UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001890 |
|---|---|
| Receipt number | R000002277 |
| Scientific Title | Clinical trial to investigate the effect of candesartan on QOL and geriatric syndome in elderly hypertensive patients |
| Date of disclosure of the study information | 2009/04/20 |
| Last modified on | 2012/02/17 14:41:22 |
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Basic information
Public title
Clinical trial to investigate the effect of candesartan on QOL and geriatric syndome in elderly hypertensive patients
Acronym
Elderly hypertension QOL-study of UnIversity & Primary care in Tokyo (EQUIP) Study
Scientific Title
Clinical trial to investigate the effect of candesartan on QOL and geriatric syndome in elderly hypertensive patients
Scientific Title:Acronym
Elderly hypertension QOL-study of UnIversity & Primary care in Tokyo (EQUIP) Study
Region
| Japan |
Condition
Condition
essential hypertension
Classification by specialty
| Medicine in general | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of candesartan on QOL and geriatric syndome in elderly hypertensive patients who are treated with calcium channel blockers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of QOL questionnaire score (SF-8)
Key secondary outcomes
1) Subjective symptoms of the geriatric syndrome questionnaire. 2) Office blood pressure and pulse rate. 3) Home blood pressure and pulse rate
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
Candesartan will be replaced with calcium channel blockers (Group A), or will be added to calcium channel blockers (Group B), depending on the blood pressure control as decided by attending physician. Candesartan can be increased up to 12 mg/day according to blood pressure.
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
1) Hypertensive patients who are taking calcium channel blockers for more than 4 weeks.
2) Outpatients
3) Those who show any impairment in SF-8 questionnaire.
Key exclusion criteria
1) Subjects with irritation to candesartan
2) Subjects with (possible) pregnancy
3) Subejects with renal artery stenosis
4) Subjects with hyperkalemia
5) Subjects taking any angiotensin receptor blockers
6) Subjects who are unable to fill out the questionnaire
7) Other ineligible subjects
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyoshi Ouchi |
Organization
University of Tokyo Hospital
Division name
Department of Geriatric Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku Tokyo
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Akishita |
Organization
University of Tokyo Hospital
Division name
Department of Geriatric Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Geriatric Medicine, University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Geriatric Medicine, University of Tokyo Hospital
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
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
| 2009 | Year | 04 | Month | 20 | 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
| 2009 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 15 | Day |
Last modified on
| 2012 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002277
