Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension (NCT00853957), a randomized phase 4 study. The primary outcome is Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP).

2. Clinical Question

The clinical question is about a measured change in blood pressure over the study period, not about long-term outcomes. The posted primary endpoint is the change from baseline in mean sitting systolic blood pressure (msSBP), measured at baseline and 8 weeks. The registry record also lists secondary measures of diastolic blood pressure, blood-pressure control, response, earlier systolic readings, and peripheral edema. Those outcomes give additional descriptions of blood pressure and safety, but they do not replace the prespecified primary question.

3. Trial Design

The registry record describes a Phase 4, randomized, double-blind, active-control, parallel-group study. It was completed and enrolled 443 participants. The study title specifies an 8-week duration and a population of African American patients with Stage 2 hypertension. The sponsor is Novartis. The record lists the start as 2009-02 and primary completion as 2009-08.

Participants were assigned to aliskiren with amlodipine or amlodipine alone. The combination regimen was 150/5 mg titrated to 300/10 mg; the monotherapy regimen was amlodipine 5 mg titrated to 10 mg. The record identifies the study as double-blind, but the details of how masking was maintained are not reported in the registry record. Likewise, the randomization procedure, allocation concealment, and the schedule or rules for dose titration are not reported in the registry record.

The primary endpoint uses the full analysis set with LOCF, and the reported endpoint group sizes are 220 for the combination and 222 for amlodipine alone. Those endpoint denominators describe the posted primary outcome; the registry record does not explain all differences in denominators across outcome types. The record does not report the original sample-size justification, the detailed protocol, or a sponsor-reported statistical analysis plan. Such details should not be inferred from the design labels or from the planning illustrations calculated from the observed effects.

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, Last Observation Carried Forward (LOCF)

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 Mean Sitting Systolic Blood Pressure (msSBP), measured over Baseline, 8 weeks.

The primary endpoint is change from baseline in mean sitting systolic blood pressure (msSBP), in mm Hg, assessed at baseline and 8 weeks. It summarizes how the average seated systolic measurement shifted during treatment in each group. A negative change represents a lower follow-up mean than baseline; the size of the group mean change describes the average shift, not the experience of every participant.

Systolic blood pressure is the higher of the two conventional blood-pressure readings, and a mean change offers a continuous measure of movement over time. As a general statistical point, continuous outcomes retain information about the magnitude of change rather than reducing each participant to a yes-or-no category. That makes the endpoint useful for comparing average shifts, while leaving questions about individual variation and clinically defined thresholds to other measures.

The registry reports arm means and standard deviations for the endpoint, with the full analysis set defined using LOCF. LOCF carries the last available observation forward when a later value is missing; this is an analysis convention, not a direct measurement at every scheduled visit. The record does not report the amount or pattern of missing primary endpoint data or the assumptions used to justify LOCF. The endpoint therefore needs to be read alongside the analysis population and the limitations of the missing-data approach.

7. Results Posted in the Registry

• Amlodipine: mean -27.80 versus -33.10 on control; difference 5.30 (95% CI 2.69 to 7.91), standardized effect d = 0.38; 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 Mean Sitting Diastolic Blood Pressure (msDBP)

• 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:
  • Amlodipine: mean -10.40 versus -13.70 on control; difference 3.30 (95% CI 1.56 to 5.04), standardized effect d = 0.35; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Amlodipine than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg)

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Amlodipine: 57.4% (117/204) versus 71.4% (147/206) on control; risk difference -14.0 percentage points (95% CI -23.2 to -4.8), risk ratio 0.80 (0.69–0.93); unadjusted two-proportion z-test p = 0.003.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically lower for Amlodipine than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg)

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Amlodipine: 86.3% (176/204) versus 92.2% (190/206) on control; risk difference -6.0 percentage points (95% CI -11.9 to 0.0), risk ratio 0.94 (0.87–1.00); unadjusted two-proportion z-test p = 0.051.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Amlodipine and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes add several views of blood-pressure change and response. The posted diastolic mean change is directionally consistent with the primary systolic result, and the blood-pressure-control percentages are also higher in the combination group. The responder percentages point in the same direction, but the unadjusted comparison is less conclusive: its confidence interval reaches across zero and its p-value is 0.051. Taken together, the numerical secondary results do not contradict the direction of the primary comparison, but they do not all provide the same degree of statistical evidence.

These measures are related, not interchangeable. Mean change retains the scale and magnitude of a continuous measurement. Blood-pressure control and responder status classify participants using thresholds, so their results depend on how those definitions are applied and on observations near the cutoffs. Agreement across different outcome types can provide context, but it does not turn secondary outcomes into independent confirmation of the primary endpoint.

