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 Open Label Study Telmisartan and Amlodipine in Hypertension (NCT00614380), a registered phase 3 study. The primary outcome is Trough Seated Diastolic Blood Pressure (DBP) Control.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00614380 |
| Phase | Phase 3 |
| Condition | Hypertension |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 976 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Boehringer Ingelheim |
| Results posted | Yes |
2. Clinical Question
Population
Patients with hypertension were eligible for the trial. The primary endpoint population was the full analysis set: patients who took at least one dose of study medication and had at least one on-treatment blood-pressure measurement taken 20-30 hours after a dose. This definition means the endpoint population is based on treatment exposure and an available measurement, rather than simply all enrolled patients. The registry record does not report further eligibility details in the information summarized for this trial.
Intervention
The trial followed patients receiving fixed-dose telmisartan 40 mg with amlodipine 5 mg, or telmisartan 80 mg with amlodipine 5 mg. The brief summary describes long-term, open-label treatment and says the combinations could be used alone or with other antihypertensive medications. The record does not report how treatment choices were assigned.
Comparator
The registry lists both dose combinations, but does not state that allocation was randomized. It therefore does not establish that the groups were intended to be like-for-like controls. Differences between their observed outcomes could reflect differences in the patients, treatment decisions, other medications, follow-up, or other factors, as well as any difference associated with the assigned combination.
Primary question
The primary endpoint counts participants who reached a trough seated diastolic blood pressure (DBP) below 90 mmHg at the end of the study, defined as 34 weeks or the last value on treatment. This is a threshold-based measure of DBP control. The registry record gives the endpoint definition and analysis population, but does not report the count or proportion who reached the target. The posted results therefore do not answer how many participants met this primary endpoint or allow a comparison of endpoint results between the treatment groups.
3. Trial Design
This completed phase 3 trial is registered as an open-label follow-up study of telmisartan and amlodipine in patients with hypertension. Its brief summary describes long-term treatment with fixed-dose telmisartan 40 mg / amlodipine 5 mg or telmisartan 80 mg / amlodipine 5 mg. It also states that the combinations could be taken alone or with other antihypertensive medications. Because treatment was open-label, the record does not describe a blinded comparison.
The registry reports enrollment of 976. The listed study start is 2008-01, and primary completion is 2009-03. The primary endpoint timeframe is end of study, defined as 34 weeks or the last value on treatment. These dates and the endpoint timeframe describe different aspects of the record: the former are registry milestones, while the latter defines when the primary outcome was assessed.
The record lists the two fixed-dose combinations as drug interventions. It does not state how participants came to receive either combination, whether treatment assignment was randomized, or whether the groups were intended to serve as direct controls for each other. Allocation is not stated, so the arm groups should not be read as a randomized comparison or as like-for-like control groups.
The primary endpoint is the number of participants whose trough seated DBP reached the target. The primary analysis population is defined as patients who received at least one dose and had at least one on-treatment blood-pressure measurement 20-30 hours post dose. Other listed outcomes concern seated systolic and diastolic pressure, response, control, and blood-pressure normality classes. The registry record reports 14 outcome measures and 6 analyses, but does not provide a statistical analysis plan in the registry record for this account.
