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 Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors (NCT00579254), a registered phase not stated study. The primary outcome is Change in Systolic and Diastolic Blood Pressure.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00579254 |
| Phase | Phase not stated |
| Condition | Hypertension and Cardiovascular Risk Factors |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 112 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Indian patients with hypertension and cardiovascular risk factors, including dyslipidemia, for whom the treating doctor had already considered a single-pill amlodipine/atorvastatin regimen appropriate. The registry record does not describe further eligibility criteria or the characteristics of participants enrolled.
Intervention
CADUET, a single pill containing amlodipine 5 mg and atorvastatin 10 mg or 20 mg. The record does not state how the two atorvastatin dose options were selected or assigned.
Comparator
No comparator is specified. Allocation is not stated, and the record does not describe a control group suitable for a like-for-like comparison.
Primary question
What change in systolic and diastolic blood pressure was recorded between baseline and 24 weeks during treatment with CADUET? The registry record says efficacy results were not available, so it does not answer this question with an outcome estimate.
The study’s stated aim was to assess the effect of single-pill therapy on management of hypertension and other cardiovascular risk factors in Indian patients. Its clinical question is therefore descriptive in the available record: it concerns blood-pressure change during use of the single-pill regimen in patients already judged suitable for it by their treating doctor. It is not framed in the posted record as a randomized comparison of the pill against another treatment or against no treatment.
That distinction matters for interpretation. A change measured from baseline can describe what happened over time among participants, but without a suitable comparison it cannot separate a treatment-associated change from other explanations, such as changes over time or differences in care. The record does not report the magnitude or direction of any blood-pressure change, nor does it report an analysis comparing outcomes across treatment groups. Consequently, the clinical question can be identified from the registered endpoint and study aim, but its outcome remains unanswered in the registry record.
3. Trial Design
The registry record identifies EXCEL as a study of CADUET in patients with cardiovascular risk factors. The intervention was a fixed single-pill combination of amlodipine 5 mg with atorvastatin 10 mg or 20 mg. Enrollment was 112. The record lists hypertension and cardiovascular risk factors as the condition and describes Indian patients whose treating doctor had considered the single pill appropriate.
The study began in 2007-12 and had a primary completion date of 2008-05. Its status is TERMINATED. The reason for termination is not reported in the registry record. Although these dates and the enrollment figure describe the administrative record, they do not establish how long each participant was followed or how many participants contributed data to the primary endpoint.
The primary outcome was change in systolic and diastolic blood pressure, with baseline and 24 weeks specified as the timeframe. The record does not state a comparator, and allocation is not stated. It therefore cannot be read as a randomized, controlled comparison. The record also does not describe a control arm as a like-for-like counterfactual for the participants receiving CADUET. The reported intervention listing alone does not clarify whether or how participants received the two dose options.
The registry lists one outcome measure and no analyses. It explicitly notes that efficacy results were not available from this terminated study. Details such as the study protocol, eligibility criteria beyond the broad population description, recruitment procedures, follow-up completeness, and the reason for stopping are not reported in the registry record. These omissions limit what can be inferred about conduct, adherence, and the relationship between enrollment and the endpoint analysis. The design can be characterized only at the level recorded: a terminated study of a single-pill regimen, with a planned blood-pressure outcome and no efficacy analysis posted.
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.
Before assignment: This was a phase 4, observational, open-label study conducted in patients who were prescribed singlepill Caduet by their treating physician per usual clinical practice. Study drug was not provided by the Sponsor.
Overall Study
| Stage | Caduet |
|---|---|
| STARTED | 112 |
| COMPLETED | 0 |
| NOT COMPLETED | 112 |
Reasons for not completing this period:
| Reason | Caduet |
|---|---|
| Lost to Follow-up | 39 |
| Discontinued when study terminated | 73 |
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 | Caduet |
|---|---|---|
| Participants analysed | 112 | |
| Age, Continuous | years | 54.7 (SD 9.6) |
| Sex: Female, Male: Female | Participants | 41 |
| Sex: Female, Male: Male | Participants | 71 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Systolic and Diastolic Blood Pressure, measured over Baseline, 24 weeks.
| 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 is change in systolic and diastolic blood pressure from baseline to 24 weeks. Systolic pressure is the pressure during heart contraction; diastolic pressure is the pressure between contractions. Reporting change over a specified interval can describe whether measured pressure shifted during follow-up, rather than presenting only a measurement at one time point.
In general, a baseline-to-follow-up change is useful because it relates a later measurement to the participant’s starting value. It can also make the clinical time window explicit. However, the interpretation depends on how measurements were taken, how change was calculated, and which participants contributed data. Those details are not reported in the registry record. The record also supplies no endpoint values, estimate of change, measure of variability, confidence interval, or statistical test result.
