Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus (NCT00877929), a randomized phase 3 study. The primary outcome is Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8.

2. Clinical Question

3. Trial Design

The registry describes a phase 3, randomized, double-blind, parallel-group study. Its official title specifies an 8-week comparison of telmisartan 80 mg plus amlodipine 10 mg against amlodipine 10 mg monotherapy as first-line therapy in participants with type 2 diabetes and hypertension. Enrollment was 706. The record lists the study as completed, with a start date of 2009-02 and primary completion in 2010-05.

The treatment regimens included a dose-titration period. The combination group received telmisartan 80 mg with amlodipine 5 mg for two weeks, then was forced to titrate to telmisartan 80 mg with amlodipine 10 mg. The comparator group received amlodipine 5 mg for two weeks, then was forced to titrate to amlodipine 10 mg. Thus, the week-8 contrast concerns the assigned regimens after both groups had reached the stated target doses.

The primary analysis population was the Treated Set, defined in the record as all randomized participants who took at least one dose of treatment. The primary endpoint was a continuous measurement of change in trough seated systolic blood pressure from baseline to week 8. The registry lists 41 outcome measures and 5 analyses. It does not report the trial's original sample-size justification, detailed allocation procedure, or further operational details of masking. Those details 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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Treated Set includes all randomized participants who took at least one dose of treatment

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 Trough Seated Systolic Blood Pressure to Week 8, measured over Baseline, week 8.

The primary endpoint was change from baseline in trough seated systolic blood pressure at week 8, measured in mmHg. A change score describes how far the measured blood pressure at follow-up differs from the participant's baseline value. Negative mean changes in the posted results indicate decreases from baseline. Trough measurements were taken at the end of the dosing interval, just before the next medication dose.

Blood pressure is a continuous outcome, so the analysis can describe the average change in each group and the average difference between groups. A continuous measure preserves information about the size of observed changes rather than reducing them to a yes-or-no classification. This endpoint also corresponds directly to the registry's stated objective of comparing blood-pressure lowering.

The reported group values are least-squares means, with standard errors. The registry also reports an ANCOVA comparison of final values. These are related but not identical presentations: the group summaries describe estimated change from baseline, while the sponsor's reported analysis is labeled as a mean difference in final values. The analysis model's covariates and other technical details are not reported in the registry record. The endpoint is a blood-pressure measurement; it does not, by itself, describe other clinical outcomes or establish the effects of treatment beyond the measured follow-up.

7. Results Posted in the Registry

• Amlodipine 10 mg: mean -22.90 versus -29.00 on control; difference 6.10 (95% CI 4.26 to 7.94), standardized effect d = 0.52; z-test p = <0.001.

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 Trough Seated Systolic Blood Pressure to Week 6

• 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:
  • Amlodipine 10 mg: mean -22.60 versus -29.70 on control; difference 7.10 (95% CI 5.37 to 8.83), standardized effect d = 0.63; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Amlodipine 10 mg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4

• 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:
  • Amlodipine 10 mg: mean -21.10 versus -27.70 on control; difference 6.60 (95% CI 4.88 to 8.32), standardized effect d = 0.59; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Amlodipine 10 mg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2

• 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:
  • Amlodipine 5 mg: mean -16.40 versus -22.40 on control; difference 6.00 (95% CI 4.20 to 7.80), standardized effect d = 0.51; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Amlodipine 5 mg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The reported secondary continuous outcomes follow the same broad direction as the primary result: the combination group has larger decreases in trough seated systolic blood pressure than the amlodipine-only group at the listed earlier follow-up times. The direction is consistent while the treatment regimens progress through their titration and subsequent follow-up. This coherence supports reading the primary result as part of a repeated pattern in the posted blood-pressure summaries rather than as an isolated time point.

Other registered secondary outcomes concern blood-pressure control at different follow-up times. The registry lists these outcomes, but the posted results described in the record do not include results for them. Results for those control outcomes are therefore not reported in the registry record. The record also indicates that 40 secondary outcomes were posted, while only a subset of their results is represented in the available continuous-outcome details.

