Open-Label Extension Study of Patients Previously Enrolled in Study CIN-107-124: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Open-Label Extension Study of Patients Previously Enrolled in Study CIN-107-124 (NCT05459688), a na phase 2 study. The primary outcome is Number of Participants With Any Treatment-emergent Adverse Events (TEAEs).

2. Clinical Question

Because this was an open-label extension involving people previously enrolled in another study, the question is about longer-term observations in this selected group. The study does not provide a randomized comparison that can separate events occurring during CIN-107 treatment from events that might have occurred over the same period without it. Its safety counts therefore describe the participants and follow-up represented in this record; they do not establish what caused an event or how the experience compares with another treatment.

3. Trial Design

This was a Phase 2, multicenter, open-label extension study of CIN-107. It enrolled 175 participants and is listed as completed. The registry lists a study start of 2022-04-06 and a primary completion date of 2023-11-07. The study was intended for people with hypertension who had completed Part 1 or Part 2 of Study CIN-107-124, and it was to be conducted at clinical sites that had participated in that earlier study.

The design is listed as single group, with no masking and no treatment allocation. The intervention description specifies 2 mg CIN-107 tablets taken orally once per day, starting at Visit 1 and ending at the end-of-treatment visit. The study description gives a duration of up to 52 weeks. As an extension, this design records participants’ experience during continued study treatment; it does not create a concurrent untreated or alternative-treatment group.

The primary outcome concerns the number of participants with any treatment-emergent adverse events. Listed secondary outcomes include changes from baseline in mean seated systolic and diastolic blood pressure, attaining mean seated systolic blood pressure below 130 mmHg, and seated systolic blood pressure response in participants described as responders or non-responders in Study CIN-107-124. The record lists 13 outcome measures and 0 analyses. Details such as the statistical analysis plan, the approach to missing observations, and the handling of repeated measurements are not reported in the registry record. The listed outcome names alone do not establish how those outcomes were analyzed.

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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Safety Population includes any participants enrolled in the study who have taken at least 1 dose of any study drug.

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.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), measured over 52 weeks.

The primary endpoint is the number of participants with any treatment-emergent adverse events (TEAEs) over a timeframe of 52 weeks. The registry defines an adverse event as an untoward medical occurrence in a participant administered a pharmaceutical product; the event need not have a causal relationship with the treatment. It may include an unfavorable or unintended sign, symptom, disease, or abnormal laboratory finding temporally associated with use of the investigational product.

The definition also distinguishes medical history from an adverse event. A condition present at enrollment is recorded as medical history unless its severity, frequency, or seriousness changes during the study, in which case it is reported as an adverse event. The safety population includes enrolled participants who took at least one dose of study drug.

Counting affected participants is a direct way to describe how many people experienced an event during follow-up. It is useful for summarizing safety observations in a single group, but a count alone does not show whether treatment caused an event, how long an event lasted, or how the rate compares with another treatment. The registry record does not separately report a result for this primary endpoint. The adverse-event summary lists 8 participants with serious adverse events and 20 participants in the other adverse-event category; those category counts should not be treated as a separately reported primary-endpoint result.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

This study has a single-group design. That feature shapes what statistical summaries can answer: the record can describe the events observed among participants receiving CIN-107, but it cannot directly compare those observations with a concurrent control group. The registry lists allocation as not applicable, masking as none, and the model as single group. It does not report a statistical analysis plan or an inferential method for the primary endpoint.

What does a participant count convey?

The primary endpoint is a count of participants who experienced any treatment-emergent adverse event during the stated timeframe. In general, a participant count answers how many people had at least one qualifying event, rather than how many separate episodes occurred. A participant with multiple events may still be counted once for an endpoint defined as the number of participants with any event. The registry does not provide a separate primary-endpoint result or explain any event-level counting rules beyond the endpoint definition.

A count can be accompanied by a proportion or a confidence interval to help convey how precisely the observed frequency estimates an underlying frequency. In general, a confidence interval reflects sampling uncertainty under the assumptions of the method used. No confidence interval or p-value for the primary endpoint is reported in the registry record. It would therefore be inappropriate to imply a particular degree of precision from the count alone. The displayed adverse-event categories remain descriptive, and the record does not state that a hypothesis test was used for them.

Why does the lack of a control group matter?

In general, a concurrent control group helps distinguish differences associated with treatment from changes over time or other influences. Here, all participants are described within the CIN-107 group, so there is no internal treatment contrast. The earlier study is part of participants’ enrollment history, but the record does not present it as a randomized control for this extension. Comparing this extension with another group or another study would require information and assumptions not reported. The counts should not be converted into a causal effect or a comparative risk estimate.

