Blood Pressure Lowering of Aliskiren HCTZ Compared to HCTZ in Stage 2 Systolic Hypertension in Older Population: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Blood Pressure Lowering of Aliskiren HCTZ Compared to HCTZ in Stage 2 Systolic Hypertension in Older Population (NCT00760266), a randomized phase 4 study. The primary outcome is Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 4.

2. Clinical Question

3. Trial Design

This was a Phase 4, randomized, triple-masked, parallel-group, multicenter, active-controlled study. The official title describes an 8-week dose-escalation study, and the registry record lists an enrollment of 451. The study status is completed. The record identifies Novartis as the sponsor, with a start of 2008-09 and primary completion in 2009-04.

The groups were aliskiren/HCTZ 300/25 mg and HCTZ 25 mg. The registry describes the purpose as evaluating the efficacy and safety of initial use of a fixed-dose aliskiren/HCTZ combination compared with HCTZ in an older population with Stage 2 systolic hypertension. The active comparator gives the study a direct comparison between the combination and HCTZ, rather than a comparison with no treatment.

Randomization is intended, in general, to reduce systematic differences between groups at assignment. Masking is intended, in general, to limit the influence of treatment knowledge on participants, investigators, or outcome assessment. The record labels the masking as triple but does not report which roles were masked or the procedures used to maintain masking. Further details of the randomization sequence and allocation concealment are not reported in the registry record.

The primary endpoint was assessed from baseline to Week 4, although the study title describes an 8-week study. The registry also lists secondary measures at Week 4 and Week 8. The posted primary endpoint analysis uses the full analysis set, with 225 participants in the aliskiren/HCTZ arm and 222 in the HCTZ arm. The registry enrollment count and outcome analysis counts describe different record elements; details of participant flow and the reasons for any differences are not reported in the registry record.

The registry record does not report the trial's original sample-size justification, the original design assumptions, or whether interim analyses were planned or conducted. Those design details cannot be inferred from planning illustrations calculated from the observed result.

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: Full analysis set

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 in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 4, measured over Baseline and Week 4.

The primary endpoint is change in mean sitting systolic blood pressure (msSBP) from baseline to Week 4, measured in mm Hg. It is a continuous outcome: each participant's blood pressure measurement can take a range of values, and the group result is expressed as a mean change. A negative change indicates a reduction from baseline in the measure as recorded. The posted least-squares means were -29.6 mm Hg for aliskiren/HCTZ and -22.3 mm Hg for HCTZ.

In general, a change-from-baseline endpoint expresses follow-up measurements relative to the starting measurement rather than describing only the Week 4 value. Systolic blood pressure is the upper pressure value measured during a heartbeat. Sitting measurements standardize body position for the recorded measure, although the registry record does not provide detailed measurement procedures or the number of readings used.

Using a continuous measure preserves information about the size and direction of observed changes. A group mean can support a direct comparison of average change, while a confidence interval communicates uncertainty around the difference. The mean does not describe every participant's response or the spread of individual outcomes. The record identifies the result as a least-squares mean and reports standard errors for the arms, but does not describe the model used to obtain the least-squares means.

Week 4 is the primary time point in the posted endpoint, not the end of the full study period described in the title. The endpoint therefore addresses an early comparison of average change, while the registry's listed Week 8 measures address a later time point. Neither time point alone establishes what happens beyond the follow-up reported in the record.

7. Results Posted in the Registry

• HCTZ: mean -22.30 versus -29.60 on control; difference 7.30 (95% CI 4.53 to 10.07), standardized effect d = 0.49; 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 in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline 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:
  • HCTZ: mean -9.20 versus -11.10 on control; difference 1.90 (95% CI -0.32 to 4.12), standardized effect d = 0.21; z-test p = 0.093.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between HCTZ and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists several secondary questions related to blood pressure: change in mean sitting diastolic blood pressure at Week 4; systolic and diastolic changes at Week 8 among patients with baseline msDBP ≥90 mmHg; responder percentages at Week 4 and Week 8; and blood-pressure control at Weeks 4 and 8. These outcomes broaden the description beyond the primary Week 4 systolic mean, including another measurement type, later follow-up, and threshold-based outcomes.

