Ignite Creation Date:
2024-05-05 @ 9:15 PM
Last Modification Date:
2024-10-26 @ 10:01 AM
Study NCT ID:
NCT00841880
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2009-02-10
Brief Title:
China Medical University Hospital CMUH Triapin Listing
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Prospective Open Label Randomized Comparative Study of Ramipril 5mg Plus Felodipine 5mg Combined Regimen and Ramipril 10mg in Uncontrolled Hypertensive Patients
Status:
COMPLETED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 SBP140mmHg andor DBP90mmHg and as SBP 130 mmHg and or DBP 80 mmHg in diabeteschronic kidney disease known Coronary Arterial Disease CAD or CAD equivalent or 10-year Framingham risk score 10
To ascertain the safety and tolerability of ramiprilfelodipine versus ramipril in Taiwanese population
To compare compliance with fixed dose combination of ramiprilfelodipine versus ramipril treatment
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 SBP140mmHg andor DBP90mmHg and as SBP 130 mmHg and or DBP 80 mmHg in diabeteschronic kidney disease known Coronary Arterial Disease CAD or CAD equivalent or 10-year Framingham risk score 10
To ascertain the safety and tolerability of ramiprilfelodipine versus ramipril in Taiwanese population
To compare compliance with fixed dose combination of ramiprilfelodipine versus ramipril treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None