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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

July 26, 2007
April 16, 2009
June 2007
April 2008   (final data collection date for primary outcome measure)
Mean changes in Systolic Blood Pressure (SBP) [ Time Frame: from baseline to Week 8 ] [ Designated as safety issue: No ]
Mean changes in Systolic Blood Pressure (SBP) [ Time Frame: from baseline to Week 8 ]
Complete list of historical versions of study NCT00507845 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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, clinical examinations, rate of discontinuation [ Time Frame: After treatment and at each follow-up visit ]
Not Provided
Not Provided
 
Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina
Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina

Primary:

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

Secondary:

  • To assess tolerability of Ramipril-Felodipine in hypertensive Argentinean patients.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
271
Not Provided
April 2008   (final data collection date for primary outcome measure)

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.

Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT00507845
RAMIP_L_01961
Not Provided
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Cristian von Schulz Hausmann, MD Sanofi
Sanofi
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP