China Medical University Hospital (CMUH) Triapin Listing

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Felodipine; Ramipril

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.