NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedHypertension
Date of first enrollment2008/09/01
Target sample size100
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeHome blood pressure and heart rate in the early morning Ratio of morning and evening blood pressure (M/E ratio)
Secondary OutcomeSeasonal change in blood pressure

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1)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

Contact

public contact
Name Shinya Minatoguchi
Address Yanagido 1-1, Gifu city Japan
Telephone 058-230-6520
E-mail 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
E-mail minatos@gifu-u.ac.jp
Affiliation Gifu university graduate school of medicine Cardiology