This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for International Multicenter, Observational, Non-Interventional Prospective Study of Azilsartan Medoxomil in Participants With Arterial Hypertension Who Are Overweight or Obese in the Russian Federation and The Republic of Kazakhstan (NCT02756819), a registered phase not stated study. The primary outcome is Change From Baseline in Clinic Systolic Blood Pressure (SBP) at Month 6.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02756819 |
| Phase | Phase not stated |
| Condition | Hypertension |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 1945 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Takeda |
| Results posted | Yes |
2. Clinical Question
Population
Participants with hypertension who were overweight or obese in the Russian Federation and the Republic of Kazakhstan. The primary analysis population is described as the full analysis set, which included enrolled participants who received azilsartan medoxomil therapy. The number analyzed at a given timepoint was defined as the number with data available for analysis at that timepoint.
Intervention
Azilsartan medoxomil tablets taken orally as prescribed by a physician according to the local summary of product characteristics. The registry describes observation during routine clinical practice, rather than assigning treatment as part of a randomized trial.
Comparator
No separate comparator group is described in the registry record. The listed treatment group is azilsartan medoxomil; allocation is not stated. Any contrast with another treatment or with an untreated group therefore cannot be read as a like-for-like controlled comparison.
Primary question
The primary endpoint asks how clinic sitting systolic blood pressure changed from baseline to Month 6 among participants with measurements available for analysis. The registry lists the endpoint but does not report its numerical result, so the magnitude and precision of the change are not reported in the registry record.
3. Trial Design
This was a prospective, observational, non-interventional study of azilsartan medoxomil in participants with hypertension who were overweight or obese. It was conducted in the Russian Federation and the Republic of Kazakhstan. The registry lists Takeda as the sponsor, enrollment of 1945, and a completed status. The study start date is 2016-07-18 and primary completion is dated 2018-05-08.
Because treatment was observed in routine clinical practice, the registry describes azilsartan medoxomil use as prescribed by a physician according to the local summary of product characteristics. Participants were observed for approximately 6 months. The record does not describe random allocation, and its allocation field is not stated. It does not identify a separate active comparator or control group. The listed treatment group should therefore be understood as an observed treatment cohort, not as one side of a randomized comparison.
The primary endpoint was change from baseline in clinic systolic blood pressure at Month 6. Other listed outcomes include clinic diastolic blood pressure change, response, achievement of target blood pressure, and subgroup outcomes. Their presence in the registry indicates that these outcomes were defined for reporting; it does not establish that numerical results are available in the record.
The registry describes the full analysis set as all participants who were enrolled and received azilsartan medoxomil therapy. For a given timepoint, the number analyzed is the number with data available at that timepoint. This distinction matters in a prospective observational study: enrollment does not necessarily mean that a participant contributes a measurement to every analysis. The registry record does not report detailed follow-up completeness, reasons for missing measurements, or a protocol-specific approach to handling missing data.
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: Participants with a diagnosis of hypertension and who were obese, prescribed azilsartan medoxomil in accordance with local summary of product characteristics (SmPC) were enrolled in this observational study.
Overall Study
| Stage | Azilsartan Medoxomil |
|---|---|
| STARTED | 1945 |
| Per-protocol Set (PPS) | 1724 |
| Safety Analysis Set (SAS) | 1934 |
| COMPLETED | 1893 |
| NOT COMPLETED | 52 |
Reasons for not completing this period:
| Reason | Azilsartan Medoxomil |
|---|---|
| Lost for observation | 23 |
| Patient's unwillingness | 16 |
| Insufficient efficacy | 2 |
| Adverse Event | 2 |
| Reason not Specified | 9 |
Analysis population for the primary outcome, as defined in the registry: Full analysis set (FAS) included all participants who were enrolled and received azilsartan medoxomil (Edarbi®) therapy. Number analyzed is the number of participants with data available for analysis at the given timepoint.
