Trial · NCT00268996
Integrated Biomarker And Imaging Study - 2
NCT00268996, Phase 2, Completed, GlaxoSmithKline; results first posted 2018-02-19
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Integrated Biomarker And Imaging Study - 2. Trials, record NCT00268996. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00268996
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Integrated Biomarker And Imaging Study - 2
- NCT number
- NCT00268996
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 336 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Atherosclerosis
- Interventions
- SB-480848, SB-480848 matching placebo
- First posted
- 2005-12-23
- Last updated
- 2018-03-20
- Results first posted
- 2018-02-19
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Circulating High Sensitivity C- Reactive Protein (Hs-CRP) Levels at Week 52. | Week 52 | hs-CRP is a pentameric protein that is rapidly upregulated in response to inflammation and tissue damage and assessed as circulating biomarkers associated with atherosclerosis and cardiovascular risk. Last Observation Carried Forward (LOCF) data was reported. Only data from 3 months onwards was carried forward. hs-CRP has a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of hs-CRP levels at Week 52 were reported. The levels were analyzed using analysis of co-variance (ANCOVA), with Acute Coronary Syndrome (ACS) status, pooled country and treatment included as covariates. |
| Primary | Change From Baseline in the Density of Rotterdam Classification (ROC) Grade III/IV Strain Spots/10 Millimeter (mm) Within the Region of Interest (ROI) on IVUS Grey Scale Based Palpography at the End of Week 52. | Baseline and Week 52 | The ROC grade III/IV strain spots per 10 millimetre (mm) within the ROI on intravascular ultrasound (IVUS) grey scale based palpography were assessed and change from Baseline at end of 52 was reported. Change from Baseline was calculated as the density of spots at the end of study minus the density of spots recorded at Baseline. If either value was considered missing then the change from Baseline value was missing for the participant. Between treatment group comparisons of change from Baseline were analyzed using ANCOVA adjusting for ACS status, pooled country, Baseline value, matched segment length and treatment. Adjusted means and associated standard errors for each treatment group were presented. The baseline value for each participant was defined as the last value prior to the first dose of study drug. |
| Secondary | Circulating Hs-CRP at the End of Week 26. | Week 26 | hs-CRP is a pentameric protein that is rapidly upregulated in response to inflammation and tissue damage and assessed as circulating biomarkers associated with atherosclerosis and cardiovascular risk. LOCF data was reported. Only data from 3 months onwards was carried forward. hs-CRP has a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of hs-CRP levels at Week 26 were reported. The levels were analyzed using ANCOVA, with ACS status, pooled country and treatment included as covariates. |
| Secondary | Mean Lipoprotein Phospholipase A2 (Lp-PLA2) Activity at the End of Week 26 and Week 52 | Week 26 and Week 52 | Lp-PLA2 is a calcium-independent phospholipase A2 enzyme associated with low density lipoprotein (LDL) in plasma. Blood samples were collected at baseline and at Week 4, 13, 26, and 52 and Lp-PLA2 activity was determined. Percentage inhibition of Lp-PLA2 activity relative to baseline was calculated as, percent inhibition = (\[baseline value - post baseline value\] x 100) / baseline value. The baseline value for each participant was defined as the last value prior to the first dose of study drug. |
| Secondary | Change From Baseline in Plaque Volume as IVUS-Grey Scale Assessments at Week 52 | Baseline and Week 52 | Change from Baseline was calculated for each IVUS grey scale assessment recorded at the end of study. The Baseline value for each participant was defined as the last value prior to the first dose of study drug. Change from Baseline was calculated as plaque volume at Week 52 minus Baseline value. The data was analyzed using ANCOVA, with ACS status, pooled country, Baseline value, matched segment length and treatment included as covariates. |
| Secondary | Change From Baseline in Percent Obstruction Volume as IVUS-Grey Scale Assessments at Week 52 | Baseline and Week 52 | Change from Baseline in percent obstruction volume was calculated for each IVUS grey scale assessment recorded. Percent obstruction volume was calculated as (Plaque volume/ Vessel volume \*100). The Baseline value for each participant was defined as the last value prior to the first dose of study drug. Change from Baseline was calculated as plaque volume at Week 52 minus Baseline value. The data was analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates. |
