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

Lipid Metabolism Disorder Clinical Trial

Official title:

Lipid Management in Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01071278
• Other study ID #: 0524A-115
• Secondary ID: 2010_011
• Status: Completed
• Phase: N/A
• First received: February 17, 2010
• Last updated: July 21, 2015
• Start date: October 2009
• Est. completion date: February 2011

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2390
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Lipid Metabolism Disorder
• Lipid Metabolism Disorders
• Metabolic Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Number of Participants Who Reported Adverse Events		Up to 22 weeks	Yes