UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007815
Receipt number R000009216
Scientific Title Effect of transdermal hormone therapy combined with ARB in hypertensive postmenopausal women
Date of disclosure of the study information 2012/04/24
Last modified on 2012/04/23 16:11:13

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Basic information

Public title

Effect of transdermal hormone therapy combined with ARB in hypertensive postmenopausal women

Acronym

Combination therapy with transdermal HT and ARB

Scientific Title

Effect of transdermal hormone therapy combined with ARB in hypertensive postmenopausal women

Scientific Title:Acronym

Combination therapy with transdermal HT and ARB

Region

Japan


Condition

Condition

Hypertension, climacteric disorder

Classification by specialty

Cardiology Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effectiveness of combination therapy with transdermal HT and ARB for postmenopausal hypertensive women

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood pressure

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

ARB

Interventions/Control_2

ARB + HRT

Interventions/Control_3

HRT

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

65 years-old >

Gender

Female

Key inclusion criteria

Postmenopausal women with climacteric symptoms

Key exclusion criteria

Women contraindicated of HRT

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akihiko Wakatsuki

Organization

Aichi Medical University

Division name

Department of Obstetrics and Gynecology

Zip code


Address

1-1 Yazakokarimata, Nagakute, Aichi 480-1195

TEL

0561-62-3311

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Aichi Medical University

Division name

Department of Obstetrics and Gynecology

Zip code


Address


TEL

0561-62-3311

Homepage URL


Email

wakatuki@aichi-med-u.ac.jp


Sponsor or person

Institute

Aichi Medical University

Institute

Department

Personal name



Funding Source

Organization

Aichi Medical University

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

2012 Year 04 Month 24 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

Preinitiation

Date of protocol fixation

2012 Year 03 Month 13 Day

Date of IRB


Anticipated trial start date

2012 Year 06 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

2012 Year 04 Month 23 Day

Last modified on

2012 Year 04 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009216


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name