An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy (NCT01103960), a randomized phase 3 study. The primary outcome is Change From Baseline in DBP After 8 Weeks of Treatment.

2. Clinical Question

The central statistical comparison is between the groups’ changes in diastolic blood pressure, rather than a comparison of their final measurements without regard to baseline. The registry reports adjusted and group-level results, which need to be distinguished from the simple, unadjusted re-calculation based on posted summaries. Those approaches do not give the same inferential result for the primary outcome.

3. Trial Design

This completed phase 3 trial used randomized allocation, double masking and a parallel-group design. It compared T80/A5 with A5 alone over 8 weeks. The registry records enrollment of 324 and identifies Boehringer Ingelheim as the sponsor. Patients in the study had hypertension and were described as having failed to respond adequately to amlodipine 5 mg monotherapy. Further details of that response criterion are not reported in the registry record.

The primary endpoint was change from baseline in diastolic blood pressure after 8 weeks. The endpoint description specifies seated trough measurement and allows the 8-week value or last observation carried forward. It also states that the analysis was to adjust for treatment, country and baseline measurement of the endpoint. The primary analysis population was the full analysis set, defined in the record by randomization, treatment, a baseline endpoint measure and at least one post-dose endpoint measure during the double-blind phase.

The registry lists systolic blood pressure changes, blood-pressure control and response, blood-pressure categories, earlier blood-pressure changes and clinical abnormalities among secondary outcomes. Not all of these listed outcomes have numerical results in the record. The protocol’s original sample-size assumptions, allocation details beyond the randomized parallel-group description, and any interim-analysis plan are not reported in the registry record.

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: Whilst there were 324 patients randomised and treated, there were only 314 in the Full analysis set (FAS).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Full analysis set (FAS) defined as patients randomised, treated, with a baseline endpoint measurement and at least one post-dose endpoint measurement during the double blind (DB) phase.

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 DBP After 8 Weeks of Treatment, measured over Baseline and 8 weeks.

The primary endpoint is change from baseline in seated trough diastolic blood pressure after 8 weeks, measured in mmHg. Diastolic blood pressure is the pressure recorded between heartbeats. A change score expresses how the measured value at follow-up differs from the participant’s baseline value; negative values in the posted group summaries indicate a decrease from baseline.

Using a change from baseline makes the comparison focus on change during the study rather than on the follow-up readings alone. The registry’s analysis description additionally specifies adjustment for baseline endpoint measurement and country, as well as treatment. Such adjustment can account statistically for baseline differences and other modeled factors, although the precise fitted model details beyond the stated ANCOVA analysis are not reported in the registry record.

The trough measurement is the endpoint timing specified in the record. The endpoint description permits the 8-week reading or last observation carried forward (LOCF), a method that uses a participant’s last available observation when a later measurement is unavailable. This defines how some missing endpoint measurements may have been handled, but the number of measurements carried forward and the amount of missing outcome data are not reported in the registry record.

7. Results Posted in the Registry

• T80/A5: mean -12.38 versus -10.19 on control; difference -2.19 (95% CI -4.80 to 0.42), standardized effect d = -0.19; z-test p = 0.099.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Change From Baseline in SBP After 8 Weeks of Treatment

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • T80/A5: mean -16.15 versus -11.66 on control; difference -4.49 (95% CI -8.14 to -0.84), standardized effect d = -0.27; z-test p = 0.016.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for T80/A5 than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change From Baseline in DBP After 4 Weeks of Treatment

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • T80/A5: mean -9.41 versus -7.51 on control; difference -1.90 (95% CI -3.46 to -0.34), standardized effect d = -0.27; z-test p = 0.017.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for T80/A5 than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change From Baseline in SBP After 4 Weeks of Treatment

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • T80/A5: mean -12.10 versus -8.19 on control; difference -3.91 (95% CI -6.47 to -1.35), standardized effect d = -0.34; z-test p = 0.003.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for T80/A5 than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The numerical secondary blood-pressure summaries follow a broadly similar direction: the combination group’s posted changes are more negative than the A5 group’s for the reported systolic and earlier blood-pressure measures. The registry also lists outcomes concerning control, response, blood-pressure categories and clinical abnormalities, but numerical results for all listed outcomes are not reported in the registry record.

