Endpoint Validation Study (0524A-015)
A Randomized, Double-Blind, Placebo-Controlled Endpoint Selection and Questionnaire Validation Study to Assess the Niacin Induced Flushing Caused by NIASPAN (TM)
3 other identifiers
interventional
165
0 countries
N/A
Brief Summary
To determine the most effective daily dose of MK0524A when compared with placebo after the 8-week treatment period for Niacin Induce Flushing (NIF).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2004
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 19, 2007
CompletedFirst Posted
Study publicly available on registry
September 21, 2007
CompletedFebruary 17, 2017
February 1, 2017
2.3 years
September 19, 2007
February 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF).
8 weeks
Secondary Outcomes (1)
To assess the the time points of Niacin Induce Flushing (NIF) across the 8-week treatment period.
8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Patients must be male or female between 18 to 70 years
- Qualified women must be sterile (through surgery) and/or post-menopausal, and/or agree to use birth control
You may not qualify if:
- You are a woman who is having hot flashes, receiving Hormone Replacement Therapy (HRT), and/or other therapies for hot flashes
- You are currently using Niacin/or Niacin containing products with a daily dose over 50 mg/day
- You are sensitive to niacin
- You have a history gout
- You drink more than 2 glasses of alcohol per day and you are not willing to stop
- You don't have access to a telephone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Norquist JM, Watson DJ, Yu Q, Paolini JF, McQuarrie K, Santanello NC. Validation of a questionnaire to assess niacin-induced cutaneous flushing. Curr Med Res Opin. 2007 Jul;23(7):1549-60. doi: 10.1185/030079907x199637.
PMID: 17559750BACKGROUNDPaolini JF, Mitchel YB, Reyes R, Thompson-Bell S, Yu Q, Lai E, Watson DJ, Norquist JM, Sisk CM, Bays HE. Measuring flushing symptoms with extended-release niacin using the flushing symptom questionnaire: results from a randomised placebo-controlled clinical trial. Int J Clin Pract. 2008 Jun;62(6):896-904. doi: 10.1111/j.1742-1241.2008.01739.x. Epub 2008 Apr 10.
PMID: 18410350BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2007
First Posted
September 21, 2007
Study Start
August 1, 2004
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
February 17, 2017
Record last verified: 2017-02