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

Hypertension Clinical Trial

— RAFEHELP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00507845
• Other study ID #: RAMIP_L_01961
• Status: Completed
• Phase: Phase 4
• First received: July 26, 2007
• Last updated: April 16, 2009
• Start date: June 2007

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics CommitteeArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

Primary:

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

Secondary:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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).

Locations

Country	Name	City	State
Argentina	Sanofi-aventis administrative office	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean changes in Systolic Blood Pressure (SBP)		from baseline to Week 8	No
Secondary	Mean changes in Diastolic Blood Pressure (DBP)		from baseline to Week 8	No
Secondary	Percentage of responders with regard to DBP and SBP		comparison to baseline	No
Secondary	Adverse events		After treatment and at each follow-up visit	Yes