This general pattern is consistent with the direction of the sponsor’s primary comparison, but secondary results do not independently settle the primary-analysis discrepancy. Secondary outcomes answer related but distinct questions, and results at different measurement times are not interchangeable with the primary 8-week diastolic endpoint. The secondary analyses also include different endpoint measures and, in some cases, different summary statistics.

Unadjusted secondary comparisons carry less weight as confirmatory evidence when many outcomes or time points are examined. The more statistical comparisons made, the greater the chance that some results appear notable by chance, even if no underlying effect exists. In general, multiplicity procedures can address this issue by controlling error across a family of tests. The registry does not report whether a multiplicity adjustment was planned or used, so the secondary p-values should be treated as exploratory evidence rather than as a collection of independent confirmations.

The registry lists 8 secondary outcomes and reports 10 outcome measures overall. The record does not provide a complete numerical account for every listed secondary outcome. Consequently, the overall pattern can be described only for the posted numerical results, not generalized to outcomes whose results are absent.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Change From Baseline in SBP After 8 Weeks of Treatment
• DBP and SBP Control and Response After 8 Weeks of Treatment
• Number of Patients in Blood Pressure Categories Over Time
• Change From Baseline in DBP After 4 Weeks of Treatment
• Change From Baseline in SBP After 4 Weeks of Treatment
• DBP and SBP Control and Response After 4 Weeks of Treatment
• Number of Patients in Blood Pressure Categories at 4 Weeks
• Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG.

9. Statistical Interpretation

10. Statistical Methods Explained

What does the ANCOVA analysis do?

ANCOVA, or analysis of covariance, compares groups while adjusting for one or more measured characteristics. The primary endpoint description says the analysis was adjusted for treatment, country and baseline measurement. Adjustment can make the treatment comparison account for those modeled variables rather than treating the groups’ observed values as if they arose without regard to them. The record does not report further details of the fitted model, such as its full specification or diagnostics.

The registry’s primary group results are labeled least-squares means and give standard errors. Least-squares means are model-based group estimates, in contrast to simple arithmetic averages. Standard errors describe uncertainty in an estimated mean; they are not the same as the spread of individual participants’ measurements. The posted arm summaries therefore should not be assumed to reproduce the sponsor’s adjusted comparison exactly.

What does the unadjusted re-calculation represent?

The re-calculation compares the posted group summaries without the sponsor’s adjustment for country and baseline. It is a simple, unadjusted comparison, not a reconstruction of the sponsor’s ANCOVA. For the primary outcome, it gives a mean difference of -2.19 mmHg, a confidence interval that crosses zero and p = 0.099. The sponsor’s reported ANCOVA gives a different inferential result. Since the record flags a discrepancy, the sponsor’s analysis takes precedence for interpreting the trial’s reported primary analysis.

Unadjusted and adjusted results can differ because they use different information and model structures. Adjustment can affect an estimate and its uncertainty; differences can also reflect how outcomes or contrasts are defined. The record does not give enough detail to identify the specific reason for the discrepancy. The sponsor’s report labels its estimate as a mean difference in final values, while the primary outcome is described as a change from baseline. The record does not provide enough information to reconcile those descriptions fully.

How should standard errors and confidence intervals be understood?

A standard error indicates the statistical uncertainty in an estimated mean or contrast. A confidence interval combines an estimate and its standard error to express a range of values compatible with the data under the model and its assumptions. A narrower interval is more precise than a wider one, all else equal. An interval that includes zero does not rule out no difference at the stated confidence level; an interval that excludes zero indicates that the data are less compatible with a zero difference under the analysis assumptions. These are general explanations, not additional trial findings.

Some re-calculations use an approximate pooled standard deviation inferred from the posted standard errors and group sizes. The record marks those estimates as approximate. Standard deviation describes variation among individual measurements, whereas standard error describes uncertainty in a group mean. The distinction matters: a group mean can be estimated with greater precision than the spread of individual values might suggest, especially as the amount of information increases. For the primary and 8-week systolic outcomes, the posted dispersion is standard error, not standard deviation.

