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

Phase 4

Completed

• Conditions: Hypertension

• Registration Number: NCT00507845
• Lead Sponsor: Sanofi

Brief Summary

Primary:

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

Secondary:

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-07-26
• Study First Submitted QC: 2007-07-26
• Study First Posted: 2007-07-27
• Primary Completion: 2008-04
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-16
• Last Update Posted: 2009-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mean changes in Systolic Blood Pressure (SBP)	from baseline to Week 8

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sanofi-aventis administrative office; 🇦🇷 Buenos Aires, Argentina