UMIN ID: UMIN000002156
Registered date:02/07/2009
Multi-center open labeled randomised trial on effects of candesartan on heart rate and blood pressure in the early morning in patients with hypertension
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Hypertension |
Date of first enrollment | 2008/09/01 |
Target sample size | 100 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | 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). |
Outcome(s)
Primary Outcome | Home blood pressure and heart rate in the early morning Ratio of morning and evening blood pressure (M/E ratio) |
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Secondary Outcome | Seasonal change in blood pressure |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude 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 |
Related Information
Primary Sponsor | Gifu university guladuate school of medicine, department of cardiology |
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Secondary Sponsor | |
Source(s) of Monetary Support | Gifu university guladuate school of medicine |
Secondary ID(s) |
Contact
public contact | |
Name | Shinya Minatoguchi |
Address | Yanagido 1-1, Gifu city Japan |
Telephone | 058-230-6520 |
minatos@gifu-u.ac.jp | |
Affiliation | Gifu university graduate school of medicine Cardiology |
scientific contact | |
Name | Shinya Minatoguchi |
Address | Yanagido 1-1, Gifu city Japan |
Telephone | 058-230-6520 |
minatos@gifu-u.ac.jp | |
Affiliation | Gifu university graduate school of medicine Cardiology |