HypertensionPhase 4NCT00841880
China Medical University Hospital (CMUH) Triapin Listing
A Phase 4 study testing Ramipril + Felodipine and Ramipril in people with Hypertension, run by Sanofi at 1 site in Taiwan.
Trial summary
The objective of this study is to compare the reduction in office seated systolic blood pressure (BP) following a 8 weeks regimen of ramipril 5mg plus felodipine 5mg versus ramipril 10mg. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Ramipril + Felodipine and Ramipril
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2009to Sep 2009
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uncontrolled essential hypertension defined by office SBP/DBP > 140/90 or > 130/80 mmHg for compelling indications (diabetes mellitus, chronic kidney disease, known CAD or CAD equivalent or 10-year Framingham risk score > 10%)
- Previously untreated, or previously treated with a single antihypertensive therapy at usual dose during the last 4 weeks
Who cannot join
- Female who are pregnant or breast feeding
- Office DBP> 110mmHg or office SBP >180mmHg
- Hypersensitivity to ramipril, felodipine or to any of the excipients
- Bilateral stenosis of the renal arteries, or unilateral stenosis in the single kidney
- History of intolerance to any ACE inhibitor
- History of significant renal diseases including: serum creatinine >3.0 mg/dl, or creatinine clearance <30 ml/min
Show all 11Show fewer
- History of hereditary and/or idiopathic angioedema; or angioedema associated with previous ACEI
- Significant cardiovascular diseases, multiple drug allergies, bronchospastic disease or other malignancies requiring current medication
- Hepatic disease as indicated by any of the following: Serum Glutamooxaloacetate Transferase (SGOT) or Serum Glutamopyruvate Transferase (SGPT)>3 x upper limit of normal, or serum bilirubin > 2 x upper limit of normal
- Any other condition or therapy that, in the investigator's opinion, or as indicated in the product(s) label may pose a risk to the patient or interfere with the study objective.
- 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
Official title: A Prospective, Open Label, Randomized, Comparative Study of Ramipril 5mg Plus Felodipine 5mg Combined Regimen and Ramipril 10mg in Uncontrolled Hypertensive Patients
The objective of this study is to compare the reduction in office seated systolic blood pressure (BP) following a 8 weeks regimen of ramipril 5mg plus felodipine 5mg versus ramipril 10mg.
To compare the response rate (defined as office systolic blood pressure (SBP) / Diastolic blood pressure (DBP) reduce more than 10mmHg from baseline), and BP controlled rate (defined as SBP<140mmHg and/or DBP<90mmHg) and as SBP < 130 mmHg and /or DBP < 80 mmHg in diabetes,chronic kidney disease, known Coronary Arterial Disease (CAD) or CAD equivalent, or 10-year Framingham risk score > 10%.
Read more
To ascertain the safety and tolerability of ramipril/felodipine versus ramipril in Taiwanese population.
To compare compliance with fixed dose combination of ramipril/felodipine versus ramipril treatment.
- Conditions
- Hypertension
- Being tested
- Ramipril + Felodipine, Ramipril
- 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
Ramipril 5mg + Felodipine 5mg once a day
RamiprilDrug
10 mg once a day
RamiprilDrug
5mg once a day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril + Felodipine Receives: Drug: Ramipril + Felodipine; Drug: Ramipril |
| 2 | Active comparator | 2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril 10 mg Receives: Drug: Ramipril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seated SBP at office
Measured: After 8-week treatment
Secondary outcomes (4)
Seated DBP at office
Measured: After 4 and 8-week treatment
Seated SBP at office
Measured: After 4-week treatment
Response rate
Measured: After 4 and 8-week treatment
BP controlled rate
Measured: After 4 and 8-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2009
- Study completionSep 2009
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Fern Lim, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841880
- Sponsor's protocol ID
- RAMFE_L_03420
- Status last verified
- Aug 2010
- First submitted
- 10 Feb 2009
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Randomized, Comparative Study of Ramipril 5mg Plus Felodipine 5mg Combined Regimen and Ramipril 10mg in Uncontrolled Hypertensive Patients
- ClinicalTrials.gov ID
- NCT00841880
- Acronym / sponsor ID
- RAMFE_L_03420
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 11 Feb 2009 (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.
The objective of this study is to compare the reduction in office seated systolic blood pressure (BP) following a 8 weeks regimen of ramipril 5mg plus felodipine 5mg versus ramipril 10mg.
To compare the response rate (defined as office systolic blood pressure (SBP) / Diastolic blood pressure (DBP) reduce more than 10mmHg from baseline), and BP controlled rate (defined as SBP<140mmHg and/or DBP<90mmHg) and as SBP < 130 mmHg and /or DBP < 80 mmHg in diabetes,chronic kidney disease, known Coronary Arterial Disease (CAD) or CAD equivalent, or 10-year Framingham risk score > 10%.
To ascertain the safety and tolerability of ramipril/felodipine versus ramipril in Taiwanese population.
To compare compliance with fixed dose combination of ramipril/felodipine versus ramipril treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ramipril + Felodipine, Drug: Ramipril2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril + Felodipine |
| 2 | Active comparator | Drug: Ramipril2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril 10 mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Uncontrolled essential hypertension defined by office SBP/DBP > 140/90 or > 130/80 mmHg for compelling indications (diabetes mellitus, chronic kidney disease, known CAD or CAD equivalent or 10-year Framingham risk score > 10%)
- Previously untreated, or previously treated with a single antihypertensive therapy at usual dose during the last 4 weeks
Key exclusion criteria (11 listed)
- Female who are pregnant or breast feeding
- Office DBP> 110mmHg or office SBP >180mmHg
- Hypersensitivity to ramipril, felodipine or to any of the excipients
- Bilateral stenosis of the renal arteries, or unilateral stenosis in the single kidney
- History of intolerance to any ACE inhibitor
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 + FelodipineRamipril 5mg + Felodipine 5mg once a day | Drug | 1 |
| Ramipril10 mg once a day | Drug | 2 |
| Ramipril5mg once a day | Drug | 1, 2 |
Primary outcome
Seated SBP at office
Time frame: After 8-week treatment
4 secondary outcomes
Seated DBP at office
Time frame: After 4 and 8-week treatment
Seated SBP at office
Time frame: After 4-week treatment
Response rate
Time frame: After 4 and 8-week treatment
BP controlled rate
Time frame: After 4 and 8-week treatment
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 27 Aug 2010.
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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.
Fern Lim 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 and Ramipril in people with Hypertension, run by Sanofi at 1 site in Taiwan.
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 11 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 27 Aug 2010. 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 Taiwan. 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?
Seated SBP at office (time frame: After 8-week treatment). 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 27 Aug 2010.