CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 276 enrolled
Drug / intervention
Niacin extended-release (NER) +3 moredrug
Likely dose
Niacin extended-release (NER) 2000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00630877
NCT00630877Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Parallel, Multicenter, Placebo-controlled, Prospective Study to Evaluate the Functionality of the Flushing ASsessment Tool (FAST) in Subjects Administered Niaspan® Plus Acetylsalicylic Acid (ASA), Niaspan® Plus ASA Placebo or Niaspan® Placebo Plus ASA Placebo Daily for Six Weeks

Abbott·interventional·Posted Mar 7, 2008·Updated Oct 9, 2009

In Brief

A Phase 3 clinical trial evaluating Niacin extended-release (NER), Niacin extended-release (NER) placebo, and 2 other interventions for Dyslipidemia. Completed, enrolled 276 participants across 40 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyslipidemia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 7, 2008
Enrollment StartFeb 1, 2008
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.3 years ago

Interventions

Niacin extended-release (NER)drug

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

Niacin extended-release (NER) placebodrug

Tablets administered once daily for 6 weeks

Aspirin (ASA)drug

Tablets (325 mg) administered once daily for 6 weeks

Aspirin (ASA) placebodrug

Tablets administered once daily for 6 weeks