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

Tracking Information
First Submitted Date ICMJE	July 26, 2007
First Posted Date ICMJE	July 27, 2007
Last Update Posted Date	April 17, 2009
Study Start Date ICMJE	June 2007
Actual Primary Completion Date	April 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 26, 2007)	Mean changes in Systolic Blood Pressure (SBP) [ Time Frame: from baseline to Week 8 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00507845 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 22, 2008)	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 ]
Original Secondary Outcome Measures ICMJE; (submitted: July 26, 2007)	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 ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina
Official Title ICMJE	Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina
Brief Summary	Primary: To assess effectiveness of Ramipril-Felodipine in hypertensive Argentinean patients Secondary: To assess tolerability of Ramipril-Felodipine in hypertensive Argentinean patients.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Hypertension
Intervention ICMJE	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
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 27, 2008)	271
Original Estimated Enrollment ICMJE; (submitted: July 26, 2007)	369
Study Completion Date	Not Provided
Actual Primary Completion Date	April 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	21 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Argentina
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00507845
Other Study ID Numbers ICMJE	RAMIP_L_01961
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Medical Affairs Study Director, sanofi-aventis
Study Sponsor ICMJE	Sanofi
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Cristian von Schulz Hausmann, MD Sanofi
PRS Account	Sanofi
Verification Date	April 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP