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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:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00507845
First received: July 26, 2007
Last updated: April 16, 2009
Last verified: April 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Mean changes in Systolic Blood Pressure (SBP) [ Time Frame: from baseline to Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean changes in Diastolic Blood Pressure (DBP) [ Time Frame: from baseline to Week 8 ] [ Designated as safety issue: No ]
  • Percentage of responders with regard to DBP and SBP [ Time Frame: comparison to baseline ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: After treatment and at each follow-up visit ] [ Designated as safety issue: Yes ]
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)
Genders Eligible for Study:   Both
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.

  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 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
Health Authority: Argentina: Human Research Bioethics Committee
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

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 September 29, 2016