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 Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients (MK0653A-168) (NCT00738972), a randomized phase 3 study. The primary outcome is Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00738972 |
| Phase | Phase 3 |
| Condition | Hypertension |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 12 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Fundación Lindavista del Corazón AC |
| Results posted | Yes |
2. Clinical Question
Population
People with hypertension were the population of interest. The registry record does not report further eligibility details in the primary outcome description, so the specific clinical characteristics required for enrollment are not reported in the registry record. The record lists an enrollment of 12 and says the study was terminated early. These details set important limits on how much can be learned about the outcome.
Intervention
The study compared valsartan alone and valsartan combined with lipid-lowering medication. The listed regimens were valsartan 80 mg plus Paravastin 40 mg, valsartan 80 mg plus simvastatin 40 mg, and valsartan 80 mg plus simvastatin 40 mg with ezetimibe 10 mg. Each arm description specifies oral daily administration for one year. The intervention list names pravastatin, while the arm description spells the drug name “Paravastin”; the registry record does not clarify this spelling difference.
Comparator
The comparator arm received valsartan 80 mg by mouth daily for one year. This provides a comparison with the statin-containing regimens, including the regimen that also included ezetimibe. The registry record identifies randomization and a parallel-group design, but does not report the allocation ratio or any additional details about how assignments were generated or concealed.
Primary question
The stated question was whether left ventricular hypertrophy changed, as measured by echocardiography, at 6 Month(s) in hypertensive patients receiving these regimens. The trial title and brief summary describe interest in hypertrophy reduction and pleiotropic effects of simvastatin. However, the posted primary outcome description says early termination and the sample size prevented further statistical analyses. It therefore does not provide a reported estimate of the treatment differences or a statistical test answering the question.
3. Trial Design
The registry identifies this as a randomized, parallel-group, phase 3 study with no masking. The listed study condition is hypertension, and the stated purpose was to evaluate pleiotropic effects of simvastatin in hypertensive patients. The record names Fundación Lindavista del Corazón AC as sponsor. The study start is recorded as 2008-01, and primary completion as 2010-08. Its current status is terminated.
Four arms are described: valsartan 80 mg with Paravastin 40 mg; valsartan 80 mg with simvastatin 40 mg; valsartan 80 mg with simvastatin 40 mg and ezetimibe 10 mg; and valsartan 80 mg alone. The arm descriptions specify oral daily administration for one year. The recorded enrollment is 12. The record does not state how participants were distributed among the arms in the enrollment description; adverse-event risk counts are reported separately and should not be used to infer the allocation plan or outcome analysis population.
Randomization means assignment to study groups is intended to limit systematic differences between groups at baseline. In a parallel design, participants remain assigned to a group rather than crossing between regimens. These are general descriptions of design features, not evidence that all potential sources of bias were eliminated in this trial. With no masking, participants and study personnel were not blinded according to the registry’s masking classification. Further details about randomization procedures, concealment, adherence, follow-up, and reasons for early termination are not reported in the registry record.
The primary outcome was an echocardiographic measure of left ventricular hypertrophy at 6 Month(s). The record states that the study was terminated early and that the sample size made further statistical analyses impossible. It does not report results for the primary endpoint or explain the decision to stop the study.
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 80 mg + Paravastin 40 mg | Valsartan 80 mg + Simvastatin 40 mg | Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg | Valsartan 80 mg |
|---|---|---|---|---|
| STARTED | 3 | 3 | 3 | 3 |
| COMPLETED | 3 | 3 | 3 | 2 |
| NOT COMPLETED | 0 | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: This study was terminated early and due to sample size it was not possible to perform further statistical analyses.
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 80 mg + Paravastin 40 mg | Valsartan 80 mg + Simvastatin 40 mg | Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg | Valsartan 80 mg | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 3 | 3 | 3 | 2 | 11 | |
| Age, Customized: >18 years | participants | 3 | 3 | 3 | 2 | 11 |
| Sex: Female, Male: Female | Participants | 2 | 2 | 2 | 2 | 8 |
| Sex: Female, Male: Male | Participants | 1 | 1 | 1 | 0 | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients, measured over 6 Month(s).
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint concerns reduction in left ventricular hypertrophy, assessed by echocardiography. The registry record identifies the measurement method and the intended timeframe as 6 Month(s), but does not report the measurement unit, the exact echocardiographic parameter, or a numerical endpoint result. It also does not specify whether the principal comparison was change from baseline, a follow-up value, or another summary of the echocardiographic measurements.
