| Outcome Measures: |
Primary: Change in Log CAC Volume Score From Baseline to Week 52 for the Combined Dose Groups vs Placebo, Coronary Artery Calcification (CAC) Volume Score is a calculation to quantify the calcification of coronary artery calcium without factoring in the calcium density as measured by the CAC Agatston Score. The CAC Score was log-transformed and the primary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for the combined dose groups vs placebo. The primary analysis used an ANCOVA model with the change in log volume score (log 52-week volume score - log baseline volume score) as the dependent variable and with a fixed effect term for the combined randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for the treatment groups was estimated and back transformed. A smaller change from baseline to follow up is a better outcome., Baseline (Week 1, Day 1) and Week 52 | Secondary: Change in Log CAC Volume Score From Baseline to Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo, Coronary Artery Calcification (CAC) Volume Score is a calculation to quantify the calcification of coronary artery calcium without factoring in the calcium density as measured by the CAC Agatston Score. The CAC Score was log-transformed and the primary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for the combined dose groups vs placebo. This secondary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for each dose group vs placebo. The analysis used an ANCOVA model with the change in log volume score (log 52-week volume score - log baseline volume score) as the dependent variable and with a fixed effect term for each randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for each of the treatment groups was estimated and back transformed. A smaller change from baseline to follow up is a better outcome., Baseline (Week 1, Day 1) and Week 52|Change in Log CAC Agatston Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and for the Combined Dose Groups vs the Placebo Group, Coronary Artery Calcification (CAC) Agatston Score is a semi-automated tool to calculate a score the reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to \>1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. This secondary outcome measure was the change in Log CAC Agatston Score from Baseline to Week 52 for each dose group and the treated arms combined vs placebo. The analysis used an ANCOVA model with the change in log score (log 52-week score - log baseline score) as the dependent variable and with a fixed effect term for each randomized treatment groups and log CAC score at baseline as a covariate. The least squares means for each of the treatment groups separately and combined was estimated and back transformed., Baseline (Week 1, Day 1) and Week 52|Number of Subjects With <15% Progression in CAC Agatston Score From Baseline to Week 52 for Each Dose Group and the Combined Dose Groups vs Placebo, Agatston score is a semi-automated tool to calculate a score that reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to \>1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. Change in Agatston Score values from baseline to Week 52 were calculated as a percentage of change (progression or worsening of calcification). The number of subjects with \<15% progression were counted., Baseline (Week 1, Day 1) and Week 52|Number of Subjects With >=15% Progression in CAC Agatston Score at Week 52 for Each Dose Group and the Combined Dose Groups vs Placebo, Agatston score is a semi-automated tool to calculate a score the reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to \>1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. Change in Agatston Score values from baseline to Week 52 was calculated as a percentage of change (progression or worsening of calcification). The number of subjects with \>=15% progression were counted for each treatment group, the combined treatments groups and placebo., Baseline (Week 1, Day 1) and Week 52|Change in Log Thoracic Aorta Calcification Volume Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo, Coronary Artery Calcification (CAC) Volume Score is a calculation to quantify the calcification of coronary artery calcium without factoring in the calcium density as measured by the CAC Agatston Score. The CAC volume score observed in the thoracic aorta was used for this analysis. The CAC volume Score was log-transformed and the primary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for the combined dose groups and each dose group vs placebo. The secondary analysis used an ANCOVA model with the change in log volume score (log 52-week volume score - log baseline volume score) as the dependent variable and with a fixed effect term for the combined randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for the treatment groups was estimated and back transformed. A smaller change from baseline to follow up is a better outcome., Baseline (Week 1, Day 1) and Week 52|Change in Log Thoracic Aorta Calcification Agatston Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo, Coronary Artery Calcification (CAC) Agatston Score is a semi-automated tool to calculate a score that reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to \>1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. This secondary outcome measure was the change in CAC Agatston Score in the thoracic aorta from Baseline to Week 52 for each dose group and the treated arms combined vs placebo. The analysis used an ANCOVA model with the change in log score (log 52-week score - log baseline score) as the dependent variable and with a fixed effect term for each randomized treatment groups and log CAC score at baseline as a covariate. The least squares means for each of the treatment groups separately and combined was estimated and back transformed. A smaller change from baseline to follow up is a better