Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200499
Status:
COMPLETED
Last Update Posted:
2005-12-16
First Post:
2005-09-13
Brief Title:
A Study of the Safety and Efficacy of Long-Term Nebivolol Use in Hypertensive Patients
Sponsor:
Mylan Bertek Pharmaceuticals
Organization:
Mylan Bertek Pharmaceuticals
Study Overview
Official Title:
A Multi-Center Parallel Group Extension Study to Determine the Safety and Efficacy of Long-Term Nebivolol Exposure 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 study was conducted to determine the long-term safety and efficacy of nebivolol in patients with mild to moderate hypertension This was an extension of the Phase III dose ranging studies NEB 202 302 and 305 Nebivolol was studied as monotherapy and in conjunction with add-on antihypertensive therapy
Detailed Description:
This was an international multicenter parallel group 9-month extension study with a 4-week follow-up phase to evaluate the long-term safety and efficacy of nebivolol administered orally once daily in patients with mild to moderate hypertension defined as an average sitting diastolic blood pressure greater then or equal to 95 mmHg and less then or equal to 109 mmHg when untreated based on entry into NEB 202 NEB 302 or NEB 305 Patients were permitted protocol-defined concomitant use of diuretic or calcium antagonist After successful completion of one of the 3-month efficacy feeder studies patients were eligible to continue nebivolol treatment in this 9-month extension study Patients who completed the extension phase and received only nebivolol monotherapy during the extension phase were eligible to enter the 1-month follow-up phase
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