As general background, echocardiography uses ultrasound to assess cardiac structure and function. A structural measure can serve as a trial endpoint when the research question concerns change in the heart’s structure over time. To interpret such an endpoint, readers generally need a clear definition of the measurement, its timing, how baseline and follow-up observations are handled, and how differences between randomized groups are estimated. Those details are not reported in the registry record.
The registry describes the outcome as reduction, but that wording does not establish that a reduction occurred. No group-specific values, between-group estimate, measure of uncertainty, or inferential test is posted for this endpoint. The stated reason is that early termination and the sample size prevented further statistical analyses. The record therefore identifies what the study intended to measure, rather than documenting a quantified treatment contrast.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive fact is that the registry record does not report a statistical analysis of the primary outcome. It states that the study was terminated early and that the sample size was insufficient for further statistical analyses. The outcome description identifies echocardiography and 6 Month(s), but no group results or comparative estimate are reported. Consequently, the posted record cannot establish the direction, size, or precision of any difference in left ventricular hypertrophy among the treatment groups.
The design information shows a randomized parallel-group comparison without masking. Randomization is intended, as a general statistical principle, to support fair comparisons by reducing systematic allocation differences. However, the design label does not substitute for outcome data, and it does not show whether treatment groups were balanced in this small study. No baseline characteristics or allocation details are reported in the registry record. The lack of masking is also relevant because knowledge of assigned treatment can affect behavior, care, measurement, or reporting, depending on the study procedures; those procedures are not reported in the registry record.
The recorded enrollment is 12, and the trial was terminated. The record does not provide a numerical reason for termination or an account of how the final enrollment affected each group. Small studies generally produce less precise estimates because the information available for estimating a treatment contrast is limited. That general principle helps explain why an outcome analysis may be difficult, but it cannot supply a missing effect estimate or show what this trial would have found with more participants.
There are no posted primary-outcome analyses, and no estimates, confidence intervals, or p-values for the echocardiographic endpoint are reported. A confidence interval is, in general, a range of values compatible with the data and the statistical model, while a p-value summarizes how surprising data would be under a specified null hypothesis and model. Neither can be interpreted for this outcome from the registry record because neither is reported.
The safety entries list zero serious adverse events and zero other adverse events in each group’s reported risk set. These are descriptive registry entries, not a substitute for an efficacy analysis. Death counts are not reported in the registry record. The limited enrollment and early termination also mean that the absence of recorded events in the posted entries should not be treated as evidence that the regimens have no safety risks.
Overall, the registry documents the study question, design, arm descriptions, termination, and limited adverse-event counts. It does not document an analyzed treatment effect on left ventricular hypertrophy. This distinction is essential: a trial can have a defined outcome and randomized design while still providing no interpretable estimate of the outcome contrast.
9. Statistical Methods Explained
The registry classifies the study as randomized and parallel, with no masking. In general, random assignment is intended to make the groups comparable with respect to measured and unmeasured characteristics on average. It does not guarantee close balance in a particular trial, especially when the enrollment is limited. A parallel-group design compares groups assigned to different regimens over the same study period. The registry record does not report the randomization sequence method, allocation concealment, stratification, or procedures for maintaining assignments.
What does the missing outcome analysis mean?
The primary outcome is described as left ventricular hypertrophy reduction measured by echocardiography at 6 Month(s). Yet the record says early termination and sample size prevented further statistical analyses. No outcome values or comparisons are reported. Thus there is no posted estimate to interpret, whether as a difference between groups, a change over time, or another endpoint summary. The endpoint’s unit and exact echocardiographic definition are not reported in the registry record.
In general, an analysis of a continuous measurement might compare group means, compare changes from baseline, or use a model that accounts for repeated measurements. Each approach requires specified data and assumptions. The registry record does not identify which approach was planned or used. No adjustment factors, model specifications, standard errors, confidence intervals, or p-values are reported. It would therefore be inappropriate to select a method retrospectively and present its output as the trial’s result.
How should uncertainty be understood?
As general statistical explanation, a confidence interval communicates the uncertainty around an estimated effect under a chosen model. A wide interval reflects limited precision; a narrow interval reflects greater precision, conditional on the model and data. A p-value is not the probability that a treatment works or that the null hypothesis is true. It is calculated from data under a specified null hypothesis and analysis procedure. Neither measure is available for the primary endpoint in the registry record, so the effect and its precision remain unknown.
Small enrollment often makes estimates unstable and uncertainty substantial. This is a general point about information and precision, not a calculation about this study. The record itself says sample size prevented further statistical analyses, but does not provide a sample-size justification, target enrollment, or explanation of the statistical threshold used to decide that analysis was not possible. Those details are not reported in the registry record.
What do the planning assumptions describe?
