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

April 16, 2009 updated by: Sanofi

Primary:

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

Secondary:

  • To assess tolerability of Ramipril-Felodipine in hypertensive Argentinean patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

271

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean changes in Systolic Blood Pressure (SBP)
Time Frame: from baseline to Week 8
from baseline to Week 8

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Cristian von Schulz Hausmann, MD, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

July 26, 2007

First Submitted That Met QC Criteria

July 26, 2007

First Posted (Estimate)

July 27, 2007

Study Record Updates

Last Update Posted (Estimate)

April 17, 2009

Last Update Submitted That Met QC Criteria

April 16, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAMIP_L_01961

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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