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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01071278
First received: February 17, 2010
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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
Lipid Metabolism Disorder

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Lipid Management in Clinical Practice

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants With Lipid Panel Control [ Time Frame: From Visit 1 entrance evaluation (Week 0) to Visit 2 (between Weeks 8-22) ] [ Designated as safety issue: No ]
    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:
  • Number of Participants Who Reported Adverse Events [ Time Frame: Up to 22 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 2390
Study Start Date: October 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071278

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01071278     History of Changes
Other Study ID Numbers: MK-0524A-115, 2010_011
Study First Received: February 17, 2010
Results First Received: February 1, 2012
Last Updated: February 1, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Merck Sharp & Dohme Corp.:
Lipid metabolism disorder

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Sphingolipidoses
Brain Diseases
Brain Diseases, Metabolic
Brain Diseases, Metabolic, Inborn
Central Nervous System Diseases
Genetic Diseases, Inborn
Lipid Metabolism, Inborn Errors
Lipidoses
Lysosomal Storage Diseases
Lysosomal Storage Diseases, Nervous System
Nervous System Diseases
Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on October 23, 2014