Additional Effect of A Life Style Program on Antihypertensive Treatment With Telmisartan: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Additional Effect of A Life Style Program on Antihypertensive Treatment With Telmisartan (NCT01108796), a registered phase not stated study. The primary outcome is Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline.

2. Clinical Question

The study’s stated aims also included examining the effect of the lifestyle education tool on blood-pressure control and its target measurements, as well as laboratory parameters during treatment. The listed secondary outcomes include LDL, HDL, triglycerides, blood glucose and metabolic effect. Those aims define the scope of the investigation, but do not establish what the results were. In particular, the registry record does not provide the estimated blood-pressure changes, their variability, or results comparing tool use with no tool.

3. Trial Design

This is a completed post-marketing surveillance study sponsored by Boehringer Ingelheim. The registry describes its purpose as supplementing information on efficacy and tolerability of Micardis® and MicardisPlus® among patients at cardiovascular risk under general-practice conditions. The study start is recorded as 2008-09 and primary completion as 2009-09. The registry lists enrollment as 1856.

The treatment period is described as six months. The primary outcome is change in mean systolic blood pressure from baseline to the final visit, with the timeframe specified as 24 weeks (Visit 1 to Visit 3). Its description says that blood-pressure changes were considered by treatment and by Tool/No Tool. The registry’s arm description is “Patients at cardiovascular risk”; it does not give further arm details there. The adverse-event record separately identifies Micardis® and MicardisPlus® groups.

The record does not state allocation methods. It should therefore not be read as establishing random assignment, and the registry specifically cautions that this is not a randomized comparison and that the arms are not a like-for-like control comparison. The exact relationship between treatment, lifestyle-tool use and the listed groups is not described in enough detail to infer a controlled contrast.

The study was conducted under general-practice conditions and is characterized as post-marketing surveillance. This setting is relevant when interpreting the stated aims: the record describes observation of treatment and lifestyle education in an unselected patient population, rather than documenting a randomized efficacy comparison. The protocol, eligibility criteria, follow-up procedures, and statistical analysis plan are not reported in the registry record. Nor are numerical primary-outcome estimates reported. The completed status indicates the recorded study status, but by itself does not supply evidence about the magnitude or precision of any blood-pressure change.

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: A total of 1856 were entered into this trial and 1841 were analysed. For 15 patients case report forms were not available or not usable for analysis

Overall Study

Reasons for not completing this period:

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 Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline, measured over 24 weeks (Visit 1 to Visit 3).

The primary endpoint is change in mean systolic blood pressure after treatment compared with baseline. Blood pressure is a continuous measurement, and the registry identifies the reported summary as a mean with standard deviation. The unit is mmHg. The stated timeframe is 24 weeks (Visit 1 to Visit 3), corresponding to the baseline and final-visit measurements described in the outcome definition.

Change from baseline is used to describe how the measured value differs over the observation period, while the mean summarizes the group’s average change. The standard deviation describes variability among the measurements; it is not the same as a confidence interval and does not directly express uncertainty in the estimated mean. These are general statistical interpretations of the endpoint’s stated summary measures.

Systolic blood pressure is the specific pressure component selected for the primary outcome. The registry’s description says the changes were examined by treatment and by Tool/No Tool. However, numerical changes, standard deviations, group sizes for the primary analysis, and any between-group estimates are not reported in the registry record. Consequently, the endpoint definition explains what was intended to be measured, but the posted record does not establish the direction, magnitude or precision of the observed change.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary measure is continuous: systolic blood pressure in mmHg, summarized as a mean and standard deviation. A mean is the arithmetic average of the measured values or changes included in an analysis. It provides a concise description of the group’s central tendency, but can be affected by extreme observations. The standard deviation describes how dispersed the individual measurements are around the mean. It does not show the precision of the estimated mean in the way a confidence interval does.

What does change from baseline describe?

