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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 26, 2007

Last Updated Date

April 16, 2009

Start Date ^ICMJE

June 2007

Primary Completion Date

April 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

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

Enrollment ^ICMJE

271

Completion Date

Not Provided

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

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

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