Compare the Efficacy and Safety of 1PC111 With Pitavastatin and Ezetimibe in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Orient Pharma Co., Ltd.
1 other identifier
interventional
390
3 countries
34
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2020
Shorter than P25 for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2020
CompletedFirst Submitted
Initial submission to the registry
November 22, 2020
CompletedFirst Posted
Study publicly available on registry
November 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2021
CompletedMay 18, 2022
May 1, 2022
1 year
November 22, 2020
May 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients
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.
12 week treatment period
Study Arms (3)
Pitavastatin
ACTIVE COMPARATORPitavastatin
Ezetimibe
ACTIVE COMPARATOREzetimibe
1PC111
EXPERIMENTAL1PC111
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Paratus Clinical Research Western Sydney
Blacktown, Australia
Northern Beaches Clinical Research
Brookvale, Australia
Emeritus Research
Camberwell, Australia
Paratus Clinical Research Central Coast
Kanwal, Australia
Southern Clinical Trials - Waitemata Ltd.
Auckland, New Zealand
Southern Clinical Trials Totara
Auckland, New Zealand
Southern Clinical Trials Group Ltd
Christchurch, New Zealand
Lakeland Clinical Trials Waikato
Hamilton, New Zealand
Southern Clinical Trials Tasman
Nelson, New Zealand
Lakeland Clinical Trials Rotorua
Rotorua, New Zealand
Culloden Research Ltd.
Tauranga, New Zealand
Changhua Christian Hospital
Changhua, Taiwan
Chiayi Christian Hospital
Chiayi City, Taiwan
E-Da Hospital
Kaohsiung City, Taiwan
Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F.
Kaohsiung City, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
Kuang Tien General Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Chi Mei Medical Center
Tainan, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Tainan Municipal Hospital (Managed By Show Chwan Medical Care Corporation)
Tainan, Taiwan
Cathay General Hospital
Taipei, Taiwan
Cheng Hsin General Hospital
Taipei, Taiwan
Far Eastern Memorial Hospital
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Tamsui Mackay Memorial Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Chang Gung Medical Foundation- LinKuo Branch
Taoyuan District, Taiwan
Related Publications (1)
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.
PMID: 36030106DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2020
First Posted
November 24, 2020
Study Start
August 1, 2020
Primary Completion
August 19, 2021
Study Completion
October 5, 2021
Last Updated
May 18, 2022
Record last verified: 2022-05