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

Information source: Mylan Bertek Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Nebivolol (Drug); Metoprolol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Mylan Bertek Pharmaceuticals

Official(s) and/or principal investigator(s):
Betty S Riggs, MD, MBA, Study Director, Affiliation: Mylan Pharmaceuticals

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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).

Secondary outcome:

SBP, pulse pressure and heart rate at peak and trough drug effects measured in the supine, sitting and standing positions.

Adverse events, ECGs, laboratory evaluations

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Mylan Pharmaceuticals Inc., Morgantown, West Virginia 26505, United States
Additional Information

Starting date: August 2005
Last updated: March 6, 2008

Page last updated: August 23, 2015

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