China Medical University Hospital (CMUH) Triapin Listing
Study Details
Study Description
Brief 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.
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril + Felodipine |
Drug: Ramipril + Felodipine
Ramipril 5mg + Felodipine 5mg once a day
Drug: Ramipril
5mg once a day
|
| Active Comparator: 2 2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril 10 mg |
Drug: Ramipril
10 mg once a day
Drug: Ramipril
5mg once a day
|
Outcome Measures
Primary Outcome Measures
- Seated SBP at office [After 8-week treatment]
Secondary Outcome Measures
- Seated DBP at office [After 4 and 8-week treatment]
- Seated SBP at office [After 4-week treatment]
- Response rate [After 4 and 8-week treatment]
- BP controlled rate [After 4 and 8-week treatment]
Eligibility Criteria
Criteria
Inclusion criteria:
-
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
Exclusion criteria:
-
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
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis Administrative Office | Taipei | Taiwan |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Fern Lim, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RAMFE_L_03420