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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

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Basic information
Public title Clinical test to examine the efficacy and
safety of pemafibrate
Acronym PEMA Trial
Scientific Title Efficacy and safety of pemafibrate in high
risk patients with coronary artery disease
Scientific Title:Acronym PEBE Trial
Region
Japan

Condition
Condition Hypertriglyceridemia
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Adult
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
Medicine
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
20 years-old <
Age-upper limit
75 years-old >=
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.
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.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Akihiro
Middle name
Last name Nakamura
Organization Iwate Prefectural Central Hospital
Division name Department of Cardiology
Zip code 020-0066
Address 1-4-1 Ueda, Morioka, Japan
TEL 0196531151
Email akihiro-nakamura@pref.iwate.jp

Public contact
Name of contact person
1st name Akihiro
Middle name
Last name Nakamura
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
Email 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
Email 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
2022 Year 05 Month 13 Day

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
2019 Year 10 Month 30 Day
Date of IRB
2019 Year 10 Month 30 Day
Anticipated trial start date
2020 Year 02 Month 01 Day
Last follow-up date
2021 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 05 Month 12 Day
Last modified on
2022 Year 05 Month 12 Day


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


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