Trial · NCT01514461
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Fasting Triglycerides From Baseline to 12 Weeks | Baseline to 12 weeks | Blood samples were collected for a fasting lipid panel, including triglycerides. If the 12-week value was missing, the measurement value at 12 weeks or the last available post-baseline measurement value during the double-blind treatment period was analyzed. Baseline is defined as the average of fasting triglyceride values taken at day -3 and day 1. Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressing as a percentage change from baseline. |
| 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 | Percentage calculated as (m/n)\*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride. |
| 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 | Percentage calculated as (m/n)\*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride. |
| 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 | Percentage calculated as (m/n)\*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride. |
| Secondary | Percentage of Patients Achieving Fasting Triglycerides (TG) Target Thresholds | 12 weeks, 24 weeks, 52 weeks | Percentage of patients reaching target values of \<1000 mg/dL or target values of \< 2000 mg/dL for fasting triglycerides is reported. Pecentage calculated as (m/n)\*100; where 'm' The number of patients who reach target values for fasting triglyceride, 'n' the number of patients with non-missing fasting triglyceride. |
| Secondary | Percent Change From Baseline in Fasting Triglycerides | Baseline, 24 weeks, 52 weeks | |
| Secondary | Percent Change From Baseline for Postprandial Triglycerides Following the Standardized Meal Tolerance Test at Week 12 | 0-24 hours at Baseline, Week 12 | Post prandial peak triglycerides - maximum triglyceride value over 0-24 hours Post prandial triglycerides AUC0-24 - area under the time curve for triglycerides over 0-24 Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressed as a percentage change from baseline. hours |
| 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 | Lowest observed blood concentration (Cmin) and observed maximum blood concentration (Cmax) following drug administration derived from non-compartmental analysis using scheduled sampling time for the whole dataset. |
| 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 | The area under the concentration-time curve from time zero to 24 hours after drug administration was calculated by using linear trapezoidal rule. |
| 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 | |
| Secondary | Pharmacokinetics of LCQ908- Average Observed Blood Concentration (Cavg) | 0, 1, 2, 3, 4, 6, and 24 hours at Week 12 | Average observed blood concentration measured by (AUC0-24)/24. |
| Secondary | Number of Patients Reported With Any Adverse Event, Serious Adverse Event and Death | 52 weeks |
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/registered