HypertensionPhase 4RAFEHELPNCT00507845
Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina
A Phase 4 study testing Ramipril-Felodipine in people with Hypertension, run by Sanofi at 1 site in Argentina.
Trial summary
Primary: To assess effectiveness of Ramipril-Felodipine in hypertensive Argentinean patients Secondary: To assess tolerability of Ramipril-Felodipine in hypertensive Argentinean patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Ramipril-Felodipine
- Type of treatment
- Pill or oral medicine
- How many people
- 271 participants
- Where
- 1 siteArgentina
- Study dates
- Jun 2007to Apr 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Primary:
- To assess effectiveness of Ramipril-Felodipine in hypertensive Argentinean patients
Secondary:
- To assess tolerability of Ramipril-Felodipine in hypertensive Argentinean patients.
- Conditions
- Hypertension
- Being tested
- Ramipril-Felodipine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramipril-FelodipineDrug
Also called Triacor
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean changes in Systolic Blood Pressure (SBP)
Measured: from baseline to Week 8
Secondary outcomes (3)
Mean changes in Diastolic Blood Pressure (DBP)
Measured: from baseline to Week 8
Percentage of responders with regard to DBP and SBP
Measured: comparison to baseline
Adverse events
Measured: After treatment and at each follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Cristian von Schulz Hausmann, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507845
- Sponsor's protocol ID
- RAMIP_L_01961
- Acronym
- RAFEHELP
- Status last verified
- Apr 2009
- First submitted
- 26 Jul 2007
- Last updated
- 17 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina
- ClinicalTrials.gov ID
- NCT00507845
- Acronym / sponsor ID
- RAFEHELP / RAMIP_L_01961
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Apr 2008 (actual)
- First posted
- 27 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary:
- To assess effectiveness of Ramipril-Felodipine in hypertensive Argentinean patients
Secondary:
- To assess tolerability of Ramipril-Felodipine in hypertensive Argentinean patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ramipril-FelodipineAlso: TriacorRamipril + 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). | Drug | – |
Primary outcome
Mean changes in Systolic Blood Pressure (SBP)
Time frame: from baseline to Week 8
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristian von Schulz Hausmann, MD study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ramipril-Felodipine in people with Hypertension, run by Sanofi at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean changes in Systolic Blood Pressure (SBP) (time frame: from baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2009.