Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina (RAFEHELP)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00507845 |
Recruitment Status :
Completed
First Posted : July 27, 2007
Last Update Posted : April 17, 2009
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Primary:
- To assess effectiveness of Ramipril-Felodipine in hypertensive Argentinean patients
Secondary:
- To assess tolerability of Ramipril-Felodipine in hypertensive Argentinean patients.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: Ramipril-Felodipine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 271 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina |
Study Start Date : | June 2007 |
Actual Primary Completion Date : | April 2008 |

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

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507845
Argentina | |
Sanofi-aventis administrative office | |
Buenos Aires, Argentina |
Study Director: | Cristian von Schulz Hausmann, MD | Sanofi |
Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
ClinicalTrials.gov Identifier: | NCT00507845 |
Other Study ID Numbers: |
RAMIP_L_01961 |
First Posted: | July 27, 2007 Key Record Dates |
Last Update Posted: | April 17, 2009 |
Last Verified: | April 2009 |
Hypertension Vascular Diseases Cardiovascular Diseases Felodipine Ramipril Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Anti-Arrhythmia Agents Calcium Channel Blockers Membrane Transport Modulators Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents |