UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032276
Receipt number R000036805
Scientific Title The differences between oral bisoprolol and bisoprolol patch on blood pressure and pulse rate in patients with hypertension and heart failure
Date of disclosure of the study information 2018/04/20
Last modified on 2018/10/16 15:25:49

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Basic information

Public title

The differences between oral bisoprolol and bisoprolol patch on blood pressure and pulse rate in patients with hypertension and heart failure

Acronym

The differences between oral bisoprolol and bisoprolol patch

Scientific Title

The differences between oral bisoprolol and bisoprolol patch on blood pressure and pulse rate in patients with hypertension and heart failure

Scientific Title:Acronym

The differences between oral bisoprolol and bisoprolol patch

Region

Japan


Condition

Condition

Hypertensive patients complicated with heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The evaluation of the differences between oral bisoprolol and bisoprolol patch on blood pressure and pulse rate

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

blood pressures and pulse rates variability

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Hypertensive patients complicated with heart failure who are treated with oral bisoprolol are entrolled in this study.
And, we evaluate blood pressure and pulse rate variability after switching from oral bisoprolol to bisoprolol patch.

Interventions/Control_2


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

30 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

Out patients with hypertension and heart failure of NHYA classification of I - III who are administrated with oral bisoprolol.
The dosage of oral bisoprolol does not change for 4 weeks or more.

Key exclusion criteria

Pregnancy, breast-feeding, patients who may be pregnant, and patients who want pregnancy during the study
Patients with skin disease
Patients who were judged inappropriate as subjects of this examination by investigators

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shunsuke Kiuchi

Organization

Toho University Omori Medical Center

Division name

Department of Cardiovascular Medicine

Zip code


Address

6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541

TEL

03-3762-4151

Email

syunnsuke@med.toho-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shunsuke Kiuchi

Organization

Toho University Omori Medical Center

Division name

Department of Cardiovascular Medicine

Zip code


Address

6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541

TEL

03-3762-4151

Homepage URL


Email

syunnsuke@med.toho-u.ac.jp


Sponsor or person

Institute

Toho University

Institute

Department

Personal name



Funding Source

Organization

Toho University Omori Medical Ce
nter, Department of Cardiovascul
ar Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2018 Year 04 Month 20 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


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

2017 Year 03 Month 30 Day

Date of IRB


Anticipated trial start date

2017 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 04 Month 16 Day

Last modified on

2018 Year 10 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036805


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name