General planning calculations translate an assumed effect, variability, significance level, and design into a prospective sample-size target. The record’s planning assumptions describe two-sided significance level 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is expressed as a stated fraction of the observed effect. Such calculations are planning illustrations, not observed power and not results from the trial. The record also distinguishes whether an illustration is expressed as participants per arm or, for time-to-event calculations, total events. These assumptions do not establish the trial’s original design plan, and the sample-size justification is not reported in the registry record.
In general, over-dispersion occurs when outcome variability is greater than assumed by a statistical model. When ignored, it can make standard errors too small and confidence intervals too narrow. No dispersion estimate or model for the echocardiographic endpoint is reported, so over-dispersion cannot be assessed for this trial. More broadly, a valid model depends on the outcome scale, data distribution, measurement process, and analysis plan; these details are not reported in the registry record.
What can be inferred from the design labels?
The phase 3 designation and randomized design describe the registry’s study classification; they do not provide evidence of an endpoint effect. Likewise, a parallel design describes the group structure but does not identify the statistical model. Because no primary-outcome analysis is posted, there is no basis for recalculating a treatment contrast from summary statistics. No recalculation is available, and there is no reported sponsor analysis to compare with a recalculation.
For the same reason, the posted safety counts should remain descriptive. A zero count in a reported risk set does not itself produce a precise estimate of event risk, particularly where enrollment and follow-up are limited. Statistical comparisons of adverse events are not reported in the registry record. The record also does not report handling of missing observations, the analysis population, or whether any interim analysis was planned or conducted.
10. Multiplicity, Missing Data and Analysis Populations
The registry records one primary outcome-measure entry, but the primary outcome is not reduced to a single comparison in the posted analysis information. The record indicates that the outcome has several categories or time points and was not reduced to one comparison. No specific comparison, multiplicity adjustment, or hierarchy among possible comparisons is reported in the registry record.
As general statistical background, multiplicity arises when several outcomes, time points, groups, or contrasts are tested. When many tests are conducted, the chance of obtaining at least one apparently unusual result can increase. A prespecified primary comparison and an appropriate multiplicity strategy can help define which inference is confirmatory. Here, no statistical analysis is posted, so there are no reported tests to interpret and no basis for assessing how multiplicity was handled. The statistical plan is not reported in the registry record.
Missing-data methods and analysis populations are also not described. The registry does not state how missing echocardiographic measurements, withdrawals, or incomplete follow-up were handled. It does not identify an intention-to-treat, per-protocol, or other analysis population. These omissions matter because the handling of missing measurements and the choice of population can affect the interpretation of a randomized comparison. No approach should be assumed from the design label alone.
The registry states that the trial ended early and that the sample size prevented further analyses. Reasons for termination, any interim analyses, and any changes to the analysis plan are not reported in the registry record. Without those details or endpoint results, neither multiplicity control nor the effects of missing data can be evaluated.
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 80 mg + Paravastin 40 mg | 0 | 3 | 0.0% |
| Valsartan 80 mg + Simvastatin 40 mg | 0 | 3 | 0.0% |
| Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg | 0 | 3 | 0.0% |
| Valsartan 80 mg | 0 | 2 | 0.0% |
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 80 mg + Paravastin 40 mg | 0 of 3 |
| Valsartan 80 mg + Simvastatin 40 mg | 0 of 3 |
| Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg | 0 of 3 |
| Valsartan 80 mg | 0 of 2 |
The adverse-event entries are reported separately by treatment group. For Valsartan 80 mg plus Paravastin 40 mg, the serious-event risk count is 3 and the serious-event count is 0; the other-event risk count is 3 and the other-event count is 0. For valsartan 80 mg plus simvastatin 40 mg, each risk count is 3 and each event count is 0. For valsartan 80 mg plus simvastatin 40 mg with ezetimibe 10 mg, each risk count is 3 and each event count is 0. For valsartan 80 mg alone, each risk count is 2 and each event count is 0.
These entries are descriptive counts in the registry, not comparative safety estimates. The record does not provide event definitions beyond the serious and other adverse-event categories, nor does it report a statistical comparison. Death counts are not reported in the registry record. The small reported risk sets and early termination limit what can be concluded from zero recorded events; they do not establish that no events could occur or that the regimens have equivalent safety. Follow-up and completeness details for adverse-event collection are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, unmasked, parallel-group trial was conducted to examine left ventricular hypertrophy in hypertensive patients. The stated endpoint was measured by echocardiography, with a timeframe of 6 Month(s). The four listed regimens varied in whether valsartan was given alone or with a statin, and whether ezetimibe was also included in one combination arm. The study was terminated early, and the record says its sample size did not permit further statistical analyses.
