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 J-TARGET,Japanese Telmisartan Study for Antihypertensive Good Effect in Long Term Observation (NCT00659581), a registered phase not stated study. The primary outcome is Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00659581 |
| Phase | Phase not stated |
| Condition | Hypertension |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 21471 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Boehringer Ingelheim |
| Results posted | Yes |
2. Clinical Question
Population
Patients with hypertension treated in routine clinical settings were the population of interest. The registry reports enrollment of 21,471 and says that 20,443 observed patients were included in the intention-to-treat set for the primary outcome. The record does not give further eligibility criteria or detailed participant characteristics, so the population cannot be described more specifically from this information.
Intervention
The intervention was telmisartan, identified in the record as Micardis Tablets. The survey was intended to observe its use in routine care over 3 years after treatment initiation. The record does not specify dose, prescribing rules, adherence measures, or whether treatment could be changed during follow-up.
Comparator
No comparison group is described. The record does not state an allocation method and does not describe a randomized comparison. It therefore does not establish a like-for-like contrast between telmisartan and another treatment or between telmisartan and no treatment.
Primary question
The primary outcome is the number of patients with cerebrovascular and cardiovascular events during the stated timeframe of 3 years after initiation of treatment. The registry describes the survey’s purpose as investigating those events, alongside adverse events, blood pressure measurements, and patient lifestyle and background factors. The primary event count itself is not reported in the registry record.
3. Trial Design
This registry record describes J-TARGET, a post-marketing survey of telmisartan among patients with hypertension. Its stated purpose was to follow patients treated in routine clinical settings and investigate adverse events and adverse drug reactions, blood pressure measurements, cerebrovascular and cardiovascular events, and lifestyle and background factors considered relevant to those events. The intervention is listed as telmisartan, also identified in the official title as Micardis Tablets.
The record gives enrollment as 21,471. For the primary outcome, it states that all of the observed 20,443 patients were included in the intention-to-treat set. The primary outcome timeframe is 3 years after treatment initiation. The registry lists the study as completed, with a start date of 2006-04 and a primary completion date of 2010-06; these dates do not, by themselves, describe each participant’s follow-up.
No comparator is specified, and allocation is not stated. The record does not describe a randomized design, so the study should be read as a survey of treatment in routine practice rather than as a randomized treatment comparison. Without a comparator, event counts describe what was recorded among the observed patients; they do not estimate a contrast with another treatment or with no treatment.
The registry lists changes from baseline in systolic and diastolic blood pressure at 6, 12, 24, and 36 months as secondary outcomes. It does not give their numerical results in the registry record for this analysis. The sponsor is Boehringer Ingelheim. Further information about recruitment procedures, prescribing, follow-up methods, and the statistical plan is 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.
Before assignment: In the survey, 21,433 patients were enrolled. The data of 439 patients have not reported after the registration, and 551 patients were not observed after the registration: 38 entry violation, 24 contract violation, 493 no office visit after initial prescription and 9 undefined study medication (the numbers were overlapping).
Overall Study
| Stage | Telmisartan |
|---|---|
| STARTED | 20994 |
| COMPLETED | 12412 |
| NOT COMPLETED | 8582 |
Reasons for not completing this period:
| Reason | Telmisartan |
|---|---|
| Adverse Event | 1006 |
| Lack of Efficacy | 1183 |
| Other | 6393 |
Analysis population for the primary outcome, as defined in the registry: All of observed 20,443 patients were included as intention to treat set
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Telmisartan |
|---|---|---|
| Participants analysed | 20443 | |
| Age, Continuous | years old | 64.6 (SD 12.0) |
| Sex: Female, Male: Female | Participants | 10278 |
| Sex: Female, Male: Male | Participants | 10165 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events, measured over 3 years after initiation of treatment.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Number of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled “Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events.” Its unit is participants, its parameter is a number, and its timeframe is 3 years after initiation of treatment. In plain terms, it is intended to count patients recorded as having cerebrovascular or cardiovascular events during that timeframe. The record states that the observed 20,443 patients were included in the intention-to-treat set for this outcome.
