UMIN-CTR Clinical Trial

Public title

Protective Effect of Efonidipine and Amlodipine for Renal Function and Effect for Pretibial Edema (PREFER Study)

Acronym

Protective Effect of Efonidipine and Amlodipine for Renal Function and Effect for Pretibial Edema (PREFER Study)

Scientific Title

Protective Effect of Efonidipine and Amlodipine for Renal Function and Effect for Pretibial Edema (PREFER Study)

Scientific Title:Acronym

Protective Effect of Efonidipine and Amlodipine for Renal Function and Effect for Pretibial Edema (PREFER Study)

Region

Japan

Condition

Hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Calcium Channel Blockers(CCBs) are the most prevalent agents for antihypertensive treatment, and recent CCBs shows long action of their pharmacokinetics which brought stable control of hypertension. In Japan amlodipine is the most dominant prescribed medicine for anti-hypertension, but both amlodipine and nifedipine are often recognized as possessing pretibial pitting edema. Pretibial edema not only sometimes suffers patents but also may confuse as congestive heart failure. Efonidipine has equivalent dilating action of afferent and efferent arteriole, which may has different action on renal function compared with amlodipine. We conducted the study to clarify the incidence of pretibial edema between amlodipine and efonidipine treatment cases, and also reno-protective effect of both agents.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Incidence of pretibial edema

Key secondary outcomes

Micro-albumin in urine

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

Concealment

Numbered container method

No. of arms

10

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

efonidipine40mg

Interventions/Control_2

efonidipine60mg

Interventions/Control_3

efonidipine60mg+ARB

Interventions/Control_4

efonidipine60mg+diuretics

Interventions/Control_5

efonidipine60mg+ARB+diuretics

Interventions/Control_6

Amlodipin2.5mg

Interventions/Control_7

Amlodipin5mg

Interventions/Control_8

Amlodipin5mg+ARB

Interventions/Control_9

Amlodipin5mg+diuretics

Interventions/Control_10

Amlodipin5mg+ARB+diuretics

Age-lower limit

15

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Newly onset hypertensive patients who are over 15 years old and consent by signature.

Key exclusion criteria

Exclusion criteria as follows: Patients who are pregnant or possibility of pregnancy, possess hypersensitivity to efonidipine or amlodipine, who are suffering from secondary hypertension, lateral or bilateral stenosis of renal arteries, cerebro-vascular diseases, hyper-potassemia, severe hepatic diseases, or elevated creatinine over 3.0mg/dl. Patient who are taking NSAID or steroids regularly, who are less than 15 years old, who are suffering from malignant neoplasm. Patients who are not selected by attendant physician. Patient who has pretibial edema at first visit.

Target sample size

246

Name of lead principal investigator

1st name
Middle name
Last name	Hisao Mori, Yokohama Sotetsu bldg clinic of internal medicine

Organization

Kanagawa Association of Medical and Dental Practitioners

Division name

Department of Clinical Research

Zip code

Address

TS plaza bldg 2 F, 2-23-2, tsuruya-Cho, Kanagawa-Ku, Yokohama, Japan

TEL

045-313-2111

Email

hmori@gem.hi-ho.ne.jp

Name of contact person

1st name
Middle name
Last name	Hisao Mori

Organization

Kanagawa Association of Medical and Dental Practitioners

Division name

Department of Clinical Research

Zip code

Address

TS plaza bldg 2 F, 2-23-2, tsuruya-Cho, Kanagawa-Ku, Yokohama, Japan

TEL

045-313-2111

Homepage URL

Email

katsumata.t@doc-net.or.jp

Institute

Kanagawa Association of Medical and Dental Practitioners

Institute

Department

Personal name

Organization

Kanagawa Association of Medical and Dental Practitioners

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

12

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Completed

Date of protocol fixation

2009

Year

11

Month

06

Day

Date of IRB

Anticipated trial start date

2009

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

12

Month

11

Day

Last modified on

2014

Year

01

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003514