Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients (NCT00904371), a registered phase not stated study. The primary outcome is Change From Baseline in Systolic Blood Pressure (SBP).

2. Clinical Question

3. Trial Design

This completed study evaluated telmisartan-based treatment in patients described as having high-risk hypertension. The listed treatment group combines Micardis® 80 mg and MicardisPlus® 80/12.5 mg. The study also aimed to evaluate cardiovascular risk factors and describe antihypertensive treatment patterns in daily practice. The record does not explain whether patients received one product or the other under a prespecified assignment process.

The enrollment is 211. The study began in 2009-12, and primary completion is recorded as 2011-01. Boehringer Ingelheim is named as sponsor. The record identifies the study as completed, but does not describe the setting, recruitment process, eligibility criteria in detail, or duration of treatment for individual participants.

This is not a randomized comparison: allocation is not stated, and the registry record cautions that the arms are not a like-for-like control comparison. The listed primary outcome is change in systolic blood pressure from baseline to the 3rd visit, with that visit described as 4-10 months. Its analysis population consists of patients with measurements at both baseline and that visit. The registry record does not report the number in this population.

Eleven outcome measures are recorded, including the primary blood-pressure outcome and secondary outcomes concerning target blood pressure, treatment patterns, heart rate, adverse events, and study completion. The record lists zero analyses. It therefore does not give an analysis result for the primary endpoint or the named secondary outcomes.

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: Phase IV, Post Marketing Surveillance Study, non-interventional, multicentre, national, observational study in routine daily practice.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Patients with data both at baseline and on 3rd visit (4-10 months)

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 Change From Baseline in Systolic Blood Pressure (SBP), measured over Baseline to 3rd visit (4-10 months).

The primary endpoint is change from baseline in systolic blood pressure, measured in mm Hg. It is defined as a mean, with standard deviation specified as the measure of dispersion. The measurement period is from baseline to the 3rd visit, described as 4-10 months. The analysis population includes patients who have data at both time points.

A change endpoint expresses how a measurement differs between a starting point and a later assessment. In general, evaluating change can describe the course of a continuous measure over time, while a mean summarizes the average change in the analyzed population. The standard deviation describes how dispersed individual changes are around that mean; it does not describe the precision of the mean itself. A confidence interval would be one way to communicate that precision, but none is reported in the registry record.

Systolic blood pressure is the pressure recorded during the heart's contraction. It is used as a continuous clinical measurement, so its mean change can retain information about the magnitude of shifts rather than reducing the outcome to whether a target was reached. The study also lists a secondary outcome about achieving target blood-pressure values, which addresses a different question from average change.

The endpoint definition does not itself show whether blood pressure rose or fell, how large the mean change was, or how much individual responses varied. The registry record does not report the observed mean or standard deviation, nor the number of patients included in this endpoint analysis.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The study's primary outcome is a continuous measurement, and the registry record specifies a mean and standard deviation. Those choices describe different features of the data. The mean represents the average change in systolic blood pressure in the analyzed population. The standard deviation describes how spread out individual changes are around that average. Neither quantity is reported numerically for the primary outcome in the registry record.

What does a mean change describe?

In general, a mean change combines the paired measurements from the same patients into an average difference between follow-up and baseline. A positive or negative value would indicate the direction under a stated subtraction convention; the record does not state that convention or give the value. A mean can also obscure variation: individuals may have changes that differ substantially even when their average is modest. The standard deviation helps describe that between-patient spread, but it is not a measure of uncertainty about the average.

The endpoint population is defined as patients with data at baseline and at the 3rd visit. This is a paired-data population because each included patient contributes measurements at both time points. In general, analysis restricted to complete pairs can exclude patients who lack either measurement. The registry record does not report how many patients had complete pairs or why data might be missing.

How is precision different from variability?

In general, a confidence interval expresses uncertainty around an estimated effect. Its width depends on features such as variability and the amount of information available. It is not interchangeable with the standard deviation: the standard deviation describes variation among individual observations, while a confidence interval describes uncertainty in an estimated quantity under a statistical model. The registry record does not report a confidence interval for the primary outcome, so its precision cannot be assessed.

A p-value, when reported, addresses how compatible the observed data are with a specified statistical null model. It does not measure the clinical importance of a result, prove that a null hypothesis is true, or provide the probability that a finding occurred by chance. No primary-outcome p-value or other analysis result is reported in the registry record. No statistical test or model for the primary endpoint is described there.

What do the planning assumptions mean?

The sample-size planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It defines the effect to detect as a stated fraction of the observed effect. These are assumptions for planning illustrations, not a description of the trial's own design or an account of the analysis performed. The study itself is not described as a randomized comparison, and its allocation is not stated. A hypothetical equal-allocation comparison should therefore not be confused with the actual study structure.

In general, planning calculations ask how much information a future study might need to detect an assumed effect under specified design and analysis conditions. Here, the stated effect basis is the observed effect, but the primary observed effect is not reported in the registry record. The record does not report a sample-size justification for this study. Planning illustrations are not observed power and do not demonstrate that the completed study had a particular probability of detecting an effect.

The planning description distinguishes outcomes analyzed as continuous measures from time-to-event outcomes: the former use participants per arm, while time-to-event calculations use a total number of events under the Schoenfeld approach. This is a general distinction in planning. The named primary endpoint is continuous, not a time-to-event outcome. The registry record does not report a time-to-event primary endpoint.

Why can over-dispersion matter?

In general, over-dispersion means that observed variation is greater than assumed by a statistical model. If a model underestimates variation, standard errors and uncertainty intervals can be too small, and tests can appear more decisive than warranted. The relevance of this issue depends on the outcome and model. The registry record does not report a model for the primary endpoint or indicate whether over-dispersion was assessed. The endpoint is a continuous blood-pressure change, and no distributional assessment is reported.

Because the record lists zero analyses and does not report endpoint estimates, readers cannot verify the model, assumptions, handling of outliers, missing-data strategy, or adjustment for covariates. These are not merely technical details: they shape how an estimate should be interpreted and how robust it may be. In their absence, the registry's endpoint definition can be described, but the statistical analysis itself cannot be independently evaluated.

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("Micardis® 80mg MicardisPlus® 80/12.5 mg")
n   <- c(204)
m   <- c(-22.6)
sp  <- c(17.1)
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  Micardis® 80mg MicardisPlus® 80/12.5 mg  204  -22.600  17.100  -24.961  -20.239

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 11 outcome measures and names secondary outcomes related to target blood pressure, additional antihypertensive treatment, heart-rate change, adverse events, and study completion. It does not report a plan for controlling multiplicity, such as a hierarchy of hypotheses or an adjustment for multiple testing. Without such a plan and the analysis results, the chance of false-positive findings across multiple tested outcomes cannot be evaluated. This is a general concern when several outcomes are assessed, not a claim that any particular finding is false.

The record lists zero analyses. It does not provide results, p-values, confidence intervals, or a statistical analysis plan for the primary or secondary outcomes. The relationship between the stated primary outcome and the secondary outcomes is identified by their labels, but the record does not state how outcome priorities were handled during analysis.

The primary population is defined by availability of both baseline and 3rd-visit data. This makes the analyzed population dependent on having paired measurements. The registry record does not report the number with complete data, the number missing either measurement, reasons for missingness, or any method of imputation. It also does not say whether participants with missing measurements were included in other analyses.

The record does not describe an intention-to-treat analysis, a per-protocol analysis, or another named analysis population. The only explicitly described population for the primary endpoint is patients with data at both time points. Thus, the extent to which the endpoint estimate would represent all enrolled participants cannot be assessed from the registry record. Missing-data assumptions and sensitivity analyses are not reported in the registry record.

12. Safety Results

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

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

Serious events with the highest arm-level rate: carcinoma in situ (0.5%), lip oedema (0.5%).

The registry record lists 2 serious adverse events among 211 at risk in the treatment group identified as Micardis® 80 mg or MicardisPlus® 80/12.5 mg. The serious-event terms listed are carcinoma in situ and lip oedema, each reported as 0.5%. The record also lists 0 other adverse events among 211 at risk. These are the recorded counts and percentages; they do not describe an event rate over a specified person-time period.

The serious-event count should not be read as a comparison between treatments. The study is not described as a randomized comparison, and the registry record cautions that its arms are not a like-for-like control comparison. The record does not state whether the serious events were considered related to treatment, how serious events were defined, or the duration over which each participant was monitored for safety.

The death count is not reported in the registry record. That absence is not evidence that there were no deaths. The listed percentages are reproduced as recorded and are not recalculated. The registry record does not provide additional context about timing, clinical course, or adjudication of the serious events.

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

The record establishes that the study was intended to assess change in mean systolic blood pressure from baseline to the 3rd visit, described as 4-10 months, among patients with measurements at both time points. It also identifies treatment patterns and several other outcomes for evaluation. These details clarify the questions the study set out to address, but they are not results.

