Trial · NCT02392559
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline to Week 24 in LDL-C | Baseline, Week 24 | Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from interactive voice response system \[IVRS\]), scheduled visit and the interaction of treatment with scheduled visit as covariates. The model uses an unstructured covariance. |
| Secondary | Mean Percent Change From Baseline to Mean of Weeks 22 and 24 in LDL-C | Baseline, Week 22, Week 24 | Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Secondary | Change From Baseline to Week 24 in LDL-C | Baseline, Week 24 | Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Secondary | Percent Change From Baseline to Week 24 in Non-HDL-C | Baseline, Week 24 | Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates |
| Secondary | Percent Change From Baseline to Week 24 in Apoliprotein-B (ApoB) | Baseline, Week 24 | Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Secondary | Percent Change From Baseline to Week 24 in Total Cholesterol/HDL-C Ratio | Baseline, Week 24 | Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Secondary | Percent Change From Baseline to Week 24 in ApoB:ApoA1 Ratio | Baseline, Week 24 | Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation (DC), Fatal TEAEs, and Device-Related TEAEs | From first dose of study drug up to and including 30 days after the last dose or end of study date (Week 24), whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for Placebo and EvoMab arms, respectively. | An adverse event (AE) is defined as any untoward medical occurrence that does not necessarily have a causal relationship with study treatment. An SAE is defined as an adverse event that: is fatal; is a life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other medically important serious event. Events were graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading scale (1=mild; 2=moderate; 3=severe; 4=life-threatening; 5=death). Events were defined as treatment emergent if they occurred after the first dose of study drug and up to and including 30 days after the last dose or the end of study date, whichever is earlier. |
| Secondary | Number of Participants With Maximum Post-Baseline Laboratory Toxicities of Grade ≥ 3 | Week 24 | Laboratory toxicity grading was based on NCI CTCAE grading. Grade 3 indicates severe toxicity and Grade 4 indicates life-threatening toxicity. Values representing a worsening from baseline are shown. |
| Secondary | Change From Baseline Over Time in Systolic Blood Pressure | Baseline, Week 4, Week 12, Week 20, Week 22, Week 24 | |
| Secondary | Change From Baseline Over Time in Diastolic Blood Pressure | Baseline, Week 4, Week 12, Week 20, Week 22, Week 24 | |
| Secondary | Change From Baseline Over Time in Heart Rate | Baseline, Week 4, Week 12, Week 20, Week 22, Week 24 | |
| Secondary | Number of Participants Testing Positive for Anti-Evolocumab Antibodies | up to Week 24 | |
| Secondary | Serum Evolocumab Concentrations Over Time | Week 12, Week 22, Week 24 |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02392559/registered