A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo

• Status: Completed
• Trial end date: 2003-07-01

Summary

Nebivolol is one of a class of drugs known as beta-blockers. These drugs are useful in the treatment of high blood pressure, angina, abnormal heart rhythms and following a heart attack. The purpose of this study is to explore the potential of nebivolol to cause a certain type of abnormal heart rhythm, known as QTc prolongation. The potential of nebivolol to cause this adverse event will be compared to three other drugs: atenolol, a beta-blocker approved by the FDA; Avelox (moxifloxacin), an anti-biotic approved for use by the FDA which is known to cause QTc prolongation; and placebo, a drug look-alike that contains no drug. The working hypothesis was that 20 or 40 mg of nebivolol would not prolong corrected QT intervals measured during peak nebivolol concentrations (i.e., 2 hours after dosing) on Day 7.

• Phase: Phase 1

Details

• Lead Sponsor: Mylan Bertek Pharmaceuticals
• Treatments: Atenolol; Fluoroquinolones; Moxifloxacin; Nebivolol; Norgestimate, ethinyl estradiol drug combination