High Dose BAYA1040_Nifedipine: a Long Term Combination Study

NCT01294215 on ClinicalTrials.gov Phase 3 Bayer (industry) Started 2011-02-28 Completed

Riskier than 6% of active trials

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 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 2012-06-30, after 2011-02-28 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 2012-06-30. 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) (lowers risk) · Wording Phrases that raised it: long termand efficacycombinationcrstudy of
Phrases that lowered it: patients whodailyblood pressureessential hypertensionmg
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Sponsor's past termination rate: 6.1% (lowers risk) · Sponsor's track record
Minimum age: 20 (lowers risk) · Who can join
Drug's FAERS reports with a death: 14.8% (lowers risk) · Drug's FDA history
Design: single group (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 128 (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Sponsor's past trials: 363 (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Drug's FAERS reports marked serious: 85.5% (lowers risk) · Drug's FDA history
Number of arms: 1 (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: 1 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 7 (typical: 1)

Who can join

Minimum age: 20 (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: 363 (typical: 32)
Sponsor's past termination rate: 6.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 128 (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: 5445 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 994 (typical: 412.5)
Drug's FAERS reports marked serious: 85.5% (typical: 85.6%)
Drug's FAERS reports with a death: 14.8% (typical: 15.9%)

Disease area and drugs

Disease areas: cardiovascular
Drugs matched to FDA substances: nifedipine

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

High Dose BAYA1040_Nifedipine: a Dose-comparative Study NCT01287260 · started 2011 · scored riskier than 5% of active trials completed
High Dose BAYA1040 CR: a Long Term Extension Study NCT01355367 · started 2011 · scored riskier than 9% of active trials completed
Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study NCT00768560 · started 2008 · scored riskier than 7% of active trials completed
Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension NCT01788358 · started 2013 · scored riskier than 33% of active trials completed
Long Term Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension NCT01237873 · started 2011 · scored riskier than 78% 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.