China Medical University Hospital (CMUH) Triapin Listing

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Open Label, Randomized, Comparative Study of Ramipril 5mg Plus Felodipine 5mg Combined Regimen and Ramipril 10mg in Uncontrolled Hypertensive Patients

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Ramipril + Felodipine
* Drug: Ramipril
* Drug: Ramipril


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril + Felodipine | Drug: Ramipril + Felodipine<br>* Ramipril 5mg + Felodipine 5mg once a day<br>Drug: Ramipril<br>* 5mg once a day<br>|
| Active Comparator: 2<br>2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril 10 mg | Drug: Ramipril<br>* 10 mg once a day<br>Drug: Ramipril<br>* 5mg once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seated SBP at office |  | After 8-week treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |