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Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina (RAFEHELP)
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00507845
First received: July 26, 2007
Last updated: April 16, 2009
Last verified: April 2009
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Purpose
Primary:
- To assess effectiveness of Ramipril-Felodipine in hypertensive Argentinean patients
Secondary:
- To assess tolerability of Ramipril-Felodipine in hypertensive Argentinean patients.
| Condition | Intervention | Phase |
|---|---|---|
| Hypertension | Drug: Ramipril-Felodipine | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Mean changes in Systolic Blood Pressure (SBP) [ Time Frame: from baseline to Week 8 ]
Secondary Outcome 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 ]
| Enrollment: | 271 |
| Study Start Date: | June 2007 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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).
Other Name: Triacor
Eligibility| Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00507845
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507845
Locations
| Argentina | |
| Sanofi-aventis administrative office | |
| Buenos Aires, Argentina | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Cristian von Schulz Hausmann, MD | Sanofi |
More Information
| Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00507845 History of Changes |
| Other Study ID Numbers: |
RAMIP_L_01961 |
| Study First Received: | July 26, 2007 |
| Last Updated: | April 16, 2009 |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Ramipril Felodipine Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Anti-Arrhythmia Agents Calcium Channel Blockers Membrane Transport Modulators Vasodilator Agents |
ClinicalTrials.gov processed this record on June 23, 2017