Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Ramipril-Felodipine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Cristian von Schulz Hausmann, MD, Study Director, Affiliation: Sanofi-Aventis
Summary
Primary:
- To assess effectiveness of Ramipril-Felodipine in hypertensive Argentinean patients
Secondary:
- To assess tolerability of Ramipril-Felodipine in hypertensive Argentinean patients.
Clinical Details
Official title: Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Mean changes in Systolic Blood Pressure (SBP)
Secondary outcome: Mean changes in Diastolic Blood Pressure (DBP)Percentage of responders with regard to DBP and SBP Adverse events
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Sanofi-aventis administrative office, Buenos Aires, Argentina
Additional Information
Starting date: June 2007
Last updated: May 27, 2008
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