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: All enrolled participants who received azilsartan medoxomil.
| Characteristic | Unit | Azilsartan Medoxomil |
|---|---|---|
| Participants analysed | 1945 | |
| Age, Continuous | years | 55.2 (SD 11.9) |
| Sex: Female, Male: Female | Participants | 1103 |
| Sex: Female, Male: Male | Participants | 842 |
| Race and Ethnicity Not Collected | Participants | — |
| Race/Ethnicity, Customized: European | Participants | 1787 |
| Race/Ethnicity, Customized: Asian | Participants | 158 |
| Region of Enrollment: Russia | Participants | 1759 |
| Region of Enrollment: Kazakhstan | Participants | 186 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Clinic Systolic Blood Pressure (SBP) at Month 6, measured over Baseline and Month 6.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mmHg |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in clinic sitting systolic blood pressure (SBP), measured in mmHg at Month 6. It is a continuous outcome: each participant’s measurement is represented on a numerical scale, and the registry specifies the mean and standard deviation as the summary statistics. Change describes the later measurement relative to the baseline measurement, making the endpoint a way to characterize the direction and size of blood-pressure change over the observation period.
SBP is a direct measure of one component of clinic blood pressure. Using a continuous measure retains information about the range of observed values rather than reducing results to categories such as response or target attainment. A mean can describe the average change in the analyzed participants, while the standard deviation describes how dispersed individual changes are around that mean. Neither statistic alone explains why participants’ measurements changed.
In an observational study, a baseline-to-follow-up change can describe what happened among participants receiving treatment in routine care, but it does not by itself estimate what would have happened to those same participants without treatment. Other changes over time, participant characteristics, clinical decisions, and measurement availability may also be relevant. The registry record does not report the numerical mean change, its standard deviation, or an interval estimate for the primary endpoint. The result’s magnitude and precision are therefore not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically interpretable primary measure: mean change in clinic sitting SBP from baseline to Month 6. However, the numerical primary outcome is not reported in the registry record. Without the mean change and a measure of uncertainty, it is not possible to describe the size, direction, or precision of the reported primary result from this record. A defined endpoint is not itself evidence of a particular result.
The study’s observational, non-interventional design is central to interpretation. The listed participants received azilsartan medoxomil as prescribed by a physician in routine practice. The record does not describe randomization or a separate comparator group, and allocation is not stated. A change over time in the observed cohort would therefore be descriptive of that cohort. It would not, on its own, isolate the effect of treatment from other influences that can accompany routine care or the passage of time.
The endpoint is a mean, so it describes an average rather than every participant’s experience. The standard deviation is the registry’s stated measure of dispersion, but its numerical value is not reported in the registry record. A mean and standard deviation would not show the full distribution of changes or establish how many participants had a particular pattern of change. Confidence intervals, if reported, would communicate uncertainty around an estimate; no numerical interval for the primary outcome is reported in the registry record.
The full analysis set is defined as participants enrolled and treated, while the number analyzed at each timepoint depends on data availability. Consequently, enrollment and outcome-specific analysis counts are not interchangeable. The registry record does not report the primary outcome’s number analyzed or detail whether missing measurements were associated with participant characteristics or outcomes. That information would help readers assess how representative the available measurements may be of the enrolled cohort.
The registry lists secondary outcomes concerning clinic DBP, response, target blood pressure, and subgroup results. Numerical findings for those outcomes are not reported in the registry record. The existence of multiple outcome definitions also makes it important to know which comparisons were prespecified and how multiplicity was addressed. Such details are not reported in the registry record. No inferential conclusion about the primary or secondary outcomes can be drawn from the outcome descriptions alone.
9. Statistical Methods Explained
The primary measure is a continuous outcome summarized as a mean with a standard deviation. In general, a mean is the arithmetic average of observed values and gives a concise description of their central tendency. A standard deviation describes spread around that average. It is not the uncertainty of the mean: uncertainty also depends on how many observations contribute and on the analysis method. The registry record specifies these summary measures but does not report their numerical primary-outcome values.
Change from baseline uses each participant’s follow-up value in relation to that participant’s baseline value. This can focus the summary on within-participant change rather than on follow-up values alone. The interpretation still depends on which participants have usable measurements at both relevant timepoints and on how the change is calculated and summarized. The registry describes the endpoint as change at Month 6 relative to baseline, but details of the calculation beyond that description are not reported in the registry record.
