Clinical Trial to Evaluate the Efficacy and Safety of CKD-391
Model scores of the 29,894 trials active now.
Model score 6% 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 9% of the time (803 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-01-31, after 2015-03-31 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2016-01-31. 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
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: to screeningrandomized doubledouble blindcontrolledscreening visit
Phrases that lowered it: patientsefficacy andand safetygrouptrial -
Sponsor's past termination rate: 2.1% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
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Minimum age: 19 (lowers risk) · Who can join
-
Drug's FAERS reports with a death: 7.5% (lowers risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 28 (lowers risk) · Sponsor's track record
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Number of arms: 6 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Drug's FAERS reports marked serious: 68.5% (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 169371 (lowers risk) · Drug's FDA history
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
- 6 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 19 (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
- 48 (typical: 32)
- Sponsor's past termination rate
- 2.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 28 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 169371 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 28655 (typical: 412.5)
- Drug's FAERS reports marked serious
- 68.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic
- Drugs matched to FDA substances
- atorvastatin, ezetimibe
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
- 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
- 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
- Evaluation of Efficacy and Safety of AVE5530 Co-administered With Atorvastatin in Primary Hypercholesterolemia NCT00741715 · started 2008 · scored riskier than 7% of active trials terminated
- Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing Statins in Patients With Primary Hypercholesterolemia NCT00729027 · started 2008 · scored riskier than 9% of active trials terminated
- Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia NCT00690443 · started 2008 · scored riskier than 5% 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.