The primary estimate and its standard deviation are not reported in the registry record. A confidence interval and a test result are also not reported. Without these quantities, the magnitude, direction, and precision of the blood-pressure change cannot be judged. The record therefore does not establish how much blood pressure changed in the analysis population or how consistent individual changes were.

The study is not a randomized comparison, and allocation is not stated. No like-for-like control comparison is described. Accordingly, the record does not establish that any change over time was caused by the treatment. A before-and-after measurement, even if its estimate were available, could describe a temporal pattern but would not by itself separate treatment effects from other influences.

The safety record lists serious adverse events and other adverse events in the identified treatment group, but it does not report a comparator suitable for a relative safety assessment. The serious-event terms and percentages are descriptive entries. The death count is not reported in the registry record, and the relationship of the listed events to treatment is not stated.

These limitations do not imply that the treatment was ineffective or harmful. They mean that the recorded information does not support those conclusions. The registry record is most informative about the planned endpoint, the eligible measurement pattern for its analysis, and the listed safety counts. It does not supply the outcome estimates and analysis details needed to characterize efficacy, precision, or comparative safety. No treatment recommendation follows from the record.

14. Why This Trial Matters Statistically

This study illustrates why a clearly named endpoint and a reported endpoint result are both necessary for statistical interpretation. The record specifies a continuous primary outcome, its unit, summary measure, dispersion measure, and measurement period. That makes the intended question understandable. Yet without the mean change, standard deviation, and uncertainty interval, readers cannot assess the size or precision of the result.

It also highlights the importance of defining the analysis population. The primary outcome concerns patients with data at baseline and at the 3rd visit, rather than an explicitly described population of all enrolled patients. This distinction matters because follow-up measurement availability can affect how representative an estimate is. The registry record does not report the size or missing-data profile of that paired-measurement group.

Study design is equally important. The record cautions that this is not a randomized comparison and that allocation is not stated. A change from baseline may be useful as a description, but without a suitable comparison it cannot by itself isolate a treatment effect. Statistical language should reflect that design rather than imply stronger causal evidence.

The safety entries show another interpretive distinction: counts and recorded percentages describe events in the group, but do not establish comparative risk, attribution, or timing. Finally, planning assumptions must be kept separate from the completed study's analysis. The stated sample-size illustration assumptions are hypothetical planning choices, not evidence of observed power or of the trial's original design. Together, these points show how endpoint definitions, missingness, study design, and reporting completeness shape what a registry record can support.

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.

The registry record does not report the primary outcome estimate, its standard deviation, a confidence interval, or an inferential test. Although the endpoint and its analysis population are named, the number of patients with paired baseline and 3rd-visit measurements is not reported. This prevents assessment of both the result and the amount of information contributing to it.

The study is not a randomized comparison, allocation is not stated, and the record cautions that the arms are not a like-for-like control comparison. The available description therefore does not establish a basis for causal or comparative treatment conclusions. The record does not explain how the two listed treatment products were selected or used.

Details needed to assess conduct and analysis are not reported in the registry record. These include fuller eligibility and setting information, the statistical analysis plan, adjustment methods, assumptions for the primary analysis, multiplicity handling, missing-data methods, and sensitivity analyses. The record lists 11 outcome measures but zero analyses, so findings for the named secondary outcomes cannot be assessed.

Safety interpretation is also limited. The registry record lists serious-event and other-event counts, but does not provide event timing, treatment attribution, monitoring duration, or a suitable comparison group. A death count is not reported. These gaps limit what can be concluded from the recorded safety information and should not be replaced by assumptions.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients — NCT00904371.
• Registry record last updated 2012-08-21; status last verified 2012-08.
• Results first posted 2012-08-21.
• 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 study, sponsored by Boehringer Ingelheim, evaluated telmisartan-based treatment in high-risk hypertensive patients. Enrollment is recorded as 211; the study began in 2009-12, with primary completion in 2011-01. The primary outcome is mean change in systolic blood pressure from baseline to the 3rd visit, described as 4-10 months, among patients with measurements at both time points.

The registry record lists 11 outcome measures and zero analyses. It does not report the primary outcome estimate or its uncertainty. The study is not a randomized comparison, allocation is not stated, and the record cautions that the arms are not a like-for-like control comparison. Safety entries include 2 serious adverse events among 211 at risk, with carcinoma in situ and lip oedema each listed at 0.5%, and 0 other adverse events among 211 at risk. A death count is not reported in the registry record.