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NCT Number: NCT00142584

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mylan Pharmaceuticals Inc.

Morgantown, West Virginia, 26505, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nebivolol (NEB)

Drug

Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks.

Metoprolol (MET)

Drug

Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks.

Primary outcomes

  1. Change in Average Sitting Diastolic Blood Pressure (DBP) Taken at Trough at the End of Treatment Compared to Baseline

    Time frame: 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 outcomes

  1. Change From Baseline in Mean Trough Sitting Diastolic Blood Pressure (DBP) at Each Study Visit (Visits 1 Through 9) Compared to Baseline

    Time frame: 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.

  2. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Through study completion (approximately 18 months)

    Summary of Participants that experienced one or more TEAEs by Treatment Group-Safety Population

Sponsors and collaborators

Lead sponsor

Mylan Bertek Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 2, 2005
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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