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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Ramipril-Felodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00507845

RAMIP_L_01961

Details and patient eligibility

About

Primary:

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

Secondary:

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

Enrollment: 271 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)