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 Endpoint Classification: Safety/Efficacy Study 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Seated DBP at office [ Time Frame: After 4 and 8-week treatment ] [ Designated as safety issue: No ]
- Seated SBP at office [ Time Frame: After 4-week treatment ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: After 4 and 8-week treatment ] [ Designated as safety issue: No ]
- BP controlled rate [ Time Frame: After 4 and 8-week treatment ] [ Designated as safety issue: No ]
| 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 |
| Genders Eligible for Study: | Both |
| 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.
For general information, see Learn About Clinical Studies.
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
No publications provided
| 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 |
| Health Authority: | Taiwan: Department of Health |
Additional relevant MeSH terms:
|
Felodipine Ramipril Angiotensin-Converting Enzyme Inhibitors Anti-Arrhythmia Agents Antihypertensive Agents Calcium Channel Blockers Cardiovascular Agents |
Enzyme Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protease Inhibitors Therapeutic Uses Vasodilator Agents |
ClinicalTrials.gov processed this record on March 03, 2015