Evaluation of the Long-Term Safety and Tolerability of Metoprolol Versus Nebivolol in Patients With Hypertension | RxWiki

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

Overview[ - collapse ][ - ]

Purpose	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
Condition	Hypertension
Intervention	Drug: Nebivolol Drug: Metoprolol
Phase	Phase 3
Sponsor	Mylan Bertek Pharmaceuticals
Responsible Party	Mylan Bertek Pharmaceuticals
ClinicalTrials.gov Identifier	NCT00142584
First Received	August 31, 2005
Last Updated	March 6, 2008
Last verified	August 2005

Tracking Information[ + expand ][ + ]

First Received Date	August 31, 2005
Last Updated Date	March 6, 2008
Start Date	August 2005
Estimated Primary Completion Date	March 2008
Current Primary Outcome Measures	Change in average sitting DBP taken at trough at the end of treatment compared to baseline (baseline is defined as the baseline of the feeder study). [Time Frame: During study.] [Designated as safety issue: No]
Current Secondary Outcome Measures	SBP, pulse pressure and heart rate at peak and trough drug effects measured in the supine, sitting and standing positions. [Time Frame: During study.] [Designated as safety issue: No] Adverse events, ECGs, laboratory evaluations [Time Frame: During study.] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Evaluation of the Long-Term Safety and Tolerability of Metoprolol Versus Nebivolol in Patients With Hypertension
Official Title	An Open-Label, Randomized Study Evaluating the Long-Term Effects of Metoprolol Versus Nebivolol as Monotherapy or in Combination With Amlodipine or Hydrochlorothiazide for the Treatment of Patients With Hypertension
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 Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Hypertension
Intervention	Drug: Nebivolol Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks. Drug: Metoprolol Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks.
Study Arm (s)	Experimental: 1-NEB Nebivolol Active Comparator: 2-MET Metoprolol

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	1000
Estimated Completion Date	March 2008
Estimated Primary Completion Date	March 2008
Eligibility Criteria	Inclusion Criteria: - Completion of previous nebivolol study - Stage 1-2 HTN at baseline of first study Exclusion Criteria: - Recent myocardial infarction or stroke - Contraindications to beta blocker therapy
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00142584
Other Study ID Numbers	NEB324
Has Data Monitoring Committee	Not Provided
Information Provided By	Mylan Bertek Pharmaceuticals
Study Sponsor	Mylan Bertek Pharmaceuticals
Collaborators	Not Provided
Investigators	Study Director: Betty S Riggs, MD, MBA Mylan Pharmaceuticals
Verification Date	August 2005

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