For each participant with the relevant measurements, a change score expresses the difference between the final measurement and baseline, according to the analysis convention. The average of those changes describes the group’s mean change. This is distinct from comparing only the final measurements between groups, and it is also distinct from comparing a group’s change with the change in a control group. The registry identifies baseline and final-visit systolic measurements and the 24-week timeframe, but does not report the numerical change estimates or specify the exact calculation convention.

When a study reports mean change and standard deviation, the mean describes the average direction and size of observed changes, while the standard deviation describes participant-to-participant variability. A confidence interval, when reported, is an estimate of the range of values reasonably compatible with the data and the statistical model. Its width reflects precision: wider intervals indicate greater uncertainty than narrower intervals. These are general explanations; no confidence interval for the primary endpoint is reported in the registry record.

Why does the comparison structure matter?

A before-and-after change in a group does not isolate the effect of treatment. Participants may differ at baseline, and factors other than treatment may change during follow-up. A concurrent comparison can help distinguish a treatment-associated change from changes that might also occur without that treatment, but valid interpretation depends on how groups were formed and whether they are comparable. The record says the primary outcome was considered by treatment and by Tool/No Tool. It also states that allocation was not stated and cautions that the arms are not a like-for-like control comparison. The record therefore does not establish the conditions needed to interpret those group contrasts as randomized causal effects.

The phrase “by Tool/No Tool” describes a comparison category in the outcome description, not an allocation method. Without information about who received the tool, why it was used, and whether the groups differed before follow-up, observed differences could reflect group composition as well as the tool. The same caution applies to contrasts by treatment. The registry does not report adjusted estimates or the covariates, if any, used in an analysis.

What can a p-value or confidence interval add?

In general, a p-value assesses how compatible the data are with a specified null hypothesis under the analysis assumptions; it does not measure the size or clinical importance of an effect. A confidence interval gives an estimate together with uncertainty, and can help readers judge which effect sizes remain compatible with the data. Neither replaces scrutiny of the design, outcome definition, missingness or analysis population. No p-value or confidence interval for the primary endpoint is reported in the registry record, so no significance or precision claim can be made from the outcome definition alone.

How should planning illustrations be read?

Any sample-size illustrations associated with the posted results are planning calculations, not observed findings and not evidence of the study’s power. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is expressed as a stated fraction of the observed effect. The record says these calculations are based on the observed effect, but does not report a numerical primary-outcome estimate in the registry record. Such illustrations do not establish that the trial used those design assumptions, and the registry does not report its own sample-size justification.

Over-dispersion is a general concern when variability is greater than a statistical model assumes. If a model underestimates variability, standard errors can be too small and confidence intervals too narrow, making evidence appear more precise than it is. This concept is most directly relevant to analyses whose distributional assumptions require attention; it should not be asserted as a problem in this study without analysis details or evidence. The record does not describe a model, distributional checks or an approach to over-dispersion.

More broadly, the validity of a statistical result depends on the analysis population, the way measurements were collected, the handling of missing values, and the model used. The registry record identifies the endpoint’s summary measure but does not report those analysis details. Therefore, the statistical methods can be explained in general, but the specific inferential procedure used for the primary endpoint cannot be reconstructed from the 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("Micardis® (Telmisartan)", "MicardisPlus® (Telmisartan Hydrochlorothiazide)", "Tool (With Lifestyle Education Tool on Weight Redu", "No Tool (Without Lifestyle Education Tool on Weigh")
n   <- c(711, 966, 1083, 594)
m   <- c(-30.71, -30.32, -30.35, -30.73)
sp  <- c(17.81, 15.05, 16.11, 16.58)
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® (Telmisartan)  711  -30.710  17.810  -32.021  -29.399
CARM  MicardisPlus® (Telmisartan Hydrochlorothiazide)  966  -30.320  15.050  -31.270  -29.370
CARM  Tool (With Lifestyle Education Tool on Weight Redu  1083  -30.350  16.110  -31.311  -29.389
CARM  No Tool (Without Lifestyle Education Tool on Weigh  594  -30.730  16.580  -32.066  -29.394

