UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047737
Receipt number 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 2022/11/21 20:07:11

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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 or person

Institute

Department of Cardiology, Iwate Prefectural Centgral Hospital

Institute

Department

Personal name



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

https://www.jstage.jst.go.jp/article/jat/advpub/0/advpub_63659/_pdf/-char/en

Publication of results

Published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/jat/advpub/0/advpub_63659/_pdf/-char/en

Number of participants that the trial has enrolled

60

Results

The %Change in TG and Apo A-I levels was significantly greater with pemafibrate than with bezafibrate (-46.1% vs. -34.7%, p<0.001; 9.2% vs. 5.7%, p=0.018, respectively). %Change in HDL-C levels was not significantly different between the two treatments. %Change in liver enzyme levels was markedly decreased with pemafibrate than with bezafibrate.

Results date posted

2022 Year 11 Month 21 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The mean age was 63 years, and 92% (n=55)
of the patients were men. The mean body mass index was 27 kg/m2, and 77% (n=46) of the patients met the Japanese criteria for MetS. Approximately 40% (n=24) of the patients had type 2 DM and 80% (n=48) had hypertension. Nearly half of the patients (n=31, 52%) received rosuvastatin as statin therapy.

Participant flow

Of 78 patients initially screened, 60 were
enrolled and randomized with 30 patients per treatment. All 60 patients completed the study and were included in both analysis sets.

Adverse events

The incidence rates of AEs were 37% (n=22) and 43% (n=26) with bezafibrate and pemafibrate treatments, respectively. Treatment related AEs occurred in one patient in each treatment group: thickening of the gallbladder with bezafibrate treatment and hot flash with pemafibrate treatment.
In the bezafibrate treatment group, SAEs occurred in five patients, of which two were related to the treatment: worsening renal function and acute cholecystitis. Conversely, in the pemafibrate treatment group, SAEs occurred in six patients, but none were related to the treatment. There were no treatment discontinuations because of AEs or SAEs.

Outcome measures

The primary efficacy endpoint was a percent
change (%Change) in the fasting serum TG levels from baseline to the study endpoint after the 24-week treatment with bezafibrate or pemafibrate. The baseline and study endpoint were defined as measurements before and after the 24-week treatment, respectively.
The secondary efficacy endpoints were %Change in the fasting serum HDL-C and Apo A-I levels from baseline to the study endpoint.

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 11 Month 21 Day



Link to view the page

Value
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