outcome., Baseline (Week 1, Day 1) and Week 52|Change in Log Aortic Valve Calcification Volume Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo, Coronary Artery Calcification (CAC) Volume Score is a calculation to quantify the calcification of coronary artery calcium without factoring in the calcium density as measured by the CAC Agatston Score. The CAC volume score observed in the aortic valve was used for this analysis. The CAC volume Score was log-transformed and the primary outcome measure was the change in Log CAC Volume Score from Baseline to Week 52 for the combined dose groups and each dose group vs placebo. The secondary analysis used an ANCOVA model with the change in log volume score (log 52-week volume score - log baseline volume score) as the dependent variable and with a fixed effect term for the combined randomized treatment groups and log CAC volume score at baseline as a covariate. The least squares means for the treatment groups was estimated and back transformed. A smaller change from baseline to follow up is a better outcome., Baseline (Week 1, Day 1) and Week 52|Change in Log Aortic Valve Calcification Agatston Score Between Baseline and Week 52 for Each Dose Group (300 mg and 600 mg) vs Placebo and the Combined Dose Groups vs Placebo, Coronary Artery Calcification (CAC) Agatston Score is a semi-automated tool to calculate a score the reflects the extent of coronary artery calcification as detected by an unenhanced CT scan. Scores range from 0 to \>1000 Agatston units where higher scores indicate an increased amount of calcification and an increased risk for a major adverse cardiac event. This secondary outcome measure was the change in Log CAC Agatston Score or the aortic valve from Baseline to Week 52 for each dose group and the treated arms combined vs placebo. The analysis used an ANCOVA model with the change in log score (log 52-week score - log baseline score) as the dependent variable and with a fixed effect term for each randomized treatment groups and log CAC score at baseline as a covariate. The least squares means for each of the treatment groups separately and combined was estimated and back transformed. A smaller change from baseline to follow up is a better outcome., Baseline (Week 1, Day 1) and Week 52|Number of Participants With the Composite Safety Endpoint (Cardiovascular Death, Nonfatal Myocardial Infarction, Non-fatal Stroke, Heart Failure or Non-fatal Cardiac Arrest., The number of subjects meeting this composite safety endpoint were counted and expressed by the randomized arm as a % of patients for the safety population.terms resulting in death from cardiovascular causes, myocardial infarction, stroke, or heart failure for each dose group and placebo were summarized ., Baseline (Week 1, Day 1) and Week 52|Mortality Rate (All-cause) for Each Dose Group and Placebo, The number of deaths were counted and expressed by the randomized arm as a % of patients for the safety population., Baseline (Week 1, Day 1) and Week 52
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| Locations: |
Bakersfield, California, 93308, United States|Chula Vista, California, 91910, United States|Escondido, California, 92025, United States|Granada Hills, California, 91344, United States|La Palma, California, 90623, United States|Long Beach, California, 90807, United States|Los Angeles, California, 90048, United States|Lynwood, California, 90262, United States|Northridge, California, 91324, United States|Riverside, California, 92505, United States|San Diego, California, 92111, United States|San Dimas, California, 91773, United States|Simi Valley, California, 93065, United States|Tarzana, California, 91356, United States|Whittier, California, 90603, United States|Arvada, Colorado, 80002, United States|Westminster, Colorado, 80031, United States|Middlebury, Connecticut, 06762, United States|Orange, Connecticut, 06477, United States|Hollywood, Florida, 33024, United States|Lauderdale Lakes, Florida, 33313-1638, United States|Miami Gardens, Florida, 33169, United States|Miami, Florida, 33133, United States|Ocala, Florida, 34471, United States|Tampa, Florida, 33614, United States|Evanston, Illinois, 60201, United States|Shreveport, Louisiana, 71101, United States|Pontiac, Michigan, 48341, United States|Roseville, Michigan, 48066, United States|Brookhaven, Mississippi, 39601, United States|Las Vegas, Nevada, 89106, United States|Reno, Nevada, 89511, United States|North Brunswick, New Jersey, 08902, United States|Bronx, New York, 10461, United States|College Point, New York, 11356, United States|Asheville, North Carolina, 28801, United States|Cincinnati, Ohio, 45267, United States|Bethlehem, Pennsylvania, 18017, United States|Knoxville, Tennessee, 37923, United States|Arlington, Texas, 76015, United States|Houston, Texas, 77024, United States|Houston, Texas, 77099, United States|Richardson, Texas, 75080, United States|San Antonio, Texas, 78207, United States|Chesapeake, Virginia, 23320, United States|Wauwatosa, Wisconsin, 53226, United States|Palma de Mallorca, Balearic Islands, 07198, Spain|Barcelona, Catalonia, 08025, Spain|Palma, Illes Balears, 07011, Spain|Palma, Islas Baleares, 07120, Spain|Galdakao, Vizcaya, 48960, Spain|Barcelona, 08003, Spain|Barcelona, 08035, Spain|Barcelona, 08036, Spain|Barcelona, 08208, Spain|Barcelona, 08970, Spain|Córdoba, 14004, Spain|Lleida, 25008, Spain|Lleida, 25198, Spain|Lugo, 27003, Spain|Madrid, 28040, Spain|Navarro, 31008, Spain|Oviedo, 33011, Spain|Palma, 07300, Spain|Santander, 39008, Spain|Sevilla, 41007, Spain|Valencia, 46010, Spain|Valencia, 46017, Spain|Zaragoza, 50009, Spain|Bradford, BD5 0NA, United Kingdom|Manchester, M13 9WL, United Kingdom|Salford, M6 8HD, United Kingdom|Shrewsbury, SY3 8XQ, United Kingdom|Swansea, SA6 6NL, United Kingdom|Westcliff-on-Sea, SS0 0RY, United Kingdom
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