Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142584
Status:
COMPLETED
Last Update Posted:
2022-03-15
First Post:
2005-08-31
Brief Title:
Evaluation of the Long-term Safety and Tolerability of Metoprolol Versus Nebivolol in Patients With Hypertension
Sponsor:
Mylan Bertek Pharmaceuticals
Organization:
Mylan Bertek Pharmaceuticals
Study Overview
Official Title:
An Open-label Randomized Study Evaluating the Long-term Effects of Metoprolol MET Versus Nebivolol NEB as Monotherapy or in Combination With Amlodipine or Hydrochlorothiazide for the Treatment of Patients With Hypertension
Status:
COMPLETED
Status Verified Date:
2022-02
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 is to evaluate long-term safetytolerability and blood pressure effects of metoprolol versus nebivolol in patients with hypertension These drugs may be given alone or in combination with other drugs that are commonly used in the treatment of hypertension
Detailed Description:
Approximately 50 million Americans have hypertension defined as a systolic blood pressure SBP greater then or equal to 140 mmHg andor a diastolic blood pressure DBP greater then or equal to 90 mmHg To control blood pressure more than 2 agents are required in many patients The current study is a randomized titration-to-effect open-label multi center study Patients will be randomized to either nebivolol or metoprolol The dose of the randomized treatment can be titrated as needed to achieve blood pressure control If necessary additional antihypertensive agents calcium antagonist diuretic etc can be added to achieve control Patients will be seen every 1-3 months for approximately 18 months to assess long-term safety tolerability and effectiveness of nebivolol versus metoprolol
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