Trial · NCT02624869
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of evolocumab in this study up to and including 30 days after the last dose or up to the end of study date, whichever was earlier; up to 80 weeks. | An adverse event is defined as any untoward medical occurrence in a clinical trial participant, not necessarily having a causal relationship with study treatment. A serious AE is as an AE that met at least 1 of the following criteria: * fatal; * life threatening; * required in-patient hospitalization or prolongation of existing hospitalization; * resulted in persistent or significant disability/incapacity; * congenital anomaly/birth defect; * other medically important serious event. AEs were graded for severity using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; urgent intervention indicated; Grade 5: Death related to AE. |
| Secondary | Percent Change From Baseline to Week 80 in Low-density Lipoprotein Cholesterol (LDL-C) in HeFH Participants | Baseline and week 80 | For HeFH participants baseline was defined as the baseline value of the parent study 20120123. |
| Secondary | Percent Change From Baseline to Week 80 in Low-density Lipoprotein Cholesterol (LDL-C) in HoFH Participants | Baseline and week 80 | For HoFH participants baseline was defined as the baseline value in this study (20120124). |
| Secondary | Percent Change From Baseline to Week 80 in Non-HDL-C in HeFH Participants | Baseline and week 80 | For HeFH participants baseline was defined as the baseline value of the parent study 20120123. |
| Secondary | Percent Change From Baseline to Week 80 in Non-HDL-C in HoFH Participants | Baseline and week 80 | For HoFH participants baseline was defined as the baseline value in this study (20120124). |
| Secondary | Percent Change From Baseline to Week 80 in Apolipoprotein B in HeFH Participants | Baseline and week 80 | For HeFH participants baseline was defined as the baseline value in the parent study 20120123. |
| Secondary | Percent Change From Baseline to Week 80 in Apolipoprotein B in HoFH Participants | Baseline and week 80 | For HoFH participants baseline was defined as the baseline value in this study (20120124). |
| Secondary | Percent Change From Baseline to Week 80 in Total Cholesterol/HDL-C Ratio in HeFH Participants | Baseline and week 80 | For HeFH participants baseline was defined as the baseline value in the parent study 20120123. |
| Secondary | Percent Change From Baseline to Week 80 in Total Cholesterol/HDL-C Ratio in HoFH Participants | Baseline and week 80 | For HoFH participants baseline was defined as the baseline value in this study (20120124). |
| Secondary | Percent Change From Baseline to Week 80 in Apolipoprotein B / Apolipoprotein A1 Ratio in HeFH Participants | Baseline and week 80 | For HeFH participants baseline was defined as the baseline value in the parent study 20120123. |
| Secondary | Percent Change From Baseline to Week 80 in Apolipoprotein B/Apolipoprotein A1 Ratio in HoFH Participants | Baseline and week 80 | For HoFH participants baseline was defined as the baseline value in this study (20120124). |
| Secondary | Change From Baseline to Week 80 in LDL-C in HeFH Participants | Baseline and week 80 | For HeFH participants baseline was defined as the baseline value of the parent study 20120123. |
| Secondary | Change From Baseline to Week 80 in LDL-C in HoFH Participants | Baseline and week 80 | For HoFH participants baseline was defined as the baseline value in this study (20120124). |
| Secondary | Change From Baseline to Week 80 in Estradiol Levels | Baseline and week 80 | For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124). |
| Secondary | Change From Baseline to Week 80 in Testosterone Levels | Baseline and week 80 | For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124). |
| Secondary | Change From Baseline to Week 80 in Follicle Stimulating Hormone (FSH) Levels | Baseline and week 80 | For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124). |
| Secondary | Change From Baseline to Week 80 in Luteinizing Hormone (LH) Levels | Baseline and week 80 | For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124). |
| Secondary | Change From Baseline to Week 80 in Adenocorticotropic Hormone (ACTH) Levels | Baseline and week 80 | For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124). |
| Secondary | Change From Baseline to Week 80 in Dehydroepiandrosterone Sulfate (DHEA-S) Levels | Baseline and week 80 | For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124). |
| Secondary | Change From Baseline to Week 80 in Cortisol Levels | Baseline and week 80 | For HeFH participants baseline was defined as the baseline value in the parent study 20120123. For HoFH participants baseline was defined as the baseline value in this study (20120124). |
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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