11. Multiplicity, Missing Data and Analysis Populations

The registry lists seven outcome measures and names secondary outcomes concerning LDL, HDL, triglycerides, blood glucose and metabolic effect. The primary endpoint is change in mean systolic blood pressure. When a study evaluates several outcomes or several comparisons, the chance of obtaining at least one apparently notable result can increase if many tests are interpreted without a prespecified strategy. Methods to address this issue may include defining a primary outcome in advance, adjusting inference across a family of tests, or treating secondary analyses as exploratory. These are general approaches; a multiplicity plan is not reported in the registry record.

The registry record does not report how missing baseline or final blood-pressure measurements were handled, whether participants were excluded from particular analyses, or what analysis population was used. It also does not give the amount or pattern of missing outcome data. These details matter because an analysis restricted to participants with both measurements may differ from one using other methods, especially if the availability of measurements is related to participant characteristics or outcomes. The appropriate interpretation depends on those details, which are not reported in the registry record.

Although enrollment is recorded as 1856, that entry does not establish how many participants contributed to the primary endpoint analysis. The record also does not report a prespecified statistical analysis plan, interim analyses, or the approach to multiple comparisons. No inference about these methods should be drawn from the completed status or the stated study aims. Without endpoint results and analysis details, readers cannot assess whether multiplicity or missing-data decisions influenced the reported estimates.

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: cerebrovascular accident (fatal stroke) (0.1%).

The adverse-event record lists serious events among the Micardis® (telmisartan) and MicardisPlus® (telmisartan hydrochlorothiazide) groups. For Micardis®, it records 0 serious events among 774 at risk. For MicardisPlus®, it records 1 serious event among 1067 at risk. The listed count for other adverse events is 0 in each group. These are recorded counts, not comparative estimates adjusted for differences between groups.

The registry also lists “Cerebrovascular accident (fatal stroke)” at 0.1% among the top serious terms. The record does not provide enough context to assign that term to a particular treatment group or to reconcile the term with a broader account of events, so it should be read as a separately listed registry entry. Death counts are not reported in the registry record.

These figures do not establish that the treatments have equivalent or different safety profiles. The groups are not described as randomized, like-for-like comparison groups, and the record does not state the method used to collect or classify adverse events. The listed at-risk counts are not a substitute for information about follow-up duration, completeness of reporting or participant characteristics. Rare-event counts in particular offer limited information about comparative risk when design and ascertainment details are unavailable. No causal safety conclusion follows from these counts alone.

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

The record establishes that a completed post-marketing surveillance study was designed to examine blood-pressure change during treatment with Micardis® or MicardisPlus® under general-practice conditions, and to investigate a lifestyle education tool. It identifies mean systolic blood-pressure change from baseline to the final visit as the primary outcome, with a 24-week (Visit 1 to Visit 3) timeframe. It also records enrollment as 1856 and lists laboratory and metabolic secondary outcomes.

However, the registry record does not report numerical results for the primary endpoint. It therefore does not show the mean blood-pressure change, its variability, the precision of an estimate, or the size of any contrast by treatment or Tool/No Tool. The intended questions cannot be answered quantitatively from the record. The study aims should not be presented as though they were observed findings.

The record also does not establish that differences between listed groups were caused by treatment or the lifestyle tool. Allocation is not stated, and the registry cautions that the arms are not a like-for-like control comparison. A within-group change over time would not alone distinguish treatment effects from other influences. The relationship between the treatment groups, tool use and analysis populations is not detailed enough to support stronger causal interpretation.

The safety entries document the recorded serious and other adverse-event counts, along with a listed serious-event term. They do not, on their own, establish comparative safety. Information on event ascertainment, follow-up and group comparability is not reported in the registry record.

