A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities

NCT01715818 on ClinicalTrials.gov Phase 3 Hoffmann-La Roche (industry) Started 2012-12-31 Completed

Riskier than 75% of active trials

Model scores of the 29,894 trials active now.

Model score 21% 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 14% of the time (493 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 2013-11-30, after 2012-12-31 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 2013-11-30. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: cancerpatientsstablepriorcell
Phrases that lowered it: evaluate thecardiovascularhistoryto evaluatescreening
Accepts healthy volunteers: No (raises risk) · Who can join
Minimum age: 40 (lowers risk) · Who can join
Has a data monitoring committee: not given (lowers risk) · Design
Sponsor's past termination rate: 9.0% (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
Disease area, cardiovascular: Yes (raises risk) · Disease area
Phase: 3 (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Sponsor type: industry (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 222 (raises risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Blinding: double (raises risk) · Design
Sponsor's past trials: 591 (raises risk) · Sponsor's track record
Disease area, metabolic: Yes (lowers risk) · Disease area

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: double (typical: none)
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 40 (typical: 18)
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 591 (typical: 32)
Sponsor's past termination rate: 9.0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 222 (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: 6 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 5 (typical: 412.5)
Drug's FAERS reports marked serious: 100% (typical: 85.6%)
Drug's FAERS reports with a death: 0% (typical: 15.9%)

Disease area and drugs

Disease areas: cardiovascular, metabolic, endocrine
Drugs matched to FDA substances: aleglitazar

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

A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus NCT01042769 · started 2010 · scored riskier than 57% of active trials completed
A Study to Evaluate the Effect of Aleglitazar on Cardiac Energetics and Function in Patients With Type 2 Diabetes Mellitus and no History of Coronary Artery Disease NCT01680978 · started 2012 · scored riskier than 14% of active trials completed
A Study of Aleglitazar in Monotherapy in Patients With Type 2 Diabetes Mellitus Who Are Drug-Naïve to Anti-Hyperglycemic Therapy NCT01871428 · started 2013 · scored riskier than 23% of active trials completed
A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Monotherapy NCT01871415 · started 2013 · scored riskier than 16% of active trials completed
A Study of The Effect of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin NCT01729403 · started 2012 · scored riskier than 37% 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.