Hypertension
Conditions
Brief summary
Primary: * To assess effectiveness of Ramipril-Felodipine in hypertensive Argentinean patients Secondary: * To assess tolerability of Ramipril-Felodipine in hypertensive Argentinean patients.
Interventions
DRUGRamipril-Felodipine
Ramipril + felodipine 2.5/2.5mg per tablet. One tablet to be taken Od for 8 weeks (this dose could be increased at week 2 to 4 to 5 mg daily because of uncontrolled hypertension).
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Outpatient * Patients who couldn´t control their hypertension after 6 weeks of treatment with monotherapy (calcium blockers, beta blockers, diuretics, ACE inhibitors, AT2 blockers)(uncontrolled hypertension).
Exclusion criteria
* Already on fixed-dose combination treatment for hypertension * Contraindication to angiotensin converting enzyme (ACE) inhibitors or CCB therapy * Known hypersensitivity to felodipine (or other dihydropyridines), ramipril, other ACE or any of the excipients of ramipril felodipine. * History of angioedema * Unstable haemodynamic conditions: cardiovascular shock, untreated heart failure, acute myocardial infarction, unstable angina pectoris, stroke. * Patients with AV block II or III * Severely impaired hepatic function. * Pre-existing bilateral renal artery stenosis or stenosis of the artery to a solitary kidney * Pregnant and lactating mothers * Patients on dialysis or haemofiltration. * Patients with creatinine clearance \< 20ml/min * Use of potassium sparing diuretics * Severe hypertension (SBP ≥ 180 mmhg or DBP ≥ 110 mmhg) 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 |
|---|---|
| Mean changes in Systolic Blood Pressure (SBP) | from baseline to Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Mean changes in Diastolic Blood Pressure (DBP) | from baseline to Week 8 |
| Percentage of responders with regard to DBP and SBP | comparison to baseline |
| Adverse events | After treatment and at each follow-up visit |
Countries
Argentina
Outcome results
None listed