A Week 4 diastolic change result is posted for the subset with available outcome counts of 130 in the aliskiren/HCTZ arm and 133 in the HCTZ arm. The posted mean difference is 1.9 mm Hg, with a 95% confidence interval from -0.317 to 4.117 and an unadjusted p-value of 0.093. The interval includes zero. The remaining listed secondary results are not reported in the registry record, so the overall secondary pattern cannot be assessed across all of the stated outcomes.

The posted Week 4 diastolic result is related to, but distinct from, the primary systolic result. It concerns a different blood pressure measure and a smaller outcome population, so it should not be treated as a replication of the primary comparison. The unadjusted result also does not establish that the primary finding is either confirmed or contradicted by the secondary endpoint.

In general, testing multiple outcomes or time points increases the opportunity for chance findings if each is interpreted separately without accounting for multiplicity. The record does not report whether a multiplicity procedure was planned or used. For that reason, unadjusted secondary results carry less weight as confirmatory evidence than a prespecified primary result interpreted within its stated analysis. The registry does not report enough detail to determine the planned hierarchy among secondary outcomes or which results were intended as confirmatory.

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

• Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 4
• Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (in Patients With msDBP ≥90 mmHg at Baseline) From Baseline to Week 8
• Percentage of Responders at Week 4 and Week 8
• Percentage of Subjects Achieving Blood Pressure Control at Weeks 4 and 8

9. Statistical Interpretation

10. Statistical Methods Explained

What does a mean difference describe?

The primary measure is continuous, and the posted arm results are least-squares mean changes from baseline. A mean difference contrasts the average changes between the two groups. The listed arm means are -29.6 mm Hg for aliskiren/HCTZ and -22.3 mm Hg for HCTZ, with a reported mean difference of 7.3 mm Hg. The estimate describes the separation between group averages; it does not say that every participant experienced a change of that size.

In general, least-squares means are model-based adjusted means. The registry record labels the arm estimates as least-squares means but does not report the model specification, covariates, or adjustment procedure. It is therefore not possible to determine from the record which factors, if any, were included in the model. The posted arm standard errors are 1.0 for each group.

How should the confidence interval and p-value be read?

A confidence interval describes a range of estimates compatible with the observed data and the method's assumptions. The primary 95% confidence interval for the mean difference runs from 4.528 to 10.07 mm Hg. In general, a confidence level describes the long-run behavior of the interval procedure across repeated use; it is not a probability statement about a fixed effect after the interval has been calculated. An interval that excludes zero indicates that the reported range does not include no difference, but does not itself establish clinical importance.

The primary unadjusted p-value is < 0.001. In general, a p-value is calculated relative to a null hypothesis and a statistical model. It does not give the probability that the result is due to chance, nor does it account automatically for multiple outcomes or analyses. The registry identifies the value as unadjusted. A multiplicity adjustment is not reported in the registry record.

What does dispersion mean for a continuous outcome?

The arm results report standard errors, which describe uncertainty in the estimated mean, rather than the variation among individual participants. In general, a standard error depends on both variability and the amount of information contributing to the estimate. It should not be read as a range containing most individual measurements. The record also includes a pooled standard deviation of 14.95 for the primary comparison, flagged as approximate. That quantity is part of an unadjusted recalculation from the posted summary statistics and is not a sponsor-reported outcome estimate.

General statistical context: if outcomes vary more than a simple model assumes, over-dispersion can make standard errors too small and confidence intervals too narrow when the model does not account for that extra variation. The registry record does not report a model diagnostic or an over-dispersion assessment, and the primary outcome is presented as a continuous measure rather than a count outcome. No conclusion about such a diagnostic can be drawn from the posted summary statistics alone.

What do standardized estimates add?

A standardized effect expresses a mean contrast relative to a measure of variation, which can help describe the magnitude on a scale without the original measurement units. The primary comparison includes a standardized estimate of 0.488 in the analysis data, but that value is not needed to interpret the endpoint in mm Hg. Standardized effects depend on the chosen variability estimate and do not replace the original-unit difference or its confidence interval. The approximate pooled standard deviation used for recalculation also means the standardized estimate should be treated as a derived summary, not a separate registry analysis.

What does “recalculated” mean?

