NCT00507845

Brief Summary

Primary:

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
271

participants targeted

Target at P50-P75 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Last Updated

April 17, 2009

Status Verified

April 1, 2009

Enrollment Period

10 months

First QC Date

July 26, 2007

Last Update Submit

April 16, 2009

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean changes in Systolic Blood Pressure (SBP)

    from baseline to Week 8

Secondary Outcomes (3)

  • Mean changes in Diastolic Blood Pressure (DBP)

    from baseline to Week 8

  • Percentage of responders with regard to DBP and SBP

    comparison to baseline

  • Adverse events

    After treatment and at each follow-up visit

Interventions

Ramipril-FelodipineDRUG

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).

Also known as: Triacor

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-aventis administrative office

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Cristian von Schulz Hausmann, MD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 26, 2007

First Posted

July 27, 2007

Study Start

June 1, 2007

Primary Completion

April 1, 2008

Last Updated

April 17, 2009

Record last verified: 2009-04

Locations

AR(1)