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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024671
Receipt No. R000028378
Scientific Title Effect of antihypertensive treatment for blood pressure and frequent urination in patients with hypertension and pollakiuria
Date of disclosure of the study information 2017/02/01
Last modified on 2016/11/01

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Basic information
Public title Effect of antihypertensive treatment for blood pressure and frequent urination in patients with hypertension and pollakiuria
Acronym Effect of antihypertensive treatment for blood pressure and frequent urination in patients with hypertension and pollakiuria
Scientific Title Effect of antihypertensive treatment for blood pressure and frequent urination in patients with hypertension and pollakiuria
Scientific Title:Acronym Effect of antihypertensive treatment for blood pressure and frequent urination in patients with hypertension and pollakiuria
Region
Japan

Condition
Condition Hypertension and pollakiuria
Classification by specialty
Cardiology Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of antihypertensive treatment for blood pressure and pollakiuria
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes blodd pressure and urinary frequency
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 ACEI/ARB
Interventions/Control_2 CCB
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with hypertension and pollakiuria
Key exclusion criteria The exclusion criteria were;
1)Patients with hypersensitivity for antihypertensive durgs
2)Patients treated with antihypertensive drugs by ACEI/ARB and CCB
3)Pregnant woman
4) Patients with severe renal and liver dysfunction
5) inappropriate candidate judged by doctors
6) Patiens with disagreement
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihiko Nishioka
Organization Saitama Medical Center, Saitama Medical University
Division name Division of Cardiology
Zip code
Address 1981 Kamoda, Kawagoe, Saitama
TEL 049-228-3400
Email nishioka@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Sasaki
Organization Saitama Medical Center, Saitama Medical University
Division name Division of Cardiology
Zip code
Address 1981 Kamoda, Kawagoe, Saitama
TEL 049-228-3400
Homepage URL
Email osasaki@saitama-med.ac.jp

Sponsor
Institute Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization None
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
2017 Year 02 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 Preinitiation
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 15 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
2016 Year 11 Month 01 Day
Last modified on
2016 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028378

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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