Both systolic and diastolic pressure are named in the endpoint, but the registry does not explain whether they were treated as separate outcomes or combined in a particular analysis. It does not specify which measure would be considered primary if results differed. These details are important for understanding the intended estimand and the precision of the result. Because no efficacy results were available, the endpoint identifies what the study intended to measure, not what the posted record establishes about participants’ blood pressure.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical fact is that this terminated study has no efficacy results available in the registry record. Although the primary endpoint is identified as change in systolic and diastolic blood pressure between baseline and 24 weeks, no numerical outcome estimate is posted. There is therefore no reported change to characterize as an increase, decrease, or absence of change, and no estimate of its precision.
Enrollment was 112, but enrollment is not the same as the number of participants with usable endpoint measurements. The record does not state how many participants completed follow-up, contributed a baseline measurement, or were included in an efficacy analysis. It lists no analyses. Thus the enrollment figure cannot substitute for an endpoint denominator or tell readers how much information underlies the intended blood-pressure assessment.
The absence of a specified comparator also restricts interpretation. A before-and-after measurement can describe temporal change if results are available, but it does not by itself establish that any change was caused by the intervention. Without an appropriate comparison group, secular changes, co-interventions, measurement variation, and participant selection remain possible alternative explanations. Allocation is not stated, and the registry record does not identify a like-for-like control comparison.
No p-value or confidence interval is reported for the primary outcome. In general, a p-value addresses how compatible data are with a specified statistical model and null hypothesis; it does not measure clinical importance or prove that an effect is present or absent. A confidence interval gives a range of effect values compatible with the data and assumptions, conveying uncertainty as well as direction and magnitude. Neither can be interpreted for this endpoint without a posted estimate and analysis.
The registry’s terminated status adds context but does not explain why the study stopped. The reason is not reported in the registry record, so it is not possible to connect termination to recruitment, safety, efficacy, logistics, or any other cause. Nor does termination itself reveal whether data were collected or whether an analysis was attempted outside the posted record. The available statement is specifically that efficacy results were not available.
Safety information is limited to the registry’s adverse-event counts. For the Caduet group, 112 were listed at risk for serious adverse events and 0 were listed as affected. The record also lists 1 under other adverse events, while the corresponding at-risk count and deaths are not reported. These entries describe what is recorded; they do not resolve the missing efficacy information, and the incomplete safety fields limit interpretation of event rates and completeness.
Overall, the posted record establishes the study’s broad population, intervention, planned endpoint, enrollment, and termination status. It does not establish the direction, size, or precision of a blood-pressure effect, nor does it support a controlled treatment comparison. Any conclusion about efficacy or comparative effectiveness would go beyond the posted results.
9. Statistical Methods Explained
The registry record identifies an intended endpoint and timeframe but does not report an efficacy analysis. Statistical methods can clarify what an analysis of this kind would ordinarily seek to estimate, but general explanations should not be mistaken for methods documented for this study. The analysis plan, model, treatment of missing measurements, and inferential procedures are not reported in the registry record.
What does a baseline-to-follow-up change represent?
In general, an analysis of change compares a participant’s measurement at follow-up with that participant’s baseline measurement. A summary across participants could describe the average change, another location measure, or the distribution of individual changes. Which summary is appropriate depends on the outcome distribution and the prespecified estimand. The registry record does not say how change was calculated or summarized for systolic and diastolic pressure.
A change score is not the only possible approach. In general, an analysis may model follow-up values while accounting for baseline values, or may use repeated measurements across time. These approaches answer related but not always identical questions and rely on assumptions about the data and model. The record names baseline and 24 weeks as the timeframe but does not describe intermediate measurements or an analytic model. It would be inappropriate to attribute any particular approach to this study.
How should precision be assessed?
In general, an effect estimate should be read together with its measure of uncertainty. A confidence interval expresses a range of values compatible with the observed data under the model assumptions. Its width conveys precision: wider intervals indicate less precise estimation, while narrower intervals indicate greater precision. The interval does not guarantee that the true effect lies inside it, and it cannot correct bias in study design or analysis. No estimate or confidence interval for the primary blood-pressure endpoint is reported.
A p-value is another inferential quantity, but it has a narrower meaning than is sometimes assumed. In general, it describes the probability, under a specified null hypothesis and model, of data at least as incompatible with that hypothesis as the observed data. It is not the probability that the null hypothesis is true, and it does not show the size or practical importance of an effect. No primary-outcome p-value is reported in the registry record.
What can a non-comparative record establish?
In general, a single-group before-and-after study can describe changes observed over time among those measured. It does not by itself distinguish an intervention effect from other time-related influences. A comparison group can help address this by providing a reference for what might have happened over the same period without the intervention, but only if the groups and their care are sufficiently comparable. Here, no comparator is specified, allocation is not stated, and the record explicitly cautions that the arms are not a like-for-like control comparison. No comparative effect estimate can therefore be read from the posted results.