What the record does not establish is whether any regimen reduced left ventricular hypertrophy, whether outcomes differed between groups, or how large or precise any such difference might have been. No primary outcome values, effect estimate, confidence interval, or p-value are reported. The endpoint’s measurement unit and exact analytic definition are also not reported in the registry record. Without those results, the trial cannot be interpreted as demonstrating either benefit or lack of benefit on the stated outcome.
The adverse-event entries record zero serious and zero other adverse events in the reported risk sets. Those counts do not resolve the primary efficacy question and are not enough to characterize safety comprehensively. Death counts and fuller safety follow-up information are not reported in the registry record.
As general interpretation, absence of a reported statistical result is not the same as a finding of no effect. A non-significant result, if one had been reported, would also not automatically demonstrate equivalence or absence of a clinically meaningful difference. Here, no test or estimate is available at all. The most defensible conclusion is therefore about the limits of the record: it describes the intended comparison and some design and safety information, but does not provide an analyzed primary outcome from which a treatment effect can be inferred.
13. Why This Trial Matters Statistically
This trial is statistically instructive because it separates study design from evidential results. Randomization, parallel groups, and a defined echocardiographic endpoint describe how the question was organized. They do not, on their own, answer the question. An interpretable estimate requires endpoint data and an analysis; the registry record explicitly says that early termination and sample size prevented further statistical analyses.
The record also illustrates why precision matters. In general, smaller studies tend to offer less information for estimating group differences, so their estimates can be unstable and uncertain. In this case there is no posted estimate at all, which means uncertainty cannot be expressed using a confidence interval and the direction or magnitude of the endpoint contrast cannot be assessed. No statistical conclusion should be reconstructed from the trial’s title or stated objective.
Another important lesson is that registry detail can be uneven. The intervention arms and adverse-event counts are described, while the primary endpoint’s unit, analytic definition, missing-data approach, and analysis population are not reported in the registry record. Such gaps constrain reproducibility and make it harder to judge whether the intended analysis matched the clinical question.
The study also shows why descriptive safety counts should not be mistaken for strong evidence about risk. Zero events in small reported risk sets are not a precise guarantee of safety. Finally, planning illustrations and design assumptions should be kept separate from observed findings. A planning calculation is about what a future study might need under assumptions; it is not an outcome result and does not turn an unanalyzed study into evidence of an effect.
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 most consequential limitation is the absence of a reported primary-outcome analysis. The record states that the trial was terminated early and that the sample size prevented further statistical analyses. It does not provide group-level echocardiographic values, a treatment contrast, or an uncertainty estimate. The reason for early termination beyond the stated sample-size issue is not reported in the registry record.
The endpoint description is limited. Although echocardiography and the 6 Month(s) timeframe are identified, the measurement unit, exact echocardiographic parameter, baseline comparison, and handling of repeated measurements are not reported in the registry record. Without these details, the intended outcome cannot be fully reconstructed.
The recorded enrollment is 12, but the enrollment description does not report how participants were allocated across the four arms. Adverse-event risk counts are available, but they do not establish the analyzed population for the primary endpoint. Baseline characteristics, participant flow, adherence, withdrawals, missing outcome data, and follow-up completeness are not reported in the registry record.
The study is classified as randomized and unmasked, but procedural details such as sequence generation and allocation concealment are not reported. The record does not provide a statistical analysis plan, sample-size justification, interim-analysis information, or a multiplicity strategy. It also does not report a complete safety assessment; death counts are not reported in the registry record.
Finally, the arm description uses “Paravastin” while the intervention list names pravastatin. The registry record does not clarify this spelling difference. Together, these reporting limitations prevent assessment of the primary treatment contrast and restrict interpretation of both the outcome and safety entries.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients (MK0653A-168) — NCT00738972.
- Registry record last updated 2013-08-26; status last verified 2013-08.
- Results first posted 2013-08-13.
- 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 record describes NCT00738972, a phase 3 randomized parallel-group study with no masking in people with hypertension. Its stated purpose was to evaluate pleiotropic effects of simvastatin. Four arms involved valsartan alone or in combination with Paravastin, simvastatin, or simvastatin plus ezetimibe. The recorded enrollment is 12; the study is terminated. The start is listed as 2008-01 and primary completion as 2010-08.
The primary endpoint concerned left ventricular hypertrophy measured by echocardiography at 6 Month(s). The record states that early termination and sample size prevented further statistical analyses, and it reports no primary-outcome estimate. Adverse-event entries show zero serious and zero other events in each group’s reported risk set. Death counts are not reported in the registry record. Further details about the endpoint analysis, missing data, analysis populations, and reasons for termination are not reported in the registry record.