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NCT00630877 · ClinicalTrials.gov registry record · Phase 3
Evaluation of a Flushing ASsessment Tool (FAST) in Subjects Receiving Niacin Extended-release Plus Aspirin
A Phase 3 study, sponsored by Abbott.
- Completed
- Registry status
- Phase 3
- Development phase
- 276
- Enrollment target
NCT00630877: Completed Phase 3 study, sponsored by Abbott.
NCT00630877 is a Phase 3 study that has completed, run by Abbott. The registered enrollment target is 276 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00630877, a Phase 3 study, has completed, sponsored by Abbott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 276 participants
- Enrollment target
Study Summary
The primary purpose of this study was to evaluate the psychometric characteristics (reliability, validity, and responsiveness) of a Flushing ASsessment Tool (FAST) in subjects receiving niacin extended-release (NER) plus aspirin (ASA) daily for 6 weeks. The FAST is a questionnaire that was developed to provide a detailed assessment of flushing symptoms and their impact in patients receiving niacin therapy. The effect of aspirin on flushing symptoms, as measured by the FAST, was also evaluated.
Primary Outcome
Test-retest reliability of the mean flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.
Interventions
- DRUG Niacin extended-release (NER)
- DRUG Niacin extended-release (NER) placebo
- DRUG Aspirin (ASA)
- DRUG Aspirin (ASA) placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2008-02 |
| Est. Completion | 2008-06 |
| Phase | Phase 3 |
What the finished NCT00630877 record still lists
NCT00630877 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 4 interventions - of which Niacin extended-release (NER) is the first listed.
NCT00630877 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00630877 about?
NCT00630877 is a clinical study titled "Evaluation of a Flushing ASsessment Tool (FAST) in Subjects Receiving Niacin Extended-release Plus Aspirin". The primary purpose of this study was to evaluate the psychometric characteristics (reliability, validity, and responsiveness) of a Flushing ASsessment Tool (FAST) in subjects receiving niacin extended-release (NER) plus aspirin (ASA) daily for 6 weeks. The FAST is a questionnaire that was develope...
What is the current status of trial NCT00630877?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 276 participants. The study started on 2008-02. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00630877?
The interventions under investigation include: Niacin extended-release (NER) (DRUG), Niacin extended-release (NER) placebo (DRUG), Aspirin (ASA) (DRUG), Aspirin (ASA) placebo (DRUG).
Who is sponsoring clinical trial NCT00630877?
This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00630877's enrollment target sits among peer trials
276 1202nd of 2000 higher than 795 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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