Trial · NCT00734032
A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients
NCT00734032, Phase 2, Completed, GlaxoSmithKline; results first posted 2018-01-12
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients. Trials, record NCT00734032. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00734032
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients
- NCT number
- NCT00734032
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 107 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Atherosclerosis
- Interventions
- SB480848 40mg EC Tablet, SB480848 80mg EC Tablet, SB480848 160mg EC Tablet, SB480848 Placebo Tablet
- First posted
- 2008-08-13
- Last updated
- 2018-01-12
- Results first posted
- 2018-01-12
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity | Baseline (Week 0, Visit 2) and Week 4 | 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). |
| Secondary | Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time | Baseline (Week 0, Visit 2) up to Follow-up (up to Week 7) | 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 \[Baseline value\]). |
| Secondary | Change From Baseline in Lp-PLA2 Activity at Week 1, 2 and Follow-up | Baseline (Week 0, Visit 2), Week 1, Week 2 and Follow-up ( Week 7) | 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). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity | Baseline (Week 0, Visit 2) and Week 4 | 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). | Log(millimole per milliliter per minute) | GEOMETRIC_MEAN |
| SECONDARY | Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time | Baseline (Week 0, Visit 2) up to Follow-up (up to Week 7) | FAS Population with LOCF analysis. | Percent inhibiton of Lp-PLA2 activity | MEAN |
| SECONDARY | Change From Baseline in Lp-PLA2 Activity at Week 1, 2 and Follow-up | Baseline (Week 0, Visit 2), Week 1, Week 2 and Follow-up ( Week 7) | FAS Population with LOCF analysis. | Log(millimole per milliliter per minute) | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity | Placebo | 0.961 | Geometric Coefficient of Variation 8.5 | Log(millimole per milliliter per minute) | |
| Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity | SB-480848 40 mg | 0.494 | Geometric Coefficient of Variation 24.6 | Log(millimole per milliliter per minute) | |
| Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity | SB-480848 80 mg | 0.404 | Geometric Coefficient of Variation 21.5 | Log(millimole per milliliter per minute) | |
| Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity | SB-480848 160 mg | 0.313 | Geometric Coefficient of Variation 24.7 | Log(millimole per milliliter per minute) | |
| Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time | Placebo | Week 1 | -4.06 | Standard Deviation 7.025 | Percent inhibiton of Lp-PLA2 activity |
| Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time | SB-480848 40 mg | Week 1 | -48.25 | Standard Deviation 15.929 | Percent inhibiton of Lp-PLA2 activity |
| Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time | SB-480848 80 mg | Week 1 | -55.83 | Standard Deviation 11.031 | Percent inhibiton of Lp-PLA2 activity |
| Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time | SB-480848 160 mg | Week 1 | -66.03 | Standard Deviation 7.656 | Percent inhibiton of Lp-PLA2 activity |
| Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time | Placebo | Week 2 | -1.96 | Standard Deviation 8.147 | Percent inhibiton of Lp-PLA2 activity |
| Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time | SB-480848 40 mg | Week 2 | -49.05 | Standard Deviation 11.094 | Percent inhibiton of Lp-PLA2 activity |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 25 | |
| Overall Study | STARTED | SB-480848 40 mg | 28 | |
| Overall Study | STARTED | SB-480848 80 mg | 28 | |
| Overall Study | STARTED | SB-480848 160 mg | 26 | |
| Overall Study | COMPLETED | Placebo | 25 | |
| Overall Study | COMPLETED | SB-480848 40 mg | 27 | |
| Overall Study | COMPLETED | SB-480848 80 mg | 28 | |
| Overall Study | COMPLETED | SB-480848 160 mg | 26 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | SB-480848 40 mg | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events44
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abnormal faeces | Gastrointestinal disorders | Placebo | 0 | 25 | |
| other | Abnormal faeces | Gastrointestinal disorders | SB-480848 40 mg | 5 | 28 | |
| other | Abnormal faeces | Gastrointestinal disorders | SB-480848 80 mg | 6 | 28 | |
| other | Abnormal faeces | Gastrointestinal disorders | SB-480848 160 mg | 5 | 26 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 25 | |
| other | Diarrhoea | Gastrointestinal disorders | SB-480848 40 mg | 1 | 28 | |
| other | Diarrhoea | Gastrointestinal disorders | SB-480848 80 mg | 2 | 28 | |
| other | Diarrhoea | Gastrointestinal disorders | SB-480848 160 mg | 3 | 26 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 0 | 25 | |
| other | Abdominal pain upper | Gastrointestinal disorders | SB-480848 40 mg | 0 | 28 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 25 |
| Total, all-cause mortality | SB-480848 40 mg | 0 | 28 |
| Total, all-cause mortality | SB-480848 80 mg | 0 | 28 |
| Total, all-cause mortality | SB-480848 160 mg | 0 | 26 |
| Total, other adverse events | Placebo | 8 | 25 |
| Total, other adverse events | SB-480848 40 mg | 12 | 28 |
| Total, other adverse events | SB-480848 80 mg | 13 | 28 |
| Total, other adverse events | SB-480848 160 mg | 13 | 26 |
| Total, serious adverse events | Placebo | 0 | 25 |
| Total, serious adverse events | SB-480848 40 mg | 1 | 28 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00734032
GET https://conductscience.org/api/trials/v1/NCT00734032/results?page=2