Adults 18 to 80, any sex, with Atherosclerosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Circulating High Sensitivity C- Reactive Protein (Hs-CRP) Levels at Week 52.Primary· 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-varianc
Group
Value
95% CI
Placebo
1.034
0.854 – 1.251
Darapladib 160 mg EC Tablet
0.913
0.765 – 1.090
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.Primary· 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
Group
Value
95% CI
Placebo
0.003
± 0.048
Darapladib 160 mg EC Tablet
-0.079
± 0.045
Circulating Hs-CRP at the End of Week 26.Secondary· 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 inc
Group
Value
95% CI
Placebo
0.924
0.774 – 1.102
Darapladib 160 mg EC Tablet
0.960
0.815 – 1.131
Mean Lipoprotein Phospholipase A2 (Lp-PLA2) Activity at the End of Week 26 and Week 52Secondary· 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.
Week 26 LOCF
Group
Value
95% CI
Placebo
151.412
143.592 – 159.657
Darapladib 160 mg EC Tablet
59.449
56.591 – 62.452
Week 52 LOCF
Group
Value
95% CI
Placebo
152.061
144.109 – 160.452
Darapladib 160 mg EC Tablet
61.850
58.838 – 65.015
Change From Baseline in Plaque Volume as IVUS-Grey Scale Assessments at Week 52Secondary· 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.
Group
Value
95% CI
Placebo
-5.126
± 2.715
Darapladib 160 mg EC Tablet
-4.873
± 2.464
Change From Baseline in Percent Obstruction Volume as IVUS-Grey Scale Assessments at Week 52Secondary· 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.
Group
Value
95% CI
Placebo
0.007
± 0.354
Darapladib 160 mg EC Tablet
-0.054
± 0.321
Change From Baseline in Necrotic Core Volume as Intravenous Ultrasound-Virtual Histology (IVUS-VH) Assessments at Week 52Secondary· 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 IV
Group
Value
95% CI
Placebo
4.633
± 1.491
Darapladib 160 mg EC Tablet
-0.531
± 1.376
Change From Baseline in Necrotic Core as a Percent of IVUS-VH Plaque at the End of Week 52.Secondary· 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.
Group
Value
95% CI
Placebo
2.502
± 0.722
Darapladib 160 mg EC Tablet
0.535
± 0.666
Mean Interlukin 6 (IL-6) Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52Secondary· 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
Week 26 LOCF
Group
Value
95% CI
Placebo
1.851
1.609 – 2.128
Darapladib 160 mg EC Tablet
1.979
1.741 – 2.250
Week 52 LOCF
Group
Value
95% CI
Placebo
2.019
1.749 – 2.331
Darapladib 160 mg EC Tablet
2.267
1.985 – 2.588
Mean Intercellular Adhesion Molecule-1 (ICAM-1) Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52Secondary· 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 co
Week 26 (LOCF)
Group
Value
95% CI
Placebo
269.444
258.932 – 280.383
Darapladib 160 mg EC Tablet
266.447
256.744 – 276.516
Week 52 (LOCF)
Group
Value
95% CI
Placebo
277.947
265.822 – 290.624
Darapladib 160 mg EC Tablet
268.950
257.998 – 280.367
Mean Myeloperoxidase (MPO) Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52Secondary· Week 26 and Week 52
Blood was collected at baseline, Week 4, 13, 26 and 52 for evaluation of biomarkers. Mean MPO 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. MPO 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 MPO levels at Week 26 and 52 were reported. The levels were analyzed using ANCOVA, with ACS status, pooled country and
Week 26 (LOCF)
Group
Value
95% CI
Placebo
324.534
294.535 – 357.589
Darapladib 160 mg EC Tablet
378.811
346.275 – 414.405
Week 52 (LOCF)
Group
Value
95% CI
Placebo
370.999
331.989 – 414.592
Darapladib 160 mg EC Tablet
405.339
365.718 – 449.253
Mean sCD40L Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52Secondary· Week 26 and Week 52
Blood was collected at baseline, Week 4, 13, 26 and 52 for evaluation of biomarkers. Mean sCD40L levels as circulating biomarker associated with inflammatory burden at Week 26 and Week 52 were assessed and reported. sCD40L 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 sCD40L levels at Week 26 and 52 were reported. The levels were analyzed using ANCOVA, with ACS status, pooled country and treatment included as covariates.
Week 26
Group
Value
95% CI
Placebo
178.738
152.832 – 209.035
Darapladib 160 mg EC Tablet
206.351
177.412 – 240.012
Week 52
Group
Value
95% CI
Placebo
183.449
149.887 – 224.526
Darapladib 160 mg EC Tablet
254.200
208.840 – 309.412
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events (AEs) were recorded from the time a participant consents to participate until completion of follow-up period (10 to 21 days after discontinuation of treatment). On-treatment (up to 52 weeks) serious-AE (SAE) and non-SAE are reported..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
IBIS-2 is a study using SB-480848 versus placebo in subjects with angiographically documented coronary heart disease. Endpoints include coronary imaging, endothelial function, biomarkers, safety and tolerability.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 20 March 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00268996.