Benidipine in Hypertensive and/or Chronic Coronary Syndrome Patients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Benidipine in Hypertensive and/or Chronic Coronary Syndrome Patients (NCT06808321), a registered phase not stated study. The primary outcome is Change From Baseline in Systolic Blood Pressure at Month 3.

2. Clinical Question

This question is descriptive: it concerns the observed course of blood pressure among a defined group receiving care in usual practice. It is not, by itself, a comparison of what would have happened to the same participants under a different treatment. Because prescribing was determined by the treating physician rather than randomized, differences in who received benidipine and who had outcome measurements could reflect clinical choices, participant characteristics, follow-up, or other factors. Details about those factors and any comparator group are not reported in the registry record.

3. Trial Design

This is a prospective, multicenter, observational registry in Türkiye concerning benidipine use in people with hypertension and/or angina pectoris associated with chronic coronary syndrome. The registry states that it is strictly non-interventional. The treating physician made the decision to prescribe benidipine as part of routine medical care, independently of and before study enrollment. No study-specific treatment assignment, intervention, or additional diagnostic procedure was mandated.

The registry lists enrollment of 1659 and status as COMPLETED. The study start is 2025-03-01, and primary completion is 2026-01-01. These registry entries describe the study record; they do not establish how many participants contributed data to the primary endpoint. That endpoint requires completion of the Month 3 follow-up and blood pressure measurements at both baseline and Month 3. The count meeting those conditions is not reported in the registry record.

The primary outcome is continuous: mean change in systolic blood pressure, in mmHg, from baseline to Month 3. Treatment persistence and patient compliance at Month 3 are listed as a secondary outcome. The registry lists 4 outcome measures and 0 analyses. Names and definitions for the other outcome measures are not reported in the registry record.

No randomized comparison is described, allocation is not stated, and arms are not a like-for-like control comparison. Details such as eligibility criteria beyond the outcome population description, the number of participating centers, follow-up procedures, and the prespecified statistical analysis plan are not reported in the registry record. The design can describe outcomes observed during routine care, but the design description alone cannot separate changes associated with treatment from changes due to other influences.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Each patient's medical history was reviewed to confirm they met the age (18-80) and diagnosis (Hypertension/Angina) criteria. Hemodynamics: Sitting blood pressure and heart rate. Initial CCS Grade for angina and the SAQ-7 score (Seattle Angina Questionnaire-7) for quality of life. Biochemical Baseline: Blood samples were taken for fasting lipid profiles, serum creatinine, and hemoglobin. The final pre-assignment detail was the Physician's Decision.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Participants who met the eligibility criteria, received benidipine as part of routine clinical care, completed the Month 3 follow-up, and had systolic blood pressure measurements available at both baseline and Month 3.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: The baseline analysis population includes all enrolled participants (N=1,659) who met the inclusion criteria and received at least one dose of benidipine hydrochloride. Analysis Set was used for the assessment of demographic characteristics, medical history, and baseline clinical parameters.

6. Primary Endpoint

The registry lists the primary outcome as Change From Baseline in Systolic Blood Pressure at Month 3, measured over Baseline and Month 3.

The primary endpoint is the change in systolic blood pressure from baseline to Month 3, measured in mmHg. It is calculated as the Month 3 value minus the baseline value. By this definition, a negative change indicates lower systolic blood pressure at Month 3 than at baseline, while a positive change indicates a higher value. The endpoint is summarized as a mean with standard deviation.

Blood pressure is a continuous measurement, so describing the average change gives a concise account of the direction and typical magnitude of change in the analyzed group. The standard deviation describes how spread out individual changes are around that mean; it is not the uncertainty interval for the mean. As a general statistical point, a mean can conceal substantial variation between individuals, so its interpretation benefits from information about the spread and the number of participants analyzed.

The registry defines the endpoint population as participants who met eligibility criteria, received benidipine in routine clinical care, completed Month 3 follow-up, and had systolic blood pressure measurements available at both time points. This complete-measurement definition is important: the endpoint does not automatically describe every enrolled participant. The number of participants included, the mean change, and its standard deviation are not reported in the registry record. Consequently, the direction, size, and precision of the observed mean change cannot be assessed from the recorded endpoint description alone.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a continuous primary measure summarized by its mean and standard deviation. The outcome is each participant's change in systolic blood pressure, calculated as the Month 3 measurement minus the baseline measurement. The mean is the arithmetic average of those changes among participants included in the endpoint population. It communicates the average direction and magnitude of change in that analyzed group, but it does not show whether individual participants changed by similar amounts.

What does the standard deviation describe?

As a general statistical concept, standard deviation describes the spread of observed values around their mean. In this setting, it would describe variability in participant-level changes in systolic blood pressure. A larger spread means individual changes are more dispersed; a smaller spread means they are more clustered around the average. Standard deviation is not a confidence interval and does not, on its own, measure how precisely the mean has been estimated. The registry does not report the observed standard deviation or the number of participants contributing to the endpoint.

How would a confidence interval be interpreted?