The registry lists additional secondary outcomes, including systolic changes at earlier visits and peripheral edema by visit, but numerical results for those outcomes are not reported in the registry record. The record also lists no reported analyses for the secondary outcomes. It does not describe a multiplicity correction or a hierarchy that would establish how these outcomes were intended to be interpreted relative to one another.

General statistical context: when many outcomes are tested, the chance of finding an apparently noteworthy result by chance can increase. Unadjusted secondary p-values should therefore be treated as exploratory evidence unless a prespecified plan explains how the family of tests was handled. The secondary findings can help describe the overall pattern, but they carry less weight than the primary endpoint and should not be read as separate definitive conclusions.

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

• Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
• Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg)
• Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg)
• Change From Baseline in MSSBP at Week 1 and 4
• Percentage of Patients With Peripheral Edema by Visit

9. Statistical Interpretation

10. Statistical Methods Explained

The primary measure is continuous: each group has a mean change in msSBP and a standard deviation. A mean describes the center of the observed group changes, while a standard deviation describes how spread out participant values are around that mean. General statistical context: a mean difference compares the group averages, whereas the standard deviation describes within-group variability. They answer related but distinct questions.

What does the mean difference represent?

The posted contrast is the amlodipine group mean change minus the aliskiren/amlodipine group mean change. The group means are -27.8 mm Hg and -33.1 mm Hg, respectively, and the contrast is 5.3 mm Hg. Because both changes are negative, the more negative mean corresponds to a larger average decrease from baseline. The contrast is an average between-group comparison; it does not mean that each participant experienced that difference.

General statistical context: comparing changes can be done by subtracting the group mean changes, but the precision of that contrast depends on the spread of values and the amount of information in each group. The posted standard deviations are 13.45 and 14.53 mm Hg, and the posted comparison includes a confidence interval. The registry record does not report a detailed model specification or indicate that the comparison adjusts for additional covariates, so no particular adjusted model should be assumed.

What does the p-value say?

The primary comparison has an unadjusted p < 0.001. General statistical context: a p-value describes how unusual the observed result, or a result more extreme, would be under a statistical null model of no group difference and the assumptions of the analysis. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of an effect. The word unadjusted matters because the record does not report a multiplicity adjustment for this comparison or for the set of secondary outcomes.

A p-value is also not a measure of precision by itself. The confidence interval gives a range of values compatible with the data and the analysis assumptions, while the p-value summarizes evidence against a null difference under a specified testing framework. The two are consistent in this result: the interval excludes zero and the p-value is small. Their interpretation remains conditional on the analysis and the quality of the underlying data.

Why does over-dispersion matter?

General statistical context: over-dispersion occurs when observed variation is greater than a statistical model expects. If a model assumes less variability than is present, standard errors can be too small and confidence intervals too narrow. This is especially relevant to count or binary outcomes analyzed with models that impose particular variance assumptions. For the primary continuous outcome, the registry provides standard deviations, but does not report a specific model diagnostic or a discussion of over-dispersion. It should not be asserted that over-dispersion occurred in this study.

The secondary binary outcomes are reported as percentages and have unadjusted risk-difference comparisons. General statistical context: a risk difference expresses the absolute separation between group proportions; it is distinct from a relative measure such as a risk ratio. A confidence interval for a risk difference helps indicate whether the data are compatible with no absolute difference. The registry record does not report the detailed inferential method or a multiplicity plan for these secondary comparisons.

How should the analysis population be understood?

The primary outcome population is described as the full analysis set with LOCF. General statistical context: an analysis population defines which participants contribute to an estimate, and different endpoint populations can produce different denominators. LOCF substitutes a participant's last observed value for an unavailable later value. This can preserve a record for analysis, but it may not reflect the value that would have been observed at the scheduled endpoint. Its suitability depends on missingness patterns and assumptions that are not reported in the registry record.

The group-level outcome values are useful summaries, but they do not disclose participant-level data, reasons for missing measurements, or the sensitivity of results to alternative missing-data methods. The record lists no reported analyses for the secondary outcomes. Interpretations should therefore stay close to the posted aggregate results and should not assume unreported modeling, imputation, or adjustment choices.

11. Confidence Intervals and Precision

The primary comparison has a 95% confidence interval from 2.689 to 7.911 mm Hg for the mean difference, with the contrast defined as amlodipine minus aliskiren/amlodipine. The interval does not include zero. In general, a confidence interval describes a range of effect values reasonably compatible with the observed data under the analysis assumptions; it is not a guarantee that the true effect lies within that particular interval.

The interval conveys both direction and uncertainty. Across its endpoints, the estimated difference remains positive under the stated contrast, but its exact size is uncertain. The posted interval is narrower than an unbounded range, yet it does not identify a single exact effect. The group standard deviations, 14.53 mm Hg and 13.45 mm Hg, also show that participant measurements vary around the averages. The interval for a group difference should not be mistaken for the range of individual changes.

