China Medical University Hospital (CMUH) Triapin Listing
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ClinicalTrials.gov Identifier: NCT00841880 |
Recruitment Status
:
Completed
First Posted
: February 11, 2009
Last Update Posted
: August 27, 2010
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: Ramipril + Felodipine Drug: Ramipril | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 49 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Open Label, Randomized, Comparative Study of Ramipril 5mg Plus Felodipine 5mg Combined Regimen and Ramipril 10mg in Uncontrolled Hypertensive Patients |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | September 2009 |
Actual Study Completion Date : | September 2009 |
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
|
- Seated SBP at office [ Time Frame: After 8-week treatment ]
- Seated DBP at office [ Time Frame: After 4 and 8-week treatment ]
- Seated SBP at office [ Time Frame: After 4-week treatment ]
- Response rate [ Time Frame: After 4 and 8-week treatment ]
- BP controlled rate [ Time Frame: After 4 and 8-week treatment ]

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Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00841880
Taiwan | |
Sanofi-Aventis Administrative Office | |
Taipei, Taiwan |
Study Director: | Fern Lim | Sanofi |
Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
ClinicalTrials.gov Identifier: | NCT00841880 History of Changes |
Other Study ID Numbers: |
RAMFE_L_03420 |
First Posted: | February 11, 2009 Key Record Dates |
Last Update Posted: | August 27, 2010 |
Last Verified: | August 2010 |
Additional relevant MeSH terms:
Ramipril Felodipine Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Antihypertensive Agents Anti-Arrhythmia Agents Calcium Channel Blockers Membrane Transport Modulators Vasodilator Agents |