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

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ClinicalTrials.gov Identifier: NCT00507845
Recruitment Status : Completed
First Posted : July 27, 2007
Last Update Posted : April 17, 2009
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief Summary:

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 Design
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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

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U.S. FDA Resources

Arms and Interventions
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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

Outcome Measures
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Primary Outcome Measures :
  1. Mean changes in Systolic Blood Pressure (SBP) [ Time Frame: from baseline to Week 8 ]

Secondary Outcome Measures :
  1. Mean changes in Diastolic Blood Pressure (DBP) [ Time Frame: from baseline to Week 8 ]
  2. Percentage of responders with regard to DBP and SBP [ Time Frame: comparison to baseline ]
  3. Adverse events [ Time Frame: After treatment and at each follow-up visit ]

Eligibility Criteria
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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.

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
Argentina
Sanofi-aventis administrative office
Buenos Aires, Argentina
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Cristian von Schulz Hausmann, MD Sanofi
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00507845     History of Changes
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

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