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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000047737 |
Receipt No. | R000054422 |
Scientific Title | Efficacy and safety of pemafibrate in high risk patients with coronary artery disease |
Date of disclosure of the study information | 2022/05/13 |
Last modified on | 2022/05/12 |
Basic information | ||
Public title | Clinical test to examine the efficacy and
safety of pemafibrate |
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Acronym | PEMA Trial | |
Scientific Title | Efficacy and safety of pemafibrate in high
risk patients with coronary artery disease |
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Scientific Title:Acronym | PEBE Trial | |
Region |
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Condition | |||||
Condition | Hypertriglyceridemia | ||||
Classification by specialty |
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Classification by malignancy | Others | ||||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To examine the efficacy and safety with pemafibrate treatment compared with those of bezafibrate |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Others |
Trial characteristics_2 | Others |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | To examine a percent change in the fasting
serum triglyceride levels from baseline to the study endpoint after the 24-week treatment with bezafibrate or pemafibrate. |
Key secondary outcomes | To examine a percent change in the fasting serum HDL-C and ApoA-1 levels from baseline
to study endpoint. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Cross-over |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Patients were randomly assigned in a 1:1 ratio to two treatments: bezafibrate of 400 mg/day or pemafibrate of 0.2 mg/day for the first 24-week treatment period. | |
Interventions/Control_2 | Patients were randomly assigned in a 1:1 ratio to two treatments: bezafibrate of 400 mg/day or pemafibrate of 0.2 mg/day for the first 24-week treatment period. | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Eligible patients were men and postmenopausal women aged 20-75 years with dyslipidemia
treated with statin and CAD who showed fasting serum TG levels of > 150 mg/dL and HDL-C levels of < 50 mg/dL in men or < 55 mg/dL in women at entry. |
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Key exclusion criteria | 1.patients who required additional
medication for dyslipidemia during the study period 2.fasting serum TG levels of over than 1000 mg/dl 3.type 1 diabetes mellitus or uncontrolled type 2 DM (HbA1c level of over than 8.5%) 4.familiar hypercholesterolemia 5.chronic kidney disease showing a serum creatinine level of over than 1.5 mg/dL 6.history or complication of gallbladder disease, cholelithiasis, pancreatitis, and malignant tumor 7.aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation to a level more than two times the upper limit of normal (ULN) range 8.uncontrolled hypertension (systolic blood pressure BP ofover tahn 160 mmHg or diastolic BP of over than 100 mmHg) 9.hemoglobin level of less than 12g/dL in men or less than 11 g/dL in women 11.recent myocardial infarction or cerebrovascular disorder within 3 months before the study 12.hospitalization for worsening heart failure within 3 months 13.use of ezetimibe and supplements containing eicosapentaenoic acid, and/or docosahexaenoic acid within 3 months before the study. Patients were also prohibited from using agents that affect lipid metabolism,such as thiazolidinedione, insulin,oral corticosteroid, or protease inhibitor. |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Iwate Prefectural Central Hospital | ||||||
Division name | Department of Cardiology | ||||||
Zip code | 020-0066 | ||||||
Address | 1-4-1 Ueda, Morioka, Japan | ||||||
TEL | 0196531151 | ||||||
akihiro-nakamura@pref.iwate.jp |
Public contact | |||||||
Name of contact person |
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Organization | Iwate Prefectural Central Hospital | ||||||
Division name | Department of Cardiology | ||||||
Zip code | 020-0066 | ||||||
Address | 1-4-1 Ueda, Morioka, Japan | ||||||
TEL | 0196531151 | ||||||
Homepage URL | |||||||
akihiro-nakamura@pref.iwate.jp |
Sponsor | |
Institute | Department of Cardiology, Iwate Prefectural Centgral Hospital |
Institute | |
Department |
Funding Source | |
Organization | Iwate Prefectural Centgral Hospital |
Organization | |
Division | |
Category of Funding Organization | Local Government |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Iwate Prefectural Central Hospital |
Address | 1-4-1 Ueda, Morioka, Japan |
Tel | 0196531151 |
akihiro-nakamura@pref.iwate.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 岩手県立中央病院 循環器内科 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 60 |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054422 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |