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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00507845

First Posted: July 27, 2007

Last Update Posted: April 17, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Sanofi

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 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

Resource links provided by NLM:

Drug Information available for: Felodipine Ramipril

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 ]

Secondary Outcome Measures:

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 ]


Enrollment:	271
Study Start Date:	June 2007
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

Information from the National Library of Medicine

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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

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


Responsible Party:	Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00507845 History of Changes
Other Study ID Numbers:	RAMIP_L_01961
First Submitted:	July 26, 2007
First Posted:	July 27, 2007
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

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