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

Primary: - To assess effectiveness of Ramipril-Felodipine in hypertensive Argentinean patients

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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• Drug: Ramipril-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).

Primary Measures

• Mean changes in Systolic Blood Pressure (SBP)
  • Time Frame: from baseline to Week 8
    Safety Issue?: No

Secondary Measures

• Mean changes in Diastolic Blood Pressure (DBP)
  • Time Frame: from baseline to Week 8
    Safety Issue?: No
• Percentage of responders with regard to DBP and SBP
  • Time Frame: comparison to baseline
    Safety Issue?: No
• Adverse events
  • Time Frame: After treatment and at each follow-up visit
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Cristian von Schulz Hausmann, MD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00507845

Study ID Number: RAMIP_L_01961

ClinicalTrials.gov Identifier: NCT00507845

Health Authority: Argentina: Human Research Bioethics Committee