Counting patients with events provides a direct description of how many people in the observed group had an event recorded. It is different from counting every event, because one patient could potentially have more than one event; the registry title specifies patients, not the total number of event episodes. It is also different from an estimated treatment effect: without a comparator and an analysis contrasting groups, the count alone cannot quantify how outcomes differ under telmisartan versus another approach.
The primary event count is not reported in the registry record. The serious adverse-event terms are not a substitute for that endpoint: they are safety listings, and the record does not establish that they use the same event definitions, ascertainment, or analysis as the primary outcome. The endpoint’s definition, event adjudication procedures, and any rules for handling recurrent events are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a prospective post-marketing survey of telmisartan use in routine clinical settings. Its primary question concerns the number of patients with cerebrovascular and cardiovascular events during 3 years after treatment initiation. The outcome is clinically relevant to the survey’s stated purpose, but the primary count is not reported in the registry record. Consequently, the record does not support a numerical description of the primary outcome or an assessment of its precision.
The record identifies 21,471 enrolled participants and an intention-to-treat set of 20,443 observed patients for the primary outcome. Those figures describe enrollment and the stated analysis population; they do not supply the missing event count. The reason for the difference between these figures, the follow-up completeness, and the handling of participants without outcome information are not reported in the registry record. No percentage, rate, confidence interval, or treatment contrast for the primary endpoint should be inferred from the enrollment or analysis-population figures.
Because the registry does not describe a comparator or allocation method, the study cannot be interpreted as a randomized comparison. An observed event count during treatment is descriptive. It does not isolate the effect of telmisartan from participants’ underlying health, other care, or other factors that may influence event occurrence. The stated interest in lifestyle and background factors does not show that these factors were measured, adjusted for, or used in an analysis; those details are not reported in the registry record.
The record lists serious adverse-event terms, including cerebral infarction, angina pectoris, cardiac failure, myocardial infarction, gastric cancer, and death, with percentages. These safety listings should be interpreted separately from the primary endpoint. The record does not explain whether those terms were judged related to treatment, how they were collected, whether they overlap with the primary endpoint, or what denominators were used for each listed percentage. They therefore cannot be treated as a causal estimate of treatment harm or as a substitute measure of the primary outcome.
The secondary outcomes concern changes from baseline in systolic and diastolic blood pressure at 6, 12, 24, and 36 months. Their numerical results, analysis methods, and precision are not reported in the registry record. The record lists 9 outcome measures and 0 analyses, which signals that outcome definitions are present without corresponding analysis details in the available record. No statistical significance claim or estimate of effect is supported by these registry entries.
Any sample-size figures associated with planning illustrations should be read as hypothetical design calculations, not as observed power. The record describes such illustrations as based on the observed effect, with assumptions about significance level, allocation, and an approximation, but no observed primary effect is available in the registry record to interpret. The sponsor’s own analysis takes precedence if a discrepancy is reported; no discrepancy is stated in the registry record summarized for this analysis.
9. Statistical Methods Explained
The registry identifies the primary measure as a count of patients with cerebrovascular and cardiovascular events, with participants as the unit and 3 years after treatment initiation as the timeframe. This describes the intended endpoint but not the statistical procedure used to estimate or present it. The number of primary events, any accompanying uncertainty interval, and the analysis method are not reported in the registry record.
What does a participant count describe?
In general, a participant count reports how many people meet an outcome definition. It is not automatically a rate, a risk estimate, or a comparison between treatments. A rate requires a clearly defined denominator and, when person-time is used, information about time at risk. A comparison requires information about the groups being contrasted and a method for estimating the difference or other contrast. The registry record gives an analysis population for the primary outcome but no primary event count or comparator. Therefore, it does not permit those additional quantities to be interpreted.
The endpoint wording refers to patients with events, rather than the total number of event episodes. In general, that distinction matters when a person can experience recurrent events: counting people answers how many had at least one qualifying event, while counting episodes answers how many events occurred. The registry does not report how recurrent events were handled or provide a detailed event definition, so the precise operational interpretation cannot be expanded beyond the stated endpoint title.
