Trial · NCT02957682
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Cognitive Domain Spatial Working Memory (SWM) Strategy Z-Score at Week 96 | Week 96 | Primary safety population included participants from the safety population who had an assessment of the SWM strategy score at baseline, and at least 1 score measured during the treatment-emergent adverse event (TEAE) period. The TEAE period is defined as the first double-blind treatment dose to last dose of double-blind treatment + 70 days (10 weeks). Participants were analyzed according to the treatment actually received. | Z-score | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in CANTAB Cognitive Domain SWM Strategy Raw Score at Week 96 | Week 96 | Primary safety population included participants from the safety population who had an assessment of the SWM strategy score at baseline, and at least 1 score measured during the treatment-emergent adverse event (TEAE) period. The TEAE period is defined as the first double-blind treatment dose to last dose of double-blind treatment + 70 days (10 weeks). Participants were analyzed according to the treatment actually received. | Units on a Scale | MEAN |
| SECONDARY | Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | Intent-to-treat (ITT) population included all participants with availability of at least 1 measurement value for calculated LDL-C before first dose of study drug (i.e. baseline) and within 1 of the analysis windows during the main efficacy period; the main efficacy period is defined as the time from the first double-blind study treatment injection up to the upper limit of the week 96 analysis window. ITT population analyzed according to treatment group allocated by randomization (as-randomized). | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein (Apo) B at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | ITT population included all participants with availability of at least 1 measurement value for calculated LDL-C before first dose of study drug (i.e. baseline) and within 1 of the analysis windows during the main efficacy period; the main efficacy period is defined as the time from the first double-blind study treatment injection up to the upper limit of the week 96 analysis window. ITT population analyzed according to treatment group allocated by randomization (as-randomized). | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | ITT population included all participants with availability of at least 1 measurement value for calculated LDL-C before first dose of study drug (i.e. baseline) and within 1 of the analysis windows during the main efficacy period; the main efficacy period is defined as the time from the first double-blind study treatment injection up to the upper limit of the week 96 analysis window. ITT population analyzed according to treatment group allocated by randomization (as-randomized). | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | ITT population included all participants with availability of at least 1 measurement value for calculated LDL-C before first dose of study drug (i.e. baseline) and within 1 of the analysis windows during the main efficacy period; the main efficacy period is defined as the time from the first double-blind study treatment injection up to the upper limit of the week 96 analysis window. ITT population analyzed according to treatment group allocated by randomization (as-randomized). | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | ITT Population was used. The two-step multiple imputation procedure is used to address missing values in the randomized population. In the first step, the monotone missing pattern is induced in the multiply-imputed data. In the second step, the missing data at subsequent visits are imputed using the regression method for continuous variables. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | ITT population included all participants with availability of at least 1 measurement value for calculated LDL-C before first dose of study drug (i.e. baseline) and within 1 of the analysis windows during the main efficacy period; the main efficacy period is defined as the time from the first double-blind study treatment injection up to the upper limit of the week 96 analysis window. ITT population analyzed according to treatment group allocated by randomization (as-randomized). | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Triglycerides (TG) at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | ITT population was used. The two-step multiple imputation procedure is used to address missing values in the randomized population. In the first step, the monotone missing pattern is induced in the multiply-imputed data. In the second step, the missing data at subsequent visits are imputed using the regression method for continuous variables | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein (Apo) A-1 at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | ITT population included all participants with availability of at least 1 measurement value for calculated LDL-C before first dose of study drug (i.e. baseline) and within 1 of the analysis windows during the main efficacy period; the main efficacy period is defined as the time from the first double-blind study treatment injection up to the upper limit of the week 96 analysis window. ITT population analyzed according to treatment group allocated by randomization (as-randomized). | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Reached Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than (<) 70 mg/dL (1.81 Millimoles Per Liter [mmol/L]) at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | ITT population was used. The two-step multiple imputation procedure is used to address missing values in the randomized population. In the first step, the monotone missing pattern is induced in the multiply-imputed data. In the second step, the missing data at subsequent visits are imputed using the regression method for continuous variables. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Reached Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than (<) 50 mg/dL (1.29 mmol/L) at Week 12, 24, 48, 72, and 96 | Week 12, 24, 48, 72, and 96 | ITT population was used. The two-step multiple imputation procedure is used to address missing values in the randomized population. In the first step, the monotone missing pattern is induced in the multiply-imputed data. In the second step, the missing data at subsequent visits are imputed using the regression method for continuous variables. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Up to Week 96 | Safety population included all participants randomized and exposed to at least 1 dose of study drug, regardless of the amount of treatment administered. | Participants | COUNT_OF_PARTICIPANTS |
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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