Trial · NCT00268996
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| 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 |
| SECONDARY | Mean Myeloperoxidase (MPO) Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52 | Week 26 and Week 52 | Biomarker evaluable population | picomole per litre (pmol/L) | GEOMETRIC_MEAN |
| SECONDARY | Mean sCD40L Levels as Circulating Biomarkers Associated With Inflammatory Burden at Week 26 and Week 52 | Week 26 and Week 52 | Safety Population comprised of all randomized participants who received at least one dose of study drug. Only those participants with data available at the indicated time points were analyzed. | pg/ml | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Matrix Metaloproteinases-9 (MMP-9) Levels as Circulating Biomarkers Associated With Plaque Instability at Week 26 and Week 52. | Week 26 and Week 52 | Biomarker evaluable population | microgram per litre (mcg/L) | GEOMETRIC_MEAN |
| SECONDARY | Mean Levels of Oxidised Phospholipids/ Apolipoprotein B100 (oxPL/apoB) Ratio as Target Circulating Biomarkers at the End of Week 26 and Week 52. | Week 26 and Week 52 | Biomarker evaluable population. | Relative light units (RLU) | GEOMETRIC_MEAN |
| SECONDARY | Mean Levels of Oxidized Non-esterified Fatty Acids (Ox-NEFA) as Target Circulating Biomarkers at the End of Week 26 and Week 52 | Week 26 and Week 52 | Biomarker evaluable population | ||
| SECONDARY | Change From Baseline in Vessel Volume and Lumen Volume as IVUS-Grey Scale Assessments at Week 52. | Baseline and Week 52 | Imaging evaluable population | mm^3 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Plaque Area, Mean Vessel Area, and Mean Lumen Area as IVUS-Grey Scale Assessments at Week 52. | Baseline and Week 52 | Imaging evaluable population | mm2 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fibrous Tissue Volume and Fibro-fatty Volume as IVUS-VH Assessments at Week 52 | Baseline and Week 52 | Imaging evaluable population | mm^3 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fibrous Tissue and Fibro-fatty as a Percent of IVUS-VH Plaque as IVUS-VH Assessments at Week 52 | Baseline and Week 52 | Imaging evaluable population | Percentage of VH | LEAST_SQUARES_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT00268996/outcomes