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Lipid Management in Clinical Practice (MK-0524A-115)

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: NCT01071278
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : March 7, 2012
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The aim of this observational program is to generate data on the use of Tredaptive (nicotinic acid/laropiprant) for lipid management under routine medical practice conditions.

Condition or disease
Lipid Metabolism Disorder

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Study Type : Observational
Actual Enrollment : 2390 participants
Time Perspective: Prospective
Official Title: Lipid Management in Clinical Practice
Study Start Date : October 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine


Group/Cohort
Patients treated within a disease management program
Participant prescribed Tredaptive® for dyslipidemia and also participated in a disease management program for treatment of diabetes mellitus, coronary heart disease or both.
Patients treated outside a disease management program
Participant prescribed Tredaptive® for dyslipidemia and did not participate in a disease management program for treatment of diabetes mellitus, coronary heart disease or both.



Primary Outcome Measures :
  1. Number of Participants With Lipid Panel Control [ Time Frame: From Visit 1 entrance evaluation (Week 0) to Visit 2 (between Weeks 8-22) ]
    Lipid Panel Control was defined as achieving target for one or more of the following parameters: low-density lipoprotein cholesterol (LDL-C) at goal (<100mg/dL), high-density lipoprotein cholesterol (HDL-C) within normal range (40mg/dL for males and 50mg/dL for females), and/or triglycerides within normal range (≤ 150mg/dL).


Secondary Outcome Measures :
  1. Number of Participants Who Reported Adverse Events [ Time Frame: Up to 22 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients in routine medical care either statutorily health insured or privately insured
Criteria

Inclusion Criteria:

  • Patients are 18 years of age or older with lipid disorder treated with nicotinic acid/laropiprant

Exclusion Criteria:

  • Patient is currently participating in a clinical trial

Information from the National Library of Medicine

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): NCT01071278


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01071278    
Other Study ID Numbers: 0524A-115
2010_011 ( Other Identifier: Merck Study Number )
First Posted: February 19, 2010    Key Record Dates
Results First Posted: March 7, 2012
Last Update Posted: August 11, 2015
Last Verified: July 2015
Keywords provided by Merck Sharp & Dohme Corp.:
Lipid metabolism disorder
Additional relevant MeSH terms:
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Metabolic Diseases
Lipid Metabolism Disorders