How should the planning illustration be understood?

The page includes a sample-size planning section. Its stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. Such calculations are planning illustrations, not observed power. They do not change the actual single-group design of this extension, and they are not evidence that the study was designed or analyzed as a two-arm comparison. The sample-size justification for the extension is not reported in the registry record. The record also does not report an observed comparative effect that would permit assessment of the illustration’s basis.

In general, power is a design-stage probability tied to a specified effect, variability, analysis, and sample size. It is not a retrospective measure of whether a study result is true. A planning calculation cannot establish that a trial had adequate ability to detect an effect unless its assumptions and design match the question being studied. No claim about observed power follows from the posted safety counts.

What about variation and repeated measurements?

The outcome list includes changes in seated systolic and diastolic blood pressure, as well as threshold and response outcomes. These names indicate different kinds of measurements: change outcomes are continuous summaries, while threshold outcomes classify participants according to whether a stated condition was reached. In general, continuous measurements are often summarized using a mean and a measure of variability, while binary outcomes may be summarized as counts and proportions. The registry record does not provide the analysis methods, estimates, variability measures, or results for these secondary outcomes.

Repeated blood pressure measurements can require choices about which visits and observations contribute to a summary. Missing follow-up observations can also affect how a change from baseline is estimated. The methods for these choices are not reported in the registry record. General statistical methods can address within-person correlation, unequal observation patterns, or extra variability, but there is no basis to say that any particular method was used. These concepts explain possible analytical considerations; they are not descriptions of this trial’s unreported methods.

Finally, the record lists 13 outcome measures and 0 analyses. The number of outcomes signals that the registry describes multiple questions, but without listed analyses it is not possible to determine which estimands, models, or uncertainty measures were applied. The interpretation should remain anchored to the clearly posted descriptive safety summaries rather than imply a more detailed analysis than the record documents.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("2mg CIN-107")
n      <- c(175)
events <- c(73)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  2mg CIN-107  175  73  41.7  34.3  49.4  34.7  49.1  34.7  49.1

11. Multiplicity, Missing Data and Analysis Populations

The record lists 13 outcome measures, including the primary safety endpoint and secondary blood pressure outcomes. When a study examines multiple outcomes, the chance of at least one apparently notable result can depend on how many comparisons are made and how they are evaluated. In general, investigators may specify a hierarchy or adjust inference to account for multiple testing. The registry record does not report whether multiplicity was addressed, which outcomes were considered confirmatory, or whether any outcome hierarchy was prespecified. Because 0 analyses are listed, there are no posted analysis results from which to assess multiplicity handling.

Missing-data methods are also not reported in the registry record. The safety population is defined as enrolled participants who took at least one dose of any study drug, but that definition does not explain how missing follow-up, withdrawals, or incomplete event information were handled. Nor does it describe the population used for each secondary outcome. This distinction matters because the participants contributing to a safety summary may not be the same as those with measurements available at each visit.

The registry describes a timeframe of 52 weeks for the primary endpoint and an extension intended to last up to 52 weeks. It does not report individual follow-up duration, censoring rules, imputation, sensitivity analyses, or assumptions about missing observations. These omissions prevent assessment of whether all participants contributed equally to the stated timeframe or how incomplete observations may affect estimates. They do not prove that such methods were absent from the full study documentation; they mean the methods are not reported in the registry record. Interpret the posted counts as the summaries shown, without assuming unreported adjustments or analysis-population rules.

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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: lacunar stroke (0.6%), chronic obstructive pulmonary disease (0.6%), pulmonary embolism (0.6%), angina pectoris (0.6%), bradycardia (0.6%).

The adverse-event summary reports 8 participants with serious adverse events and 20 participants in the other adverse-event category, with 175 participants at risk in each listed category. It also reports 0 deaths. The terms listed among the serious adverse events are lacunar stroke, chronic obstructive pulmonary disease, pulmonary embolism, angina pectoris, bradycardia, and myocardial infarction; each is shown as 0.6%.

These categories are not a substitute for event-level detail. The record does not say how many events of each type occurred, when they arose, whether participants had more than one event, or whether investigators considered them related to CIN-107. Do not add the serious and other category counts to create a total: the record does not state that the categories are mutually exclusive, and participants may be represented across event categories. Likewise, the listed percentages describe the registry’s presentation and do not establish causality or comparative risk. The serious-event list identifies reported terms; it is not evidence that the treatment caused those events.

