The investigators want to find out whether a recently introduced combination of two blood pressure lowering agents (olmesartan and amlodipine) has a different blood pressure lowering effect than a single active substance. In addition the investigators want to find out whether there is a difference in the changes in blood pressure over the course of a day depending on the time when the medications are taken (in the morning or at night). Male and female patients over 18 years of age may participate.
Investigation of changes in blood pressure after six weeks therapy with a fixed combination of 40 mg olmesartan and 10 mg amlodipine compared to a monotherapy with 32 mg candesartan. Investigation of changes in dipping-profile after a further six weeks of therapy with the fixed combination when time of intake is switched from morning to evening.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
83
candesartan 16 mg tablets p. o. for 14 days (morning), then candesartan 32 mg tablets for 28 day (morning)s,
olmesartan/amlodipine 40/5 mg tablets for 14 days (morning), then olmesartan/amlodipine 40/10 mg tablets for 28 days (morning), then olmesartan/amlodipine 40/10 mg tablets for 42 days (evening)
Praxis Dr. Loddo
Rastede, Lower Saxony, Germany
Praxis Dr. Paschmionka
Leipzig, Saxony, Germany
Praxis Dr. Reimer
Anderbeck, Germany
Praxis Dr. Heinz
Change in ABPM (ambulatory blood pressure measurement) mean daytime systolic values and change in systolic OBPM (office blood pressure measurement).
After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan
Time frame: after six and after 12 weeks
change in systolic OBPM
After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan: change in systolic OPM.
Time frame: after 6 and after 12 weeks
change in diastolic OBPM
After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan
Time frame: after six and after 12 weeks
Change in systolic and diastolic ABPM night mean values
first ABPM to be performed after 2 weeks wash-out followed by six weeks monotherapy with candesartan. Second ABPM to be performed after six weeks therapy with the fixed combination, given in the morning.
Time frame: after 6 weeks therapy with fixed combination of olmesartan and amlodipine
change in 24 hr mean values and diastolic day mean value
Time frame: after six and after 12 weeks
Distribution of patients over the four dipper types
Time frame: after six and after 12 weeks
Number of patients achieving target values for OBPM and ABPM
Time frame: after six and after 12 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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Bergisch Gladbach, Germany
Praxis Dr. Zemmrich
Berlin, Germany
Praxis Dr. Biedermann
Blankenhain, Germany
St.-Josefs-Hospital
Cloppenburg, Germany
Praxis Dr. Pohl
Dresden, Germany
Praxis Koßler-Wiesweg
Essen, Germany
Praxis Dr. Rövenich
Frankfurt, Germany
...and 2 more locations
Time frame: From screening visit to end of follow-up, up to 20 weeks