Where recalculated summaries are presented, they are simple, unadjusted calculations from posted summary statistics. They can be useful for orientation, but they are not a substitute for the sponsor's analysis. The record indicates no discrepancy between the recalculated and posted primary results, so there is no stated conflict requiring the sponsor's analysis to take precedence. These calculations do not reveal the trial's original statistical plan or account for model details that are not reported.

What are the limits of the reported methods?

The registry identifies randomization, triple masking, a parallel-group design, the full analysis set for the primary outcome, and least-squares mean estimates. It does not report the statistical analysis plan, the model formula, covariate handling, missing-data methods, sensitivity analyses, or interim-analysis procedures. The exact definition of the full analysis set and the approach to exclusions are also not reported in the registry record. These omissions matter because the interpretation of an estimate depends on how outcomes and participants were handled, not just on the numerical result.

General explanation: randomized assignment can support a fair comparison by balancing factors across groups on average, but the result still depends on follow-up, outcome measurement, and analysis choices. Masking can limit some forms of influence, but the record's label does not establish which people were masked or whether masking was maintained. These design features provide context; they do not remove uncertainty or answer questions that the record does not document.

11. Confidence Intervals and Precision

The primary estimate is a mean difference of 7.3 mm Hg, and its 95% confidence interval extends from 4.528 to 10.07 mm Hg. The interval quantifies uncertainty in the estimated group contrast under the analysis and assumptions used. It is not a range of individual participant responses, and it does not mean that the true effect has a 95% probability of falling inside this particular interval.

The interval does not include zero. In general, zero represents no difference on a difference scale, so this feature is consistent with the reported unadjusted p-value of < 0.001. The estimate's location and the interval's width should be considered together: the point estimate gives one summary of the contrast, while the interval shows a range of values compatible with the analysis. Statistical precision does not by itself determine whether a difference matters clinically.

The primary outcome standard errors are 1.0 in each arm, and the reported sample sizes are 225 for aliskiren/HCTZ and 222 for HCTZ. Standard errors reflect uncertainty around group means, not the range of measurements among participants. No confidence intervals are reported for the separate arm means in the registry record, while the comparison interval is explicitly posted.

Precision is also limited in scope by the endpoint and follow-up. The interval concerns the primary mean change at Week 4 in the full analysis set. It does not quantify uncertainty for the unreported Week 8 results or for outcomes not included in the posted result. The registry record does not report sensitivity analyses that could show how robust the interval is to alternative assumptions, including assumptions about missing measurements.

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 sample-size table and curve are planning illustrations based on the observed effect, not the trial's original design calculation. The registry record does not report the trial's original sample-size justification or design assumptions. For these illustrations, the stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set at the stated fraction of the observed effect. Because this is a continuous outcome, the figures are participants per arm, not total events.

The 80% power column gives the illustrative participants per arm for a design that would have an 80% chance of detecting the specified effect under the stated assumptions, if that effect and the assumptions were correct. The 90% power column gives the corresponding illustration for a 90% chance. These are planning concepts, not guarantees about a future study's result. The displayed rows consider planning for 100%, 75%, and 50% of the observed effect. As the assumed effect becomes smaller, more participants are needed to detect it at the same nominal power and significance level.

For example, planning for 100% of the observed effect gives 66 participants per arm for 80% power and 89 participants per arm for 90% power. Planning for 75% gives 118 participants per arm for 80% power and 157 participants per arm for 90% power. Planning for 50% gives 264 participants per arm for 80% power and 353 participants per arm for 90% power. These illustrations concern the primary comparison and do not establish the actual design rationale. This is not observed power: it does not describe the probability that the completed trial detected an effect after seeing its results.

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 = 7.300; pooled standard deviation σ = 14.950.
2. n = 2 × (1.96 + 0.842)² × 14.950² / 7.300² = 65.8, rounded up to 66 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 <- 7.3                      # observed difference in means
sigma <- 14.9502545917971                     # 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(760266)
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 = 66 (80% power), 89 (90% power)
 75% of observed effect: n per arm = 118 (80% power), 157 (90% power)
 50% of observed effect: n per arm = 264 (80% power), 353 (90% power)
power.t.test: 66.8 
Simulated power at n = 66 per arm: 0.796 (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. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when a study evaluates several outcomes, time points, subgroups, or analyses. In general, the more separate comparisons made, the greater the chance that at least one result may appear notable by chance if each is judged using the same threshold without adjustment. This trial lists multiple secondary blood-pressure outcomes across Week 4 and Week 8, in addition to the primary Week 4 systolic endpoint. The registry record does not report a multiplicity-adjustment method, a testing hierarchy, or a statistical analysis plan specifying how these results were to be interpreted.

