Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145210
Status:
COMPLETED
Last Update Posted:
2008-03-07
First Post:
2005-09-01
Brief Title:
Safety and Efficacy of Nebivolol in the Treatment of Hypertension in African Americans
Sponsor:
Mylan Bertek Pharmaceuticals
Organization:
Mylan Bertek Pharmaceuticals
Study Overview
Official Title:
A Double-Blind Randomized Placebo- and Active-Controlled Forced Titration Study Evaluating the Effects of Nebivolol on Blood Pressure and Heart Rate in African American Patients With Hypertension
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effects of nebivolol on blood pressure and heart rate in African American patients with hypertension
Detailed Description:
Despite the established benefits of beta-blockers their use is limited by their side effect profile and by a perception of reduced efficacy in certain populations such as African Americans Amudha 2003 This is a double-blind randomized placebo and active-controlled multi-center parallel group forced titration study Patients will be stratified across all treatment arms by age gender and diabetes status history of diabetes mellitus vs no history of diabetes mellitus The study consists of 3 periods screening run-in double-blind randomized forced titration and double-blind washout period only for patients who complete the double-blind forced titration period and who are not participating in the long-term follow-up study After a 14-28 day single-blind placebo controlled run-in period which includes washout if applicable eligible patients will be randomized to one of 3 treatment regimens for approximately 12 weeks
This study will test the safety and efficacy of Nebivolol in the treatment of African American patients with hypertension
This study will test the safety and efficacy of Nebivolol in the treatment of African American patients with hypertension
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