China Medical University Hospital (CMUH) Triapin Listing
NCT ID: NCT00841880
Last Updated: 2010-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
49 participants
INTERVENTIONAL
2009-01-31
2009-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril + Felodipine
Ramipril + Felodipine
Ramipril 5mg + Felodipine 5mg once a day
Ramipril
5mg once a day
2
2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril 10 mg
Ramipril
10 mg once a day
Ramipril
5mg once a day
Interventions
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Ramipril + Felodipine
Ramipril 5mg + Felodipine 5mg once a day
Ramipril
10 mg once a day
Ramipril
5mg once a day
Eligibility Criteria
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Inclusion Criteria
* Previously untreated, or previously treated with a single antihypertensive therapy at usual dose during the last 4 weeks
Exclusion Criteria
* 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.
20 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Fern Lim
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Taipei, , Taiwan
Countries
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Other Identifiers
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RAMFE_L_03420
Identifier Type: -
Identifier Source: org_study_id
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