The primary comparison has an unadjusted p-value of < 0.001. The posted Week 4 diastolic comparison has an unadjusted p-value of 0.093. These values should be understood as reported for their respective analyses, without assuming that any correction was or was not applied beyond the explicit unadjusted labeling. The record does not give enough information to evaluate the full family of planned comparisons or identify which secondary tests were performed but not posted.

Missing-data handling is another important analytic issue. The record identifies the primary population as the full analysis set, but does not define that set or state how participants with missing baseline or Week 4 measurements were handled. It does not report imputation procedures, sensitivity analyses, or the number of missing outcome measurements. Consequently, it is not possible to assess from the registry record whether the reported estimates depend on particular assumptions about missing outcomes.

Analysis populations can differ across outcomes. The primary result has arm counts of 225 and 222, while the posted Week 4 diastolic result has arm counts of 130 and 133. The registry describes the diastolic endpoint as applying to patients with baseline msDBP ≥90 mmHg. Details about eligibility for each analysis, participant flow, and reasons for the different outcome counts are not reported in the registry record.

The registry also does not report whether interim analyses were planned or conducted, or whether any statistical stopping rules were specified. These are distinct from the post-result planning illustrations, which are not a record of the trial's original design. Without the analysis plan and missing-data details, the estimates remain interpretable as posted results, but their full confirmatory context cannot be reconstructed.

15. 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: non-cardiac chest pain (0.4%), subdural haematoma (0.4%), wrist fracture (0.4%), colitis (0.4%), renal function test abnormal (0.4%).

The registry reports serious adverse events affecting 4 participants at risk in the aliskiren/HCTZ group and 3 in the HCTZ group. The corresponding numbers at risk were 227 and 223. The record also reports other adverse events affecting 17 participants in the aliskiren/HCTZ group and 26 in the HCTZ group, with the same respective numbers at risk. These are counts of participants with reported events, not rates calculated.

The registry lists non-cardiac chest pain, subdural haematoma, wrist fracture, colitis, renal function test abnormal, and muscle spasms among the top serious terms, each displayed as 0.4%. The record does not attribute these listed terms to a particular arm in the available summary. Death counts are not reported in the registry record.

These figures describe reported events during the study, but they do not establish that an event was caused by a study treatment. The registry summary does not give event timing, severity details beyond the serious-event classification, participant-level histories, or a full account of how adverse events were assessed. Comparisons of the counts should therefore be read descriptively, not as a standalone measure of relative safety.

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

The primary result describes a Week 4 difference between group averages in change from baseline in mean sitting systolic blood pressure. The aliskiren/HCTZ group had a posted least-squares mean change of -29.6 mm Hg, and the HCTZ group had a posted change of -22.3 mm Hg. The reported mean difference was 7.3 mm Hg, with a 95% confidence interval from 4.528 to 10.07 and an unadjusted p-value < 0.001. These are statistical findings for the outcome and analysis population reported in the registry.

The result does not describe the response of every participant. Group means can conceal variation, including participants whose measurements changed more, less, or in a different direction. The registry does not report the distribution of individual changes in the available summary. The primary finding also does not establish the results at Week 8: the registry lists Week 8 secondary outcomes, but those results are not reported in the registry record.

In general, a statistically distinguishable group contrast is not by itself a judgment about clinical importance. The registry provides the outcome scale and estimated contrast but does not report a threshold for what would count as a clinically important difference. It also does not establish effects on outcomes beyond the blood-pressure measures described, durability beyond the recorded follow-up, or applicability to populations not represented in the study.

The study compared a fixed-dose aliskiren/HCTZ combination with HCTZ in older patients with Stage 2 systolic hypertension. It was randomized and triple-masked according to the registry, but details about the masking roles and analysis procedures are not reported. The posted estimates should be understood within this particular population, comparison, endpoint, and time point. They are not medical advice and do not determine an appropriate treatment choice for an individual.

