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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | Placebo Comparator | Matched Placebo |
|
| SB480848 40mg Group | Experimental | SB480848 40mg/day |
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| SB480848 80mg Group | Experimental | SB480848 80mg/day |
|
| SB480848 160mg Group | Experimental | SB480848 160mg/day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB480848 40mg EC Tablet | Drug | 1 tablet once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity | Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Change from Baseline was calculated as the post-Baseline (Week 4) assessment value minus the Baseline assessment value. If either value was missing, then the change from Baseline was set to be missing. The natural logarithm (log) was used for transformation in Lp-PLA2 activity. In case of zero values, an offset of 0.0001 was added to the zero values to ensure that the log transformation was successfully applied. The log transformation was conducted on the original value and then taken the change from Baseline on that log original value, calculated as log (post-Baseline value [week 4]) minus log (Baseline value). | Baseline (Week 0, Visit 2) and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time | Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Percentage inhibition of Lp-PLA2 activity relative to a Baseline value was calculated as: 100 multiplied by (post-Baseline values (Week 1, 2, 4 and Follow-up-Baseline value) divided by [Baseline value]). |
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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
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Fukuoka | 812-0025 | Japan | |||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| LPL110118 | Informed Consent Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Out of 116 participants screened, 9 were screen failures; 107 participants were randomized in a ratio of 1:1:1:1, to receive placebo or any 1 of the 3 doses of SB-480848 (40 milligram [mg], 80 mg, 160 mg), prior to which they continued their statin therapy with no change in lipid-lowering medication or dose during 4 weeks of Run-in period.
The study was planned in 100 dyslipidemic male or female participants, aged 20 to 80 years, undergoing statin therapy and no change in lipid-lowering medication or dose during the 4 weeks prior to randomization from 26 August 2008 to 16 January 2009 at 7 centers in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received oral dose of matching placebo tablet once daily, after breakfast in the morning for 4 weeks of treatment period. |
| FG001 | SB-480848 40 mg | Participants received oral dose of SB-480848 40 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period. |
| FG002 | SB-480848 80 mg | Participants received oral dose of SB-480848 80 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period. |
| FG003 | SB-480848 160 mg | Participants received oral dose of SB-480848 160 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received oral dose of matching placebo tablet once daily, after breakfast in the morning for 4 weeks of treatment period. |
| BG001 | SB-480848 40 mg | Participants received oral dose of SB-480848 40 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity | Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Change from Baseline was calculated as the post-Baseline (Week 4) assessment value minus the Baseline assessment value. If either value was missing, then the change from Baseline was set to be missing. The natural logarithm (log) was used for transformation in Lp-PLA2 activity. In case of zero values, an offset of 0.0001 was added to the zero values to ensure that the log transformation was successfully applied. The log transformation was conducted on the original value and then taken the change from Baseline on that log original value, calculated as log (post-Baseline value [week 4]) minus log (Baseline value). | Full Analysis Set (FAS) Population was defined as all randomized participants who received at least one dose of study medication during treatment period and who had at least one evaluable assessment of Lp-PLA2 activity after randomization. Missing values during treatment period, except for Baseline were imputed by last observed response (LOCF). | Posted | Geometric Mean | Geometric Coefficient of Variation | Log(millimole per milliliter per minute) | Baseline (Week 0, Visit 2) and Week 4 |
Adverse events (AEs) were recorded up to Follow-up (up to Week 7).
Safety Population comprised of all participants who received at least one dose of the study medication during the treatment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received oral dose of matching placebo tablet once daily, after breakfast in the morning for 4 weeks of treatment period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal faeces | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C529040 | darapladib |
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| SB480848 80mg EC Tablet | Drug | 1 tablet once a day |
|
| SB480848 160mg EC Tablet | Drug | 1 tablet once a day |
|
| SB480848 Placebo Tablet | Drug | 1 tablet once a day |
|
| Baseline (Week 0, Visit 2) up to Follow-up (up to Week 7) |
| Change From Baseline in Lp-PLA2 Activity at Week 1, 2 and Follow-up | Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Change from Baseline was calculated as the post-Baseline (Week 1, Week 2 and Follow-up) assessment values minus the Baseline assessment value. If either value was missing, then the change from Baseline was set to be missing. The log was used for transformation in Lp-PLA2 activity. In case of zero values, an offset of 0.0001 was added to the zero values to ensure that the log transformation was successfully applied. The log transformation was conducted on the original value and then taken change from Baseline on that log original value, calculated as log (post-Baseline [Week 1, Week 2 and Follow-up] values) minus log (Baseline value). | Baseline (Week 0, Visit 2), Week 1, Week 2 and Follow-up ( Week 7) |
| Fukuoka |
| 818-0036 |
| Japan |
| GSK Investigational Site | Fukuoka | 819-1102 | Japan |
| GSK Investigational Site | Tokyo | 105-0004 | Japan |
| GSK Investigational Site | Tokyo | 154-0024 | Japan |
| GSK Investigational Site | Tokyo | 160-0017 | Japan |
| GSK Investigational Site | Tokyo | 174-0051 | Japan |
For additional information about this study please refer to the GSK Clinical Study Register |
| LPL110118 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LPL110118 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LPL110118 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LPL110118 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LPL110118 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BG002 | SB-480848 80 mg | Participants received oral dose of SB-480848 80 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period. |
| BG003 | SB-480848 160 mg | Participants received oral dose of SB-480848 160 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period. |
| BG004 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
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|
|
|
| Secondary | Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time | Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Percentage inhibition of Lp-PLA2 activity relative to a Baseline value was calculated as: 100 multiplied by (post-Baseline values (Week 1, 2, 4 and Follow-up-Baseline value) divided by [Baseline value]). | FAS Population with LOCF analysis. | Posted | Mean | Standard Deviation | Percent inhibiton of Lp-PLA2 activity | Baseline (Week 0, Visit 2) up to Follow-up (up to Week 7) |
|
|
|
| Secondary | Change From Baseline in Lp-PLA2 Activity at Week 1, 2 and Follow-up | Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Change from Baseline was calculated as the post-Baseline (Week 1, Week 2 and Follow-up) assessment values minus the Baseline assessment value. If either value was missing, then the change from Baseline was set to be missing. The log was used for transformation in Lp-PLA2 activity. In case of zero values, an offset of 0.0001 was added to the zero values to ensure that the log transformation was successfully applied. The log transformation was conducted on the original value and then taken change from Baseline on that log original value, calculated as log (post-Baseline [Week 1, Week 2 and Follow-up] values) minus log (Baseline value). | FAS Population with LOCF analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | Log(millimole per milliliter per minute) | Baseline (Week 0, Visit 2), Week 1, Week 2 and Follow-up ( Week 7) |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 8 |
| 25 |
| EG001 | SB-480848 40 mg | Participants received oral dose of SB-480848 40 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period. | 0 | 28 | 1 | 28 | 12 | 28 |
| EG002 | SB-480848 80 mg | Participants received oral dose of SB-480848 80 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period. | 0 | 28 | 0 | 28 | 13 | 28 |
| EG003 | SB-480848 160 mg | Participants received oral dose of SB-480848 160 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period. | 0 | 26 | 0 | 26 | 13 | 26 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Urine odour abnormal | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Skin odour abnormal | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D052439 |
| Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Week 2 |
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| Week 4 |
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| Week 7 (Follow-up) |
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| Week 2 |
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| Week 7 (Follow-up) |
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