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China Medical University Hospital (CMUH) Triapin Listing
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00841880
First received: February 10, 2009
Last updated: August 26, 2010
Last verified: August 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Hypertension | Drug: Ramipril + Felodipine Drug: Ramipril | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Seated SBP at office [ Time Frame: After 8-week treatment ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 49 |
| Study Start Date: | January 2009 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00841880
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841880
Locations
| Taiwan | |
| Sanofi-Aventis Administrative Office | |
| Taipei, Taiwan | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Fern Lim | Sanofi |
More Information
| Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00841880 History of Changes |
| Other Study ID Numbers: |
RAMFE_L_03420 |
| Study First Received: | February 10, 2009 |
| Last Updated: | August 26, 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 |
ClinicalTrials.gov processed this record on June 23, 2017