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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002156
Receipt No. R000002536
Scientific Title Multi-center open labeled randomised 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 2009/07/02
Last modified on 2018/10/31

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Basic information
Public title Multi-center open labeled randomised 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-2)
Scientific Title Multi-center open labeled randomised 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-2)
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 amlodipine on heart rate and blood pressure in the early morning in patients with hypertension.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

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 Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 If an average home blood pressure in the early morning of 7 days shows more than 135/85 mmHg in patients with candesartan, with drugs other than ARBs or without treatment and his/her birth month is odd-numbered, candesartan 4mg/day will be prescribed and follows up for one year. Home blood pressure in the early morning will be evaluated every 3 month and if an average home blood pressure in the morning of 7 days shows more than 135/85 mmHg, candesartan 4mg/day will further be added (Maximal dose of candesartan is 12mg/day).
Interventions/Control_2 If an average home blood pressure in the early morning of 7 days shows more than 135/85 mmHg in patients with candesartan, drugs other than ARBs or without treatment and his/her birth month is even-numbered, amlodipine 2.5mg/day will be prescribed and follows up for one year. Home blood pressure in the early morning will be evaluated every 3 month and if an average home blood pressure in the morning of 7 days shows more than 135/85 mmHg, amlodipine 2.5mg/day will further be added (Maximal dose of amlodipine is 10mg/day).
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
Email 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 Yanagido 1-1, Gifu city
TEL 058-230-6520
Homepage URL
Email minatos@gifu-u.ac.jp

Sponsor
Institute Gifu university guladuate school of medicine, department of cardiology
Institute
Department

Funding Source
Organization Gifu university guladuate school of medicine
Organization
Division
Category of Funding Organization Other
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 07 Month 02 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 07 Month 02 Day
Last modified on
2018 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002536

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/07/10 Minatoguchi et al.pdf


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