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Study to Test GSK256073 in Patients With Dyslipidemia

NCT00903617 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-12-05

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-15
Primary Completion
2010-02-16
Completion
2010-02-16

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00903617 on ClinicalTrials.gov