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 Blood Pressure Lowering Ability and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Patients With Stage I and Stage II Hypertension (NCT00527514), a non-randomized phase 3 study. The primary outcome is Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00527514 |
| Phase | Phase 3 |
| Condition | Hypertension |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 185 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Daiichi Sankyo |
| Results posted | Yes |
2. Clinical Question
Population
People with stage 1 or stage 2 hypertension were the intended population. The primary endpoint description uses an ambulatory blood pressure monitoring subset: participants who received at least one dose of active study medication and had both baseline and end-of-study ambulatory measurements. The record states that this subset comprised 172 participants.
Intervention
The study assessed an amlodipine- and olmesartan-based treatment regimen. Listed regimen groups include amlodipine 5 mg alone and combinations of amlodipine with olmesartan at different doses. The record does not explain how participants were assigned to these regimens or how treatment was adjusted.
Comparator
There was no randomized control group. The registry describes a non-randomized, open-label, single-group study, while also listing several regimen groups for outcome reporting. Those groups should not be read as randomized, like-for-like comparison arms.
Primary question
What was the change from baseline to 12 weeks in mean 24-hour systolic blood pressure measured by ambulatory monitoring among the eligible participants in the monitoring subset? The numerical change and its uncertainty are not reported in the registry record.
The clinical question is therefore about change during treatment, not about a randomized contrast between the regimen and an untreated or alternative-treatment group. A baseline-to-follow-up change can describe what happened over the study period, but by itself does not isolate treatment effects from other influences on blood pressure, such as natural variation or changes in care outside the study. The registry names the endpoint and its measurement period, but does not report the estimated change, its standard deviation, a confidence interval, or a test result. That means the direction, magnitude, and precision of the primary finding cannot be evaluated from the registry record.
3. Trial Design
This was a phase 3, prospective, open-label study listed as completed. It was non-randomized and the registry describes its model as single-group. The study concerned an amlodipine- and olmesartan-based regimen in people with stage 1 and stage 2 hypertension. The listed interventions are amlodipine and olmesartan medoxomil plus amlodipine. Several regimen groups appear in the outcome and safety descriptions, including amlodipine alone and combinations with olmesartan.
The study began in 2007-09, and primary completion was recorded as 2008-04. Enrollment is listed as 185. These are registry-level design details; they do not establish how many participants contributed data to each endpoint. For the primary ambulatory blood pressure endpoint, the registry specifically describes a subset of 172 participants who received at least one dose of active study medication and had both baseline and end-of-study measurements.
Because treatment allocation was non-randomized and masking was absent, participants and investigators were not blinded to treatment assignment. The registry does not report how treatment groups were formed, whether treatment changes followed a prespecified sequence, or whether all participants received the same regimen at any point. The listed groups are not a basis for a causal comparison: differences between people in different groups could reflect how treatment was selected as well as treatment itself.
The record identifies change from baseline to 12 weeks in mean 24-hour systolic blood pressure by ambulatory monitoring as the primary outcome. It also lists secondary outcomes concerning daytime and nighttime ambulatory systolic blood pressure and cuff systolic blood pressure in named regimen groups. The record does not report the protocol’s statistical analysis plan, a sample-size justification, interim analyses, or rules for handling treatment changes. Those design details are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: After placebo treatment, participants with a mean systolic blood pressure (SBP)≥140 mmHg and ≤199 mmHg or a mean diastolic BP (DBP)≥90 and ≤109 mmHg with a difference between mean SBPs ≤15 mmHg and a mean 8-hr daytime SBP of ≥135 mmHg and ≤199 mmHg, and mean 8-hr daytime DBP of \<110 mmHg by ambulatory BP monitoring were considered eligible.