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

The study provides a descriptive account of adverse events recorded during an open-label extension of CIN-107. The posted safety summary gives counts for serious adverse events, other adverse events, and deaths in the listed group of 175 participants at risk. The primary endpoint is defined, but a separate primary-endpoint result is not reported in the registry record. These observations can help readers understand what the registry reports for this group, while the absent analysis details limit how precisely the results can be interpreted.

The counts do not show what would have occurred in the same participants without treatment, nor do they establish that CIN-107 caused or prevented any event. With no concurrent comparator, the study cannot provide a randomized estimate of comparative safety. Open-label conduct also means masking was not used, though the registry does not describe how knowledge of treatment may have affected reporting or assessment.

The record lists blood pressure outcomes, but results for those outcomes are not reported. Their presence in the outcome list should not be mistaken for evidence of a particular change or response. The study also does not provide, in this record, confidence intervals, p-values, missing-data methods, or a detailed analysis plan. The appropriate interpretation is therefore bounded: these are posted observations from a selected extension population, not a complete account of comparative effect, statistical precision, or treatment causality.

In general, longer follow-up can describe events that arise while participants remain under observation, but an extension cohort may differ from people who do not continue from an earlier study. The registry does not report enough information about nonparticipants or the enrolled group’s characteristics to determine how broadly these findings apply. The study’s results should be considered in that context rather than treated as a definitive estimate for all people with hypertension.

14. Why This Trial Matters Statistically

This trial is statistically notable because it illustrates the distinction between describing events and estimating a comparative treatment effect. A single-group extension can document the number of participants with reported events during follow-up. It does not, by itself, establish whether those events occur more or less often than they would under another treatment or without the study drug.

The registry also highlights why an endpoint definition and an endpoint result are different things. It defines the primary safety question and the safety population, and it posts adverse-event category summaries. Yet a separate result for the primary endpoint, a confidence interval, and a statistical analysis are not reported in the registry record. Readers can identify what the study intended to measure, but cannot infer unreported analyses or quantify precision from those definitions alone.

The record lists both safety and blood pressure outcomes, while leaving the analysis approach and multiplicity handling unreported. That makes it important to distinguish outcome listings from analyzed findings. A sample-size planning illustration may help explain assumptions for a hypothetical comparison, but it cannot turn this study into a randomized two-arm design or be interpreted as observed power. Together, these features make the study a useful example of reading extension-study results within the limits of their design and reporting.

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.

This extension includes participants who had completed Part 1 or Part 2 of Study CIN-107-124. As a result, its population is defined by prior participation and completion, rather than by a general sample of people with hypertension. The registry does not report characteristics of participants who entered or did not enter the extension, so selection into continued study participation cannot be evaluated from this record.

The design is single group and open label, with no comparator. It can describe observed events but cannot isolate treatment effects from other explanations or provide a controlled comparison. The registry record does not report the primary endpoint result separately, confidence intervals, p-values, or an analysis plan. It also does not report the approach to missing data, individual follow-up, event adjudication, or the treatment-relatedness of the listed serious events. These details limit assessment of precision, completeness, and causality.

The study was intended to continue for up to 52 weeks, and the primary endpoint timeframe is listed as 52 weeks. The record does not give participant-level exposure or follow-up duration. It also lists secondary blood pressure outcomes without posting their results. Consequently, neither the magnitude nor the uncertainty of changes in those outcomes can be evaluated from the registry summary. These are limitations of what is reported in this record, not claims about what may appear in other study documents.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Open-Label Extension Study of Patients Previously Enrolled in Study CIN-107-124 — NCT05459688.
• Registry record last updated 2024-12-16; status last verified 2024-12.
• Results first posted 2024-12-16.
• 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

This completed Phase 2 study was an open-label, single-group extension of Study CIN-107-124 in participants with hypertension. The registry lists 175 enrolled participants and treatment with 2 mg CIN-107 tablets taken orally once per day, with an intended duration of up to 52 weeks.

The primary endpoint was the number of participants with any treatment-emergent adverse events. The posted adverse-event summary lists 8 participants with serious adverse events, 20 in the other adverse-event category, and 0 deaths; six serious-event terms are each shown as 0.6%. A separate primary-endpoint result and results for the listed blood pressure outcomes are not reported in the registry record. The single-group design supports descriptive interpretation, not a controlled estimate of comparative safety or effectiveness.