Even when a comparison is available, analysis depends on assumptions about allocation, baseline differences, follow-up, and outcome measurement. Random allocation, when used, can balance prognostic factors on average, but the registry does not state an allocation method for this study. The absence of that information means the design should not be described as randomized or treated as having the protections of randomization.
What do planning calculations mean?
In general, sample-size planning calculations describe how many participants might be needed under specified assumptions about an effect, variability, significance level, allocation, and analysis. They are not results from enrolled participants and do not show observed power. A planning illustration based on an assumed fraction of an observed effect remains hypothetical; it cannot repair missing outcome data or create a causal comparison.
The record describes a planning illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect defined as a stated fraction of the observed effect. It also distinguishes total events for time-to-event calculations from participants per arm for other calculations. These are assumptions for an illustration, not evidence that the trial was designed or conducted with those properties. The registry record does not report the trial’s own sample-size justification or design assumptions. Because the primary efficacy results are unavailable, such planning quantities should not be interpreted as evidence about the study’s observed treatment effect or its power.
Finally, a well-specified analysis should define its population, outcome, treatment contrast, missing-data strategy, and handling of multiple outcomes before examining results. In general, those choices affect estimates and uncertainty. The record identifies no analysis population, gives no missing-data approach, and lists no analyses. Accordingly, the statistical methods actually used for the primary endpoint are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint names two measurements: systolic and diastolic blood pressure. The registry record does not state whether these were analyzed as separate outcomes, whether one was designated as the key measure, or whether any adjustment for multiple testing was planned. It also does not describe secondary or exploratory analyses beyond listing one outcome measure. The multiplicity strategy is not reported in the registry record.
In general, multiplicity arises when several outcomes, time points, subgroups, or statistical tests are examined. If the analysis treats each test as an independent opportunity to declare a finding, the chance of at least one false-positive result can increase. Prespecifying a primary outcome and analysis, or applying an adjustment when appropriate, can help control that risk. Since no efficacy analyses are posted, there are no reported tests to evaluate for multiplicity, and no correction should be inferred.
The registry record does not report an analysis population, such as all enrolled participants or only those with complete follow-up. It also does not report how missing blood-pressure measurements were handled. In general, missingness can affect both the number of observations and the validity of an estimate. Complete-case analyses may be biased if participants with missing data differ systematically from those with observed data. Model-based methods can use available measurements under assumptions about why data are missing, while sensitivity analyses can examine how conclusions change under alternative assumptions. None of these approaches is documented for this study.
Enrollment of 112 does not establish that all participants posted endpoint data or were included in an analysis. The number with baseline and 24-week measurements, withdrawals, exclusions, and reasons for missing data are not reported in the registry record. As a result, neither the completeness of outcome follow-up nor the potential impact of missing data can be assessed.
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 |
|---|---|---|---|
| Caduet | 0 | 112 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Caduet | 1 of n/a |
Most frequent non-serious adverse event terms
| Event term | Organ system | Caduet |
|---|---|---|
| High Density Lipoprotein decreased | Investigations | 1 of 112 |
For the Caduet group, the registry lists 112 participants at risk for serious adverse events and 0 affected by a serious adverse event. It lists 1 under other adverse events. The at-risk count for other adverse events and the death count are not reported in the registry record. No serious adverse-event terms are listed.
These are registry entries, not a complete account of event types, timing, severity, or relatedness. A count of 0 in the serious-event affected field means that no affected participants are recorded in that field; it does not independently establish how events were collected or whether reporting was complete. The entry of 1 under other adverse events has no accompanying event description in the posted information, and its denominator is not available. It therefore cannot be converted into a rate or used to compare safety with another treatment.
In general, adverse-event counts need their denominators, definitions, observation period, and ascertainment methods for meaningful interpretation. The registry does not report those details for the other-adverse-event count, and no comparator is specified. The safety figures should consequently be read narrowly as the counts recorded, not as proof of absence of risk or as evidence of a comparative safety profile.
12. What the Result Does, and Does Not, Mean
The record documents a terminated study of a single-pill amlodipine/atorvastatin regimen in Indian patients with cardiovascular risk factors. It identifies change in systolic and diastolic blood pressure from baseline to 24 weeks as the primary endpoint and records enrollment of 112. It also reports that efficacy results were not available. These registry entries describe the study and its reporting status, but they do not supply a blood-pressure effect estimate.
Accordingly, the posted results do not show whether blood pressure rose, fell, or remained similar over the planned timeframe. They do not quantify variability or precision, and they do not provide a p-value or confidence interval for the primary endpoint. The absence of an efficacy result is not evidence that no change occurred; it means the registry record does not present an efficacy estimate that can be evaluated.