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 | Telmisartan 40mg and Amlodipine 5mg | Telmisartan 80mg and Amlodipine 5mg | Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive |
|---|---|---|---|---|
| STARTED | 564 | 206 | 25 | 181 |
| COMPLETED | 529 | 198 | 24 | 179 |
| NOT COMPLETED | 35 | 8 | 1 | 2 |
Reasons for not completing this period:
| Reason | Telmisartan 40mg and Amlodipine 5mg | Telmisartan 80mg and Amlodipine 5mg | Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive |
|---|---|---|---|---|
| Adverse Event | 14 | 4 | 0 | 0 |
| Lost to Follow-up | 6 | 1 | 0 | 0 |
| Non compliant with the protocol | 12 | 2 | 1 | 2 |
| Consent withdrawn | 3 | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose
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 40mg and Amlodipine 5mg | Telmisartan 80mg and Amlodipine 5mg | Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 564 | 206 | 25 | 181 | 976 | |
| Age, Continuous | Years | 54.8 (SD 10.9) | 52.9 (SD 10.6) | 54.4 (SD 10.8) | 52.4 (SD 9.6) | 53.9 (SD 10.6) |
| Sex: Female, Male: Female | Participants | 240 | 72 | 8 | 45 | 365 |
| Sex: Female, Male: Male | Participants | 324 | 134 | 17 | 136 | 611 |
6. Primary Endpoint
The registry lists the primary outcome as Trough Seated Diastolic Blood Pressure (DBP) Control, measured over End of study (34 weeks or last value on treatment).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants who reached a trough seated DBP below 90 mmHg at the end of the study. The assessment time is defined as 34 weeks or the last value on treatment. The unit is participants, and the endpoint is a count of people meeting a threshold, not an average DBP or an average change from baseline.
Threshold-based control measures can make a clinical target easy to interpret: each person either meets the stated cutoff or does not. This is a general feature of binary outcomes. It also means that the endpoint does not show how far an individual’s DBP was from the cutoff, or how much it changed over time. The registry record lists change-from-baseline measures among secondary outcomes, but those are distinct from the primary count endpoint.
The primary analysis population is the full analysis set, defined in the record as patients who took at least one dose of study medication and had at least one on-treatment blood-pressure measurement 20-30 hours post dose. That definition determines whose measurements contribute to the endpoint analysis; it is not the same as a result. The registry record does not report the number who reached the target, a denominator for a primary endpoint proportion, or an estimate of uncertainty around the outcome. Accordingly, the endpoint’s definition can be described, but its observed result cannot be interpreted from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically interpretable primary outcome: the count of patients reaching a trough seated DBP target below 90 mmHg at end of study. It also specifies the analysis population and endpoint timeframe. However, it does not report the observed primary endpoint count, a proportion, or an estimate of uncertainty. The posted information therefore does not establish the observed level of DBP control in either group, nor does it show a comparative effect for the primary outcome.
The record lists two telmisartan/amlodipine combinations, but it does not state how participants were allocated. The registry’s own note flags that this is not a randomized comparison and that allocation is not stated. As a general statistical consideration, nonrandom assignment can leave groups different in ways that influence outcomes. For example, treatment selection, other antihypertensive medications, or baseline clinical characteristics could be associated with both group membership and blood pressure. Without information on assignment and adjustment, an observed difference between groups would not by itself isolate a treatment effect.
The safety listings give counts of participants with serious events and other events, along with at-risk denominators for each listed group. These are descriptive counts. The registry record does not provide a comparison adjusted for differences between groups, and the serious event counts alone do not establish that an event was caused by treatment. Death counts are not reported in the registry record. The listed serious terms each have a reported frequency of 0.3%; the record does not give a fuller context for interpreting those entries, such as the full event listing or a comparative estimate.
The registry includes additional blood-pressure outcomes, including seated systolic and diastolic measures, response, control, and normality classes. Their presence indicates that the study recorded a broader set of outcomes, but the information does not provide results for those measures. The registry record also does not report whether the analyses were adjusted, how missing measurements were handled, or how multiplicity was addressed. Those omissions limit assessment of the statistical strength and completeness of any conclusions drawn from the study.
The overall enrollment is reported as 976, while the safety listings show different at-risk denominators by group. These figures refer to different elements of the registry record and should not be combined to infer an unreported analysis population or group allocation. In particular, enrollment is not itself the denominator for the primary endpoint, whose analysis population has a separate definition.
In short, the record gives enough information to describe the design and intended primary measure, but not the primary result. No claim about the observed comparative efficacy of the combinations can be supported from the outcome information reported in the registry record.
9. Statistical Methods Explained
The registry describes a binary primary outcome: whether each participant reached the DBP target. For each participant in the defined analysis population, the endpoint is classified as meeting or not meeting the cutoff. The reported primary measure is a count of participants meeting it. A count is descriptive; to interpret how common the outcome was, readers also need the relevant denominator. To compare groups statistically, an analysis would generally also need an effect estimate and information about its uncertainty. Those primary result details are not reported in the registry record.