Why can over-dispersion matter?

In general, over-dispersion means that observed variability is greater than a statistical model assumes. When a model understates variability, standard errors can be too small and inferential results can appear more certain than warranted. It is a general statistical consideration; the registry does not report an over-dispersion assessment or identify this as an issue in this trial. The primary endpoint is continuous, and the listed primary analysis is ANCOVA, so no claim about over-dispersion in the trial results is justified by the record.

What does the analysis population mean?

The full analysis set is defined as patients who were randomized, treated, had a baseline endpoint measurement and had at least one post-dose endpoint measurement during the double-blind phase. This definition includes a post-dose measurement requirement, so it is not identical to a population defined solely by randomization. The record does not report how many randomized patients were excluded from this analysis set or give the reasons for any exclusions. It also does not report a separate intention-to-treat analysis or a per-protocol analysis.

The endpoint description permits LOCF for the 8-week measure. In general, LOCF carries a participant’s last observed value forward to a later time point when that later outcome is unavailable. This can simplify analysis but relies on assumptions about the meaning of the carried-forward value. The record does not report missingness by group, the number of LOCF values, or sensitivity analyses evaluating alternative missing-data assumptions.

11. Confidence Intervals and Precision

Precision is reflected in the uncertainty around an estimate, not just in the point estimate itself. For the primary endpoint, the unadjusted re-calculation’s confidence interval crosses zero, so the posted summary statistics do not pin down the unadjusted difference with enough precision to exclude no difference at that confidence level. Its p-value is 0.099. These are properties of the re-calculation, not the sponsor’s adjusted analysis.

The sponsor’s reported primary ANCOVA has p = 0.007 and a 95% confidence interval that does not include zero. This indicates a more conclusive result under the sponsor’s stated analysis than under the unadjusted re-calculation. The two results cannot be combined as though they were estimates from the same model. The record flags a discrepancy, and the sponsor’s own analysis takes precedence.

The posted group standard errors also indicate uncertainty around the estimated changes, while the re-calculated intervals express uncertainty around between-group contrasts. A point estimate alone does not show how much uncertainty surrounds it. Conversely, a statistically distinguishable estimate is not automatically large enough to be clinically important. The registry does not report a clinical-importance threshold for this endpoint.

For secondary outcomes, estimates also have uncertainty, and the record’s unadjusted comparisons should be interpreted cautiously. The registry does not report a multiplicity-adjustment procedure for the secondary comparisons. The confidence intervals and p-values therefore should not be read as if each were the sole, prespecified confirmatory test.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total participants and not total events. The assumptions listed for these illustrations are a two-sided significance level of 0.05, equal allocation between the two arms and a normal approximation. They use the observed effect as a reference and consider planning for 100%, 75% or 50% of that observed effect. The trial’s own original sample-size assumptions are not reported in the registry record.

The 80% power column gives the illustrative number of participants per arm for a design intended to have an 80% chance of detecting the specified effect under the stated assumptions, if that effect and the assumptions hold. The 90% power column gives the corresponding planning number for a higher chance of detection. These are design calculations, not guarantees about what a future study will find.

Smaller effects require more participants to detect under otherwise similar assumptions. The posted planning illustrations show this pattern: planning for 75% or 50% of the observed effect requires more participants per arm than planning for 100% of the observed effect. The figures are not observed power and do not describe the probability that the completed trial’s result is correct. They are planning illustrations based on the observed estimate, not the trial’s original design justification.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -2.190; pooled standard deviation σ = 11.777.
2. n = 2 × (1.96 + 0.842)² × 11.777² / -2.190² = 453.9, rounded up to 454 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -2.19                      # observed difference in means
sigma <- 11.7765919496567                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(1103960)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 454 (80% power), 608 (90% power)
 75% of observed effect: n per arm = 807 (80% power), 1,081 (90% power)
 50% of observed effect: n per arm = 1,816 (80% power), 2,431 (90% power)
power.t.test: 454.9 
Simulated power at n = 454 per arm: 0.799 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The sponsor’s primary analysis is an ANCOVA comparison and reports p = 0.007 with a 95% confidence interval that excludes zero. The unadjusted re-calculation from the posted group summaries gives p = 0.099 and an interval crossing zero. These analyses differ in adjustment and are not interchangeable. The registry marks the discrepancy as true; accordingly, the sponsor’s own analysis takes precedence when describing the trial’s reported primary finding.