What can the analysis population tell readers?
The registry states that all of the observed 20,443 patients were included as the intention-to-treat set for the primary outcome. That is a description of the stated population for the endpoint, not proof that all enrolled participants had complete follow-up or that all had outcome status determined. The record does not explain the difference between enrollment of 21,471 and the observed analysis set, or describe exclusions, missing outcome status, censoring, or follow-up duration for individual participants. Those details are not reported in the registry record.
In general, an analysis population should be interpreted alongside the rules used to define it. A label alone does not reveal whether participants were analyzed as enrolled, how treatment changes were handled, or how missing observations were addressed. This is particularly important in a longitudinal survey, where some participants may not have outcome information for the full intended timeframe. No assumptions about those procedures can be made from the population label alone.
Why does the absence of a comparator matter?
In general, randomized comparisons can support causal interpretation when allocation, follow-up, and analysis are appropriately conducted. This registry record does not describe a randomized comparison and does not name a control group. The results, if reported, would therefore describe events observed in the survey population, not establish what would have happened to the same population under a different treatment. Differences in health status, clinical decisions, and other factors could influence observed outcomes, but the extent to which these factors were measured or addressed is not reported in the registry record.
A descriptive event count can still be informative about what was recorded in a routine-care population. Its interpretation depends on a clearly stated outcome definition, ascertainment process, observation period, and denominator. The record states the timeframe and analysis population but does not supply the primary count or details of event ascertainment. As a result, even a descriptive estimate cannot be assessed for precision or completeness from these registry entries.
How should uncertainty and statistical tests be read?
In general, a confidence interval expresses the range of estimates compatible with the data under a specified statistical procedure. Its width reflects uncertainty, and it is interpreted together with the outcome definition and study design. No confidence interval for the primary endpoint is reported in the registry record. A p-value would address compatibility with a specified statistical hypothesis under stated assumptions; it would not, on its own, establish clinical importance or causation. No primary-outcome p-value or analysis is reported in the registry record.
In general, a statistical method should match the outcome and design. A binary outcome can be analyzed as whether each participant had an event, while a count outcome may represent the number of events or people meeting a definition. The registry classifies the primary outcome as a participant count, but it does not report the model, estimator, adjustment variables, or variance method. No particular method should be attributed to the investigators based on the endpoint label alone.
Over-dispersion is a general concern when count data vary more than a statistical model expects. It can make conventional uncertainty estimates too narrow if the method does not account for that extra variation. This concept does not establish that over-dispersion occurred in this survey or that a count model was used; the statistical model and relevant diagnostics are not reported in the registry record.
What do planning calculations mean?
In general, a sample-size calculation describes the amount of information a future study might need under specified assumptions about an effect, significance level, allocation, and statistical approximation. It is a planning illustration, not evidence that a study had a particular probability of detecting an effect after the results are observed. The assumptions listed for the planning illustrations in this record include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect expressed as a fraction of an observed effect. The record also distinguishes planning outputs for time-to-event outcomes from those for other outcomes.
Those assumptions do not describe the design of this survey, which has no stated two-arm comparison. The values of any planning illustrations are not included in the registry record for this analysis, and the primary effect needed to interpret an illustration is not reported in the registry record. Such calculations should not be presented as the survey’s actual sample-size justification or as observed power. The registry does not report its original sample-size rationale or statistical analysis plan.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 9 outcome measures. The primary outcome concerns patients with cerebrovascular and cardiovascular events, and the secondary outcomes include systolic and diastolic blood-pressure changes at 6, 12, 24, and 36 months. It reports 0 analyses. This means the available record identifies outcomes but does not provide analysis results or the methods used to produce them.
When a study examines several outcomes or several time points, multiplicity can arise: the more statistical questions considered, the greater the chance that at least one result appears notable by chance under some testing approaches. In general, investigators may specify a primary hypothesis, prioritize outcomes, or adjust inference for multiple comparisons. The registry record does not report a multiplicity strategy, a hierarchy of statistical tests, or whether any adjustment was planned or performed. No claim about statistical significance across the outcomes can therefore be assessed from these registry entries.
