UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002079 |
|---|---|
| Receipt number | R000002529 |
| Scientific Title | Multi-center open labeled trial on effects of candesartan on heart rate and blood pressure in the early morning in patients with hypertension |
| Date of disclosure of the study information | 2009/07/01 |
| Last modified on | 2018/10/31 18:34:42 |
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Basic information
Public title
Multi-center open labeled trial on effects of candesartan on heart rate and blood pressure in the early morning in patients with hypertension
Acronym
Domestic Observation of Heart Rate and Systemic Arterial Blood Pressure in the Morning (DOHSAM study-1)
Scientific Title
Multi-center open labeled trial on effects of candesartan on heart rate and blood pressure in the early morning in patients with hypertension
Scientific Title:Acronym
Domestic Observation of Heart Rate and Systemic Arterial Blood Pressure in the Morning (DOHSAM study-1)
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to compare the effect of candesartan and other ARBs on heart rate and blood pressure in the early morning in patients with hypertension.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Home blood pressure and heart rate in the early morning
Ratio of morning and evening blood pressure (M/E ratio)
Key secondary outcomes
Seasonal change in blood pressure
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In patients with hypertension treating with ARBs other than candesartan with blood pressure more than 135/85 mmHg, we will change ARBs to candesartan and follow up for 1 year.
When we change ARBs to candesartan , we regard that candesartan 4mg corresponds to losartan 25mg, valsartan 40mg, telmisartan 20mg and olmesartan 10mg, respectively. Maximal dose of each ARB corresponds to candesartan 12mg.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hypertensive patients with home blood pressure more than 135/85 mmHg in the early morning.
Key exclusion criteria
1)Patient with allergy to candesartan or amlodipine
2)Pregnant woman or possible pregnant woman
3)Patients with maximal dose of candesartan or amlodipine
4)Patients receiving Ca channel blockers other than amlodipine
5)Patients with atrial fibrillation or its past history
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Minatoguchi |
Organization
Gifu university graduate school of medicine
Division name
Cardiology
Zip code
Address
Yanagido 1-1, Gifu city
TEL
058-230-6520
minatos@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Minatoguchi |
Organization
Gifu university graduate school of medicine
Division name
Cardiology
Zip code
Address
Yanagido1-1
TEL
058-230-6520
Homepage URL
minatos@gifu-u.ac.jp
Sponsor or person
Institute
Gifu university graduate school of medicine, department of cardiology
Institute
Department
Personal name
Funding Source
Organization
Gifu university graduate school of medicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 07 | Month | 01 | 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
Main results already published
Date of protocol fixation
| 2008 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 16 | Day |
Last modified on
| 2018 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002529
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/12/22 | Candesaratn論文.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2017/12/22 | Candesaratn論文.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/12/22 | Candesaratn論文.pdf |
