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

NCT01071278 | Completed Results

• 2 other identifiers: 0524A-1152010_011
• Study Type: observational
• Target: 2,390
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lipid Metabolism Disorder

Keywords

Lipid metabolism disorder

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Lipid Panel Control

  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).

  From Visit 1 entrance evaluation (Week 0) to Visit 2 (between Weeks 8-22)

Secondary Outcomes (1)

• Number of Participants Who Reported Adverse Events

  Up to 22 weeks

Study Arms (2)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in routine medical care either statutorily health insured or privately insured

You may qualify if:

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

You may not qualify if:

• Patient is currently participating in a clinical trial

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 19, 2010
• Study Start: October 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: August 11, 2015
• Results First Posted: March 7, 2012

Record last verified: 2015-07