A confidence interval is a general statistical tool for expressing the uncertainty around an estimate under a specified method. It gives a range of values compatible with the data and assumptions of that method; it is not a guarantee that the true value lies in the interval. A narrow interval generally indicates greater precision than a wide interval. The registry record does not report a confidence interval for the primary outcome, so its precision cannot be assessed from the record. A standard deviation alone would describe participant-level variation, not directly provide a confidence interval for the mean.
In general, repeated measurements in the same participant are related rather than independent. Analyses that compare baseline and follow-up values can account for that pairing, but the precise statistical procedure matters. The registry record identifies a mean change and its standard deviation, yet a detailed statistical analysis plan, including the precise inferential procedure, is not reported in the registry record. It is therefore not appropriate to attribute a particular model or adjustment strategy to the study.
The study is observational, so statistical adjustment, if used, would not automatically remove confounding. Confounding occurs when other characteristics or events are associated with both treatment circumstances and the outcome, making an observed association difficult to attribute to treatment alone. In a non-interventional setting, prescribing and follow-up occur in clinical practice; the registry’s description does not establish that participants were exchangeable with an untreated or alternative-treatment group. No such comparison group is listed.
The registry’s sample-size assumptions describe a planning illustration based on the observed effect, not the trial’s own design. The illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; its target effect is a stated fraction of the observed effect. These assumptions do not turn this observational cohort into a two-arm trial. Any resulting sample sizes are planning illustrations, not observed power or proof that the study was adequately or inadequately powered. The numerical primary result needed to interpret the observed effect is not reported in the registry record.
In general, over-dispersion means that variability is greater than a statistical model’s assumptions allow. When present, it can make standard errors and uncertainty estimates unreliable unless the analysis accounts for the extra variation. That concept is relevant to some outcome types and models, but the primary endpoint is described as a continuous mean with a standard deviation. The registry record does not report an over-dispersion assessment or model-based method, so no claim about its presence or handling can be made.
The study also lists response, target blood pressure, and subgroup outcomes. These involve different summaries from a continuous mean: a response or target outcome is categorical, while subgroup analyses describe results within selected participant categories. In general, converting a continuous measure into a category can make results easier to interpret against a threshold, but it discards information about values within each category. Subgroup estimates may also be less precise than an overall estimate. Numerical results, subgroup definitions, and methods for those analyses are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary SBP outcome and secondary outcomes involving DBP, response, target blood pressure, and subgroup results. When multiple outcomes or subgroup comparisons are examined, the chance of finding an apparently notable result by chance can increase. In general, multiplicity procedures or a prespecified hierarchy can help define how such results should be interpreted. The registry record does not report a multiplicity adjustment, testing hierarchy, or detailed statistical plan, so it is not possible to determine how multiple analyses were handled.
The full analysis set includes participants who were enrolled and received azilsartan medoxomil. The registry further states that the number analyzed is the number with data available at the given timepoint. This means that the participants contributing to an endpoint analysis may not be identical to the full enrolled and treated set. The record does not report outcome-specific analysis counts for the primary endpoint, follow-up completeness, reasons for missing data, or whether missingness was addressed through imputation, modeling, or another method. Those details are not reported in the registry record.
In general, missing outcome data can affect both the estimate and its precision, particularly when availability is related to a participant’s health, treatment experience, or observed measurements. A complete-case analysis describes those with available data and may not represent all enrolled participants when missingness is systematic. These are general considerations, not claims about what occurred in this study. The registry’s description alone does not establish the extent or pattern of missing primary measurements.
