Trial · NCT04233918
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Maximum Observed Serum Concentration (Cmax) of Evinacumab | At day 12 | Pharmacokinetic (PK) Analysis Set included all participants who received any study drug and who had at least 1 non-missing result for concentration of evinacumab following the first dose of study drug. | Milligrams per Liter (mg/L) | MEAN |
| PRIMARY | Part A: Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUClast) of Evinacumab | Up to Week 12 | PK Analysis Set included all participants who received any study drug and who had at least 1 non-missing result for concentration of evinacumab following the first dose of study drug. | Days*Milligrams per Liter (day*mg/L) | MEAN |
| PRIMARY | Part A: Terminal Half-Life (t1/2) of Evinacumab | Up to week 12 | PK Analysis Set included all participants who received any study drug and who had at least 1 non-missing result for concentration of evinacumab following the first dose of study drug. | Days | MEDIAN |
| PRIMARY | Part B: Percent Change in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 24 | Baseline to Week 24 | The intent-to-treat (ITT) population included all participants who received at least 1 dose or part of a dose of study drug in Part B. | Percentage of Change | MEAN |
| SECONDARY | Part A and Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Part A: up to Week 24; Part B: up to Week 48 | The safety analysis set (SAF) includes all patients in Part A or Part B who received at least 1 dose or part of a dose of study drug in the respective study treatment period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part B: Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 24 | Baseline to Week 24 | ITT population included all participants who received at least 1 dose or part of a dose of study drug in Part B. | Percentage of Change | MEAN |
| SECONDARY | Part B: Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 24 | Baseline to Week 24 | ITT population included all participants who received at least 1 dose or part of a dose of study drug in Part B. | Percentage of Change | MEAN |
| SECONDARY | Part B: Percent Change in Total Cholesterol (TC) From Baseline to Week 24 | Baseline to Week 24 | ITT population included all participants who received at least 1 dose or part of a dose of study drug in Part B. | Percentage of Change | MEAN |
| SECONDARY | Part B: Percentage of Participants With ≥50 Percent (%) Reduction in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24 | Week 24 | ITT population included all participants who received at least 1 dose or part of a dose of study drug in Part B. | Percentage of Participants | NUMBER |
| SECONDARY | Part B: Percent Change in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 24 in Participants Who Have Negative/Negative and Null/Null Mutations | Baseline to Week 24 | ITT population included all participants who received at least 1 dose or part of a dose of study drug in Part B. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specified category. | Percentage of Change | MEAN |
| SECONDARY | Part B: Percent Change in Lipoprotein A (Lp[a]) From Baseline to Week 24 | Baseline to Week 24 | ITT population included all participants who received at least 1 dose or part of a dose of study drug in Part B. | Percentage of Change | MEAN |
| SECONDARY | Part B: Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Week 24 | Baseline, Week 24 | ITT population included all participants who received at least 1 dose or part of a dose of study drug in Part B. | Milligrams per Deciliter (mg/dL) | MEAN |
| SECONDARY | Part B: Serum Concentration of Total Evinacumab | Pre-dose at Weeks 0, 4, 8, 12; End of infusion at Weeks 0.006, 4.006, 8.006, 12.006 and 24 | PK Analysis Set included all participants who received any study drug and who had at least 1 non-missing result for concentration of evinacumab following the first dose of study drug. Here, Number Analyzed signifies those participants who were evaluable for this outcome measure at specified timepoints. | Milligrams per Liter (mg/L) | MEAN |
| SECONDARY | Part B: Maximum Serum Concentration at Steady State (Cmax,ss) of Evinacumab | Post-dose up to day 169 | PK Analysis Set included all participants who received any study drug and who had at least 1 non-missing result for concentration of evinacumab following the first dose of study drug. | Milligrams per Liter (mg/L) | MEAN |
| SECONDARY | Part B: Area Under the Serum Concentration-time Curve at Steady State (AUCtau.ss) of Evinacumab | Post-dose up to day 169 | PK Analysis Set included all participants who received any study drug and who had at least 1 non-missing result for concentration of evinacumab following the first dose of study drug. | Day*Milligrams per Liter (Day*mg/L) | MEAN |
| SECONDARY | Part B: Minimum Serum Concentration at Steady State (Ctrough.ss) of Evinacumab | Post-dose up to day 169 | PK Analysis Set included all participants who received any study drug and who had at least 1 non-missing result for concentration of evinacumab following the first dose of study drug. | Milligrams per Liter (mg/L) | MEAN |
| SECONDARY | Part B: Percent Change in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 24 in Participants Who Have by Null/Null vs. Non-null/Null and Negative/Negative vs.Non-negative/Negative Mutations | Baseline to Week 24 | ITT population included all participants who received at least 1 dose or part of a dose of study drug in Part B. | Percentage of Change | MEAN |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04233918/outcomes