This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension (NCT00931710), a randomized phase 4 study. The primary outcome is Change in Mean Sitting Systolic Blood Pressure After 6 Weeks.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00931710 |
| Phase | Phase 4 |
| Condition | Stage 2 Systolic Hypertension |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 488 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Novartis |
| Results posted | Yes |
2. Clinical Question
Population
Patients with Stage 2 systolic hypertension. The brief summary describes eligible blood pressure as mean systolic blood pressure greater than 160 and less than 200 mmHg. The primary endpoint population is the Full Analysis Set, with last observation carried forward used for missing measurements.
Intervention
A valsartan/amlodipine-based regimen, with HCTZ added during the described treatment sequence. At randomization, the stated regimen began with valsartan/amlodipine 160/5 mg for 3 weeks, followed by valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks. The arm description then begins to describe a further titration, but its details are not reported in the registry record.
Comparator
A losartan-based regimen, with HCTZ added during the described sequence. The stated schedule began with losartan 100 mg for 3 weeks, followed by losartan/HCTZ 100/25 mg. At Week 6, participants were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks. Later details are not reported in the registry record.
Primary question
How did mean sitting systolic blood pressure change from baseline to Week 6 in the two regimen groups? The registry record states that this comparison concerns the change in mean sitting systolic blood pressure after 6 weeks. It does not report the numerical between-group comparison or its uncertainty.
3. Trial Design
The registry describes a Phase 4, randomized, double-blind, parallel-group, active-control study. Its official title identifies a 12-week study conducted at multiple centers. The listed condition is Stage 2 systolic hypertension, and the recorded enrollment is 488. The study status is completed. The recorded study start is 2009-07, and primary completion is listed as 2010-01.
The comparison was between a valsartan/amlodipine-based regimen and a losartan-based regimen. Both arms included treatment changes over time, so the contrast is not simply between two fixed single-drug treatments throughout the study. The descriptions state that the valsartan/amlodipine arm began with valsartan/amlodipine and then added HCTZ. The losartan arm began with losartan and then added HCTZ; at Week 6, participants were switched to valsartan/amlodipine/HCTZ. Some later arm-description text is incomplete in the registry record, so the full treatment sequence cannot be reconstructed from that record.
Randomization allocates participants to treatment groups by chance, while double masking is intended to limit the influence of treatment knowledge on participants’ experiences and study assessments. A parallel-group design assigns participants to a group for comparison rather than describing a crossover between groups. These are general descriptions of the design terms; details of how randomization and masking were implemented are not reported in the registry record.
The planned trial duration and primary endpoint timing should be distinguished: the official title describes a 12-week study, while the primary endpoint is the change from baseline to Week 6. The record lists six outcome measures and no analysis records. Further details of the protocol, including the randomization procedure and statistical analysis plan, are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Valsartan/Amlodipine/HCTZ | Losartan/HCTZ |
|---|---|---|
| STARTED | 241 | 247 |
| COMPLETED | 207 | 209 |
| NOT COMPLETED | 34 | 38 |
Reasons for not completing this period:
| Reason | Valsartan/Amlodipine/HCTZ | Losartan/HCTZ |
|---|---|---|
| Adverse Event | 16 | 10 |
| Abnormal test procedure results | 2 | 0 |
| Unsatisfactory therapeutic effects | 5 | 12 |
| Patient withdrew consent | 4 | 9 |
| Lost to Follow-up | 6 | 5 |
| Protocol deviation | 1 | 2 |
Analysis population for the primary outcome, as defined in the registry: Full Analysis Set (FAS). 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.
| Characteristic | Unit | Valsartan/Amlodipine/HCTZ | Losartan/HCTZ | Total |
|---|---|---|---|---|
| Participants analysed | 241 | 247 | 488 | |
| Age Continuous | years | 55.0 (SD 9.83) | 57.1 (SD 9.69) | 56.1 (SD 9.81) |
| Sex: Female, Male: Female | Participants | 102 | 111 | 213 |
| Sex: Female, Male: Male | Participants | 139 | 136 | 275 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Mean Sitting Systolic Blood Pressure After 6 Weeks, measured over Baseline to Week 6.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mmHg |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in mean sitting systolic blood pressure from baseline to Week 6, measured in mmHg. It is a continuous outcome summarized as a mean, with standard deviation identified as the measure of dispersion. The stated primary population is the Full Analysis Set, and the record specifies last observation carried forward for missing values.
In general, a change endpoint expresses how a measurement differs from a participant’s baseline value by a defined follow-up time. Comparing average changes between groups can describe whether their observed blood-pressure trajectories differed over that interval. Sitting systolic blood pressure is the specific measure chosen for this trial’s primary comparison; the registry does not explain why it was selected over other measures.
