UMIN-CTR Clinical Trial

Basic information
Public title	Study on the effect on bone metabolism markers of ARB combination drug that targets high blood pressure patients
Acronym	Study on the effect on bone metabolism markers of ARB combination drug that targets high blood pressure patients
Scientific Title	Study on the effect on bone metabolism markers of ARB combination drug that targets high blood pressure patients
Scientific Title:Acronym	Study on the effect on bone metabolism markers of ARB combination drug that targets high blood pressure patients
Region	Japan

Condition
Condition	Hypertension
Classification by specialty	Endocrinology and Metabolism Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of bone metabolic effects and antihypertensive effect in combination with thiazide diuretics and losartan in elderly hypertensive patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of clinical and laboratory data before and after the start of combination therapy.
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	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	losartan, Trichlormethiazide
Interventions/Control_2	losartan
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients with age of 65 years and more. 2)Male or female. 3)Outpatient or hospitalization. 4)Hypertension; Patient uses ARB for one month or more, In hospital, patient with systolic blood pressure of 140 mmHg and more, or diastolic blood pressure of 90 mmHg and more. In home, patient with systolic blood pressure of 135 mmHg and more, or diastolic blood pressure of 85 mmHg and more.
Key exclusion criteria	1)Patients with hypersensitivity for the study drugs. 2)Patients with bilateral renal artery stenosis. 3)Patients with hyperkalemia. 4)Patients with eGFR value of 29 mL/min/1.73m2 or less. 5)Patients who uses of corticosteroid and/or immunosuppressant. 6)Patients who are considered to be inappropriate by the investigators.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shigemitsu Yasuda
Organization	Saitama Medical University
Division name	Department of Endocrinology and Diabetes
Zip code
Address	Morohongo 38, Moroyama, Iruma-gun, Saitama
TEL	049-276-1204
Email	shigemitsuyasuda@msn.com

Public contact
Name of contact person	1st name Middle name Last name Shigemitsu Yasuda
Organization	Saitama Medical University
Division name	Department of Endocrinology and Diabetes
Zip code
Address	Morohongo 38, Moroyama, Iruma-gun, Saitama
TEL	049-276-1204
Homepage URL
Email	shigemitsuyasuda@msn.com

Sponsor
Institute	Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama 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	2014 Year 06 Month 02 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	Terminated
Date of protocol fixation	2014 Year 06 Month 02 Day
Date of IRB
Anticipated trial start date	2014 Year 06 Month 02 Day
Last follow-up date	2014 Year 06 Month 02 Day
Date of closure to data entry	2014 Year 06 Month 02 Day
Date trial data considered complete	2014 Year 06 Month 02 Day
Date analysis concluded	2014 Year 06 Month 02 Day

Other
Other related information

Management information
Registered date	2014 Year 06 Month 01 Day
Last modified on	2018 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016455

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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