| Secondary | Change From Baseline in Necrotic Core Volume as Intravenous Ultrasound-Virtual Histology (IVUS-VH) Assessments at Week 52 | Baseline and Week 52 | Change from Baseline was calculated for each IVUS-VH assessment recorded at the end of study. The necrotic core volume was calculated as mean necrotic area multiplied by mean of Baseline and follow-up length. Change from Baseline was calculated as plaque volume at Week 52 minus Baseline value. The data was analyzed using ANCOVA, with ACS status, pooled country, Baseline value, matched segment length and treatment included as covariates. The Baseline value for each participant was defined as the last value prior to the first dose of study drug. Change from Baseline in necrotic core volume as IVUS-VH assessments at Week 52 was reported. |
| Secondary | Change From Baseline in Necrotic Core as a Percent of IVUS-VH Plaque at the End of Week 52. | Baseline and Week 52 | Change from baseline was calculated for each IVUS-VH assessment recorded at the end of study. The baseline value for each participant was defined as the last value prior to the first dose of study drug. Change from baseline in percent necrotic core was calculated as percent necrotic core at Week 52 minus baseline value. The data was analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates. Change from Baseline in necrotic core as a percent of IVUS-VH plaque at the end of week 52 was reported. |
| Secondary | Mean Interlukin 6 (IL-6) Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52 | Week 26 and Week 52 | Blood was collected at baseline, Week 4, 13, 26 and 52 for evaluation of biomarkers. Mean IL-6 levels as circulating biomarkers associated with inflammatory burden at Week 26 and Week 52 were assessed and reported. LOCF data was reported. Only data from 3 months onwards was carried forward. IL-6 had a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of IL-6 levels at Week 26 and 52 were reported. The levels were analyzed using ANCOVA, with ACS status, pooled country and treatment included as covariates. |
| Secondary | Mean Intercellular Adhesion Molecule-1 (ICAM-1) Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52 | Week 26 and Week 52 | Blood was collected at baseline, Week 4, 13, 26 and 52 for evaluation of biomarkers. Mean ICAM-1 levels as circulating biomarkers associated with inflammatory burden at Week 26 and Week 52 were assessed and reported. LOCF data was reported. Only data from 3 months onwards was carried forward. ICAM-1 had a skewed distribution and values were log transformed before analysis. The statistics was calculated on the log transformed data and back transformed. The adjusted geometric means of ICAM-1 levels at Week 26 and 52 were reported. The levels were analyzed using ANCOVA, with ACS status, pooled country and treatment included as covariates. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Circulating High Sensitivity C- Reactive Protein (Hs-CRP) Levels at Week 52. | Week 52 | The biomarker evaluable population was comprised of all randomized participants who received at least one dose of study drug, with an evaluable biomarker assessment at 3 months (Day 77) or later. | mg per litre (mg/L) | GEOMETRIC_MEAN |
| PRIMARY | Change From Baseline in the Density of Rotterdam Classification (ROC) Grade III/IV Strain Spots/10 Millimeter (mm) Within the Region of Interest (ROI) on IVUS Grey Scale Based Palpography at the End of Week 52. | Baseline and Week 52 | The imaging evaluable population was comprised of all randomized participants who received at least one dose of study drug, with an evaluable baseline and end of treatment imaging assessment at 6 months (Day 154) or later. The participants available at the time of assessment were included in the analysis. | Spots/10 mm | LEAST_SQUARES_MEAN |
| SECONDARY | Circulating Hs-CRP at the End of Week 26. | Week 26 | Biomarker evaluable population | mg/L | GEOMETRIC_MEAN |
| SECONDARY | Mean Lipoprotein Phospholipase A2 (Lp-PLA2) Activity at the End of Week 26 and Week 52 | Week 26 and Week 52 | The biomarker evaluable population was comprised of all randomized participants who received at least one dose of study drug, with an evaluable biomarker assessment at 3 months (Day 77) or later. | micromole per minute per Litre | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Plaque Volume as IVUS-Grey Scale Assessments at Week 52 | Baseline and Week 52 | Imaging evaluable population | Cubic millimetre (mm^3) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percent Obstruction Volume as IVUS-Grey Scale Assessments at Week 52 | Baseline and Week 52 | Imaging evaluable population | Percentage of mm^3 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Necrotic Core Volume as Intravenous Ultrasound-Virtual Histology (IVUS-VH) Assessments at Week 52 | Baseline and Week 52 | Imaging evaluable population. Only those participants with data available at the indicated time points were analyzed. | mm^3 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Necrotic Core as a Percent of IVUS-VH Plaque at the End of Week 52. | Baseline and Week 52 | Imaging evaluable population | Percent Necrotic core | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Interlukin 6 (IL-6) Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52 | Week 26 and Week 52 | Biomarker evaluable population | Nanograms per litre (ng/L) | GEOMETRIC_MEAN |
