Unique ID issued by UMIN | UMIN000002156 |
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Receipt number | 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 18:34:05 |
Multi-center open labeled randomised trial on effects of candesartan on heart rate and blood pressure in the early morning in patients with hypertension
Domestic Observation of Heart Rate and
Systemic Arterial Blood Pressure in the
Morning (DOHSAM study-2)
Multi-center open labeled randomised trial on effects of candesartan on heart rate and blood pressure in the early morning in patients with hypertension
Domestic Observation of Heart Rate and
Systemic Arterial Blood Pressure in the
Morning (DOHSAM study-2)
Japan |
Hypertension
Medicine in general | Cardiology |
Others
NO
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.
Efficacy
Home blood pressure and heart rate in the
early morning
Ratio of morning and evening blood pressure (M/E ratio)
Seasonal change in blood pressure
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Pseudo-randomization
2
Treatment
Medicine |
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).
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).
20 | years-old | <= |
Not applicable |
Male and Female
Hypertensive patients with home blood
pressure more than 135/85 mmHg in the
early morning.
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
100
1st name | |
Middle name | |
Last name | Shinya Minatoguchi |
Gifu university graduate school of medicine
Cardiology
Yanagido 1-1, Gifu city
058-230-6520
minatos@gifu-u.ac.jp
1st name | |
Middle name | |
Last name | Shinya Minatoguchi |
Gifu university graduate school of medicine
Cardiology
Yanagido 1-1, Gifu city
058-230-6520
minatos@gifu-u.ac.jp
Gifu university guladuate school of medicine, department of cardiology
Gifu university guladuate school of medicine
Other
NO
2009 | Year | 07 | Month | 02 | Day |
Unpublished
Main results already published
2008 | Year | 08 | Month | 05 | Day |
2008 | Year | 09 | Month | 01 | Day |
2010 | Year | 09 | Month | 01 | Day |
2009 | Year | 07 | Month | 02 | Day |
2018 | Year | 10 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002536
Research Plan | |
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Registered date | File name |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |
2018/07/10 | Minatoguchi et al.pdf |