What does a confidence interval communicate?
As a general statistical explanation, a confidence interval expresses uncertainty around an estimated quantity under the assumptions of the analysis. A narrower interval indicates greater precision, while a wider interval indicates less precision. It is not a guarantee that the true value lies within the particular interval, nor does it remove bias from a nonrandomized comparison. The registry record does not report a confidence interval for the primary endpoint in the registry record for this account.
Why does allocation matter?
The registry lists both dose combinations but does not state how treatment was allocated. It explicitly notes that the comparison is not randomized and that allocation is not stated. Random allocation, when used and implemented as intended, can balance measured and unmeasured characteristics between groups on average. Without that design feature, or clear information about another assignment process and relevant adjustment, group comparisons can be affected by differences in who received each regimen. This is a general consideration, not a claim about the actual reasons participants received a particular combination in this trial.
The open-label description also matters for interpretation. It indicates that the trial was not described as blinded. In general, awareness of treatment can influence reporting, clinical decisions, or measurement processes, depending on the outcome and conduct of the study. Blood pressure is a measured outcome, but the registry record does not describe measurement procedures beyond the timing of the on-treatment measurement used to define the primary analysis population. The extent of any influence cannot be assessed from the available record.
What do the planning assumptions mean?
The stated sample-size illustration uses the observed effect as a reference and considers detecting a stated fraction of that effect. Its assumptions are a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. The assumptions describe a planning illustration, not the trial’s own design. The registry record does not report that these assumptions were used to design the trial, and the illustration is not observed power. Any sample sizes calculated under such assumptions are hypothetical planning quantities, not observed participant counts or evidence that the trial had a particular probability of finding an effect.
As a general principle, a planning calculation depends on the outcome, effect size, variability or event frequency, significance level, power target, and allocation assumptions. Changing an assumed effect changes the amount of information needed to detect it. The listed planning framework does not by itself establish whether the study was adequately powered for its primary endpoint; the registry record does not report the original sample-size justification or protocol-based calculation.
How should a count outcome be assessed?
For a binary outcome, the observed count is informative only in relation to the number of participants who could have met the endpoint. A proportion or between-group effect measure can make that relationship clearer, with uncertainty estimates showing how much precision the data support. These are general statistical principles. The registry record specifies the outcome count and defines the full analysis set, but the primary outcome result and its uncertainty are not reported. No new proportion or comparison can be calculated in the registry record in the registry record.
Statistical significance, when reported, would address compatibility with a specified null hypothesis under an analysis model; it would not by itself establish clinical importance or eliminate bias. Conversely, a lack of statistical significance would not prove that groups are equivalent. Those general interpretations require the estimated effect, uncertainty, model, and analysis plan. The available record does not report a primary endpoint test or a comparative estimate.
Finally, the registry lists multiple outcomes and analyses. As a general matter, examining multiple outcomes can increase the chance of finding apparently notable results by chance if the testing strategy does not account for multiplicity. Whether and how to address that issue depends on the prespecified hierarchy and analysis plan. Those details are not reported in the registry record, so no adjustment strategy or confirmatory status should be inferred.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 14 outcome measures and 6 analyses. It includes the primary DBP-control endpoint and several secondary measures of seated systolic and diastolic blood pressure, response, control, and blood-pressure normality classes. The presence of multiple outcomes raises a general question about multiplicity: when many outcomes or analyses are examined, interpretation depends in part on which were prespecified as primary and how testing was organized. The statistical plan, any testing hierarchy, and any multiplicity adjustment are not reported in the registry record.
The primary endpoint population is defined as the full analysis set: patients who took at least one dose and had at least one on-treatment blood-pressure measurement 20-30 hours post dose. This definition is reported, but the record does not explain how missing measurements were handled, whether participants without an eligible measurement were excluded from the primary analysis, or how incomplete follow-up affected the endpoint. The timeframe allows the last value on treatment as an endpoint assessment, but that wording alone does not describe a general missing-data procedure.
