Hypertension
Conditions
Brief summary
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.
Interventions
DRUGRamipril + Felodipine
Ramipril 5mg + Felodipine 5mg once a day
DRUGRamipril
10 mg once a day
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Uncontrolled essential hypertension defined by office SBP/DBP \> 140/90 or \> 130/80 mmHg for compelling indications (diabetes mellitus, chronic kidney disease, known CAD or CAD equivalent or 10-year Framingham risk score \> 10%) * Previously untreated, or previously treated with a single antihypertensive therapy at usual dose during the last 4 weeks
Exclusion criteria
* Female who are pregnant or breast feeding * Office DBP\> 110mmHg or office SBP \>180mmHg * Hypersensitivity to ramipril, felodipine or to any of the excipients * Bilateral stenosis of the renal arteries, or unilateral stenosis in the single kidney * History of intolerance to any ACE inhibitor * History of significant renal diseases including: serum creatinine \>3.0 mg/dl, or creatinine clearance \<30 ml/min * History of hereditary and/or idiopathic angioedema; or angioedema associated with previous ACEI * Significant cardiovascular diseases, multiple drug allergies, bronchospastic disease or other malignancies requiring current medication * Hepatic disease as indicated by any of the following: Serum Glutamooxaloacetate Transferase (SGOT) or Serum Glutamopyruvate Transferase (SGPT)\>3 x upper limit of normal, or serum bilirubin \> 2 x upper limit of normal * Any other condition or therapy that, in the investigator's opinion, or as indicated in the product(s) label may pose a risk to the patient or interfere with the study objective. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seated SBP at office | After 8-week treatment |
Secondary
| Measure | Time frame |
|---|---|
| Seated DBP at office | After 4 and 8-week treatment |
| Seated SBP at office | After 4-week treatment |
| Response rate | After 4 and 8-week treatment |
| BP controlled rate | After 4 and 8-week treatment |
Countries
Taiwan
Outcome results
None listed