Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158093
Status:
COMPLETED
Last Update Posted:
2005-09-12
First Post:
2005-09-07
Brief Title:
A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol Atenolol Moxifloxacin or Placebo
Sponsor:
Mylan Bertek Pharmaceuticals
Organization:
Mylan Bertek Pharmaceuticals
Study Overview
Official Title:
A Randomized Parallel Group Safety Evaluation of Electrocardiographic Intervals and Blood Pressure in Normal Healthy Volunteers After Nebivolol Atenolol Moxifloxacin or Placebo Administration After Single and Repeated Doses
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 2 hours after dosing on Day 7
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None