As a general explanation, a confidence interval expresses statistical uncertainty around an estimated quantity under the assumptions of the analysis method. For a mean change, it would help show which values remain compatible with the data and method used. A narrower interval indicates greater precision than a wider interval, while neither width nor position can be assessed without the interval itself. No confidence interval is reported in the registry record. A p-value, its interpretation, and the method used to calculate it are also not reported.

What does the sign of change mean?

The endpoint definition determines the sign: Month 3 minus baseline. Thus a negative value means the Month 3 measurement is below baseline, and a positive value means it is above baseline. This is a general interpretation of the specified calculation, not a reported result. No numerical estimate is available in the registry record to establish which direction the observed mean took or how large it was.

What does the analysis population represent?

The defined endpoint population consists of eligible participants who received benidipine in routine care, completed the Month 3 follow-up, and had both blood pressure measurements available. An estimate from that population would describe participants meeting those conditions, rather than necessarily all 1659 enrolled participants. The analysis count, handling of missing observations, and any approach to participants without complete measurements are not reported in the registry record. As a general matter, restricting analysis to complete observations can affect interpretation if completion or measurement availability is related to the outcome or participant characteristics.

How should the planning illustration be read?

The registry's stated sample-size assumptions describe a planning illustration computed from the observed effect, not the study's own design. The assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. These assumptions are hypothetical for planning and do not mean the observational registry randomized participants into two arms. Allocation is not stated, and arms are not a like-for-like control comparison. Any resulting sample sizes are planning illustrations, not observed power. Numerical planning values are not reported in the registry record.

As a general statistical point, a planning calculation depends on its assumed effect, variability, allocation, and analysis approach. It describes a hypothetical design under those assumptions; it cannot substitute for an observed confidence interval or analysis of the data. The registry does not report the numerical inputs or outputs needed to assess such a calculation, beyond the assumptions stated above.

Why does the observational design matter?

In a randomized study, assignment is designed to make treatment groups comparable in expectation. This registry instead observes treatment selected by physicians in routine care. As a general principle, treatment selection can be associated with clinical features that also relate to outcomes. A before-and-after mean change can describe the observed course, but cannot by itself isolate the effect of treatment from time trends, other care, or differences in participants. The registry record does not report a comparator analysis or methods for adjusting for such factors. Statistical methods beyond the endpoint summary are not reported in the registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Benidipine Treatment Group")
n   <- c(1659)
m   <- c(-12.5)
sp  <- c(8.4)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Benidipine Treatment Group  1659  -12.500  8.400  -12.905  -12.095

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 4 outcome measures, including the primary endpoint of mean systolic blood pressure change from baseline to Month 3 and the secondary outcome of treatment persistence and patient compliance at Month 3. The names and definitions of the other outcome measures are not reported in the registry record. The record lists 0 analyses, and does not report a statistical analysis plan, inferential results, or a strategy for accounting for multiple outcomes.

As a general statistical concept, multiplicity arises when several outcomes or statistical tests are considered. Examining many results can increase the chance that some appear noteworthy by chance, so an analysis plan may identify a primary outcome and specify how other outcomes will be interpreted. The registry identifies a primary endpoint, but whether or how multiplicity was addressed is not reported in the registry record. No p-values are reported, so there is no basis for assessing how the results were tested or adjusted.

The primary endpoint definition requires complete blood pressure measurements at baseline and Month 3 and completion of follow-up. The number meeting this definition, the amount of missing data, reasons for missingness, and the handling of missing observations are not reported in the registry record. As a general matter, missingness can affect both the number of observations and the interpretation of an estimate. Complete-case results describe participants with the required measurements; they may not represent all enrolled participants if availability is related to outcomes or participant characteristics.

The registry record does not report whether analyses used an intention-to-treat, per-protocol, or other analysis population. In this non-interventional setting, the outcome-specific population is defined by eligibility, routine-care receipt of benidipine, follow-up completion, and available measurements. This definition should be kept distinct from the enrollment figure of 1659.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

The adverse-event record lists 1659 participants at risk for serious adverse events and 1659 at risk for other adverse events. It records 0 participants affected in each category and 0 deaths. These are the recorded counts in the registry; they should be read as reported figures rather than as proof that no event occurred outside the recorded information.

The group is labeled “Non-serious Adverse Events,” while the record also gives serious-event and other-event counts. No serious adverse-event terms are listed. The registry does not report additional details about event definitions, collection methods, assessment periods, severity grading, or attribution to benidipine. It is therefore not possible to assess how events were identified, how completely they were captured, or whether the categories were applied consistently.

As a general statistical point, zero recorded events do not establish that the underlying risk is zero. Interpretation depends on the amount and duration of observation, event ascertainment, and the population followed. The safety follow-up period and completeness of event reporting are not reported in the registry record. The listed at-risk counts should not be assumed to establish the number contributing to every efficacy endpoint or the length of time each participant was observed.

13. What the Result Does, and Does Not, Mean

The registry establishes a prospective, multicenter, non-interventional setting for observing clinical outcomes after benidipine was prescribed in routine care. It specifies a primary endpoint: mean systolic blood pressure change from baseline to Month 3 among participants with completed follow-up and measurements at both time points. The definition provides the direction convention, with negative change indicating a decrease and positive change indicating an increase. A numerical estimate and its uncertainty are not reported in the registry record.

