Trial · NCT02304926
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Cholesterol Before and After Simvastatin/Ezetimibe Administration | Baseline, 4 weeks and 8 weeks | Total cholesterol concentration was measured by enzymatic assay |
| Primary | Low-density Lipoprotein Cholesterol (LDLc) Before and After Simvastatin/Ezetimibe Administration | Baseline, 4 weeks and 8 weeks | Low-density lipoprotein cholesterol (LDLc) concentration was calculated using the method of Friedewald. |
| Primary | High-density Lipoprotein Cholesterol (HDLc) Before and After Simvastatin/Ezetimibe Administration | Baseline, 4 weeks and 8 weeks | High-density lipoprotein cholesterol (HDLc) concentration was measured using a direct method |
| Primary | Triglycerides Before and After Simvastatin/Ezetimibe Administration | Baseline, 4 weeks and 8 weeks | Triglyceride concentration were measured by enzymatic assay |
| Primary | Non-HDL Cholesterol Before and After Simvastatin/Ezetimibe Administration | Baseline, 4 weeks and 8 weeks | Non-HDLc concentration was obtained by calculating the difference between total cholesterol and HDLc |
| Primary | Low Density Lipoprotein Size Before and After Simvastatin/Ezetimibe Administration | Baseline, 4 weeks and 8 weeks | LDL subfractions were separated by high-resolution polyacrylamide gel tubes using the Lipoprint® system. The LDL electrophoretic profile allows 2 patterns to be defined: pattern A or large and buoyant LDL, and pattern non-A or small and dense LDL. |
| Primary | Apolipoprotein B Before and After Simvastatin/Ezetimibe Administration | Baseline, 4 weeks and 8 weeks | Levels of apolipoprotein B were determined by inmunonephelometry |
| Secondary | Levels of High-sensitive C-reactive Protein (hsCRP) Before and After Simvastatin/Ezetimibe Administration | Baseline, 4 weeks and 8 weeks | Levels of high-sensitive C-reactive protein (hsCRP) were analysed by a latex-enhanced inmunonephelometric assay |
| Secondary | Levels of Interleukin-6 (IL-6) Before and After Simvastatin/Ezetimibe Administration | Baseline, 4 weeks and 8 weeks | Levels of proinflammatory cytokines (interleukin-6 (IL-6)) were analysed with a Luminex® 200™ system |
| Secondary | Levels of Tumor Necrosis Factor α (TNF-α) Before and After Simvastatin/Ezetimibe Administration | Baseline, 4 weeks and 8 weeks | Levels of proinflammatory cytokines (tumor necrosis factor α (TNF-α)) were analysed with a Luminex® 200™ system |
| Secondary | Mitochondrial Oxygen (O2) Consumption Before and After Simvastatin/Ezetimibe Administration | Baseline, 4 weeks and 8 weeks | Oxidative stress markers (mitochondrial oxygen (O2) consumption) was measured at baseline and after treatment by Clark electrode |
| Secondary | Reactive Oxygen Species (ROS) Production Before and After Simvastatin/Ezetimibe Administration | Baseline, 4 weeks and 8 weeks | Oxidative stress markers (Reactive oxygen species (ROS) production) was measured at baseline and after treatment by fluorometric techniques |
| Secondary | Membrane Potential Before and After Simvastatin/Ezetimibe Administration | Baseline, 4 weeks and 8 weeks | Oxidative stress markers (membrane potential) was measured at baseline and after treatment by fluorometric techniques |
| Secondary | Levels of Glutathione (GSH) Before and After Simvastatin/Ezetimibe Administration | Baseline, 4 weeks and 8 weeks | Oxidative stress markers (levels of glutathione (GSH)) was measured at baseline and after treatment by fluorometric techniques |
| Secondary | Leukocyte Rolling Flux Before and After Simvastatin/Ezetimibe Administration | Baseline, 4 weeks and 8 weeks | Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy. Leukocyte rolling was estimated as the number of leukocytes rolling over 100 μm2 of the endothelial monolayer during a 1-min period. |
| Secondary | Leukocyte Adhesion Before and After Simvastatin/Ezetimibe Administration | Baseline, 4 weeks and 8 weeks | Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy. Adhesion was evaluated by counting the number of polymorphonuclear cells that maintained stable contact with human umbilical vein endothelial cells (HUVEC) for 30 seconds. |
| Secondary | Leukocyte Rolling Velocity Before and After Simvastatin/Ezetimibe Administration | Baseline, 4 weeks and 8 weeks | Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy.The rolling velocity in the field of focus was determined by measuring the time required by 20 consecutive leukocytes to cover a distance of 100 μm. |
| Secondary | Levels of Vascular Cell Adhesion Molecule 1 (VCAM-1) Before and After Simvastatin/Ezetimibe Administration | Baseline, 4 weeks and 8 weeks | The vascular cell adhesion molecule 1 (VCAM-1) was evaluated in serum by Luminex® 200™ system |
| Secondary | Levels of Intercellular Adhesion Molecule 1 (ICAM-1) Before and After Simvastatin/Ezetimibe Administration | Baseline, 4 weeks and 8 weeks | The intercellular adhesion molecule 1 (ICAM-1) was evaluated in serum by Luminex® 200™ system |
| Secondary | Levels of E-selectin Before and After Simvastatin/Ezetimibe Administration | Baseline, 4 weeks and 8 weeks | E-selectin was evaluated in serum by Luminex® 200™ system |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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