The record does not provide enough detail to reconcile the numerical discrepancy fully. The primary endpoint description specifies change from baseline and adjustment for treatment, country and baseline measurement, while the sponsor analysis is labeled as a mean difference in final values. No further explanation of the difference in estimates or intervals is reported in the registry record. The re-calculation is useful as a check on the posted summaries, but it should not be presented as a replacement for the sponsor’s analysis.

The sponsor’s analysis supports a statistically distinguishable between-group result under its reported model. That statement concerns the analysis and endpoint in this trial; it is not, by itself, a conclusion about clinical importance or effects beyond the studied population and follow-up.

15. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when several hypotheses are tested, such as across multiple secondary outcomes or follow-up times. If each test is considered separately at a chosen significance threshold, the chance of at least one false-positive result across the collection can increase. Statistical plans can define which tests are confirmatory and may use adjustments or a testing sequence to manage that risk. These are general principles; the registry does not report a multiplicity-adjustment procedure for this trial or describe a hierarchy of secondary hypotheses.

The primary endpoint and its stated analysis are identified in the record, but the full statistical analysis plan is not reported in the registry record. The record does not report the original sample-size justification, interim analyses, stopping boundaries or whether any analyses were prespecified beyond the descriptions attached to the outcomes. Their absence from the registry record should not be interpreted as proof that they were not conducted; it means their details are not reported there.

The primary endpoint description defines the full analysis set and states that the endpoint may use an 8-week reading or LOCF. It does not provide the number of participants with missing outcomes, the timing or reasons for missing measurements, or the number of values carried forward. Nor does it describe sensitivity analyses for missing data. This limits assessment of how missingness may have affected the estimates.

The record does not report group-level adherence or protocol deviations, nor does it describe the handling of intercurrent events beyond the stated endpoint approach. It also does not provide a detailed account of exclusions from the analysis population. These omissions limit the ability to assess how closely the analysis represents all randomized participants and how robust the result is to alternative analysis choices.

16. 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.

The registry reports zero serious adverse events in the A5 group among 164 patients at risk and zero in the T80/A5 group among 160 patients at risk. It also reports zero affected patients for the other adverse-event category in each group, using the same at-risk counts. These are the event figures recorded for the listed categories; they do not establish that no adverse events of any kind occurred.

The death figures are null, and the serious adverse-event terms list is empty. The number of deaths is therefore not reported in the registry record, and no serious-event terms are listed. Zero recorded events in these categories should be interpreted in light of the trial’s size, follow-up and the registry’s reporting. The record does not provide detailed event narratives or additional information needed to assess uncommon or later-occurring harms.

These safety entries are descriptive. They do not establish equivalence between treatments or prove that either regimen is free of risk. The registry’s recorded adverse-event figures should be read as a limited account of the reported categories during the study, not as a complete assessment of safety outside the trial.

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

The registry’s sponsor-reported primary ANCOVA indicates a between-group difference in the specified 8-week diastolic blood-pressure analysis, with p = 0.007 and a 95% confidence interval that excludes zero. The posted arm summaries show reductions in both groups. The unadjusted re-calculation gives a different inferential result, and the record flags this discrepancy; the sponsor’s analysis takes precedence for the trial’s reported primary result.

This statistical finding does not, by itself, establish whether the size of the difference is important to patients or clinicians. The registry does not report a threshold for clinical importance. Statistical significance and clinical importance are different questions: the former concerns compatibility with a null hypothesis under an analysis, while the latter requires context about meaningful changes and the consequences of those changes.