Secondary analyses can add context about timing and consistency, but they do not automatically carry the same evidential weight as a designated primary endpoint. When numerous outcomes and time points are examined, chance findings become more likely unless multiplicity is addressed. The registry record does not report whether a multiplicity adjustment or formal testing hierarchy was used. Accordingly, the secondary pattern is descriptive support for the primary comparison, not a collection of independent confirmations or a substitute for the primary analysis.

The interpretation also depends on the analysis population and missing-data handling. The registry record names the Treated Set for the primary outcome, but does not report detailed missing-data methods for the secondary outcomes. That limits how fully their comparability across follow-up times can be assessed.

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

• Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6
• Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4
• Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2
• Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1
• Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks
• BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks
• BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks
• BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: it records a numerical change in systolic blood pressure, in mmHg. The registry reports least-squares means for the group changes and standard errors around those estimates. A least-squares mean is a model-based group estimate; its interpretation depends on the analysis model and any covariates included. The registry names ANCOVA for the sponsor's comparison of final values, but does not report the full model specification or the covariates used.

General: ANCOVA compares groups while accounting for other variables included in the model. In clinical trials, baseline values may be included to account for starting measurements, but the specific adjustment variables in this trial are not reported in the registry record. The registry's description of the sponsor's analysis as ANCOVA should therefore be distinguished from assumptions about the model details. The posted primary arm summaries are labeled least-squares means of change, whereas the sponsor's test is labeled a mean difference in final values.

The standard error describes the precision of an estimated mean under its statistical model. It is not the spread of individual participants' measurements. For the week-8 group estimates, the reported standard errors were 0.66 mmHg and 0.67 mmHg. The reported standard error of a group estimate helps describe uncertainty in that estimate; it should not be confused with a standard deviation, which describes variation among individual measurements.

The unadjusted recalculation uses the posted group summaries to estimate a difference between the two means and a confidence interval. It is a simple comparison based on those summaries, rather than a reconstruction of the sponsor's ANCOVA. The recalculated pooled standard deviation is approximate because it is inferred from the reported standard errors. That approximation supports descriptive effect-size and planning calculations, but it does not reproduce the original participant-level analysis. The posted recalculated estimate and interval are close in magnitude to the sponsor's reported ANCOVA result, with the sign reversed because the comparison is ordered differently.

General: a confidence interval describes uncertainty in an estimated quantity under the model and assumptions used to construct it. A 95% confidence interval is produced by a procedure that, under its assumptions, would contain the target value in 95% of repeated applications. It is not a statement that there is a 95% probability that a fixed, already calculated effect lies inside the particular interval. In this study, the interval gives a useful view of the range of between-group differences compatible with the reported comparison.

The reported p-value evaluates how unusual a result at least as incompatible with a no-difference hypothesis would be, assuming that hypothesis and the analysis assumptions. The recalculation reports p < 0.001, while the sponsor's ANCOVA reports p < 0.001. These are not identical presentations of the same computation: one is an unadjusted recalculation and the other is the registry's reported model-based analysis. Neither p-value expresses the size or clinical importance of the difference, and neither conveys the range of plausible effect sizes as directly as the interval.

General: over-dispersion matters when the variability in data is greater than a model assumes. If a model understates variability, its standard errors may be too small and its confidence intervals too narrow. The registry does not report an over-dispersion assessment or a correction, and the posted continuous outcome is analyzed as a mean comparison. The available record does not establish whether over-dispersion was considered in another part of the analysis.

The registry labels the study randomized, double-blind, and parallel-group. Randomization is intended to make treatment groups comparable on average, while masking is intended to limit bias in treatment delivery or outcome assessment. These design labels do not eliminate the need to assess missing data, adherence, analysis populations, and model assumptions. Details of the randomization sequence, allocation concealment, and how masking was implemented are not reported in the registry record.