The record states that 20,443 observed patients were included in the intention-to-treat set for the primary endpoint, compared with enrollment of 21,471. It does not explain the participant flow between those figures, define how an observed patient was distinguished from a participant with missing outcome data, or describe imputation, censoring, or sensitivity analyses. Missing-data procedures are not reported in the registry record.
The term “intention to treat” is reported as the name of the primary analysis population. In general, an analysis-population label does not by itself establish how treatment changes, incomplete follow-up, or missing outcome status were handled. Those details are needed to judge whether the analysis population corresponds to the intended estimand. The registry record does not provide them.
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 |
|---|---|---|---|
| Telmisartan | 1058 | 20443 | 5.2% |
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 |
|---|---|
| Telmisartan | 0 of 20443 |
Most frequent serious adverse event terms
| Event term | Organ system | Telmisartan |
|---|---|---|
| Cerebral infarction | Nervous system disorders | 169 of 20443 |
| Angina pectoris | Cardiac disorders | 90 of 20443 |
| Cardiac failure | Cardiac disorders | 76 of 20443 |
| Myocardial infarction | Cardiac disorders | 58 of 20443 |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 42 of 20443 |
| Death | General disorders | 35 of 20443 |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 32 of 20443 |
| Cerebral haemorrhage | Nervous system disorders | 31 of 20443 |
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26 of 20443 |
| Renal failure chronic | Renal and urinary disorders | 23 of 20443 |
Serious events with the highest arm-level rate: cerebral infarction (0.8%), angina pectoris (0.4%), cardiac failure (0.4%), myocardial infarction (0.3%), gastric cancer (0.2%).
The registry’s safety fields list 20,443 patients at risk for serious adverse events and 1,058 serious adverse events. The listed count for other adverse events is 0. These entries describe what appears in the posted safety fields; the record does not explain the precise event-collection rules or how the categories were assigned. The serious-event count should not be interpreted as the number of patients with the primary cerebrovascular and cardiovascular endpoint.
The record lists serious adverse-event terms and percentages: cerebral infarction, 0.8%; angina pectoris, 0.4%; cardiac failure, 0.4%; myocardial infarction, 0.3%; gastric cancer, 0.2%; and death, 0.2%. The registry does not state the denominator or calculation method for each term in the registry record, so these percentages should be read as reported, not recalculated or combined. The record also does not clarify whether terms can overlap within a patient.
These safety listings do not establish that telmisartan caused the events. The record does not provide a comparator, treatment-relatedness judgments for these terms, or a detailed ascertainment method. The primary event count is not reported in the registry record, and the safety listings cannot fill that gap.
12. What the Result Does, and Does Not, Mean
The record describes a completed post-marketing survey of telmisartan use among patients with hypertension in routine clinical settings. It sets out a primary question about the number of patients with cerebrovascular and cardiovascular events during 3 years after treatment initiation, along with secondary blood-pressure outcomes and safety objectives. These stated aims show what the survey was intended to investigate.
The primary outcome result is not reported in the registry record. Without that count, readers cannot describe the observed frequency of the primary endpoint from this record, assess its precision, or compare it with a benchmark. The record also does not report numerical results for the blood-pressure outcomes. The listed safety counts and terms provide separate descriptive information but do not substitute for those missing efficacy-oriented outcome results.
The study has no stated comparator and no reported allocation method. Its observations therefore cannot establish how outcomes under telmisartan compare with outcomes under another treatment or with no treatment. Nor can an event observed during treatment, by itself, show that the treatment caused it. Interpreting cause would require a design and analysis capable of separating treatment effects from other influences; the relevant comparative analysis is not reported in the registry record.
In general, absence of a reported result is not evidence that an outcome did or did not occur. It means the result cannot be evaluated from the registry information. The distinction is important: the survey’s objectives, enrollment, analysis-population statement, and safety listings are available, while its primary event count, outcome estimates, uncertainty, and analysis methods are not reported in the registry record.