The result applies to the population and treatment comparison described in the record: patients with hypertension who had not responded adequately to amlodipine 5 mg, receiving the combination or amlodipine alone, with the primary endpoint assessed after 8 weeks. It should not be generalized automatically to other populations, doses, settings or durations.

The safety entries report no affected patients in the listed serious and other adverse-event categories, but the death count is not reported in the registry record. Those entries do not show that no other adverse events occurred or establish long-term safety. Likewise, secondary blood-pressure summaries provide related information but do not replace the primary analysis, particularly given the unreported multiplicity plan and incomplete numerical reporting for listed secondary outcomes.

18. Why This Trial Matters Statistically

This trial illustrates why a reported adjusted analysis and a re-calculation from summary statistics should be kept distinct. The posted group estimates make it possible to calculate a simple unadjusted comparison, but that comparison is not the sponsor’s ANCOVA. In this case, the re-calculation and sponsor result differ in inferential conclusion, and the registry flags the discrepancy. The sponsor’s analysis therefore has priority when reporting the trial’s own primary analysis.

It also illustrates why the endpoint definition and analysis population matter. The primary outcome is a change from baseline in seated trough diastolic pressure, with an analysis description that specifies adjustment and a population definition that requires post-dose measurement. Understanding these details helps readers distinguish the target comparison from a generic comparison of final readings or all randomized participants.

The trial also shows the limits of reading secondary results as a broad confirmation. Several related blood-pressure measures are listed, but not every listed outcome has numerical results, and the registry does not report a multiplicity approach. Statistical interpretation depends not only on effect estimates and p-values, but also on which outcomes were planned, how missing data were handled, and how multiple comparisons were addressed.

Finally, the planning illustrations demonstrate how assumptions about the effect size influence design requirements. They are based on the observed effect and stated planning assumptions, not on the study’s original design rationale. Keeping planning calculations separate from observed results avoids interpreting them as evidence about the completed trial’s power.

19. 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 discrepancy between the sponsor’s ANCOVA and the unadjusted re-calculation is a central interpretive limitation. The registry flags it, but does not explain its source in enough detail to reconcile the analyses. The sponsor’s result takes precedence, while the disagreement limits independent verification from the posted summaries alone.

The registry does not report the original sample-size justification, interim analyses, a complete statistical analysis plan or a multiplicity procedure. It also does not report detailed missing-data counts, the number of LOCF values, sensitivity analyses, or a full account of exclusions from the defined analysis population. These omissions restrict assessment of the robustness of the reported results and the potential effects of analysis choices.

Numerical results are not reported for every listed secondary outcome. The secondary evidence therefore cannot be assessed comprehensively, and unadjusted comparisons across outcomes and times should be interpreted cautiously. The safety record is also limited: it records zero affected patients in specified categories, while deaths are not reported and the serious-event terms list is empty.

The primary follow-up is 8 weeks. The record does not establish the persistence of blood-pressure changes beyond that timeframe. It also does not report a clinical-importance threshold, so statistical evidence cannot be translated directly into a judgment about the practical importance of the estimated difference. These are limitations of what the registry record allows readers to conclude, not evidence that unreported analyses or assessments were necessarily absent.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy — NCT01103960.
• Registry record last updated 2014-06-27; status last verified 2013-12.
• Results first posted 2012-09-20.
• 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.

23. Record Summary

NCT01103960 is a completed randomized, double-blind, parallel-group phase 3 study sponsored by Boehringer Ingelheim. It compared telmisartan 80 mg plus amlodipine 5 mg with amlodipine 5 mg alone in patients with hypertension who had not responded adequately to amlodipine monotherapy. The primary endpoint was change from baseline in seated trough diastolic blood pressure after 8 weeks.

The registry reports an adjusted ANCOVA primary analysis with p = 0.007. A simple unadjusted re-calculation from the posted group summaries gives p = 0.099 and a confidence interval crossing zero. Because the registry flags a discrepancy, the sponsor’s own analysis takes precedence. The record lists additional blood-pressure and safety outcomes, but does not report numerical results for every listed secondary outcome. Details of multiplicity handling, the original sample-size justification and several missing-data assessments are not reported in the registry record.