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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017270
Receipt No. R000020020
Scientific Title Comparison of satisfaction in personalized medicine with hypotensive drug between elderly hypertensive Patients-voice and physician of voice.
Date of disclosure of the study information 2015/04/27
Last modified on 2017/01/05

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Basic information
Public title Comparison of satisfaction in personalized medicine with hypotensive drug between elderly hypertensive Patients-voice and physician of voice.
Acronym Patients-Voice Study
Scientific Title Comparison of satisfaction in personalized medicine with hypotensive drug between elderly hypertensive Patients-voice and physician of voice.
Scientific Title:Acronym Patients-Voice Study
Region
Japan

Condition
Condition essential hypertension
Classification by specialty
Cardiology Geriatrics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the difference of satisfaction in antihypertentsive treatment between hypertensive patients and physician by questionnaire survey before and after olmesartane/azelnidipine combination tablet administration.
Examine patient's satisfaction and the relations of the blood pressure.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patient and physician's satisfaction(0week and 12week)
Key secondary outcomes 1)Patient's satisfaction and blood pressure(0week and 12week)
2)Patient's satisfaction, blood pressure(home,Office), the pulse, QOL (SF-12, VAS)(before and after the study drug administration )
3)Physician's satisfaction(before and after the study drug administration)
4)Age division (under 75 years old, 75 years old or older)

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 Switching from olmesartan 20mg/day or azelnidipine 16mg/day to olmesartan 20mg/azelnidipine16mg combination tablet for 12 weeks.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria At provisional registration
1)Patients who have grade1 or grade2 essential hypertension
2) Patient who remedy are possible before this registration with 20 mg/day of olmesartan tablet or 16 mg/day of azelnidipine tablet more than eight weeks
3)Patients of 65 years old or older
4)Outpatients
5)The written informed consent provided by the patient

At definitive registration
1)Patients who are using olmesartan 20 mg/day or azelnidipine 16 mg/day eight weeks or longer (at definitive registration)
2)Patients with insufficient hypotensive effect
Key exclusion criteria Provisional registration
1)Patients who has moderate or high cognitive impairment (it is diagnosed by CGA7)
2)Patients who are taking dementia therapeutic drug
3)Patients with a history of brain, cardiovascular disorder within six months before informed consent
4)Patients who cannot accomplish 6 meters of walks
5)Patients who are taking an azole-based antifungal drug (itraconazole, miconazole)
6)Patients who are taking a HIV protease inhibitor (ritonavir, saquinavir, indinavir)
7)Patients who are taking a drug containing cobicistat
8)Diabetic patients who are taking an aliskiren fumarate(exclud the patients with insufficient hypotensive effect remarkably even if give other hypertensive therapy treatment)
9)Patients with history of hypersensitivity to olmesartan tablet
10)Patients with history of hypersensitivity to azelnidipine tablet
11)Patients who has possibility of pregnancy or pregnancy
12)Patients who judged that a study responsibility doctor was unsuitable for this study
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuru Ohishi
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Department of cardiovascular medicine and hypertension
Zip code
Address 8-35-1 Sakuragaoka Kagoshima, 890-8544, Japan
TEL 099-275-5316
Email ohishi@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Ikeda
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Department of cardiovascular medicine and hypertension
Zip code
Address 8-35-1 Sakuragaoka Kagoshima, 890-8544, Japan
TEL 099-275-5316
Homepage URL
Email alltezza@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization DAIICHI SANKYO COMPANY, LIMITED
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor DAIICHI SANKYO COMPANY, LIMITED
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
2015 Year 04 Month 27 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
2015 Year 02 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 24 Day
Last modified on
2017 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020020

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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