Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200434
Status:
COMPLETED
Last Update Posted:
2005-09-20
First Post:
2005-09-12
Brief Title:
A Study of the Efficacy and Safety of Nebivolol Added to Existing Antihypertensive Treatment in Patients With Hypertension
Sponsor:
Mylan Bertek Pharmaceuticals
Organization:
Mylan Bertek Pharmaceuticals
Study Overview
Official Title:
A Double-Blind Multi-Center Randomized Placebo-Controlled Parallel Group Study of the Efficacy and Safety of Nebivolol Added to Existing Antihypertensive Treatment in Patients With Mild to Moderate 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 was to contrast the efficacy and safety of 3 dose levels of nebivolol vs placebo when added to a patients existing antihypertensive medications for 3 months in patients with mild to moderate hypertension
Detailed Description:
Following a washout of any previous beta-blocker medication if applicable supine sitting and standing cuff blood pressure and pulse rate 24-hour ambulatory blood pressure monitoring ABPM ECG laboratory assessments and genomics testing were performed before randomization Patients were randomized to receive placebo or nebivolol once daily in the morning together with their curently prescribed antihypertensive therapy Patients had four scheduled clinical visits during the study following the screening visit
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