This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record.
1. Trial at a Glance
TRISTAN was a completed clinical study evaluating Tricor (fenofibrate), 145 mg film-coated tablets, in patients with metabolic syndrome and hypertriglyceridemia.
| Feature | TRISTAN |
|---|---|
| NCT Identifier | NCT04650152 |
| Status | COMPLETED |
| Study title | Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome (TRISTAN) |
| Sponsor | Abbott |
| Sponsor type | INDUSTRY |
| Conditions | Hypertriglyceridemia; Metabolic Syndrome |
| Intervention | Tricor (fenofibrate), 145 mg, film-coated tablet |
2. Clinical Question
Population
Patients with metabolic syndrome and hypertriglyceridemia.
Intervention
Tricor (fenofibrate), 145 mg, film-coated tablet.
Comparator
The registry describes a single-arm study; no comparator arm is listed.
Primary question
What change in triglycerides occurs after 6 months of fenofibrate treatment compared with baseline?
3. Trial Design
2020-10-27
2021-11-12
4. Endpoints
| Endpoint | Definition | Time Frame |
|---|---|---|
| Change of TG at Visit 3 versus baseline level at Visit 1 | Triglycerides represented in mmol/L; change displayed as mean difference of TG at Visit 3 versus Visit 1. | 6 months |
5. Planned Analysis
The registry lists the primary endpoint as the change in triglyceride concentration from baseline to Visit 3 after 6 months of fenofibrate treatment.
For a continuous laboratory measurement such as triglycerides, the statistical analysis would typically focus on estimating the mean change from baseline and its uncertainty. The registry specifies that the change will be displayed as the mean difference of triglycerides at Visit 3 versus Visit 1.
6. Statistical Methodology
Continuous endpoint analysis
The primary outcome is a continuous measurement. Analyses of continuous outcomes generally compare observed values over time or estimate the average within-participant change between two visits.
The estimated mean difference summarizes the average change in triglyceride concentration over the analysis population.
Baseline-to-follow-up comparisons
When participants are measured before and after treatment, statistical interpretation depends on the distribution of changes, variability between participants, missing observations, and the analysis population defined for the study.
Confidence intervals
A confidence interval around a mean change provides information about statistical precision. A narrower interval generally indicates a more precise estimate, while a wider interval reflects greater uncertainty.
7. Statistical Methods Explained
Why is triglyceride change analyzed rather than only the final value?
A change-from-baseline endpoint accounts for each participant's starting triglyceride level and evaluates movement over time.
What does a mean difference represent?
A mean difference summarizes the average amount by which triglyceride values changed between Visit 1 and Visit 3.
Why does variability matter?
Two studies can have the same average change but different levels of participant-to-participant variation. Statistical uncertainty depends on both the size of the change and its variability.
Why is the time frame important?
The endpoint is defined at 6 months, so interpretation is tied to the specified Visit 3 assessment rather than an unspecified longer-term period.
What information is needed to interpret a treatment effect fully?
For a complete statistical assessment, results such as the estimated change, confidence interval, and associated statistical analysis would be required.
8. Limitations
- No comparator arm: The registry describes a one-arm study, so changes over time cannot be directly compared with a randomized control group.
- No posted statistical analyses: The registry does not report endpoint estimates, confidence intervals, or p-values.
- Unreported analysis details: The registry does not provide additional statistical analysis details such as missing-data handling or subgroup analyses.
- Single endpoint focus: Interpretation is limited to the registered triglyceride change endpoint.
9. Why This Trial Matters Statistically
TRISTAN is a useful example for understanding statistical analysis of longitudinal continuous outcomes.
| Concept | How it appears in TRISTAN |
|---|---|
| Continuous outcome | Triglycerides measured in mmol/L |
| Change from baseline | Visit 3 compared with Visit 1 |
| Repeated measurement | Baseline and 6-month assessments |
| Mean difference | Registry-defined summary of TG change |
| Single-arm design | One listed study arm |
10. Sources
- ClinicalTrials.gov record: TRISTAN (NCT04650152)