Overall, the available record is informative about purpose, setting, endpoint definition and selected safety entries, but not about the magnitude or precision of the primary clinical outcome. It does not support a conclusion that either treatment, or the lifestyle tool, did or did not produce a particular effect. Those judgments would require the outcome estimates and analysis information not reported in the registry record.

14. Why This Trial Matters Statistically

This study raises several important statistical interpretation issues because it combines a continuous primary outcome, treatment groups, a lifestyle-tool question and a post-marketing general-practice setting. Mean systolic blood-pressure change is a clear summary target, but understanding its meaning requires the actual estimate, its variability and an uncertainty measure. The registry record defines the measure but does not report those primary results. That gap illustrates why a precise endpoint definition is not a substitute for outcome data.

The record’s reference to comparisons by treatment and by Tool/No Tool also highlights the importance of allocation and group comparability. A comparison can be statistically calculated even when groups differ in ways that affect the outcome. The registry says allocation was not stated and warns that the arms are not a like-for-like control comparison. This makes design information central to interpretation, not a technical footnote.

The surveillance context is relevant as well. The stated aim was to collect information under general-practice conditions in an unselected patient population. Such aims concern performance in routine settings, while causal attribution still depends on how treatment and tool use were assigned and analyzed. The record does not describe those methods in sufficient detail to assess them.

Finally, the listed safety counts and laboratory outcomes show why studies can address several kinds of questions at once. Multiple outcomes require attention to prespecification and multiplicity, while missing measurements can affect continuous-outcome analyses. Neither the multiplicity plan nor missing-data handling is reported in the registry record. This study is therefore a useful reminder that design context, analysis transparency and uncertainty are essential alongside the clinical endpoint itself.

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 central limitation for interpreting the primary question is that numerical blood-pressure results are not reported in the registry record. Without mean changes, variability, confidence intervals or comparative estimates, the magnitude and precision of the primary outcome cannot be assessed. The record identifies a 24-week (Visit 1 to Visit 3) timeframe but does not provide the actual outcome values.

Design and allocation details are limited. Allocation is not stated, and the registry explicitly cautions that the arms are not a like-for-like control comparison. The primary-outcome description refers to treatment and Tool/No Tool, but does not explain how participants entered those groups or how the treatment and tool categories relate to each other. This limits interpretation of any intended contrast and precludes a confident causal reading.

The analysis population, number of participants with primary-outcome measurements, missing-data approach, and statistical model are not reported in the registry record. The enrollment entry alone cannot resolve those questions. Eligibility criteria and further details about measurement collection and follow-up are also not reported. Without these details, it is difficult to assess selection, attrition, and the assumptions underlying any analysis.

The registry lists secondary outcomes and selected adverse-event counts, but does not report a multiplicity strategy or enough context to interpret the serious-event term by treatment group. Death counts are not reported. The stated post-marketing, general-practice setting provides context for the study’s aims, but does not remove uncertainty about group comparability or outcome ascertainment. These limitations constrain interpretation of the record; they do not establish that the study was conducted incorrectly.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Additional Effect of A Life Style Program on Antihypertensive Treatment With Telmisartan — NCT01108796.
• Registry record last updated 2014-04-10; status last verified 2014-02.
• Results first posted 2011-12-30.
• 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

NCT01108796 is recorded as a completed post-marketing surveillance study sponsored by Boehringer Ingelheim. The registry lists hypertension as the condition, enrollment of 1856, a start date of 2008-09 and primary completion in 2009-09. The stated focus is treatment with Micardis® or MicardisPlus® under general-practice conditions and evaluation of a lifestyle education tool for weight reduction.

The primary outcome is change in mean systolic blood pressure from baseline to final visit, in mmHg, over 24 weeks (Visit 1 to Visit 3). The record names several laboratory and metabolic secondary outcomes. It does not report numerical results for the primary endpoint or the analysis details needed to interpret a treatment or tool comparison. Allocation is not stated, and the registry cautions that the arms are not a like-for-like control comparison. Serious and other adverse-event counts are listed, but they do not support a causal comparative safety conclusion on their own.