| SECONDARY | Mean Intercellular Adhesion Molecule-1 (ICAM-1) Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52 | Week 26 and Week 52 | Biomarker evaluable population. | nanogram per millilitre (ng/mL) | GEOMETRIC_MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Circulating High Sensitivity C- Reactive Protein (Hs-CRP) Levels at Week 52. | Placebo | 1.034 | 95% Confidence Interval 0.854 to 1.251 | mg per litre (mg/L) | |
| Mean Circulating High Sensitivity C- Reactive Protein (Hs-CRP) Levels at Week 52. | Darapladib 160 mg EC Tablet | 0.913 | 95% Confidence Interval 0.765 to 1.090 | mg per litre (mg/L) | |
Change From Baseline in the Density of Rotterdam Classification (ROC) Grade III/IV Strain Spots/10 Millimeter (mm) Within the Region of Interest (ROI) on IVUS Grey Scale Based Palpography at the End of Week 52. | Placebo | 0.003 | Standard Error 0.048 | Spots/10 mm | |
Change From Baseline in the Density of Rotterdam Classification (ROC) Grade III/IV Strain Spots/10 Millimeter (mm) Within the Region of Interest (ROI) on IVUS Grey Scale Based Palpography at the End of Week 52. | Darapladib 160 mg EC Tablet | -0.079 | Standard Error 0.045 | Spots/10 mm | |
| Circulating Hs-CRP at the End of Week 26. | Placebo | 0.924 | 95% Confidence Interval 0.774 to 1.102 | mg/L | |
| Circulating Hs-CRP at the End of Week 26. | Darapladib 160 mg EC Tablet | 0.960 | 95% Confidence Interval 0.815 to 1.131 | mg/L | |
| Mean Lipoprotein Phospholipase A2 (Lp-PLA2) Activity at the End of Week 26 and Week 52 | Placebo | Week 26 LOCF | 151.412 | 95% Confidence Interval 143.592 to 159.657 | micromole per minute per Litre |
| Mean Lipoprotein Phospholipase A2 (Lp-PLA2) Activity at the End of Week 26 and Week 52 | Darapladib 160 mg EC Tablet | Week 26 LOCF | 59.449 | 95% Confidence Interval 56.591 to 62.452 | micromole per minute per Litre |
| Mean Lipoprotein Phospholipase A2 (Lp-PLA2) Activity at the End of Week 26 and Week 52 | Placebo | Week 52 LOCF | 152.061 | 95% Confidence Interval 144.109 to 160.452 | micromole per minute per Litre |
| Mean Lipoprotein Phospholipase A2 (Lp-PLA2) Activity at the End of Week 26 and Week 52 | Darapladib 160 mg EC Tablet | Week 52 LOCF | 61.850 | 95% Confidence Interval 58.838 to 65.015 | micromole per minute per Litre |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 151 | |
| Overall Study | STARTED | Darapladib 160mg EC Tablet | 172 | |
| Overall Study | COMPLETED | Placebo | 130 | |
| Overall Study | COMPLETED | Darapladib 160mg EC Tablet | 152 | |
| Overall Study | NOT COMPLETED | Placebo | 21 | |
| Overall Study | NOT COMPLETED | Darapladib 160mg EC Tablet | 20 |
Source ClinicalTrials.gov
Adverse events140
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 | Angina pectoris | Cardiac disorders | Placebo | 12 | 151 | 14 |
| other | Angina pectoris | Cardiac disorders | Darapladib 160 mg EC Tablet | 18 | 172 | 23 |
| other | Urine odour abnormal | Renal and urinary disorders | Placebo | 4 | 151 | 4 |
| other | Urine odour abnormal | Renal and urinary disorders | Darapladib 160 mg EC Tablet | 17 | 172 | 17 |
| other | Abnormal faeces | Gastrointestinal disorders | Placebo | 2 | 151 | 2 |
| other | Abnormal faeces | Gastrointestinal disorders | Darapladib 160 mg EC Tablet | 18 | 172 | 18 |
| other | Fatigue | General disorders | Placebo | 10 | 151 | 11 |
| other | Fatigue | General disorders | Darapladib 160 mg EC Tablet | 10 | 172 | 10 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 10 | 151 | 12 |
| other | Nasopharyngitis | Infections and infestations | Darapladib 160 mg EC Tablet | 7 | 172 | 8 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 151 |
| Total, all-cause mortality | Darapladib 160 mg EC Tablet | 0 | 172 |
| Total, other adverse events | Placebo | 37 | 151 |
| Total, other adverse events | Darapladib 160 mg EC Tablet | 59 | 172 |
| Total, serious adverse events | Placebo | 45 | 151 |
| Total, serious adverse events | Darapladib 160 mg EC Tablet | 46 | 172 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 18765397 | BACKGROUND |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Darapladib 160 mg EC Tablet vs Placebo: deaths from any cause | Trial comparisons |
| Darapladib 160 mg EC Tablet vs Placebo: serious adverse events | Trial comparisons |
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/NCT00268996
GET https://conductscience.org/api/trials/v1/NCT00268996/results?page=2