The sample-size planning illustrations use the observed effect as a reference and consider stated fractions of it. General: power is the probability that a specified statistical procedure will reject a null hypothesis under a particular assumed effect and model. Planning power is conditional on those assumptions. A post hoc calculation based on an observed effect does not measure the probability that the completed trial detected an effect; the planning illustrations are not observed power.

There are many outcome measures in the registry, including additional blood-pressure changes and blood-pressure-control outcomes. If many hypotheses are tested, the chance of at least one apparently positive result can rise unless the analysis accounts for multiplicity. The registry record does not report a multiplicity adjustment or a prespecified hierarchy for these outcomes. This makes the primary endpoint and its reported analysis the clearest focal result, while secondary results should be interpreted with more caution.

11. Confidence Intervals and Precision

The primary recalculated mean difference is 6.1 mmHg, with a 95% confidence interval from 4.257 to 7.943. This interval describes uncertainty in the estimated group contrast under the unadjusted recalculation. Because the interval does not include zero, the posted estimate is not only directionally consistent with a difference but also has a range that remains on one side of zero under this analysis. The interval is not a prediction interval for individual participants and does not show how much responses varied from person to person.

The sponsor's ANCOVA result is reported as -6.1 mmHg, with a 95% confidence interval from -7.9 to -4.2. The signs differ because the contrast is expressed in the reverse group order. The endpoints are also rounded differently from the recalculated interval, and the analyses are not identical: one is the sponsor's model-based analysis and the other is a simple unadjusted recalculation from posted summary statistics.

The group standard errors at week 8 are 0.66 mmHg and 0.67 mmHg. These indicate precision of the estimated group means, not the distribution of participants' measurements. The primary comparison's interval is more directly useful for judging precision of the between-group effect than the two separate standard errors.

General: narrower confidence intervals indicate greater precision, while wider intervals indicate more uncertainty about the effect size. Precision does not establish clinical importance, and a statistically distinguishable difference does not by itself resolve whether a difference matters to patients. The registry record does not state a threshold for clinical importance or report additional analyses that would translate the blood-pressure contrast into other outcomes.

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 for 80% power and participants per arm for 90% power. They are not total event counts. The illustrations use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect assumed for each planning row is the stated fraction of the observed effect. The original trial's own design assumptions and sample-size justification are not reported in the registry record.

The 80% power column gives the number of participants per arm that the planning calculation estimates would be needed to have an 80% chance of detecting the assumed effect under the listed assumptions. The 90% power column gives the corresponding number per arm for a 90% chance. These are planning targets for hypothetical designs, not descriptions of the trial's actual enrollment or analysis population.

The rows consider planning for 100%, 75%, and 50% of the observed effect. Smaller assumed effects require more participants because smaller differences are harder to distinguish from random variation. The calculations use the observed effect as their reference, so they should not be treated as an independent basis for claiming that the trial was adequately designed. These figures are not observed power.

The underlying planning illustrations are specific to the primary continuous outcome and the assumptions listed in the record. They do not establish that the actual trial used the same significance level, allocation assumptions, or approximation. Those original design details are not reported in the registry record.

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 = 6.100; pooled standard deviation σ = 11.811.
2. n = 2 × (1.96 + 0.842)² × 11.811² / 6.100² = 58.9, rounded up to 59 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 <- 6.1                      # observed difference in means
sigma <- 11.8109443062528                     # 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(877929)
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 = 59 (80% power), 79 (90% power)
 75% of observed effect: n per arm = 105 (80% power), 141 (90% power)
 50% of observed effect: n per arm = 236 (80% power), 316 (90% power)
power.t.test: 59.8 
Simulated power at n = 59 per arm: 0.793 (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 reported primary analysis is an ANCOVA comparison of final values. It gives a mean difference of -6.1 mmHg, a 95% confidence interval from -7.9 to -4.2, and p < 0.001. The unadjusted recalculation from the posted group summaries gives a difference of 6.1 mmHg, with a 95% confidence interval from 4.257 to 7.943 and p < 0.001.

