NCT00765284

Effect of Niaspan on Cholesterol in Men

Effect of Niaspan on Parameters of Reverse Cholesterol Transport and HDL-C Subclasses in Male Subjects With Low HDL-C Levels

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: KineMed · Industry
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

To determine whether 8 weeks of Niaspan treatment increases cholesterol efflux in male subjects with low HDL-C cholesterol when compared to no treatment. To determine whether 8 weeks of Niaspan treatment increases fecal cholesterol excretion when compared to no treatment. To determine whether 8 weeks of Niaspan treatment increases the rate of global reverse cholesterol transport when compared to no treatment.

Detailed description

This will be a single center, open-label, randomized, mechanism of action study consisting of 8 weeks of active treatment preceded by a screening phase from one to 8 weeks and a baseline measurement of parameters of reverse cholesterol transport for 10 days. The population for this trial is 15 non-diabetic men aged 18-70 years. Ten subjects will be low HDL-C male volunteers who will receive aspirin and Niaspan and five subjects will be low HDL-C male volunteers who will receive only aspirin.

Conditions

• HDL Cholesterol

Timeline

• Start date: 2007-12-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2008-10-02
• Last updated: 2011-06-30

Locations

1 site across 1 country: United States