Status:
COMPLETED
China Medical University Hospital (CMUH) Triapin Listing
Lead Sponsor:
Sanofi
Conditions:
Hypertension
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00841880
Start Date
January 1 2009
End Date
September 1 2009
Last Update
August 27 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis Administrative Office
Taipei, Taiwan