The signs are opposite because the sponsor's contrast and the recalculation use different group orders. Both report a difference of the same stated magnitude and point in the same substantive direction: the combination group's mean change is more negative than the amlodipine-only group's mean change. The sponsor's interval and p-value come from the sponsor's model-based analysis; the recalculation is an unadjusted comparison and should not be treated as a replacement for that analysis.

The registry does not report a discrepancy between the posted recalculation and the sponsor's analysis. The sponsor's analysis remains the primary reported inferential result, while the recalculation is useful as a transparent check based on summary statistics. Details needed to reproduce the ANCOVA from participant-level data, including its covariates, are not reported in the registry record.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists 41 outcome measures and 5 analyses, and it reports 40 secondary outcomes posted. With multiple outcomes, time points, and potential comparisons, the chance of obtaining at least one small p-value by chance can increase. Statistical approaches such as family-wise error control or a prespecified testing sequence can address this issue, but the registry record does not report a multiplicity adjustment, a testing hierarchy, or how the family of hypotheses was defined. The secondary p-values should therefore not be read as though each were the sole planned test.

The primary population is described as the Treated Set, including randomized participants who took at least one dose. The record does not state how many participants contributed to the primary outcome analysis at week 8 beyond the group-level values and analysis counts, nor does it explain exclusions or deviations from the Treated Set. Whether a separate intention-to-treat analysis was conducted is not reported in the registry record.

Missing-data handling is also not reported in the registry record. The record does not state how missing week-8 blood-pressure measurements were addressed, whether imputation was used, or whether sensitivity analyses tested alternative assumptions. Missingness can affect a group comparison if availability of measurements is related to treatment or outcome, so this omission limits assessment of robustness.

The registry identifies ANCOVA for the sponsor's reported comparison but does not provide its full model specification, the covariates included, or diagnostic checks. It also does not report interim analyses or stopping rules. These absent details should not be inferred from the fact that the study is randomized and double-blind. They are not reported in the registry record.

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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: ulcer (0.3%), lower limb fracture (0.3%), hyperglycaemia (0.3%), arteriosclerosis (0.3%), anaemia (0.3%).

The registry reports serious adverse events among 3 participants in the combination group, with 352 participants at risk, and among 4 participants in the amlodipine-only group, with 354 participants at risk. For other adverse events, it reports 62 affected participants in the combination group and 71 in the amlodipine-only group, using the same respective at-risk counts. These are descriptive counts; they do not by themselves establish a causal difference between regimens.

The record lists serious-event terms including ulcer, lower limb fracture, hyperglycaemia, arteriosclerosis, anaemia, and cardiac failure. Each listed term is reported as 0.3%. The registry does not provide event narratives or the timing and duration needed to interpret individual cases. Death counts are not reported in the registry record.

Safety comparisons depend on how events were collected, defined, and attributed, and on the exposure and follow-up available for participants. Those details are not fully reported in the registry record. The counts should therefore be read as the adverse-event information posted for this trial, not as a complete assessment of comparative safety.

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

The posted results describe an average change in trough seated systolic blood pressure over the trial's 8-week follow-up. At week 8, the estimated mean decrease was larger in the group assigned telmisartan plus amlodipine than in the group assigned amlodipine alone. The recalculated difference and the sponsor's reported ANCOVA result are consistent in magnitude and direction once their opposite sign conventions are recognized. The confidence intervals and p-values indicate that the recorded analyses distinguish the group averages under their respective assumptions.

This finding concerns the measured endpoint and the enrolled trial population. It does not establish how every participant responded, whether any individual experienced a particular change, or whether the group difference leads to changes in other outcomes. It does not establish effects beyond the follow-up period or outcomes not reported in the registry. The record does not report the results for all listed secondary outcomes, including blood-pressure-control outcomes.

