UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011328
Receipt number R000013220
Scientific Title Comparison of blood pressure lowering effects of increasing dose of calcium channel blocker or adding diuretics in patients with insufficient blood pressure control with moderate dose of angiotensin receptor blocker and calcium channel blocker.
Date of disclosure of the study information 2013/08/01
Last modified on 2016/02/01 15:15:25

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Basic information

Public title

Comparison of blood pressure lowering effects of increasing dose of calcium channel blocker or adding diuretics in patients with insufficient blood pressure control with moderate dose of angiotensin receptor blocker and calcium channel blocker.

Acronym

Comparison of blood pressure lowering effects of increasing dose of calcium channel blocker or adding diuretics

Scientific Title

Comparison of blood pressure lowering effects of increasing dose of calcium channel blocker or adding diuretics in patients with insufficient blood pressure control with moderate dose of angiotensin receptor blocker and calcium channel blocker.

Scientific Title:Acronym

Comparison of blood pressure lowering effects of increasing dose of calcium channel blocker or adding diuretics

Region

Japan


Condition

Condition

Hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare blood pressure lowering effects of increasing dose of calcium channel blocker or adding diuretics in patients with insufficient blood pressure control with moderate dose of angiotensin receptor blocker and calcium channel blocker.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in clinic blood pressure and morning home blood pressure.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

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

Calcium channel blocker

Interventions/Control_2

Diuretic

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Inclusion criteria:Male or female patients with essential hypertension whose clinic and/or home blood pressure remain above goal blood pressures indicated by the 2009 guidelines by Japan Hypertension Society despite treatment with moderate amount of angiotensin receptor blocker and calcium channel blocker.

Key exclusion criteria

1) Patients receiving angiotensin converting enzyme inhibitor,renin inhibitor or diuretics.
2) Patients considered not feasible to receive diuretics or 10mg of amlodipine. 3) Patents with poor compliance to treatment.
4) Shift workers.
5) Patients on hemodialysis.

Target sample size

170


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshio Kushiro

Organization

Surugadai Nihon University Hospital

Division name

Cardiology

Zip code


Address

1-8-13 Kandasurgadai, Chiyodaku, Tokyo, Japan

TEL

+81-03-3293-1711

Email

tanishigem@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshio Kushiro

Organization

Surugadai Nihon University Hospital

Division name

Cardiology

Zip code


Address

1-8-13 Kandasurgadai, Chiyodaku, Tokyo, Japan

TEL

03-3293-1711

Homepage URL


Email

tanishigem@yahoo.co.jp


Sponsor or person

Institute

Toshio Kushiro

Institute

Department

Personal name



Funding Source

Organization

Surugadai Nihon University Hospital

Organization

Division

Category of Funding Organization

Self funding

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

2013 Year 08 Month 01 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

2013 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 08 Month 01 Day

Last follow-up date

2015 Year 10 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

2013 Year 07 Month 31 Day

Last modified on

2016 Year 02 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013220


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name