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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olmesartan/Amlodipin fixed combination | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan cilexetil | Drug | candesartan 16 mg tablets p. o. for 14 days (morning), then candesartan 32 mg tablets for 28 day (morning)s, |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | after 6 and after 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in diastolic OBPM | After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan | after six and after 12 weeks |
| Change in systolic and diastolic ABPM night mean values |
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Inclusion Criteria:
Exclusion Criteria:
systolic office bp > 180 mm Hg at screening visit
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Lueders, Dr.med. | Krankenhaus St.-Josef-Stift, Krankenhausstraße 13, D-49661 Cloppenburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis Dr. Loddo | Rastede | Lower Saxony | 26180 | Germany | ||
| Praxis Dr. Paschmionka |
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| Olmesartan/Amlodipin | Drug | 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) |
|
|
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.
| after 6 weeks therapy with fixed combination of olmesartan and amlodipine |
| change in 24 hr mean values and diastolic day mean value | after six and after 12 weeks |
| Distribution of patients over the four dipper types | after six and after 12 weeks |
| Number of patients achieving target values for OBPM and ABPM | after six and after 12 weeks |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | From screening visit to end of follow-up, up to 20 weeks |
| Leipzig |
| Saxony |
| 04316 |
| Germany |
| Praxis Dr. Reimer | Anderbeck | 38836 | Germany |
| Praxis Dr. Heinz | Bergisch Gladbach | 51429 | Germany |
| Praxis Dr. Zemmrich | Berlin | 12043 | Germany |
| Praxis Dr. Biedermann | Blankenhain | 99444 | Germany |
| St.-Josefs-Hospital | Cloppenburg | 49661 | Germany |
| Praxis Dr. Pohl | Dresden | 01129 | Germany |
| Praxis Koßler-Wiesweg | Essen | 45138 | Germany |
| Praxis Dr. Rövenich | Frankfurt | 65929 | Germany |
| Praxis Dr. Strzata | Kapellendorf | 99510 | Germany |
| Praxis Dr. Pitule | Ludwigshafen | 67061 | Germany |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C077793 | candesartan cilexetil |
| C437965 | olmesartan |
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