NCT00533611

Brief Summary

The primary objective of the study is to assess the effects of MK0524A in reducing flushing associated with niacin.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2007

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

4 months

First QC Date

September 19, 2007

Last Update Submit

February 16, 2017

Conditions

Flushing

Outcome Measures

Primary Outcomes (1)

  • MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by maximum Global Flushing Severity Score (GFSS) categorized as none/mild, moderate, severe, extreme.

    Over 1 week

Secondary Outcomes (1)

  • MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by (a) maximum daily GFSS; and (b) percentage of patients with a maximum GFSS =4 (moderate or greater).

    Daily

Interventions

MK0524A, /Duration of Treatment : 4 WeeksDRUG
Comparator : niacin /Duration of Treatment : 1 WeeksDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is male or female between 18 and 70 years of age
  • Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study

You may not qualify if:

  • Patient has a history of hypersensitivity to niacin or niacin-containing products
  • Patient is currently experiencing menopausal hot flashes
  • Patient consumes more than 2 alcoholic beverages per day
  • Patient has poorly controlled Type 1 or Type 2 diabetes mellitus
  • Patient engages in vigorous exercise or an aggressive diet regimen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kush D, Hu DY, Ye P, Kim HS, Chen E, Sirah W, McCrary Sisk C, Paolini JF, Maccubbin D. Flushing profile of extended-release niacin/laropiprant at initiation of therapy in Asian lipid clinic patients. Cardiology. 2009;114(3):192-8. doi: 10.1159/000228585. Epub 2009 Jul 15.

    PMID: 19602880BACKGROUND

MeSH Terms

Conditions

Flushing

Interventions

Duration of Therapy

Condition Hierarchy (Ancestors)

Skin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
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

April 1, 2007

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

February 17, 2017

Record last verified: 2017-02