Statins in Children With Type 1 Diabetes and Hypercholesterolemia

NCT01236365 on ClinicalTrials.gov Phase 3 Nemours Children's Clinic (academic or other) Started 2010-10-31 Completed

Riskier than 5% of active trials

Model scores of the 29,894 trials active now.

Model score 5% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 8% of the time (159 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

How it ended

Completed on 2014-11-30, after 2010-10-31 start.

The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2014-11-30. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Collaborators: 3 (lowers risk) · Design
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: plaqueabdominaldltherapyfunction
Phrases that lowered it: healthybmi20smokinginvestigate the
Drug's FAERS reports with a death: 6.7% (lowers risk) · Drug's FDA history
Phase: 3 (lowers risk) · Design
Design: parallel (raises risk) · Design
Blinding: quadruple (lowers risk) · Design
Responsible party: principal investigator (lowers risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Drug's FAERS reports marked serious: 70.4% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Has a data monitoring committee: Yes (raises risk) · Design
Primary purpose: treatment (raises risk) · Design
Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
Drug's FAERS reports in the prior 12 months: 14336 (lowers risk) · Drug's FDA history
Disease area, neurology: No (lowers risk) · Disease area
Drug's FAERS reports before start: 57577 (lowers risk) · Drug's FDA history
Minimum age: 10 (lowers risk) · Who can join
Keywords listed: 12 (raises risk) · Design

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: quadruple (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 3 (typical: 0)
Keywords listed: 12 (typical: 1)

Who can join

Minimum age: 10 (typical: 18)
Maximum age: 20 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 7 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 4 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 57577 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 14336 (typical: 412.5)
Drug's FAERS reports marked serious: 70.4% (typical: 85.6%)
Drug's FAERS reports with a death: 6.7% (typical: 15.9%)

Disease area and drugs

Disease areas: metabolic, immunology, endocrine
Drugs matched to FDA substances: atorvastatin

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

EMERALD: Effects of Metformin on Cardiovascular Function in Adolescents With Type 1 Diabetes NCT01808690 · started 2013 · scored riskier than 27% of active trials completed
Effect of Metformin in Children With Type 1 Diabetes NCT04879511 · started 2018 · scored riskier than 7% of active trials completed
Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial NCT01581476 · started 2009 · scored riskier than 10% of active trials completed
The Impact of Sitagliptin as an Add on Therapy With Closed Loop Control in Adolescents With Diabetic Nephropathy NCT06115460 · started 2022 · scored riskier than 14% of active trials completed
Dyslipidemia of Obesity Intervention in Teens NCT02956590 · started 2018 · scored riskier than 49% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.