The endpoint is tied to Week 6, not to the full 12-week duration named in the study title. It therefore addresses an earlier point in the treatment schedules, including the period when the comparator arm was described as receiving losartan/HCTZ. The record does not report the group means, mean changes, treatment contrast, confidence interval, or p-value for this endpoint. Without those numerical results, the direction, size, and precision of the observed primary comparison cannot be described.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical question is a comparison of average change in sitting systolic blood pressure from baseline to Week 6 between the randomized regimen groups. The registry record identifies this endpoint and the population used for its analysis, but it does not include a numerical estimate of the primary treatment contrast. It also does not report a confidence interval or p-value for that comparison. Consequently, the magnitude, direction, and precision of the primary result are not reported in the registry record.
This absence matters for interpretation. A trial’s objective and endpoint definition do not establish what its results were. The fact that the study was randomized and double-blind describes aspects of design, not the observed effect. Likewise, the listed enrollment does not reveal how much the groups’ blood-pressure changes differed, or how uncertain that difference was.
In general, an estimate describes the observed contrast, while a confidence interval describes the range of values compatible with the data under the method used. A p-value addresses how compatible the observed data are with a specified null model; it does not measure clinical importance or the probability that a treatment is effective. Those concepts can be applied to this trial only if the relevant estimates and analysis details are available. They are not reported in the registry record.
The record lists secondary outcomes concerning diastolic blood pressure at Week 6, blood-pressure control, treatment response, systolic and diastolic pressure at Week 12, and peripheral edema over visits. Their presence indicates additional questions were tracked, but numerical results for these outcomes are not reported in the registry record. No secondary result should be inferred from the titles alone.
Safety information is separately recorded for serious adverse events and other adverse events, including counts of affected participants in the treatment groups. These counts offer descriptive safety information but do not substitute for the missing primary efficacy comparison. The serious-event counts are small as reported, and the registry does not provide a statistical comparison of them. They should not be treated as proof of equal risk or of a treatment-related difference.
The posted sample-size assumptions describe a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such illustrations concern hypothetical future planning. They are not observed power and do not recover the missing primary analysis. The numerical planning outputs are not reported in the registry record.
9. Statistical Methods Explained
The registry identifies a continuous primary outcome: mean sitting systolic blood pressure change from baseline to Week 6. The outcome is expressed in mmHg, summarized as a mean, and accompanied by standard deviation as the stated dispersion measure. The named analysis population is the Full Analysis Set, with last observation carried forward for missing measurements. The numerical analysis itself is not reported in the registry record.
What does a mean change represent?
In general, a mean change is calculated by comparing follow-up measurements with baseline measurements and summarizing those changes across participants. A between-group contrast then compares the average changes in the two treatment groups. This approach can account for baseline values in the form of change scores, but it does not by itself explain whether the analysis adjusted for other variables. Such adjustment details are not reported in the registry record.
Standard deviation describes variation among individual measurements or changes around the group mean. It is not the same as the standard error of a group mean or the uncertainty interval for the between-group treatment contrast. Confidence intervals and standard errors depend on the analysis and its assumptions. The registry does not report these quantities for the primary comparison.
What does randomization contribute?
In general, random allocation aims to make treatment groups comparable, on average, with respect to factors known and unknown at assignment. It supports interpretation of a between-group contrast as an effect of assignment to the regimens, subject to the study’s conduct, follow-up, and analysis. Randomization does not guarantee that groups are identical, and it does not eliminate uncertainty. The method used to generate or conceal assignments is not reported in the registry record.
The double-blind designation indicates that the study was recorded as double-masked. In general, masking can reduce bias that might arise if knowledge of treatment affects behavior, reporting, or assessment. The identities of those masked and the practical procedures used are not reported in the registry record. The parallel-group designation means the study compares groups assigned to different regimens over the study rather than presenting a within-person crossover comparison.
How should missing measurements be considered?
The primary population is identified as the Full Analysis Set, and the record specifies last observation carried forward (LOCF). In general, LOCF replaces a missing later measurement with that participant’s last recorded measurement. This makes an analysis possible for participants without a measurement at the target time, but it relies on an assumption that the last observed value is a suitable stand-in for the missing value. That assumption may be implausible when the measured condition changes over time or when missingness is related to outcome or treatment.
The record does not describe how many measurements were missing, the reasons for missingness, whether LOCF was applied to all missing values, or whether alternative missing-data analyses were conducted. These details affect how robustly the result can be interpreted. No sensitivity analysis is reported in the registry record.