Accordingly, the endpoint description does not show how much blood pressure changed, whether the mean change was positive or negative, how variable individual changes were, or how precisely the mean was estimated. The enrollment of 1659 does not establish how many participants contributed to the endpoint. The registry also lists 0 analyses, so no inferential result or adjusted estimate is reported.

The study's observational nature also limits causal interpretation. Physicians chose whether to prescribe benidipine as part of usual care before study enrollment. There is no randomized comparison described, allocation is not stated, and arms are not a like-for-like control comparison. If an observed change were reported, it would describe change among the analyzed participants, not by itself demonstrate that benidipine caused that change or establish how the outcome would compare under another treatment.

Similarly, the adverse-event record reports 0 affected participants for serious and other adverse events among 1659 at risk in each category and 0 deaths. These counts describe what the registry records; details about event ascertainment and follow-up are not reported. They do not establish that the underlying event risk is absent. Overall, the record supports a description of the study question, design, and listed counts, but does not report the outcome results needed to assess the magnitude or precision of the primary endpoint.

14. Why This Trial Matters Statistically

This registry illustrates an important distinction in biostatistics: a clearly defined endpoint is not the same as a reported result. The primary measure specifies the population, time points, units, summary statistic, and direction of calculation. Those details help readers understand what an eventual estimate would mean. However, because the numerical mean change, standard deviation, and analysis count are not reported in the registry record, the endpoint's magnitude and precision cannot be evaluated.

The design is also statistically important. Prospective observation in routine care can describe outcomes in the setting where prescribing occurs, while the non-randomized design leaves treatment selection outside the study's control. Physician preference determined prescribing before enrollment. Therefore, a before-and-after outcome would need cautious interpretation: it would characterize change among observed participants, but would not alone distinguish treatment-associated change from other influences. No randomized comparator or adjustment methods are reported.

The endpoint population makes follow-up and data availability consequential. Only eligible participants completing Month 3 and having both blood pressure measurements qualify for the primary outcome as defined. Enrollment of 1659 is not interchangeable with the analysis population. The number with complete measurements and the handling of missing data are not reported in the registry record, so the representativeness of the analyzed group cannot be assessed.

The registry also lists multiple outcomes, but provides 0 analyses and no reported multiplicity strategy. This underscores why prespecified analysis methods and transparent reporting matter: they allow readers to distinguish planned questions from exploratory findings and to judge uncertainty. The stated planning assumptions are not observed power and do not convert this observational registry into a randomized comparison. In statistical terms, the record is useful for understanding the intended measurement and design, but it does not provide the numerical findings needed for a result-focused assessment.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

Important outcome information is absent from the registry record. The mean change in systolic blood pressure, its standard deviation, a confidence interval, a p-value, and the number of participants contributing to the primary endpoint are not reported. Without these values, neither the size nor the precision of the primary result can be described. Although enrollment is 1659, the defined endpoint population requires follow-up completion and measurements at both baseline and Month 3, and its size is not reported.

The record lists 4 outcome measures but 0 analyses. The other outcome definitions beyond treatment persistence and patient compliance at Month 3 are not reported in the registry record. A statistical analysis plan, multiplicity approach, adjustment methods, and missing-data strategy are not reported. Reasons for missing measurements and whether availability differed by participant characteristics are also not reported.

The observational design limits comparisons and causal interpretation. Benidipine was prescribed according to physician preference in routine care before enrollment; there is no randomized comparison described, allocation is not stated, and arms are not a like-for-like control comparison. Details about potential confounding factors, concomitant care, center-level variation, and the number of participating centers are not reported in the registry record. The registry description therefore does not allow assessment of how these factors may have influenced observed outcomes.

Safety interpretation is limited as well. The record lists 0 affected participants for serious and other adverse events and 0 deaths, but event ascertainment methods, observation period, definitions, and completeness of reporting are not reported. These limitations mean the listed counts cannot fully characterize safety over an unspecified follow-up period.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Benidipine in Hypertensive and/or Chronic Coronary Syndrome Patients — NCT06808321.
• Registry record last updated 2026-11-04; status last verified 2026-10.
• Results first posted 2026-11-04.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

The registry describes a completed, prospective, multicenter, non-interventional study in Türkiye of benidipine use among people with hypertension and/or angina pectoris associated with chronic coronary syndrome. Enrollment is 1659; the study start is 2025-03-01 and primary completion is 2026-01-01. Benidipine was prescribed by physician preference as part of routine care, independently of and before enrollment.

The primary endpoint is mean change in systolic blood pressure from baseline to Month 3, defined as Month 3 minus baseline, among participants with completed follow-up and measurements at both times. A numerical result and endpoint analysis count are not reported in the registry record. Treatment persistence and patient compliance at Month 3 are listed as a secondary outcome. The registry lists 4 outcome measures and 0 analyses.

For adverse events, the record lists 1659 at risk in each of the serious and other-event categories, 0 affected in each, and 0 deaths. Event ascertainment details are not reported. The non-randomized design and absence of a like-for-like comparator limit causal interpretation.