NCT00111891

Brief Summary

This is a 3-week trial in normal healthy or lipid clinic patients studying a novel approach to treating dyslipidemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
575

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

May 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2005

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

2 months

First QC Date

May 26, 2005

Last Update Submit

February 16, 2017

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

  • Acute cutaneous symptoms induced by niacin for 7 days.

    7 days

Secondary Outcomes (1)

  • Tolerability

    7 days

Interventions

niacin (+) laropiprantDRUG
Also known as: MK0524A
Comparator: placebo (unspecified)DRUG

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females (ages 25-75)

You may not qualify if:

  • A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dyslipidemias

Interventions

NiacinMK-0524

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

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

May 26, 2005

First Posted

May 27, 2005

Study Start

June 1, 2005

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

February 17, 2017

Record last verified: 2017-02