Back to resultsAn Investigational Drug Study Evaluating a Novel Approach to Treat Dyslipidemia (0524A-032)
Primary Purpose
Dyslipidemia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
niacin (+) laropiprant
Comparator: placebo (unspecified)
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia
Eligibility Criteria
Inclusion Criteria: Males and females (ages 25-75) Exclusion Criteria: A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study
Sites / Locations
Outcomes
Primary Outcome Measures
Acute cutaneous symptoms induced by niacin for 7 days.
Secondary Outcome Measures
Tolerability
Full Information
NCT ID
NCT00111891
First Posted
May 26, 2005
Last Updated
February 16, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00111891
Brief Title
An Investigational Drug Study Evaluating a Novel Approach to Treat Dyslipidemia (0524A-032)
Official Title
A Dose Ranging Study to Evaluate the Tolerability of MK0524 (Niacin (+) Laropiprant) and Its Effects on Niacin-Induced Acute Flushing in Lipid Clinic Patients and/or Normal Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
This is a 3-week trial in normal healthy or lipid clinic patients studying a novel approach to treating dyslipidemia.
Detailed Description
The duration of treatment is 7 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
575 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
niacin (+) laropiprant
Other Intervention Name(s)
MK0524A
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo (unspecified)
Primary Outcome Measure Information:
Title
Acute cutaneous symptoms induced by niacin for 7 days.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Tolerability
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males and females (ages 25-75)
Exclusion Criteria:
A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
An Investigational Drug Study Evaluating a Novel Approach to Treat Dyslipidemia (0524A-032)
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