Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Other | Candesartan 16 mg tablets p. o. once daily for 14 days, 32 mg tablets once daily for 28 days, then olmesartan 40 mg tablets once daily for 42 days, then olmesartan/amlodipine 40/5 mg tablets once daily for 14 days, then olmesartan/amlodipine 40/10 mg tablets once daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan cilexetil | Drug | Candesartan 16 mg tablets p. o. once daily for 14 days, 32 mg tablets once daily for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | ABPM will be performed after 6 weeks treatment with each of the different therapy regimes. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | after 6 and 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephan Lüders, Dr.med. | St.-Josefs-Hospital Cloppenburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis Dr. Reimer | Anderbeck | 38836 | Germany | |||
| Praxis Dr. Heinz |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Olmesartan medoxomil | Drug | Switch to olmesartan 40 mg tablets once daily for 42 days, |
|
|
| Olmesartan/amlodipine | Drug | 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 |
|
|
| Bergisch Gladbach |
| 51429 |
| Germany |
| Praxis Dr. Zemmrich | Berlin | 12043 | Germany |
| St.-Josefs-Hospital | Cloppenburg | 49661 | Germany |
| Praxis Dr. Pohl | Dresden | 01129 | Germany |
| Praxis Dr. Koßler-Wiesweg | Essen | 45138 | Germany |
| Praxis Dr. Rövenich | Frankfurt | 65929 | Germany |
| Praxis Dr. Strzata | Kapellendorf | 99510 | Germany |
| Praxis Dr. Paschmionka | Leipzig | 04316 | Germany |
| Praxis Dr. Pitule | Ludwigshafen | 67061 | Germany |
| Praxis Dr. Loddo | Rastede | 26180 | Germany |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C077793 | candesartan cilexetil |
| D000068557 | Olmesartan Medoxomil |
| C437965 | olmesartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
Not provided
Not provided