Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)

NCT00862251 on ClinicalTrials.gov Phase 3 Organon and Co (industry) Started 2009-04-30 Completed

Riskier than 13% of active trials

Model scores of the 29,894 trials active now.

Model score 9% for any early termination, 1% 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 2011-03-31, after 2009-04-30 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 2011-03-31. 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

Sponsor's past termination rate: 4.1% (lowers risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: patientcontrolledpurposecurrentlyheart
Phrases that lowered it: the efficacyrosuvastatincardiovascularcombinationdrugs
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 49 (lowers risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Drug's FAERS reports with a death: 6.2% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports marked serious: 77.0% (lowers risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Sponsor's past trials: 320 (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Number of arms: 3 (lowers risk) · Design
Drug's FAERS reports before start: 88053 (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports in the prior 12 months: 19113 (lowers risk) · Drug's FDA history
Maximum age: 79 (lowers risk) · Who can join

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: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: double (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 1

Who can join

Minimum age: 18
Maximum age: 79 (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: 320 (typical: 32)
Sponsor's past termination rate: 4.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 49 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 4 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 88053 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 19113 (typical: 412.5)
Drug's FAERS reports marked serious: 77.0% (typical: 85.6%)
Drug's FAERS reports with a death: 6.2% (typical: 15.9%)

Disease area and drugs

Disease areas: cardiovascular, metabolic, endocrine
Drugs matched to FDA substances: atorvastatin, ezetimibe simvastatin, rosuvastatin, simvastatin

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

MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162) NCT01154036 · started 2010 · scored riskier than 21% of active trials completed
Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED) NCT00782184 · started 2008 · scored riskier than 20% of active trials completed
A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139) NCT00783263 · started 2008 · scored riskier than 12% of active trials completed
Efficacy/Safety of Rosuvastatin+Ezetimibe in High Risk Patients With Primary Hypercholesterolemia/Mixed Dyslipidemia NCT01420549 · started 2013 · scored riskier than 34% of active trials completed
A Study to Evaluate the Efficacy and the Safety of Single Pill Combination (SPC) Ezetimibe/Rosuvastatin in Chinese Adult Patients With Primary Hypercholesterolemia Not Adequately Controlled on Statin Therapy NCT04669041 · started 2020 · scored riskier than 35% 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.