A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00734032
First received: August 12, 2008
Last updated: June 21, 2012
Last verified: May 2012
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Purpose
The primary objective of this study is to examine the effects of SB-480848 on plasma lipoprotein associated phospholipase A2 (Lp-PLA2) activity in dyslipidemic patients during a 4-week treatment with SB-480848.
| Condition | Intervention | Phase |
|---|---|---|
|
Dyslipidaemia Atherosclerosis |
Drug: SB480848 40mg EC Tablet Drug: SB480848 80mg EC Tablet Drug: SB480848 160mg EC Tablet Drug: SB480848 Placebo Tablet |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients - A Multicenter, Randomized, Double-blind, Placebo-controlled Study of SB-480848 to Evaluate the Efficacy and Safety - |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Change from baseline to week 4 in plasma Lp-PLA2 activity [ Time Frame: 4 weeks ]
Secondary Outcome Measures:
- •Percent inhibition of Lp-PLA2 activity in plasma at week 4•Overtime changes of Lp-PLA2 activity and the inhibition rate of Lp-PLA2 activity in plasma from baseline [ Time Frame: 4 weeks ]
| Enrollment: | 107 |
| Study Start Date: | August 2008 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo Group
Matched Placebo
|
Drug: SB480848 Placebo Tablet
1 tablet once a day
|
|
Experimental: SB480848 40mg Group
SB480848 40mg/day
|
Drug: SB480848 40mg EC Tablet
1 tablet once a day
Other Name: Darapladib
|
|
Experimental: SB480848 80mg Group
SB480848 80mg/day
|
Drug: SB480848 80mg EC Tablet
1 tablet once a day
|
|
Experimental: SB480848 160mg Group
SB480848 160mg/day
|
Drug: SB480848 160mg EC Tablet
1 tablet once a day
|
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
Dyslipidemic subject who is currently undergoing statin therapy and no change in lipid-lowering therapy or dose during the 4 week prior to randomization
Exclusion criteria:
Recent (i.e.,<6 months prior to screening) CV event and/or vascular procedure defined as:
A)ST-elevation MI or non-ST-elevation MI B)Unstable angina C)Coronary revascularization [(percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)] D)Stroke of any etiology E)Peripheral arterial disease with critical limb ischemia (resting pain or ischemic skin lesions, either ulcers or gangrene) F)Resuscitated cardiac arrest
- Planned CABG or planned PCI or planned major non-cardiac surgery within study period
- No measurable Lp-PLA2 activity in plasma (<10 nmol/min/mL) at screening
- Change in a lipid-lowering medication, regimen or dosage during the 4 week prior to randomization
- Poorly controlled dyslipidemia (LDL-c >=160 mg/dL) at screening
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734032
Locations
| Japan | |
| GSK Investigational Site | |
| Fukuoka, Japan, 819-1102 | |
| GSK Investigational Site | |
| Fukuoka, Japan, 818-0036 | |
| GSK Investigational Site | |
| Fukuoka, Japan, 812-0025 | |
| GSK Investigational Site | |
| Tokyo, Japan, 154-0024 | |
| GSK Investigational Site | |
| Tokyo, Japan, 160-0017 | |
| GSK Investigational Site | |
| Tokyo, Japan, 105-0004 | |
| GSK Investigational Site | |
| Tokyo, Japan, 174-0051 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00734032 History of Changes |
| Other Study ID Numbers: | LPL110118 |
| Study First Received: | August 12, 2008 |
| Last Updated: | June 21, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by GlaxoSmithKline:
|
SB-480848 Dyslipidaemia |
Additional relevant MeSH terms:
|
Atherosclerosis Dyslipidemias Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013