The registry describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These are planning assumptions rather than a reported analysis plan for this observational cohort. Sample-size illustrations should not be interpreted as observed power. A protocol-specific sample-size justification, interim analysis plan, and handling of multiplicity are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Azilsartan Medoxomil | 6 | 1934 | 0.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Azilsartan Medoxomil | 0 of 1934 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Azilsartan Medoxomil | 39 of 1934 |
Most frequent serious adverse event terms
| Event term | Organ system | Azilsartan Medoxomil |
|---|---|---|
| Angioedema | Skin and subcutaneous tissue disorders | 1 of 1934 |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 1934 |
| Deafness neurosensory | Ear and labyrinth disorders | 1 of 1934 |
| Skull fracture | Injury, poisoning and procedural complications | 1 of 1934 |
| Pancreatitis | Gastrointestinal disorders | 1 of 1934 |
| Hypertension | Vascular disorders | 1 of 1934 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Azilsartan Medoxomil |
|---|---|---|
| Hypotension | Vascular disorders | 14 of 1934 |
| Hypertension | Vascular disorders | 4 of 1934 |
| Dizziness | Nervous system disorders | 2 of 1934 |
| Dyslipidaemia | Metabolism and nutrition disorders | 2 of 1934 |
| Left ventricular hypertrophy | Cardiac disorders | 2 of 1934 |
| Blood pressure decreased | Investigations | 2 of 1934 |
| Headache | Nervous system disorders | 2 of 1934 |
| Hyperglycaemia | Metabolism and nutrition disorders | 1 of 1934 |
| Palpitations | Cardiac disorders | 1 of 1934 |
| Blood cholesterol increased | Investigations | 1 of 1934 |
Serious events with the highest arm-level rate: angioedema (0.1%), prostate cancer (0.1%), deafness neurosensory (0.1%), skull fracture (0.1%), pancreatitis (0.1%).
The safety record lists 1934 participants at risk in the azilsartan medoxomil group. It reports 6 participants affected by serious adverse events and 39 affected by other adverse events. Deaths are recorded as 0. The listed serious adverse event terms are angioedema, prostate cancer, deafness neurosensory, skull fracture, pancreatitis, and hypertension, each shown at 0.1%.
These figures describe events recorded in the observed treatment group. They are not a comparison of safety between azilsartan medoxomil and another treatment, because no comparator group is described. They also do not establish that treatment caused an event. In an observational record, an event reported during follow-up and an event attributable to a treatment are not equivalent concepts.
The serious-event count and the list of terms should be read as different summaries. The terms identify reported event categories; their displayed percentages should not be added to obtain a total. The record does not report event timing, duration, severity detail beyond the serious classification, causal attribution, or participant-level overlap among event categories. A count of participants affected also does not convey the clinical course of each event. These safety figures are descriptive and do not by themselves determine the balance of risks and benefits.
12. What the Result Does, and Does Not, Mean
The registry describes a prospective observational study of azilsartan medoxomil use in routine practice among participants with hypertension who were overweight or obese. Its primary endpoint was change in clinic sitting SBP from baseline to Month 6. This defines the question being measured, but the numerical primary result is not reported in the registry record. The record therefore does not establish the direction, magnitude, or precision of the mean change.
Even if a before-and-after change were available, an observational change would describe what occurred in the observed cohort over time. Without a separate comparator and a design supporting causal inference, it would not by itself show what would have happened under a different treatment or without treatment. Clinical decisions, participant characteristics, other care, measurement availability, and time can contribute to observed changes. The registry record does not provide a controlled treatment contrast.
The posted safety figures describe adverse events recorded in the treatment group and are not comparative estimates. They should not be interpreted as proving that treatment caused an event, or that an unlisted event did not occur. The record’s event counts do not provide a complete account of clinical context or causal assessment.
The record does support a clear description of the study’s scope, design, endpoint definition, and analysis population definition. It identifies enrollment of 1945 and an approximately 6-month observation period. However, the numerical primary and secondary outcome findings, detailed analysis methods, missing-data handling, and multiplicity approach are not reported in the registry record. Those absences limit conclusions about effectiveness, precision, subgroup patterns, and robustness.
Accordingly, this record is best read as documentation of an observational study question and its planned outcome framework, with descriptive safety information. It does not support a randomized comparison or a causal conclusion. Nor does the lack of numerical outcome reporting establish that the endpoint was unchanged; it means the outcome estimate is not reported in the registry record.