The registry can therefore support a description of the study’s setting, stated aims, and some safety reporting, but it does not support a quantitative conclusion about the primary outcome or a causal treatment claim. Readers should separate what the record says was planned or measured from what it actually reports as an analyzed result.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of the difference between a registry’s stated objectives and its reported results. The record describes a large post-marketing survey in routine clinical settings and names a primary event-count endpoint, yet the primary count and its analysis are not reported in the registry record. A clearly stated outcome is not enough to evaluate an estimate when its result and uncertainty are absent.
The design also illustrates why descriptive evidence and comparative evidence answer different questions. Observing patients treated with telmisartan can describe events recorded in that setting, but the lack of a stated comparator prevents a direct treatment contrast. The record’s intention-to-treat label does not change that design limitation, nor does it supply the missing outcome data or clarify how follow-up and missingness were handled.
The listed safety information demonstrates another interpretive distinction. Serious adverse-event terms and percentages can summarize reported safety events, but they are not automatically equivalent to the primary endpoint, and they do not establish treatment causation. Clear definitions, denominators, ascertainment procedures, and comparative context are important for interpreting such data.
Finally, the record identifies several blood-pressure outcomes and time points without reporting analysis results or multiplicity methods. This makes it difficult to assess how the outcomes were prioritized or how uncertainty across multiple analyses was addressed. The central statistical lesson is that outcome labels, sample size, and safety listings should not be mistaken for an estimate of treatment effect. Interpretation depends on the results, methods, and design details actually reported.
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 endpoint is specified by title, unit, and timeframe, but its numerical result and definition details are not reported in the registry record. The record does not state how cerebrovascular and cardiovascular events were identified, whether events were independently adjudicated, or how recurrent events were handled. Without these details, the endpoint’s operational meaning and completeness of ascertainment cannot be assessed.
The record describes a single treatment group and does not state allocation or identify a comparator. This limits interpretation to the survey’s observed experience and prevents a direct treatment comparison. The registry also does not report participant characteristics, eligibility criteria, dose, adherence, treatment changes, concomitant care, or the methods used to account for lifestyle and background factors.
Enrollment is reported as 21,471, while the stated primary analysis population is 20,443 observed patients. The record does not explain the difference, provide a participant flow, or report the completeness of outcome follow-up. Missing-data handling, censoring, sensitivity analyses, and the analysis plan are not reported in the registry record.
The secondary blood-pressure outcomes are listed, but their numerical estimates and analysis methods are not reported. The registry lists 9 outcome measures and 0 analyses; multiplicity procedures and the statistical model are not reported. Safety listings include serious adverse-event counts and selected terms, but definitions, relatedness assessments, term-specific denominators, and overlap are not clarified in the registry record for this analysis. These limitations constrain both quantitative interpretation and causal conclusions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: J-TARGET,Japanese Telmisartan Study for Antihypertensive Good Effect in Long Term Observation — NCT00659581.
- Registry record last updated 2016-08-25; status last verified 2016-07.
- Results first posted 2012-03-20.
- 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
J-TARGET is a completed post-marketing survey of telmisartan among patients with hypertension in routine clinical settings. The record lists Boehringer Ingelheim as sponsor, enrollment of 21,471, a study start of 2006-04, and primary completion of 2010-06. Its stated objectives include investigating safety, blood pressure, cerebrovascular and cardiovascular events, and relevant lifestyle and background factors over 3 years.
The primary endpoint is the number of patients with cerebrovascular and cardiovascular events during 3 years after treatment initiation. The registry states that 20,443 observed patients were included in the primary intention-to-treat set, but the primary event count and its analysis are not reported in the registry record. Secondary outcomes cover systolic and diastolic blood-pressure changes at 6, 12, 24, and 36 months; numerical results are not reported in the registry record for this analysis.
No comparator or allocation method is stated. The record lists serious adverse-event information, but it does not provide enough detail to interpret those listings as causal or as a substitute for the primary outcome. Statistical methods, missing-data procedures, and multiplicity handling are not reported in the registry record.