The safety summary is also limited. It reports counts of participants with serious and other adverse events and lists several serious-event terms, but does not establish causation or provide a complete account of event details. The efficacy and safety summaries should be considered as distinct parts of the registry record, with the limitations of each in view.

17. Why This Trial Matters Statistically

This trial is statistically notable for the contrast between an early continuous primary endpoint and a broader set of listed secondary questions. Its primary outcome is a mean change in sitting systolic blood pressure at Week 4, while the registry also names diastolic change, Week 8 measurements, responder status, and blood-pressure control. These outcomes address related but not identical questions. Distinguishing the primary endpoint from secondary measures helps keep interpretation aligned with the endpoint that anchors the reported comparison.

The primary result illustrates why an effect estimate and its interval are more informative than a significance label alone. The mean difference is reported in mm Hg, and its confidence interval communicates the uncertainty around that contrast. The p-value indicates statistical compatibility with a null model under analysis assumptions, but does not quantify the effect's importance or the experience of individual participants. Reading these statistics together supports a more complete description of the posted result.

The record also illustrates the difference between an observed result and a planning calculation. Sample-size illustrations based on fractions of an observed effect can show how assumptions about target effect size relate to participant requirements. They do not recover the original design rationale and do not tell whether a completed trial had a particular probability of success after its results are known.

Finally, the missing analytic details matter. The registry identifies randomization, masking, the analysis population label, and least-squares means, but does not report the full model, missing-data approach, multiplicity plan, or original sample-size justification. This makes the posted numerical result useful for understanding the recorded comparison while limiting independent reconstruction of its full statistical context.

18. 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 gives a concise outcome summary rather than a complete statistical report. It identifies the primary endpoint as a least-squares mean change but does not provide the model specification, covariates, or details of how the estimates were adjusted. The record also does not explain the randomization sequence or allocation concealment, or identify which roles were masked under the triple-masked designation.

The primary endpoint is measured at Week 4, while the study title describes an 8-week study. Although the registry lists secondary outcomes at Week 8, their results are not reported in the registry record. The available result therefore does not describe whether the primary comparison was maintained through the later time point. The record does not report the measurement schedule and procedures in enough detail to assess consistency of blood pressure collection.

The outcome counts differ across the primary and posted secondary analyses, and the diastolic outcome is restricted to patients with baseline msDBP ≥90 mmHg. The record does not explain participant flow, the reasons for differences in analysis counts, or the handling of missing measurements. It also does not define the full analysis set beyond naming it as the primary population.

The registry lists multiple secondary outcomes, but does not report a multiplicity plan, testing hierarchy, or the full statistical analysis plan. It does not report interim-analysis procedures or the trial's original sample-size justification. These gaps prevent a full assessment of the prespecified analysis framework and the confirmatory status of secondary comparisons.

The safety information is summarized as participant counts and selected serious-event terms. Death counts are not reported in the registry record, and the summary does not provide detailed event timing, severity, attribution, or participant-level context. The registry also does not report outcomes beyond those named in the record. These limitations restrict what can be concluded about longer-term effects, individual responses, and the broader safety profile.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Blood Pressure Lowering of Aliskiren HCTZ Compared to HCTZ in Stage 2 Systolic Hypertension in Older Population — NCT00760266.
• Registry record last updated 2011-04-04; status last verified 2011-03.
• Results first posted 2011-01-21.
• 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.

22. Record Summary

NCT00760266 is a completed Phase 4 randomized, triple-masked, parallel-group, multicenter, active-controlled study sponsored by Novartis. The registry reports enrollment of 451 and describes a comparison of aliskiren/HCTZ 300/25 mg with HCTZ 25 mg in older patients with Stage 2 systolic hypertension.

The primary endpoint was change in mean sitting systolic blood pressure from baseline to Week 4 in the full analysis set. The posted mean changes were -29.6 mm Hg and -22.3 mm Hg, respectively; the mean difference was 7.3 mm Hg, with a 95% confidence interval from 4.528 to 10.07 and an unadjusted p-value < 0.001.

The registry lists additional blood-pressure outcomes and adverse-event summaries. It does not report the trial's original sample-size justification, detailed statistical analysis plan, missing-data methods, or multiplicity procedures. The available findings describe the recorded comparison and time point, not outcomes beyond those reported.