Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina - Full Text View

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

This study has been completed.

First Received: July 26, 2007 Last Updated: April 16, 2009 History of Changes

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00507845

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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Felodipine Ramipril

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Mean changes in Systolic Blood Pressure (SBP) [ Time Frame: from baseline to Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

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).

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507845

Locations

Argentina
Sanofi-aventis administrative office
Buenos Aires, Argentina

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Cristian von Schulz Hausmann, MD

Sanofi-Aventis

More Information

Additional Information:

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	RAMIP_L_01961
Study First Received:	July 26, 2007
Last Updated:	April 16, 2009
ClinicalTrials.gov Identifier:	NCT00507845 History of Changes
Health Authority:	Argentina: Human Research Bioethics Committee; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Ramipril
Pharmacologic Actions

Protease Inhibitors
Membrane Transport Modulators
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Anti-Arrhythmia Agents
Felodipine
Hypertension

ClinicalTrials.gov processed this record on November 20, 2009