The record also does not support a causal or comparative conclusion. No comparator is specified, and allocation is not stated. Even if a within-participant change had been posted, a before-and-after observation without a suitable control would not by itself isolate an effect attributable to the intervention. The registry does not provide the information needed to assess confounding, co-interventions, or differences in follow-up.
The listed safety entries are limited: 112 were at risk for serious adverse events, 0 were recorded as affected, and 1 appears under other adverse events. Missing at-risk and death entries are not equivalent to confirmed zero counts. These data do not provide a comprehensive safety comparison or replace the missing efficacy results.
The study’s termination is a relevant feature of the record, but its reason is not reported. It would be speculative to attribute termination to the outcome, participant experience, study operations, or any other cause. Likewise, the registry does not report the protocol, analysis population, missing-data approach, or statistical plan. The defensible interpretation is therefore limited: the record identifies what was intended to be evaluated and provides sparse safety counts, but it does not establish an efficacy result or comparative treatment effect.
13. Why This Trial Matters Statistically
This study illustrates an important distinction between a registered endpoint and an available result. The registry identifies blood-pressure change at baseline and 24 weeks as the primary outcome, but it explicitly states that efficacy results were not available. A clearly named endpoint does not itself provide evidence about its result; interpretation requires an estimate, information about uncertainty, and enough detail to understand who contributed data and how the analysis was performed.
The case also highlights the limits of enrollment totals. Enrollment was 112, yet the record does not identify the number with complete endpoint data or the analysis population. In clinical research, the relationship between participants enrolled, followed, and analyzed is essential for judging precision and possible selection bias. Without those details, the enrollment figure cannot tell readers how informative an efficacy analysis would have been.
Design information matters alongside outcome reporting. Allocation is not stated, no comparator is specified, and the record cautions that the arms are not a like-for-like control comparison. Statistical interpretation depends on the design that generated the data: a change observed over time and a contrast against a suitable control answer different questions. The record does not provide a basis for a controlled treatment-effect estimate.
Finally, a terminated status and limited safety entries make transparent reporting especially important. The reason for termination, analysis methods, and missing-data handling are not reported in the registry record. Those omissions leave uncertainty about how the study proceeded and why efficacy results are absent. The statistical lesson is not to fill gaps with assumptions: distinguish what the record documents from what it does not, and do not treat hypothetical planning calculations or sparse event counts as substitutes for a reported outcome analysis.
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.
Several limitations are specific to the available record. The study is marked TERMINATED, but the reason for termination is not reported in the registry record. Without that explanation, readers cannot determine whether the study stopped because of operational issues, recruitment, safety, efficacy, or another reason. None of these possible explanations should be presumed.
The registered population is described broadly as Indian patients with hypertension and cardiovascular risk factors, with treatment already considered appropriate by the treating doctor. Detailed eligibility criteria, baseline characteristics, and the number of participants in any dose group are not reported. The record also does not clarify how the atorvastatin 10 mg or 20 mg options were selected or assigned.
There is no stated comparator, and allocation is not stated. The record explicitly does not support treating arms as a like-for-like control comparison. This prevents a straightforward comparative interpretation and leaves the role of other care or time-related influences unclear. The method of blood-pressure measurement, the calculation of change, and the handling of the systolic and diastolic outcomes are not described.
Although enrollment was 112, the number with available measurements at baseline and 24 weeks is not reported. Participant flow, withdrawals, adherence, and reasons for missing measurements are also not reported in the registry record. No analysis population, statistical model, or missing-data strategy is documented, and no efficacy analyses are posted. These gaps prevent assessment of attrition, precision, and robustness.
Safety reporting is also incomplete in the available entries. The record gives a serious-event at-risk count and affected count, but the other-event denominator and death count are not reported; event descriptions are not available. These limitations do not establish that events were absent. Together, the omissions mean that the record supports a description of the study’s intended endpoint and recorded counts, but not a detailed evaluation of efficacy, comparative safety, or study conduct.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors — NCT00579254.
- Registry record last updated 2021-01-28; status last verified 2021-01.
- Results first posted 2009-06-19.
- 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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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes the EXCEL study of CADUET, containing amlodipine 5 mg and atorvastatin 10 mg or 20 mg, in Indian patients with hypertension and cardiovascular risk factors. Enrollment was 112. The study began in 2007-12, had a primary completion date of 2008-05, and is listed as TERMINATED.
Change in systolic and diastolic blood pressure from baseline to 24 weeks was the primary outcome. The record states that efficacy results were not available and lists no analyses. It does not specify a comparator or allocation method, and the reason for termination is not reported in the registry record.
For Caduet, the record lists 112 at risk and 0 affected for serious adverse events, along with 1 under other adverse events. The at-risk count for other adverse events and the death count are not reported. These entries do not supply an efficacy estimate or a comparative safety assessment.