For the secondary blood-pressure-control comparison, the risk-difference interval is -0.232 to -0.048. For the responder comparison, it is -0.119 to < 0.001 and therefore reaches across zero. Those intervals concern different outcome scales and should not be directly compared with the primary mean-difference interval. They also arise among secondary outcomes, for which the registry record does not report a multiplicity adjustment.

General statistical context: a confidence interval's width depends on the amount of information, variability, and method used to estimate uncertainty. The registry record does not report enough methodological detail to evaluate every modeling assumption or alternative analysis. Precision should therefore be read as conditional on the posted analysis, rather than as certainty about the effect in other populations, settings, or time periods.

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 illustrations describe participants per arm for this continuous primary outcome, not a total event count. They use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to a stated fraction of the observed effect. These are planning assumptions calculated from the observed result; the original trial's sample-size assumptions and justification are not reported in the registry record.

For planning around 100% of the observed effect, the illustration gives 110 participants per arm for 80% power and 147 participants per arm for 90% power. For 75% of the observed effect, the corresponding figures are 195 and 261 participants per arm. For 50% of the observed effect, they are 439 and 587 participants per arm. These values are not a reconstruction of the enrollment decision for the trial.

In plain terms, 80% power is the assumed chance that a study designed under the stated conditions would detect an effect of the specified size using the stated testing threshold, if that effect were present. The 90% power column represents a higher target chance of detecting that effect under those same assumptions, which generally requires more participants. Smaller effects are harder to distinguish from random variation, so planning to detect a smaller fraction of the observed effect requires more participants per arm.

This is not observed power. The illustrations are planning calculations based on the observed effect and stated assumptions; they do not measure how much power the completed trial actually had or establish whether its original design was adequate.

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 = 5.300; pooled standard deviation σ = 13.998.
2. n = 2 × (1.96 + 0.842)² × 13.998² / 5.300² = 109.5, rounded up to 110 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 <- 5.3                      # observed difference in means
sigma <- 13.9979649170221                     # 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(853957)
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 = 110 (80% power), 147 (90% power)
 75% of observed effect: n per arm = 195 (80% power), 261 (90% power)
 50% of observed effect: n per arm = 439 (80% power), 587 (90% power)
power.t.test: 110.5 
Simulated power at n = 110 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. Multiplicity, Missing Data and Analysis Populations

The registry record names a primary endpoint and several secondary outcomes, but it does not report a multiplicity strategy. It is not reported in the registry record whether the investigators used a testing hierarchy, adjusted significance thresholds, or another method to control the chance of false-positive findings across outcomes. The posted p-values should therefore be read as unadjusted where identified as such, rather than as values known to account for all outcome testing.

General statistical context: multiplicity arises when several statistical questions are examined. Even when each test uses a conventional threshold, testing many outcomes can make at least one apparently unusual result more likely by chance. Adjustment methods or a prespecified hierarchy can address this concern, but the particular approach matters and should not be inferred when it is not documented.

The primary endpoint is distinguished in the registry record, which makes it possible to focus interpretation on the stated main question. However, the record does not report a protocol or statistical analysis plan describing endpoint hierarchy, subgroup analyses, interim analyses, or rules for handling multiple comparisons. Those details are not reported in the registry record and cannot be reconstructed from the posted results.

The primary outcome population is the full analysis set using LOCF. The registry record does not report the number or pattern of missing primary measurements, reasons for missingness, or sensitivity analyses using alternative assumptions. LOCF uses an earlier observation when a later one is unavailable; general statistical context is that this may fail to represent the unobserved endpoint value if the measure would have changed over time. Without missingness details or sensitivity analyses, the robustness of the primary estimate to the imputation choice cannot be assessed from the record.

The record states that the primary measure uses the full analysis set, but it does not provide the detailed analysis-population definition or participant flow. The observed denominators differ across outcomes, including the serious-adverse-event listings. Those variations should not be interpreted as errors or explained by assumption: their reasons are not reported in the registry record. The record also does not report interim analyses or the original sample-size justification.

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: angina unstable (0.5%), pneumonia (0.4%), back pain (0.4%).

The serious adverse event listings show 1 affected participant in the aliskiren/amlodipine group among 220 at risk, and 1 affected participant in the amlodipine group among 223 at risk. The registry also lists serious-event terms including Angina unstable at 0.5%, Pneumonia at 0.4%, and Back pain at 0.4%. The record does not attribute those listed terms to a particular treatment group in the information.

The listed counts are descriptive. They do not by themselves establish whether an event was caused by a study treatment, and the registry record does not provide event narratives or a comparative statistical analysis of serious events. The separate other-adverse-event listings report 25 affected among 220 at risk for the combination and 31 among 223 at risk for amlodipine alone. The record does not provide further detail in these figures about event severity, duration, or relationship to treatment.

