Trial · NCT01507831
Outcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Experienced Adverse Events (AEs) | Up to 10 weeks after last study drug administration (maximum of 86 weeks) | Safety population: all randomized participants who received at least one dose or part of a dose of a study drug (treated). | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis | From Baseline to Week 52 | ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis | From Baseline to Week 52 | Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | From Baseline to Week 52 | ITT population. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis | From Baseline to Week 52 | mITT population. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis | From Baseline to Week 52 | Participants of the ITT population with one baseline and at least one post-baseline measured LDL-C value on- or off-treatment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis | From Baseline to Week 52 | Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis | From Baseline to Week 52 | Participants of the mITT population with one baseline and at least one post-baseline Apo-B value on-treatment (Apo B mITT population). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis | From Baseline to Week 52 | Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis | From Baseline to Week 52 | Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis | From Baseline to Week 52 | Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apo B at Week 12 - ITT Analysis | From Baseline to Week 52 | Apo B ITT population. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis | From Baseline to Week 52 | Non-HDL-C ITT population. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total-C at Week 12 - ITT Analysis | From Baseline to Week 52 | Total-C ITT population. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Very High Cardiovascular (CV) Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis | Up to Week 52 | ITT population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis | Up to Week 52 | mITT population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis | Up to Week 52 | ITT population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis | Up to Week 52 | mITT population. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis | From Baseline to Week 52 | ITT population. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis | From Baseline to Week 52 | Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population). | percent change | LEAST_SQUARES_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
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GET https://conductscience.org/api/trials/v1/NCT01507831/outcomes