The record does not report an interim analysis plan, imputation methods, sensitivity analyses, or a complete statistical analysis plan. Their use or absence cannot be inferred. The outcome and analysis counts do not reveal which results were selected for reporting or how many comparisons were tested. These missing details limit assessment of multiplicity and the potential effects of missing data.
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 40mg and Amlodipine 5mg | 22 | 976 | 2.3% |
| Telmisartan 80mg and Amlodipine 5mg | 6 | 397 | 1.5% |
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 40mg and Amlodipine 5mg | 57 of 976 |
| Telmisartan 80mg and Amlodipine 5mg | 45 of 397 |
Most frequent serious adverse event terms
| Event term | Organ system | Telmisartan 40mg and Amlodipine 5mg | Telmisartan 80mg and Amlodipine 5mg |
|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | 1 of 976 | 1 of 397 |
| Dizziness | Nervous system disorders | 1 of 976 | 1 of 397 |
| Atrial fibrillation | Cardiac disorders | 1 of 976 | 0 of 397 |
| Cardiac failure | Cardiac disorders | 0 of 976 | 1 of 397 |
| Cronary artery disease | Cardiac disorders | 1 of 976 | 0 of 397 |
| Mitral valve incompetence | Cardiac disorders | 0 of 976 | 1 of 397 |
| Cystic lymphangioma | Congenital, familial and genetic disorders | 1 of 976 | 0 of 397 |
| Epigastric discomfort | Gastrointestinal disorders | 1 of 976 | 0 of 397 |
| Small intestinal obstruction | Gastrointestinal disorders | 1 of 976 | 0 of 397 |
| Anal abscess | Infections and infestations | 0 of 976 | 1 of 397 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Telmisartan 40mg and Amlodipine 5mg | Telmisartan 80mg and Amlodipine 5mg |
|---|---|---|---|
| Oedema peripheral | General disorders | 32 of 976 | 21 of 397 |
| Back pain | Musculoskeletal and connective tissue disorders | 25 of 976 | 24 of 397 |
Serious events with the highest arm-level rate: acute myocardial infarction (0.3%), cardiac failure (0.3%), mitral valve incompetence (0.3%), anal abscess (0.3%), post procedural cellulitis (0.3%).
The registry lists serious-event counts and counts for other events, with at-risk denominators shown for each treatment group. For telmisartan 40mg and amlodipine 5mg, the listing reports 22 participants with a serious event and 57 with other events, with 976 at risk for each category. For telmisartan 80mg and amlodipine 5mg, it reports 6 participants with a serious event and 45 with other events, with 397 at risk for each category. These are registry counts, not adjusted comparisons.
The most frequently listed serious-event terms each have a reported frequency of 0.3%: acute myocardial infarction, cardiac failure, mitral valve incompetence, anal abscess, post procedural cellulitis, and thyroid neoplasm. The record does not establish that these events were caused by treatment, and the term list does not provide a complete account of event timing or clinical circumstances. Death counts are not reported in the registry record.
Because allocation is not stated and the comparison is not randomized, the group counts should not be read as a direct causal comparison of safety. The denominators also differ across the listed groups. No additional percentages or relative risks can be inferred without calculation, and the registry record does not report adjusted safety estimates or uncertainty intervals.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the trial assessed open-label use of two telmisartan/amlodipine fixed-dose combinations in patients with hypertension. It defines the primary endpoint as the number of participants reaching a trough seated DBP below 90 mmHg at the end of study, with the assessment defined as 34 weeks or the last value on treatment. It also defines the population whose measurements were intended to contribute to that endpoint.
However, the record does not report the primary endpoint result. Without the observed count, an appropriate denominator, and an estimate of uncertainty, the endpoint definition cannot show how frequently the target was reached or how precisely it was estimated. The listed secondary outcomes similarly do not provide results in the information summarized for this account. Thus, the posted data do not support a conclusion about the observed blood-pressure outcomes.
