SB-480848 In Subjects With Coronary Heart Disease
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ClinicalTrials.gov Identifier: NCT00269048 |
Recruitment Status
:
Completed
First Posted
: December 23, 2005
Last Update Posted
: August 8, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atherosclerosis | Drug: SB-480848 Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 969 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | September 2006 |
Actual Study Completion Date : | September 2006 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm 1
SB-480848
|
Drug: SB-480848
SB-480848
|
Placebo Comparator: Arm 2
placebo
|
Drug: placebo
placebo
|
- On treatment sustained inhibition of plasma Lp-PLA2 activity. [ Time Frame: 12 Weeks ]
- Difference in dose-dependent effects of SB-480848 on plasma Lp-PLA2 activity, other biomarkers, and safety. [ Time Frame: 12 Weeks ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Female subjects must be of non-childbearing potential.
- Stable CHD or CHD-risk equivalent.
- Must have been on a stable dose of a statin for =4 weeks with LDL <130 mg/dL (3.4 mmol/L) or off statin therapy for =4 weeks with LDL <160 mg/dL (4.1 mmol/L).
- On a stable dose of at least one oral antiplatelet agent (e.g., aspirin, clopidogrel, or ticlopidine).
Exclusion criteria:
- Recent cardiovascular event and / or vascular procedure.
- History of difficult to manage dyslipidemia.
- Planned cardiac surgery or PCI (percutaneous coronary intervention) or planned major non-cardiac surgery.
- Inadequately controlled hypertension.
- Poorly controlled diabetes mellitus.
- Serum triglycerides >400 mg/dL (4.52 mmol/L).
- Recent or ongoing acute infection.
- History of chronic inflammatory disease.
- Receiving topical, oral, inhaled or injectable corticosteroids.
- History of chronic viral hepatitis, or other chronic hepatic disorders.
- History of kidney transplant.
- History of myopathy or inflammatory muscle disease, or elevated total serum CK (3 x ULN).
- Severe heart failure (NYHA class III or IV), or severe left ventricular dysfunction (ejection fraction <30%).
- Asthma manifested by bronchospasm in the past 6 months, or currently taking inhaled bronchodilator on regular basis.
- History of anaphylaxis, anaphylactoid reactions or severe allergic responses within the past 6 months.
- Malignancy within the past 2 years, other than non-melanoma skin cancer.
- Current life-threatening condition other than vascular disease that may prevent a subject from completing the study.
- QTc interval >440 msec (males) or >450 msec (females).
- Alcohol or drug abuse within the past 6 months.
- Previous exposure to SB-480848.
- Use of an investigational drug within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of study medication (blinded atorvastatin).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00269048

Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00269048 History of Changes |
Other Study ID Numbers: |
LPL104884 |
First Posted: | December 23, 2005 Key Record Dates |
Last Update Posted: | August 8, 2016 |
Last Verified: | August 2016 |
Keywords provided by GlaxoSmithKline:
CHD Lp-PLA2 SB-480848 |
Additional relevant MeSH terms:
Heart Diseases Atherosclerosis Coronary Disease Coronary Artery Disease Myocardial Ischemia |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |