This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: July 26, 2007
Last updated: April 16, 2009
Last verified: April 2009


  • To assess effectiveness of Ramipril-Felodipine in hypertensive Argentinean patients


  • 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: 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

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

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00507845

Sanofi-aventis administrative office
Buenos Aires, Argentina
Sponsors and Collaborators
Study Director: Cristian von Schulz Hausmann, MD Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis 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:
Vascular Diseases
Cardiovascular Diseases
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 processed this record on September 21, 2017