Statistical evidence of a group difference is not the same as evidence of clinical importance. The registry does not state a threshold for a clinically important difference, and the blood-pressure contrast alone does not answer questions about other benefits or harms. Nor does a p-value measure the probability that a treatment hypothesis is true.

Interpretation is also bounded by what the registry records about the analysis. The primary population is defined, but missing-data methods, multiplicity handling, and full ANCOVA details are not reported in the registry record. The results should be understood as the posted comparison of group averages, with those reporting limits in view, rather than as a complete account of every possible clinical or statistical question.

18. Why This Trial Matters Statistically

This trial illustrates how a continuous endpoint can convey both direction and size of a group-level change. Reporting mean changes in blood pressure retains more information than reducing measurements to categories alone. The primary result also demonstrates why the sign of a mean difference must be interpreted alongside the stated group order: the sponsor and unadjusted recalculation present opposite signs for a contrast of similar magnitude.

The registry reports both a model-based ANCOVA and enough summary information for a simple unadjusted recalculation. Those analyses offer different views of the comparison. The recalculation is a check on the posted summaries, while the sponsor's ANCOVA is the trial's reported inferential analysis. The distinction matters because a reconstruction from summary values cannot reproduce all details of a participant-level adjusted model.

The time-point outcomes provide a descriptive view of whether the direction of the group estimates persists during the treatment period. At the same time, the number of registered outcomes makes multiplicity and prespecification relevant. Without a reported adjustment or hierarchy, secondary findings should not be treated as independent confirmatory tests.

Finally, the record shows the difference between trial results and trial-planning calculations. Planning illustrations based on observed effects can help readers understand how assumed effect size relates to participant requirements, but they do not establish what assumptions guided the original design or how much power the completed trial had. Together, these statistical distinctions help readers separate estimates, uncertainty, planning, and interpretation.

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 registry record does not report the original sample-size justification or the assumptions used to plan enrollment. The posted planning illustrations are based on the observed effect and cannot establish the rationale for the trial's actual enrollment. The record also does not report a multiplicity procedure despite the many registered outcomes and analyses.

Several details needed to assess the analysis are absent: the full ANCOVA model and covariates, missing-data handling, sensitivity analyses, and the number of participants with observed primary endpoint measurements at week 8. The stated Treated Set definition excludes randomized participants who did not take at least one dose, but the record does not describe the results under another analysis population. The availability of an intention-to-treat analysis is not reported in the registry record.

The primary summaries are least-squares means with standard errors, while the sponsor's comparison is labeled as a mean difference in final values. The record does not provide enough detail to fully reproduce the model-based analysis from participant-level data. The unadjusted recalculation relies on summary statistics and an approximate pooled standard deviation, so it is not a substitute for that model.

The follow-up is described as 8 weeks, and the registry results address blood-pressure measurements over this period. Longer-term outcomes, results for all registered secondary measures, and deaths are not reported in the registry record. The record also provides limited detail about adverse-event ascertainment. These limitations constrain broader conclusions from the posted information.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus — NCT00877929.
• Registry record last updated 2014-03-12; status last verified 2014-02.
• Results first posted 2011-06-07.
• 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

The registry describes a completed phase 3 randomized, double-blind, parallel-group study with enrollment of 706 and an 8-week treatment comparison in participants with hypertension and type 2 diabetes. The intervention was telmisartan plus amlodipine, titrated from amlodipine 5 mg to 10 mg alongside telmisartan 80 mg; the comparator was amlodipine alone, titrated from 5 mg to 10 mg.

The primary outcome was change from baseline in trough seated systolic blood pressure at week 8. The posted estimates show a larger mean decrease in the combination group. The sponsor's ANCOVA and an unadjusted recalculation report the contrast with opposite signs because of group ordering, but similar magnitude and direction.

The registry does not report the original sample-size justification, multiplicity handling, missing-data methods, or full model specification. Those omissions limit assessment beyond the posted analyses.