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Completed Phase 2 Interventional

SB-480848 In Subjects With Coronary Heart Disease

ClinicalTrials.gov ID: NCT00269048

Public ClinicalTrials.gov record NCT00269048. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 5:49 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study of SB-480848, an Oral Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Inhibitor, in Subjects With Stable Coronary Heart Disease (CHD) or CHD-risk Equivalent to Examine Chronic Inhibition of Lp-PLA2 Effects on Circulating Biomarkers Associated With Cardiovascular Risk, Safety and Tolerability Over 12 Weeks

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This trial of SB-480848 in approximately 920 subjects with Coronary Heart Disease (CHD) or CHD-risk equivalent will examine whether SB-480848 produces sustained inhibition of plasma Lp-PLA2 activity, explore the effects of SB-480848 on other circulating biomarkers associated with cardiovascular risk, and evaluate the pharmacokinetics, safety and tolerability of SB-480848 over 12 weeks of once-daily oral dosing. Subjects will first be randomized 1:1 to double-blind atorvastatin 20 mg or 80 mg once daily for a minimum of 3 weeks. Subjects will then be randomized 1:1:1:1 to oral doses of SB-480848 40 mg, 80 mg, 160 mg or placebo once daily for 12 weeks. Blood samples will be collected at various timepoints. Vital signs, electrocardiograms, clinical laboratory safety tests and adverse event assessments will be performed to evaluate the safety and tolerability of SB-480848.

Study identification

NCT ID
NCT00269048
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
GlaxoSmithKline
Industry
Enrollment
969 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 31, 2005
Primary completion
Aug 31, 2006
Completion
Aug 31, 2006
Last update posted
Aug 7, 2016

2005 – 2006

United States locations

U.S. sites
28
U.S. states
16
U.S. cities
27
Facility City State ZIP Site status
GSK Investigational Site Birmingham Alabama 35294
GSK Investigational Site Northport Alabama 35476
GSK Investigational Site Phoenix Arizona 85014
GSK Investigational Site Tucson Arizona 85715
GSK Investigational Site Spring Valley California 91978
GSK Investigational Site Torrance California 90509
GSK Investigational Site Walnut Creek California 94598
GSK Investigational Site Fort Lauderdale Florida 33308
GSK Investigational Site Jacksonville Florida 32205
GSK Investigational Site Pembroke Pines Florida 33024
GSK Investigational Site Chicago Illinois 60607
GSK Investigational Site Chicago Illinois 60610
GSK Investigational Site Indianapolis Indiana 46260
GSK Investigational Site Lacombe Louisiana 70445
GSK Investigational Site Slidell Louisiana 70458
GSK Investigational Site Auburn Maine 04210
GSK Investigational Site New York New York 10016
GSK Investigational Site Statesville North Carolina 28677
GSK Investigational Site Cincinnati Ohio 45219
GSK Investigational Site Oklahoma City Oklahoma 73132
GSK Investigational Site Camp Hill Pennsylvania 17011
GSK Investigational Site Philadelphia Pennsylvania 19104
GSK Investigational Site Bryan Texas 77802
GSK Investigational Site Houston Texas 77030
GSK Investigational Site San Antonio Texas 78229
GSK Investigational Site Salt Lake City Utah 84143
GSK Investigational Site Norfolk Virginia 23502
GSK Investigational Site Richmond Virginia 23294

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 91 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00269048, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 7, 2016 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00269048 live on ClinicalTrials.gov.

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