UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017270 |
|---|---|
| Receipt number | 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 10:27:36 |
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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
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
alltezza@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020020
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