Ignite Creation Date:
2024-05-06 @ 3:02 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02182830
Status:
COMPLETED
Last Update Posted:
2018-07-31
First Post:
2014-07-03
Brief Title:
24 Week Efficacy and Safety Study of Empagliflozin BI 10773 in Hypertensive BlackAfrican American Patients With Type 2 Diabetes Mellitus and Hypertension
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Parallel Group Efficacy and Safety Study of Empagliflozin 10mg 25mg Administered Orally Once Daily Over 24 Weeks in Hypertensive BlackAfrican American Patients With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2018-06
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:
This trial is designed to investigate the efficacy and safety of empagliflozin compared with placebo in hypertensive blackAfrican Americans with type 2 Diabetes Mellitus Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications assessment of both glucose and BP lowering effects of empagliflozin in hypertensive African American patients with type 2 Diabetes Mellitus could provide clinically highly relevant new information for the use of empagliflozin
Essential hypertension is four times more common in African Americans than in Caucasians
One of the risk factors for hypertension is sodium sensitivity and approximately one third of the essential hypertensive population is responsive to sodium intake There is a higher association of hypertension with sodium sensitivity in African American patients with type 2 Diabetes Mellitus
The treatment duration of this trial 24 weeks will enable assessment of the clinically relevant endpoint of a decrease in HbA1c a well accepted measurement of chronic glycaemic control and the key secondary endpoints of decreases in systolic BP SBP and diastolic BP DBP at 12 and 24 weeks
Essential hypertension is four times more common in African Americans than in Caucasians
One of the risk factors for hypertension is sodium sensitivity and approximately one third of the essential hypertensive population is responsive to sodium intake There is a higher association of hypertension with sodium sensitivity in African American patients with type 2 Diabetes Mellitus
The treatment duration of this trial 24 weeks will enable assessment of the clinically relevant endpoint of a decrease in HbA1c a well accepted measurement of chronic glycaemic control and the key secondary endpoints of decreases in systolic BP SBP and diastolic BP DBP at 12 and 24 weeks
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