Trial · NCT03156621
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12 (Intent-to-Treat [ITT] Estimand) | Baseline to Week 12 | The percent change in LDL-C from baseline to week 12 is defined as: 100x (LDL-C value at week 12 - LDL-C value at baseline) / LDL-C value at baseline. |
| Secondary | Percent Change in Apolipoprotein (Apo) B From Baseline to Week 12 (ITT Estimand) | Baseline to Week 12 | ITT estimand; The percent change in Apo B from baseline to week 12 is defined as: 100x (Apo B value at week 12 - Apo B value at baseline) / Apo B value at baseline. |
| Secondary | Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 12 | Baseline to Week 12 | ITT estimand; The percent change in non-HDL-C from baseline to week 12 is defined as: 100x (non-HDL-C value at week 12 - non-HDL-C value at baseline) / non-HDL-C value at baseline. |
| Secondary | Percent Change in Total Cholesterol (TC) From Baseline to Week 12 | Baseline to Week 12 | ITT estimand; The percent change in TC from baseline to week 12 is defined as: 100x (TC value at week 12 - TC value at baseline) / TC value at baseline. |
| Secondary | Percentage of Participants With ≥15% Reduction in LDL-C at Week 12 | At Week 12 | ITT estimand |
| Secondary | Percentage of Participants With ≥30% Reduction in LDL-C at Week 12 | At Week 12 | ITT estimand |
| Secondary | Percent Change in Lipoprotein(a) [Lp(a)] From Baseline to Week 12 | Baseline to Week 12 | ITT estimand; The percent change in Lp(a) from baseline to week 12 is defined as: 100x (Lp(a) value at week 12 - Lp(a) value at baseline) / Lp(a) value at baseline. |
| Secondary | Percentage of Participants With ≥50% Reduction in LDL-C at Week 12 | At Week 12 | ITT estimand |
| Secondary | Percent Change in HDL-C From Baseline to Week 12 - ITT Analysis | Baseline to Week 12 | ITT estimand; The percent change in HDL-C from baseline to week 12 is defined as: 100x (HDL-C value at week 12 - HDL-C value at baseline) / HDL-C value at baseline. |
| Secondary | Percent Change in Fasting Triglycerides (TG) From Baseline to Week 12 | Baseline to Week 12 | ITT estimand; The percent change in TG from baseline to week 12 is defined as: 100x (TG value at week 12 - TG value at baseline) / TG value at baseline. |
| Secondary | Percent Change in Apo A-1 From Baseline to Week 12 -- ITT Analysis | Baseline to Week 12 | ITT estimand; The percent change in Apo A-1 from baseline to week 12 is defined as: 100x (Apo A-1 value at week 12 - Apo A-1 value at baseline) / Apo A-1 value at baseline. |
| Secondary | Percent Change in LDL-C From Baseline to Week 12 (On-treatment Estimand) | Baseline to Week 12 | Percent change for LDL-C from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first double-blind investigational study drug injection up to 21 days after the last double-blind investigational study drug injection, or the first dose of the open-label investigational study drug, whichever is earlier. |
| Secondary | Percent Change in Apo B From Baseline to Week 12 (On-treatment Estimand) | Baseline to Week 12 | Percent change for Apo B from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first double-blind investigational study drug injection up to 21 days after the last double-blind investigational study drug injection, or the first dose of the open-label nvestigational study drug, whichever is earlier. |
| Secondary | Percent Change in Non-HDL-C From Baseline to Week 12 (On-treatment Estimand) | Baseline to Week 12 | Percent change for non-HDL-C from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first double-blind investigational study drug injection up to 21 days after the last double-blind investigational study drug injection, or the first dose of the open-label investigational study drug, whichever is earlier. |
| Secondary | Percent Change in TC From Baseline to Week 12 (On-treatment Estimand) | Baseline to Week 12 | Percent change for TC from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first double-blind investigational study drug injection up to 21 days after the last double-blind investigational study drug injection, or the first dose of the open-label investigational study drug, whichever is earlier. |
| Secondary | Percent Change in Lp(a) From Baseline to Week 12 (On-treatment Estimand) | Baseline to Week 12 | Percent change for LP(a) from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first double-blind investigational study drug injection up to 21 days after the last double-blind investigational study drug injection, or the first dose of the open-label investigational study drug, whichever is earlier. |
| Secondary | Percent Change in HDL-C From Baseline to Week 12 (On-treatment Estimand) | Baseline to Week 12 | Percent change for HDL-C from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first double-blind investigational study drug injection up to 21 days after the last double-blind investigational study drug injection, or the first dose of the open-label investigational study drug, whichever is earlier. |
| Secondary | Percent Change in Fasting TG From Baseline to Week 12 (On-treatment Estimand) | Baseline to Week 12 | Percent change for fasting TG from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first double-blind investigational study drug injection up to 21 days after the last double-blind investigational study drug injection, or the first dose of the open-label investigational study drug, whichever is earlier. |
| Secondary | Percent Change in Apo A-1 From Baseline to Week 12 (On-treatment Estimand) | Baseline to Week 12 | Percent change for Apo A-1 from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first double-blind investigational study drug injection up to 21 days after the last double-blind investigational study drug injection, or the first dose of the open-label investigational study drug, whichever is earlier. |
| Secondary | Percentage of Participants With ≥15% Reduction, ≥30% Reduction, and ≥50% Reduction in LDL-C at Week 12 (On-treatment Estimand) | At Week 12 |
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/NCT03156621/registered