13. Why This Trial Matters Statistically
This study matters statistically because it illustrates the distinction between a treatment effect estimated under a controlled comparison and a change observed during routine care. The registry describes a prospective, non-interventional cohort, not a randomized treatment contrast. That design can characterize clinical practice and follow outcomes over time, but interpretation of change must account for the absence of a listed comparator and the potential influence of other factors.
The primary endpoint is continuous, which preserves the scale of blood-pressure change and can describe its average as well as its variability. Yet the usefulness of that measure depends on having the actual estimate, a clear analysis population, and uncertainty information. The registry defines the measure and states that it is summarized by a mean and standard deviation, but the primary numerical result is not reported in the registry record. This makes the difference between an endpoint definition and a result especially important.
The population definition also highlights an analysis issue common to prospective studies: enrollment, treatment receipt, and availability of an outcome measurement are not necessarily the same. The record defines the full analysis set and says the analyzed count depends on data availability at the timepoint. Reporting outcome-specific denominators and missing-data methods would help readers understand how well an estimate represents the enrolled cohort.
Finally, multiple secondary and subgroup outcomes can raise multiplicity and precision concerns. The registry lists those outcomes but does not report a multiplicity approach or numerical findings. Its planning illustrations use assumptions for a two-arm allocation and should be understood as illustrations rather than observed power for this non-interventional study. Together, these features show why design, analysis population, uncertainty, and completeness of reporting all shape statistical interpretation.
14. 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.
Several limitations follow directly from the registry description. The study is observational and non-interventional, and no separate comparator group is listed. Allocation is not stated. Consequently, a change from baseline, if numerically reported, would not alone provide a controlled estimate of the effect attributable to azilsartan medoxomil. The registry record does not report adjustment methods that might address differences in participant characteristics or other influences on outcomes.
The registry defines an approximately 6-month observation period and a primary endpoint at Month 6. It does not report the primary outcome’s numerical estimate, standard deviation, confidence interval, or outcome-specific analysis count. Numerical results for the listed secondary outcomes are also not reported in the registry record. This prevents assessment of the magnitude and precision of the primary result, as well as the pattern of secondary and subgroup findings.
The full analysis set includes enrolled participants who received therapy, while timepoint analysis depends on data availability. Follow-up completeness, reasons for missing measurements, and missing-data methods are not reported in the registry record. Without those details, the representativeness of measurements available at Month 6 cannot be assessed.
The registry lists several secondary and subgroup outcomes but does not report how multiplicity was handled, which subgroup analyses were prespecified, or the detailed statistical analysis plan. A protocol-specific sample-size justification and interim analysis plan are not reported in the registry record. Planning illustrations based on the observed effect do not fill these gaps and are not observed power.
Finally, the safety figures are descriptive. No comparator is listed, and the registry record does not report the event-level clinical context or causal attribution. These limitations constrain both causal interpretation and the breadth of conclusions that can be drawn from the recorded safety information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: International Multicenter, Observational, Non-Interventional Prospective Study of Azilsartan Medoxomil in Participants With Arterial Hypertension Who Are Overweight or Obese in the Russian Federation and The Republic of Kazakhstan — NCT02756819.
- Registry record last updated 2019-11-20; status last verified 2019-10.
- Results first posted 2019-11-20.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT02756819 is a completed, prospective, observational, non-interventional study sponsored by Takeda. It enrolled 1945 participants with hypertension who were overweight or obese in the Russian Federation and the Republic of Kazakhstan. The study dates are 2016-07-18 for start and 2018-05-08 for primary completion. Participants received oral azilsartan medoxomil as prescribed by a physician and were observed for approximately 6 months.
The primary outcome was change in clinic sitting SBP from baseline to Month 6, summarized as a mean with standard deviation. The registry defines the full analysis set as enrolled participants who received therapy, with the number analyzed at a timepoint determined by data availability. Numerical primary and secondary outcome results, detailed statistical methods, missing-data handling, and multiplicity procedures are not reported in the registry record.
The safety record lists 6 participants affected by serious adverse events and 39 affected by other adverse events among 1934 at risk, with 0 deaths. These are descriptive observations without a listed comparator.