Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitavastatin | Active Comparator | Pitavastatin |
|
| Ezetimibe | Active Comparator | Ezetimibe |
|
| 1PC111 | Experimental | 1PC111 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin | Drug | Pitavastatin, QD |
| |
| Ezetimibe |
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy of 1PC111 is superior to pitavastatin and ezetimibe in patients | 12 week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy and safety profile of 1PC111 , pitavastatin and ezetimibe during the treatment period and 2 week follow up period. | 12 week treatment period |
Not provided
Inclusion Criteria:
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
Exclusion Criteria:
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:
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)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paratus Clinical Research Western Sydney | Blacktown | Australia | ||||
| Northern Beaches Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36030106 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Double-Blind
| Drug |
Ezetimibe, QD |
|
| 1PC111 | Drug | 1PC111, QD |
|
| 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 | Taiwan |
| ID | Term |
|---|---|
| C108475 | pitavastatin |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided