Evaluation of the Long-term Safety and Tolerability of Metoprolol Versus Nebivolol in Patients With Hypertension

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Nebivolol (NEB); Drug: Metoprolol (MET)

• Registration Number: NCT00142584
• Lead Sponsor: Mylan Bertek Pharmaceuticals

Brief Summary

The purpose of this study is to evaluate long-term safety,tolerability 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 and/or 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 Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-08-31
• Study First Posted: 2005-09-02
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Results First Submitted: 2020-09-14
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-17
• Last Update Submitted: 2022-02-17
• Results First Posted: 2022-03-15
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

• Completion of previous nebivolol study
• Stage 1-2 Hypertension (HTN) at baseline of first study

Exclusion Criteria

• Recent myocardial infarction or stroke
• Contraindications to beta blocker therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1-NEB	Nebivolol (NEB)	Nebivolol
2-MET	Metoprolol (MET)	Metoprolol

Primary Outcome Measures

Name	Time	Method
Change in Average Sitting Diastolic Blood Pressure (DBP) Taken at Trough at the End of Treatment Compared to Baseline	Through study duration (approximately 18 months)	The primary efficacy parameter was the change in the average trough sitting DBP at the end of treatment (Visit 10 or Early Termination) compared with baseline (baseline was defined as the baseline visit in Study NEB 310 \[NCT00145210\]).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Trough Sitting Diastolic Blood Pressure (DBP) at Each Study Visit (Visits 1 Through 9) Compared to Baseline	Through study completion (approximately 18 months)	Data for the analysis of the change from baseline in mean trough sitting DBP at each study visit (Visits 1 through 9) compared with baseline (baseline was defined as the baseline visit in Study NEB 310 \[NCT00145210\]) by treatment group are provided below.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Through study completion (approximately 18 months)	Summary of Participants that experienced one or more TEAEs by Treatment Group-Safety Population

Trial Locations

Locations (1)

Mylan Pharmaceuticals Inc.; 🇺🇸 Morgantown, West Virginia, United States