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NCT00999102 · ClinicalTrials.gov registry record · Phase 4
Nebivolol Versus Metoprolol: Comparative Effects on Fatigue and Quality of Life
A Phase 4 study of Hypertension, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 4
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT00999102: Completed Phase 4 study of Hypertension, sponsored by Weill Medical College of Cornell University.
NCT00999102 is a Phase 4 study of Hypertension that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 37 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00999102, a Phase 4 study of Hypertension, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
Beta-blockers are prescribed to millions of people for treatment of hypertension. Fatigue is a recognized and common side effect of beta-blockers that can have significant effects on quality of life. Worse, many people taking a beta-blocker for years are not even aware of the reduction of energy with which they are living. A new vasodilating beta-blocker, nebivolol, which is approved by the FDA for treatment of hypertension, appears to be far less associated with fatigue than are most currently available beta-blockers. The purpose of this study is to compare nebivolol with the current best-selling beta-blocker, metoprolol, and determine whether there is a significant difference in side effects including fatigue, reduced exertion tolerance, and reduced quality of life. In this study, 30 subjects will take each of the 2 study drugs for 8 weeks, consisting of 4 weeks at a lower dose, and 4 weeks at a higher dose. All dosages are FDA-approved for treatment of hypertension. Subjects and investigators will not know which drug is being administered until completion of the study. Subjects will undergo a treadmill stress test and will complete fatigue and quality of life questionnaires after each 4 weeks of treatment. An echocardiogram and non-invasive measurement of aortic blood pressure will be performed after 8 weeks on each drug. Also, blood will be drawn and stored for possible measurement of drug levels, after 4 and 8 weeks on each drug. Results on each drug will then be compared. If nebivolol is found to cause significantly less fatigue, it would be of substantial importance to the many millions of people who are on life-long beta-blocker therapy, and are living with reduced energy.
Primary Outcome
A 16 item scale that measures 4 dimensions of fatigue: severity, distress, timing, and degree of interference in activities of daily living. Range: 1 (no fatigue) to 50 (extreme fatigue).
Conditions Studied
Interventions
- DRUG Nebivolol
- DRUG Metoprolol
Study Locations (1)
New York
- Weill Cornell Medical College - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-01 |
| Phase | Phase 4 |
What the finished NCT00999102 record still lists
NCT00999102 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Nebivolol is the first listed.
NCT00999102 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00999102 about?
NCT00999102 is a clinical study titled "Nebivolol Versus Metoprolol: Comparative Effects on Fatigue and Quality of Life". Beta-blockers are prescribed to millions of people for treatment of hypertension. Fatigue is a recognized and common side effect of beta-blockers that can have significant effects on quality of life. Worse, many people taking a beta-blocker for years are not even aware of the reduction of energy wit...
What is the current status of trial NCT00999102?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 37 participants. The study started on 2009-10. Estimated completion is 2011-01.
What conditions does trial NCT00999102 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT00999102?
The interventions under investigation include: Nebivolol (DRUG), Metoprolol (DRUG).
Who is sponsoring clinical trial NCT00999102?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00999102 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00999102's enrollment target sits among peer trials
37 396th of 470 higher than 74 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension 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.
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