Ignite Creation Date:
2024-05-05 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00547300
Status:
TERMINATED
Last Update Posted:
2019-05-21
First Post:
2007-10-19
Brief Title:
Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-release ER for Hypertension
Sponsor:
Forest Laboratories
Organization:
Forest Laboratories
Study Overview
Official Title:
Tolerability of Nebivolol Compared With Metoprolol ER in Patients With Mild to Moderate Hypertension Taking Hydrochlorothiazide HCTZ
Status:
TERMINATED
Status Verified Date:
2019-04
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 purpose of this study was to compare the tolerability of nebivolol to metoprolol ER in a general population of patients with mild to moderate hypertension receiving hydrochlorothiazide HCTZ
Detailed Description:
This study was an 18-week study to evaluate the tolerability of nebivolol compared to metoprolol ER in outpatients with mild to moderate hypertension taking HCTZ It is a multi-center randomized double blind DB active-control parallel-group study starting with a 4-week HCTZ run-in phase followed by a 12-week DB treatment phase Patients meeting the entry criteria at the end of run-in are randomized to one of two treatment groups nebivolol or metoprolol ER Up-titration of dose of study drug will occur if needed during the first 4 weeks of the DB phase after which there is an 8-week stable-dose period of treatment A 2-week double-blind withdrawal phase follows during which tapering off study drug occurs
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