NCT00903617

Study to Test GSK256073 in Patients With Dyslipidemia

A Two Part, Multicenter Phase IIa, Placebo Controlled Study, to Examine the Safety, Tolerability, and Effects of GSK256073 on Lipids in Subjects With Dyslipidemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a two part study (Part A and Part B) that will first aim to establish the PK/PD relationship between exposure and lipid effects (Part A: 75 subjects), and will then confirm the effect using the most relevant dose(s) (Part B: \~90 subjects). Doses of 5mg, 50mg and 150mg of GSK256073 will be administered in Part A, and the dose(s) for Part B will be based on the PK/PD data from Part A. Data from Part A and Part B will be combined to decrease overall subject numbers needed in part B. Part B of the study will include a niaspan arm for relative comparison of the effects of GSK256073 and niacin on lipids and flushing

Conditions

• Dyslipidaemias
• Dyslipidemias

Interventions

Type	Name	Description
DRUG	GSK256073	5 mg for 8 weeks
DRUG	GSK256073	50 mg for 8 weeks
DRUG	GSK256073	150 mg for 8 weeks
DRUG	Placebo	placebo for 8 weeks
DRUG	Niaspan	1500 mg for 8 weeks
DRUG	GSK256073	x mg for 8 weeks based from data from Part A
DRUG	GSK256073	optional dose based on data from Part A

Timeline

• Start date: 2009-06-15
• Primary completion: 2010-02-16
• Completion: 2010-02-16
• First posted: 2009-05-18
• Last updated: 2019-12-05
• Results posted: 2017-09-21

Locations

11 sites across 1 country: United States