Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00158093 · ClinicalTrials.gov registry record · Phase 1
A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo
A Phase 1 study, sponsored by Mylan Bertek Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 260
- Enrollment target
NCT00158093: Completed Phase 1 study, sponsored by Mylan Bertek Pharmaceuticals.
NCT00158093 is a Phase 1 study that has completed, run by Mylan Bertek Pharmaceuticals. The registered enrollment target is 260 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (333% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00158093, a Phase 1 study, has completed, sponsored by Mylan Bertek Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 260 participants
- Enrollment target
Study 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.
Interventions
- DRUG Atenolol
- DRUG Moxifloxacin
- DRUG Nebivolol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2003-06 |
| Est. Completion | 2003-07 |
| Phase | Phase 1 |
What the finished NCT00158093 record still lists
NCT00158093 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (333% higher).
The record links to 0 conditions, and to 3 interventions - of which Atenolol is the first listed.
NCT00158093 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00158093 about?
NCT00158093 is a clinical study titled "A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo". 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 rhyth...
What is the current status of trial NCT00158093?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 260 participants. The study started on 2003-06. Estimated completion is 2003-07.
What interventions are being tested in trial NCT00158093?
The interventions under investigation include: Atenolol (DRUG), Moxifloxacin (DRUG), Nebivolol (DRUG).
Who is sponsoring clinical trial NCT00158093?
This trial is sponsored by Mylan Bertek Pharmaceuticals, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00158093's enrollment target sits among peer trials
260 160th of 2000 higher than 1,834 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02283996 · 260 participants · Phase 4
Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment
- NCT03276793 · 260 participants · NA
Brain Connectivity in Depression
- NCT03407469 · 260 participants
Measurement of Adherence and Health-Related Quality of Life, and Health-Care Resource Utilization
- NCT03713125 · 260 participants · NA
Executive Function in Early Childhood
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia