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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. 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00158093
The ClinicalTrials.gov registry entry for NCT00158093 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Bertek Pharmaceuticals, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Atenolol is the first listed.
NCT00158093 reports 0 study locations.
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.
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