What do the planning assumptions mean?
The registry’s sample-size assumptions describe an illustration based on the observed effect. They specify a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. In general, a planning calculation estimates how many participants per arm might be needed to detect a chosen effect under stated assumptions. The assumptions are not a report of the trial’s original design rationale, and the numerical illustrations are not reported in the registry record.
Planning calculations should not be confused with observed power. Observed power is not a substitute for reporting the treatment estimate and its uncertainty. Sample-size illustrations based on an observed effect also inherit uncertainty in that effect estimate. The trial’s sample-size justification and any original design assumptions are not reported in the registry record.
What cannot be assessed from the registry analysis listing?
The registry lists no analysis records. It also does not provide the primary estimate, confidence interval, or p-value. The analysis model, handling of baseline differences, any covariate adjustment, and detailed testing strategy are not reported in the registry record. Without these elements, readers cannot reproduce the primary comparison or assess whether its assumptions were checked.
General statistical concepts help explain what information would be useful, but they cannot fill in absent results. The direction and size of the treatment contrast, the precision of the estimate, and the analysis choices remain unknown from the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists six outcome measures, including the primary Week 6 systolic blood-pressure change and secondary measures concerning diastolic pressure, blood-pressure control, treatment response, Week 12 pressure, and peripheral edema. Multiple outcomes and time points can create multiple opportunities for statistical testing. In general, a multiplicity strategy defines how to interpret or adjust inference when several comparisons are considered, helping control the chance of misleading findings from repeated testing.
The multiplicity strategy, any hierarchy among outcomes, and any adjustment to significance thresholds are not reported in the registry record. The record also lists no analysis records, and it does not provide numerical results for the primary comparison. The primary endpoint is described as a mean change at Week 6, but no reported analysis is available to establish which statistical tests or models were used.
The primary population is named as the Full Analysis Set, with LOCF for missing measurements. In general, analysis populations specify which participants contribute to an analysis, while missing-data methods determine how incomplete observations are handled. The record does not explain the operational definition of the Full Analysis Set, provide missing-data counts, state reasons for missingness, or report sensitivity analyses. How participants who discontinued or lacked a Week 6 measurement were treated is not reported in the registry record.
Details of the statistical analysis plan, including treatment of protocol deviations and whether analyses were adjusted for baseline measurements, are not reported in the registry record. These omissions limit assessment of the analysis strategy and the reliability of any unreported result.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Valsartan / Amlodipine / HCTZ | 1 | 241 | 0.4% |
| Losartan / HCTZ | 2 | 247 | 0.8% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Valsartan / Amlodipine / HCTZ | 13 of 241 |
| Losartan / HCTZ | 8 of 247 |
Most frequent serious adverse event terms
| Event term | Organ system | Valsartan / Amlodipine / HCTZ | Losartan / HCTZ |
|---|---|---|---|
| Non-cardiac chest pain | General disorders | 1 of 241 | 0 of 247 |
| Urinary tract infection | Infections and infestations | 0 of 241 | 1 of 247 |
| Dizziness | Nervous system disorders | 0 of 241 | 1 of 247 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Valsartan / Amlodipine / HCTZ | Losartan / HCTZ |
|---|---|---|---|
| Dizziness | Nervous system disorders | 13 of 241 | 8 of 247 |
Serious events with the highest arm-level rate: non-cardiac chest pain (0.4%), urinary tract infection (0.4%), dizziness (0.4%).
The registry records serious adverse events for the two regimen groups. In the Valsartan / Amlodipine / HCTZ group, 1 participant was reported as affected among 241 at risk; in the Losartan / HCTZ group, 2 were reported as affected among 247 at risk. The record lists non-cardiac chest pain, urinary tract infection, and dizziness as top serious-event terms, each at 0.4%. These terms are listed without a group-specific breakdown in the available record.
These are descriptive counts, not a statistical comparison. In general, serious adverse event counts can be influenced by event definitions, follow-up, reporting, and the number of participants observed. The registry record does not report a formal comparison, confidence interval, or p-value for serious adverse events. The listed figures therefore do not establish whether the groups differ in risk.
Deaths are not reported in the registry record. Other adverse-event counts are also listed: 13 affected among 241 at risk in the Valsartan / Amlodipine / HCTZ group and 8 among 247 at risk in the Losartan / HCTZ group. These counts should be read as recorded event information, not as evidence of a causal relationship or as a complete safety assessment. The registry does not provide further detail about event severity, timing, or attribution.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, double-blind, parallel-group comparison was conducted in patients with Stage 2 systolic hypertension. It identifies the treatment strategies, the primary Week 6 endpoint, and the analysis population and missing-data approach named for that endpoint. It also records safety counts and a list of secondary outcome topics.
