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Effect of MK0524A on Flushing Caused by Niacin (0524A-056)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00533611
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
The primary objective of the study is to assess the effects of MK0524A in reducing flushing associated with niacin.

Condition or disease Intervention/treatment Phase
Flushing Drug: MK0524A, /Duration of Treatment : 4 Weeks Drug: Comparator : niacin /Duration of Treatment : 1 Weeks Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Tolerability and Effect of MK0524A on Niacin-Induced Acute Flushing in Lipid Clinic Patients
Study Start Date : April 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: Over 1 week ]

Secondary Outcome Measures :
  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). [ Time Frame: Daily ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533611


Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme LLC
More Information
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Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT00533611    
Other Study ID Numbers: 0524A-056
MK0524A-056
2007_604
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Flushing
Skin Manifestations
Niacin
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hypolipidemic Agents
 Antimetabolites
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients