UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007701
Receipt number R000009054
Scientific Title The effect of AT1 receptor blocker/Ca antagonist combination drug on hypertensive patients - Effect of change in medication from AT1 receptor blocker/Ca antagonist concurrent dosage to its combination drug -
Date of disclosure of the study information 2012/04/09
Last modified on 2014/10/31 08:48:13

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Basic information

Public title

The effect of AT1 receptor blocker/Ca antagonist combination drug on hypertensive patients
- Effect of change in medication from AT1 receptor blocker/Ca antagonist concurrent dosage to its combination drug -

Acronym

The effect of AT1 receptor blocker/Ca antagonist combination drug on hypertensive patients

Scientific Title

The effect of AT1 receptor blocker/Ca antagonist combination drug on hypertensive patients
- Effect of change in medication from AT1 receptor blocker/Ca antagonist concurrent dosage to its combination drug -

Scientific Title:Acronym

The effect of AT1 receptor blocker/Ca antagonist combination drug on hypertensive patients

Region

Japan


Condition

Condition

Hypertension

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examine the effect of AT1 receptor blocker/Ca antagonist combination drug on hypertensive patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood pressure

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

Exchange to combination drug

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

20 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

Hypertensive patients who are medicated with AT1 receptor blocker and Ca antagonist

Key exclusion criteria

The exclusion criteria were an age >75 years, current history of myocardial infarction and/or cerebral stroke, renal failure, abnormal liver or muscle enzymes (ALT>100, ALT>100), applied for other clinical trial within 3 months, expectant mother, lactating woman, inappropriate patients judged by the physician in charge

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Minoru Takemoto

Organization

Chiba University Hospital

Division name

Department of Medicine, Division of Diabetes, Metabolism and Endocrinology

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan

TEL

043-222-7171

Email

minoru.takemoto@faculty.chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Minoru Takemoto

Organization

Chiba University Hospital

Division name

Department of Medicine, Division of Diabetes, Metabolism and Endocrinology

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan

TEL

043-222-7171

Homepage URL


Email

minoru.takemoto@faculty.chiba-u.jp


Sponsor or person

Institute

Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

2012 Year 04 Month 09 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

Open public recruiting

Date of protocol fixation

2011 Year 06 Month 27 Day

Date of IRB


Anticipated trial start date

2011 Year 07 Month 01 Day

Last follow-up date

2013 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 04 Month 09 Day

Last modified on

2014 Year 10 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009054


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name