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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2008

Interventions

  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • Mean changes in Systolic Blood Pressure (SBP)
    • Time Frame: from baseline to Week 8

Secondary Measures

  • Mean changes in Diastolic Blood Pressure (DBP)
    • Time Frame: from baseline to Week 8
  • Percentage of responders with regard to DBP and SBP
    • Time Frame: comparison to baseline
  • Adverse events
    • Time Frame: After treatment and at each follow-up visit

Participating in This Clinical Trial

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: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Provider of Information About this Clinical Study
    • Medical Affairs Study Director, sanofi-aventis
  • Overall Official(s)
    • Cristian von Schulz Hausmann, MD, Study Director, Sanofi

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