Skip to main content
OpenTrials
Completed

NCT Number: NCT00507845

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

Primary:

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

Secondary:

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-aventis administrative office

Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ramipril-Felodipine

Drug

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 names: Triacor

Primary outcomes

  1. Mean changes in Systolic Blood Pressure (SBP)

    Time frame: from baseline to Week 8

Secondary outcomes

  1. Mean changes in Diastolic Blood Pressure (DBP)

    Time frame: from baseline to Week 8

  2. Percentage of responders with regard to DBP and SBP

    Time frame: comparison to baseline

  3. Adverse events

    Time frame: After treatment and at each follow-up visit

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Acronym: RAFEHELP

Important dates

Study start
2007
Primary completion
2008
First posted
Jul 27, 2007
Registry last updated
Apr 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.