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The objective of this study is to compare the reduction in office seated systolic blood pressure (BP) following a 8 weeks regimen of ramipril 5mg plus felodipine 5mg versus ramipril 10mg.
To compare the response rate (defined as office systolic blood pressure (SBP) / Diastolic blood pressure (DBP) reduce more than 10mmHg from baseline), and BP controlled rate (defined as SBP<140mmHg and/or DBP<90mmHg) and as SBP < 130 mmHg and /or DBP < 80 mmHg in diabetes,chronic kidney disease, known Coronary Arterial Disease (CAD) or CAD equivalent, or 10-year Framingham risk score > 10%.
To ascertain the safety and tolerability of ramipril/felodipine versus ramipril in Taiwanese population.
To compare compliance with fixed dose combination of ramipril/felodipine versus ramipril treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril + Felodipine |
|
| 2 | Active Comparator | 2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril 10 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramipril + Felodipine | Drug | Ramipril 5mg + Felodipine 5mg once a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Seated SBP at office | After 8-week treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Seated DBP at office | After 4 and 8-week treatment | |
| Seated SBP at office | After 4-week treatment | |
| Response rate |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Fern Lim | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017257 | Ramipril |
| D015736 | Felodipine |
| ID | Term |
|---|---|
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004095 | Dihydropyridines |
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| Ramipril |
| Drug |
10 mg once a day |
|
| Ramipril | Drug | 5mg once a day |
|
| After 4 and 8-week treatment |
| BP controlled rate | After 4 and 8-week treatment |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |