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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001890
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Geriatric Medicine, University of Tokyo Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002277

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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