Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Primary:

• To assess effectiveness of Ramipril-Felodipine in hypertensive Argentinean patients

Secondary:

• To assess tolerability of Ramipril-Felodipine in hypertensive Argentinean patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Felodipine; Ramipril

Criteria

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.