Evaluation of the Long-Term Safety and Tolerability of Metoprolol Versus Nebivolol in Patients With Hypertension
Information source: Mylan Bertek Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
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
Ending date: March 2008
Last updated: March 6, 2008
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