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Trial record 2 of 379 for:    experience corps

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01071278
First Posted: February 19, 2010
Last Update Posted: August 11, 2015
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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) ]
    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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01071278     History of Changes
Other Study ID Numbers: 0524A-115
2010_011 ( Other Identifier: Merck Study Number )
First Submitted: February 17, 2010
First Posted: February 19, 2010
Results First Submitted: February 1, 2012
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:
Metabolic Diseases
Lipid Metabolism Disorders