Efficacy and Safety of CKD-828 to Stage 2 Hypertension
Model scores of the 29,894 trials active now.
Model score 7% 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 2013-05-31, after 2012-07-31 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 2013-05-31. 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: stagerandomizationheartckddisease
Phrases that lowered it: efficacy andand safetyto evaluatethe efficacysafety of -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (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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Has a data monitoring committee: No (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 21 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 11.0% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports marked serious: 77.5% (lowers risk) · Drug's FDA history
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Blinding: triple (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Drug's FAERS reports in the prior 12 months: 15984 (lowers risk) · Drug's FDA history
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Sponsor's past trials: 23 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (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
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 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
- 23 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 21 (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
- 70272 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 15984 (typical: 412.5)
- Drug's FAERS reports marked serious
- 77.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- amlodipine, levamlodipine
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
- CKD-828 Primary Hypertension Trial(Dose-selection) NCT01128322 · started 2010 · scored riskier than 14% of active trials completed
- CKD-828 S-Amlodipine Non-Responder Trial NCT01501253 · started 2011 · scored riskier than 12% of active trials completed
- CKD-828 Telmisartan Non-Responder Trial NCT01426100 · started 2011 · scored riskier than 12% of active trials completed
- Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Stage 2 Hypertension NCT01127217 · started 2009 · scored riskier than 8% of active trials completed
- Efficacy and Safety of TAH Combination in Comparison With Telmisartan/Amlodipine Combination for Essential Hypertension Patients NCT02738632 · started 2015 · scored riskier than 12% 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.