Deaths are not reported in the registry record. The serious-event counts are small descriptive totals over the study period and should not be treated as proof of equivalent safety or as a complete account of all possible harms. Differences in adverse-event denominators compared with the primary outcome are not explained in the registry record.

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

The posted primary result describes an 8-week difference in average change in sitting systolic blood pressure between two randomized treatment groups. The combination group's average change was more negative than the amlodipine group's, and the unadjusted mean-difference interval does not include zero. This is evidence about the measured endpoint in the analyzed study population under the posted analysis, not a claim about every participant or every possible outcome.

The result does not establish that the observed difference is clinically important. The registry record does not supply a threshold for clinical importance, and statistical evidence for a difference is not the same as a judgment about its practical value. Nor does an 8-week measurement establish persistence after the study period, long-term outcomes, or effects in people outside the described population.

The study compared an initial combination regimen with amlodipine monotherapy, using the titration regimens listed in the record. The result should be interpreted for that comparison rather than generalized to other doses, treatment sequences, or combinations. The registry record does not report enough detail about adherence, missing measurements, or sensitivity analyses to assess how those factors might affect the estimate.

Secondary outcomes offer supporting descriptive context, but their unadjusted analyses and the absence of a reported multiplicity plan limit the strength of conclusions drawn from them. Safety listings are also descriptive, and the record does not report deaths. Neither the efficacy summaries nor the adverse-event counts alone establish an overall benefit-risk judgment. The appropriate statistical reading is narrower: the posted primary summaries indicate a difference in average short-term change, with uncertainty described by the confidence interval and limitations from the record's incomplete methodological detail.

17. Why This Trial Matters Statistically

This trial illustrates why a result should be read on its measurement scale. The primary endpoint is a continuous change in mean sitting systolic blood pressure, while some secondary outcomes classify participants using thresholds. A mean difference and a difference in proportions answer distinct questions, even when both relate to blood pressure.

It also demonstrates the value of reading effect estimates and confidence intervals together. The p-value indicates evidence against a null difference under the unadjusted comparison, while the interval communicates a range of compatible effect sizes. Neither measure describes the spread of individual responses on its own; the arm standard deviations add separate information about variability.

The design labels identify randomization and double masking, but they do not fill gaps in reporting. The registry record does not report a detailed statistical plan, multiplicity approach, missing-data pattern, or the original sample-size justification. Recognizing those absences is part of sound statistical interpretation, not a reason to invent likely methods.

Finally, planning illustrations based on an observed effect are not a measure of the completed study's power. They show how assumed detectable effects and power targets relate to planned participants per arm under stated assumptions. Separating that planning exercise from the observed trial result helps prevent a common misreading of post-study calculations.

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 trial's primary outcome is measured at 8 weeks, so the record does not establish whether the observed difference persisted beyond that period. The described population is specific to African American patients with Stage 2 hypertension; the registry record does not provide evidence in other populations or clinical settings. Generalization beyond the stated population should not be assumed from the randomized comparison alone.

The primary analysis uses LOCF, but missing-data counts, patterns, reasons, and sensitivity analyses are not reported in the registry record. Because LOCF substitutes an earlier observation for an unavailable later value, the result may depend on assumptions about how measurements would have changed. The record does not provide enough information to assess that sensitivity.

The registry record does not report a detailed statistical analysis plan, covariate adjustment, multiplicity strategy, original sample-size justification, or interim-analysis procedures. It also does not report detailed participant flow, adherence, or the rationale for differences in outcome denominators. These gaps restrict assessment of the analysis choices and the robustness of the aggregate estimates.

Secondary results are unadjusted and several listed outcomes have no numerical results reported in the registry record. The responder comparison has an interval reaching across zero, while the other posted secondary contrasts do not establish a comprehensive pattern across all listed measures. Adverse-event figures are descriptive, do not provide causal attribution, and do not include a reported death count. This record therefore supports a focused reading of the posted short-term endpoint summaries, not a complete account of long-term effectiveness or safety.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension — NCT00853957.
• Registry record last updated 2012-04-30; status last verified 2012-04.
• 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

The registry record describes a completed Phase 4 randomized, double-blind, active-control, parallel-group study of aliskiren/amlodipine versus amlodipine alone in African American patients with Stage 2 hypertension. The primary endpoint was change from baseline in mean sitting systolic blood pressure at 8 weeks, analyzed in a full analysis set using LOCF.

The posted group means were -33.1 mm Hg for the combination and -27.8 mm Hg for amlodipine alone. The mean difference was 5.3 mm Hg, with a 95% confidence interval from 2.689 to 7.911 and an unadjusted p < 0.001. Secondary summaries provide additional blood-pressure outcomes, while some listed secondary results and methodological details are not reported in the registry record. The posted estimates should be interpreted within the stated population, follow-up period, and analysis limitations.