Trial · NCT01514461
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Fasting Triglycerides From Baseline to 12 Weeks | Baseline to 12 weeks | Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized. The number of randomized patients with non-missing fasting triglycerides values at baseline and Week 12 are included in this analysis. | percent change | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline or Final Fasting TG < 8.4 mmol/L (750 mg/dL) | Baseline, 12 weeks, 24 weeks, 52 weeks | Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Responding to Investigational Treatment by Achieving Final Fasting Triglycerides < 8.4 mmol/L (750 mg/dL) | 12 weeks, 24 weeks, 52 weeks | Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline | Baseline, 12 weeks, 24 weeks, 52 weeks | Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Achieving Fasting Triglycerides (TG) Target Thresholds | 12 weeks, 24 weeks, 52 weeks | Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized. | Percentage of patients | NUMBER |
| SECONDARY | Percent Change From Baseline in Fasting Triglycerides | Baseline, 24 weeks, 52 weeks | Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized. | Percent change | GEOMETRIC_MEAN |
| SECONDARY | Percent Change From Baseline for Postprandial Triglycerides Following the Standardized Meal Tolerance Test at Week 12 | 0-24 hours at Baseline, Week 12 | Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized. For each category, the number of randomized patients who have non-missing values are included in this analysis. | Percent change | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics of LCQ908 - Trough Concentration (Cmin) and Observed Maximum Blood Concentration (Cmax) | 0, 1, 2, 3, 4, 6, and 24 hours at Week 12 | Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment | ng/mL | MEAN |
| SECONDARY | Pharmacokinetics of LCQ908- Area Under the Plasma Concentration Time Curve AUC (0-24hour) | 0, 1, 2, 3, 4, 6, and 24 hours at Week 12 | Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment | ng/mL *hr | MEAN |
| SECONDARY | Pharmacokinetics of LCQ908- Time to Reach Maximum Concentration Following Drug Administration Tmax (Hours) | 0, 1, 2, 3, 4, 6, and 24 hours at Week 12 | Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. | hours | MEDIAN |
| SECONDARY | Pharmacokinetics of LCQ908- Average Observed Blood Concentration (Cavg) | 0, 1, 2, 3, 4, 6, and 24 hours at Week 12 | Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. | ng/mL | MEAN |
| SECONDARY | Number of Patients Reported With Any Adverse Event, Serious Adverse Event and Death | 52 weeks | Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. | Participants | NUMBER |
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/NCT01514461/outcomes