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Evaluation of a Flushing ASsessment Tool (FAST) in Subjects Receiving Niacin Extended-release Plus Aspirin

NCT00630877 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2009-10-09

Study results available
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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.

Conditions

Interventions

DRUG

Niacin extended-release (NER)

Tablets administered once daily for 6 weeks; titrated to a maximum dose of 2000 mg

DRUG

Niacin extended-release (NER) placebo

Tablets administered once daily for 6 weeks

DRUG

Aspirin (ASA)

Tablets (325 mg) administered once daily for 6 weeks

DRUG

Aspirin (ASA) placebo

Tablets administered once daily for 6 weeks

Sponsors & Collaborators

Principal Investigators

  • Roopal Thakkar, MD · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00630877 on ClinicalTrials.gov