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NCT01665508 · ClinicalTrials.gov registry record · Phase 4
Study to Evaluate Effect of Nebivolol on Angina in Women With Microvascular Disease
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT01665508: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT01665508 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01665508, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study Summary
Women have less significant blockages of coronary arteries, however have greater symptoms and worse outcomes compared to their age-matched male counterparts. This paradox has led to the recognition and importance of the microvasculature ( small vessels) as a contributor to symptoms and outcomes. Nebivolol has unique antioxidant properties and dilates blood vessels and it is therefore proposed that treatment with nebivolol will reduce angina (chest symptoms) in women with microvascular disease as well as improve exercise capacity, reduce resource utilization and improve other measures of artery function.
Primary Outcome
Seattle Angina Questionnaire (SAQ): The SAQ is a 5 part survey that is widely used and well validated tool to assess angina stability and angina frequency among patients with coronary artery disease. The SAQ is a validated, self-administered 19-item questionnaire with 5 different dimensions of health status in patients with CAD including: angina frequency, angina stability, disease-specific quality of life, physical limitations and treatment satisfaction. Each SAQ domain score ranges from 0-10
Interventions
- DRUG Nebivolol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-05 |
| Phase | Phase 4 |
What the finished NCT01665508 record still lists
NCT01665508 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Nebivolol is the first listed.
NCT01665508 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01665508 about?
NCT01665508 is a clinical study titled "Study to Evaluate Effect of Nebivolol on Angina in Women With Microvascular Disease". Women have less significant blockages of coronary arteries, however have greater symptoms and worse outcomes compared to their age-matched male counterparts. This paradox has led to the recognition and importance of the microvasculature ( small vessels) as a contributor to symptoms and outcomes. Neb...
What is the current status of trial NCT01665508?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2013-04. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01665508?
The interventions under investigation include: Nebivolol (DRUG).
Who is sponsoring clinical trial NCT01665508?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01665508's enrollment target sits among peer trials
12 1913th of 2000 higher than 70 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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