It does not report the numerical primary treatment comparison. No group mean changes, between-group estimate, confidence interval, or p-value are available in the registry record. Therefore, the posted information does not establish the direction or size of the primary result, or how precisely it was estimated. Design features and outcome definitions cannot be used to infer those results.
In general, a treatment estimate is most informative when considered alongside its uncertainty and the analysis population. A narrow interval can indicate greater precision than a wide interval, while either interval must be interpreted in relation to the question and the data. Since no primary interval or estimate is reported, this kind of precision assessment cannot be made for this comparison.
The serious adverse event counts provide a limited descriptive account, but the registry does not report a formal comparison or enough detail to determine whether the counts reflect a meaningful difference between regimens. The secondary outcome titles likewise do not establish what the results were. No medical conclusion should be drawn from the presence of an outcome in the registry.
The planning assumptions are not a substitute for trial results or an assessment of observed power. Their role is illustrative: they describe assumptions for sample-size planning based on an observed effect. The numerical planning outputs are not reported in the registry record. Overall, the registry supports a description of the study’s question and design, but not a quantitative judgment about the primary treatment contrast.
13. Why This Trial Matters Statistically
This trial raises several useful statistical questions. First, it compares treatment regimens that changed over time rather than two unchanging drug exposures. The primary endpoint is at Week 6, and the arm descriptions include treatment changes around that point. Interpreting the endpoint therefore requires attention to the timing of measurement relative to the assigned regimen. The registry record identifies the endpoint timing but does not report a numerical result.
Second, the primary outcome is a continuous measure analyzed as a mean change. Such an analysis needs more than a statement of the endpoint: the treatment contrast and its uncertainty are central to understanding the evidence. The registry record does not provide those quantities. This makes the record a useful illustration of the distinction between a clear research question and a reportable statistical result.
Third, the Full Analysis Set and LOCF designation show why analysis populations and missing-data choices matter. In general, a method for replacing missing follow-up measurements embodies assumptions about how outcomes evolve. The registry does not report missingness patterns or sensitivity analyses, so the effect of this choice cannot be assessed.
Finally, the record lists multiple outcomes and time points, while the multiplicity strategy is not reported. When several outcomes are tested, interpretation depends in part on how those tests were planned and handled. The absence of analysis records also means the statistical model and testing details cannot be evaluated. These issues illustrate why trial design, endpoint definitions, analysis methods, and numerical results all contribute to statistical interpretation.
14. 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 primary limitation for interpreting this trial from the registry record is the absence of numerical efficacy results. Although the primary endpoint is defined as change in mean sitting systolic blood pressure from baseline to Week 6, its group estimates and treatment contrast are not reported. No uncertainty interval or p-value is reported either. The primary result’s direction, magnitude, and precision therefore cannot be assessed.
The record lists no analysis records. It does not describe the analysis model, any adjustment for baseline values, the randomization implementation, or the multiplicity strategy. The Full Analysis Set is named, but its operational definition is not reported in the registry record. LOCF is identified, but missing-measurement counts, reasons for missingness, and sensitivity analyses are not reported.
Some treatment arm descriptions end before the full regimen sequence is specified. The schedule is described in part, including stated treatment changes through the Week 6 period, but later details are not reported in the registry record. This limits reconstruction of exposure over the full study period.
Safety figures are descriptive and lack a reported inferential comparison. The record does not give further context on serious-event timing, attribution, or severity beyond the listed counts and terms. It also does not report deaths. These limitations restrict interpretation of the safety information as well as the efficacy evidence.
The record’s sample-size assumptions are planning illustrations, not a reported justification for the trial’s original enrollment. The original sample-size rationale is not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension — NCT00931710.
- Registry record last updated 2011-03-07; status last verified 2011-03.
- Results first posted 2011-02-04.
- 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.
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18. Record Summary
The registry describes a completed Phase 4, randomized, double-blind, parallel-group, active-control study of regimens based on valsartan/amlodipine and losartan in Stage 2 systolic hypertension. The official title identifies a 12-week, multicenter study. Recorded enrollment is 488. The study start is listed as 2009-07 and primary completion as 2010-01.
The primary outcome is change in mean sitting systolic blood pressure from baseline to Week 6, measured in mmHg. The named population is the Full Analysis Set, with LOCF specified for missing measurements. Numerical primary efficacy results and analysis records are not reported in the registry record. The record lists secondary outcome topics and descriptive adverse-event counts, but does not provide a formal safety comparison. Statistical analysis details, multiplicity handling, and the original sample-size justification are not reported in the registry record.