The registry’s safety information describes participant counts for serious events and other events, as well as several serious-event terms with reported frequencies. These figures describe what the record lists; they do not establish causation. The absence of randomized allocation information further limits direct group comparisons, because differences in group outcomes could reflect differences in participants or treatment circumstances rather than the combination itself.
The trial record therefore supports a description of the design, endpoint definition, analysis population, and listed safety counts. It does not establish that either regimen is more effective or safer than the other, nor does it establish equivalence. Those interpretations would require reported outcome estimates, uncertainty, relevant analysis details, and a design that supports the intended comparison. The registry record does not report those elements in the information available for this account.
13. Why This Trial Matters Statistically
This trial illustrates why a clearly named endpoint is not the same as a reported result. The registry identifies a concrete target for DBP control and specifies how the endpoint population and assessment time are defined. Those details help readers understand what investigators intended to measure. Yet without the outcome count and its denominator, the primary endpoint cannot be interpreted as an observed level of control.
It also illustrates how design features shape the meaning of comparisons. Two regimens may be listed, but a comparison is not automatically randomized or balanced. Here, allocation is not stated, and the registry explicitly cautions that the arms are not a like-for-like control comparison. That distinction matters when readers move from describing group counts to considering whether a difference could be attributed to treatment.
The record’s planning assumptions offer another useful statistical distinction. A sample-size illustration based on an observed effect and stated assumptions is not the same as the original trial design, and it is not observed power. Planning calculations answer hypothetical questions about the information needed under specified assumptions; they do not substitute for the observed effect and its uncertainty.
Finally, the combination of multiple listed outcomes and missing analysis-plan details shows why outcome definitions, missing-data rules, and multiplicity procedures matter. These details affect how robustly results can be interpreted. In this case, the record gives important elements of the study description, but not enough reported outcome or analysis information to support a statistical conclusion about comparative effectiveness.
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 specific to this registry record constrain interpretation. The primary endpoint result is not reported, so the number of participants reaching the DBP target and the uncertainty around that outcome are unavailable. Although the outcome is defined as a participant count, the record does not give a primary endpoint denominator or comparative estimate in the information.
The design is described as open-label, and allocation is not stated. The registry notes that this is not a randomized comparison and that the groups are not a like-for-like control comparison. This limits causal interpretation of any between-group differences. The brief summary also permits use alone or with other antihypertensive medications, but the record does not describe how concurrent medication use was distributed or handled analytically.
The primary analysis population is defined, but missing-data methods and handling of incomplete follow-up are not reported. The endpoint timeframe permits use of the last value on treatment, but the record does not explain how that rule was applied or how missing measurements were addressed. The analysis plan, including any adjustment for multiple outcomes, is also not reported.
Safety counts are presented with group-specific at-risk denominators, but the registry does not provide adjusted comparisons or uncertainty intervals in the registry record. Death counts are not reported in the registry record. The limited serious-event term list and the absence of event-level context also restrict interpretation of those entries. These limitations mean the record is useful for describing the study and its registered outcomes, but insufficient for a complete assessment of efficacy or comparative safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Open Label Study Telmisartan and Amlodipine in Hypertension — NCT00614380.
- Registry record last updated 2014-02-13; status last verified 2013-12.
- Results first posted 2010-01-18.
- 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 3, open-label follow-up trial of telmisartan and amlodipine in hypertension. It reports enrollment of 976, a start date of 2008-01, and primary completion in 2009-03. The listed regimens are telmisartan 40mg with amlodipine 5mg and telmisartan 80mg with amlodipine 5mg.
The primary endpoint is the number of participants reaching trough seated DBP below 90 mmHg at end of study, defined as 34 weeks or the last value on treatment. The full analysis set requires at least one dose and at least one on-treatment blood-pressure measurement 20-30 hours post dose. The primary endpoint result is not reported in the registry record.
The record lists 14 outcome measures and 6 analyses. Its safety information includes serious-event and other-event counts, but allocation is not stated and the registry warns against treating the arms as like-for-like controls. Missing-data handling, multiplicity procedures, and the statistical analysis plan are not reported in the registry record.