The investigators want to find out if a treatment with a new combination of two different antihypertensive drugs (olmesartan and amlodipine) in one tablet in patients with moderately elevated blood pressure is more effective than treatment with just one substance (candesartan). All antihypertensive treatment will be ceased for two weeks to achieve comparable baseline conditions. Treatment is then started with the single substance. After six weeks, therapy is changed to another single substance and after a further six weeks, to the fixed combination tablet. Blood pressure is determined by office measurements taken by the doctor and via long-term ambulatory blood pressure monitoring (ABPM). Participants may be male or female and must be over 18 years of age.
SEVICONTROL-2: Efficacy and Safety of a sequential therapy change from Candesartan 32 mg to the fixed combination of olmesartan 40 mg/amlodipine 10 mg in patients with poorly controlled moderate hypertension - an open phase IV trial
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Candesartan 16 mg tablets p. o. once daily for 14 days, 32 mg tablets once daily for 28 days
Switch to olmesartan 40 mg tablets once daily for 42 days,
then switch to olmesartan/amlodipine 40/5 mg tablets once daily for 14 days, then olmesartan/amlodipine 40/10 mg tablets once daily for 28 days
Praxis Dr. Reimer
Anderbeck, Germany
Praxis Dr. Heinz
Bergisch Gladbach, Germany
Praxis Dr. Zemmrich
Berlin, Germany
St.-Josefs-Hospital
Cloppenburg, Germany
Praxis Dr. Pohl
Dresden, Germany
Praxis Dr. Koßler-Wiesweg
Essen, Germany
Praxis Dr. Rövenich
Frankfurt, Germany
Praxis Dr. Strzata
Kapellendorf, Germany
Praxis Dr. Paschmionka
Leipzig, Germany
Praxis Dr. Pitule
Ludwigshafen, Germany
...and 1 more locations
Change in systolic daytime mean ABPM (long-term ambulatory blood pressure monitoring) values
After six weeks therapy with a monotherapy with olmesartan 40 mg and further six weeks treatment with a fixed combination of olmesartan 40 mg and amlodipine 10 mg compared to previous monotherapy with candesartan.
Time frame: ABPM will be performed after 6 weeks treatment with each of the different therapy regimes.
Change in systolic/diastolic office blood pressure and mean values (night-time and 24 hr for systolic bp and day-time, night-time and 24 hr for diastolic bp)
from candesartan to olmesartan 40 mg and then to a fixed combination of olmesartan 40 mg and amlodipine 10 mg.
Time frame: after 6 and 12 weeks
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