the study treatment (recheck this criterion at Day 1)
10. Use any investigational product within 6 weeks prior to initiating the study treatment ( recheck this criterion at Day 1)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/10/2021
Sample size
Target
Accrual to date
Final
390
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Paratus Clinical Research Western Sydney - Blacktown
Recruitment hospital [2] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [3] 0 0
Emeritus Research - Camberwell
Recruitment hospital [4] 0 0
Paratus Clinical Research Central Coast - Kanwal
Recruitment postcode(s) [1] 0 0
- Blacktown
Recruitment postcode(s) [2] 0 0
- Brookvale
Recruitment postcode(s) [3] 0 0
- Camberwell
Recruitment postcode(s) [4] 0 0
- Kanwal
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton
Country [4] 0 0
New Zealand
State/province [4] 0 0
Nelson
Country [5] 0 0
New Zealand
State/province [5] 0 0
Rotorua
Country [6] 0 0
New Zealand
State/province [6] 0 0
Tauranga
Country [7] 0 0
Taiwan
State/province [7] 0 0
Changhua
Country [8] 0 0
Taiwan
State/province [8] 0 0
Chiayi City
Country [9] 0 0
Taiwan
State/province [9] 0 0
Kaohsiung
Country [10] 0 0
Taiwan
State/province [10] 0 0
Taichung
Country [11] 0 0
Taiwan
State/province [11] 0 0
Tainan
Country [12] 0 0
Taiwan
State/province [12] 0 0
Taipei
Country [13] 0 0
Taiwan
State/province [13] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Orient Pharma Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT04643093
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04643093