Weeks 1-3: Amlodipine (Aml) 5mg
| Stage | Amlodipine and Olmesartan, if Necessary |
|---|---|
| STARTED | 185 |
| COMPLETED | 184 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Amlodipine and Olmesartan, if Necessary |
|---|---|
| Adverse Event | 1 |
Weeks 4-6: Aml 5mg+Olmesartan 20 mg
| Stage | Amlodipine and Olmesartan, if Necessary |
|---|---|
| STARTED | 180 |
| COMPLETED | 178 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Amlodipine and Olmesartan, if Necessary |
|---|---|
| Withdrawal by Subject | 2 |
Weeks 7-9: Aml 5 mg + Olmesartan 40 mg
| Stage | Amlodipine and Olmesartan, if Necessary |
|---|---|
| STARTED | 161 |
| COMPLETED | 158 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | Amlodipine and Olmesartan, if Necessary |
|---|---|
| Adverse Event | 1 |
| Lost to Follow-up | 1 |
| Withdrawal by Subject | 1 |
Weeks 10-12:Aml 10 mg +Olmesartan 40 mg
| Stage | Amlodipine and Olmesartan, if Necessary |
|---|---|
| STARTED | 134 |
| COMPLETED | 132 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Amlodipine and Olmesartan, if Necessary |
|---|---|
| Adverse Event | 1 |
| Withdrawal by Subject | 1 |
Analysis population for the primary outcome, as defined in the registry: The ambulatory blood pressure monitoring (ABPM) subset were subjects who received at least one dose of active study medication and had a baseline ABPM and end of study ABPM measurement.This = 172 participants.
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 | Amlodipine and Olmesartan, if Necessary |
|---|---|---|
| Participants analysed | 185 | |
| Age Continuous | years | 56.8 (SD 9.28) |
| Sex: Female, Male: Female | Participants | 80 |
| Sex: Female, Male: Male | Participants | 105 |
| Race/Ethnicity, Customized: Asian | Participants | 14 |
| Race/Ethnicity, Customized: Black or African American | Participants | 26 |
| Race/Ethnicity, Customized: White | Participants | 144 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | Participants | 1 |
| Region of Enrollment: United States | participants | 185 |
| Stage of Hypertension: Stage 1 | Participants | 82 |
| Stage of Hypertension: Stage 2 | Participants | 103 |
| 24-Hour Ambulatory Diastolic Blood Pressure | mm Hg | 85.8 (SD 7.91) |
| 24-hour Ambulatory Systolic Blood Pressure | mm Hg | 144.6 (SD 10.88) |
| Heart Rate | beats/minute | 75.1 (SD 10.82) |
| Systolic Blood Pressure | mm Hg | 158.2 (SD 12.63) |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring, measured over Baseline to 12 Weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mm Hg |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in mean 24-hour systolic blood pressure measured by ambulatory blood pressure monitoring, with the stated timeframe of baseline to 12 weeks and the unit mm Hg. Systolic blood pressure is the pressure recorded when the heart contracts. Ambulatory monitoring collects readings during everyday activity across a full day, rather than relying only on a measurement taken in a clinic.
A 24-hour mean combines readings across daytime and nighttime periods into one continuous measure. This can describe blood pressure across a broader portion of daily life than a single cuff reading. The registry also lists daytime and nighttime ambulatory systolic pressure as a secondary outcome, which can describe those periods separately. Cuff systolic pressure is listed for the amlodipine and combination regimen groups as another secondary outcome.
Change from baseline expresses the follow-up measurement relative to the participant’s starting measurement. It is a way to describe movement over the treatment period, but it does not by itself show what would have happened without the regimen. In a non-randomized study without a like-for-like control group, change can also reflect variation over time or other influences. The registry identifies the primary endpoint as a mean, with standard deviation as the dispersion measure. However, it does not report the numerical mean change or standard deviation, nor a confidence interval. The observed size and precision of the primary endpoint therefore cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record establishes what the primary outcome was intended to measure, but it does not report the numerical primary result. There is no posted mean change in 24-hour systolic blood pressure, standard deviation, confidence interval, or p-value in the registry record. Without those results, it is not possible to describe whether the endpoint increased or decreased, how large any change was, or how precisely it was estimated. The intervention’s effect cannot be judged from the endpoint description alone.
The design also sets limits on what a within-study change could mean. The study was open-label, non-randomized, and listed as single-group. It additionally lists several treatment regimens for outcome and safety reporting. The record says the groups are not a like-for-like control comparison. Thus, even if group-specific changes were available, differences would not necessarily be attributable to the regimen: treatment selection and participant characteristics could differ across groups. No randomized contrast is reported.
The primary endpoint uses ambulatory monitoring and includes participants with baseline and end-of-study measurements who received at least one dose of active study medication. That definition describes the monitoring subset, not necessarily every enrolled participant or everyone included in other outcomes. The record states that the subset comprised 172 participants. It does not report the distribution of missing measurements, reasons for missingness, or whether any imputation was used. The endpoint population should therefore be understood according to the registry’s stated eligibility description, without assuming how absent measurements were handled.
The record lists six outcome measures and six analyses. It names several secondary blood pressure outcomes, but does not report their numerical results or explain how conclusions across multiple outcomes were handled. When many outcomes are examined, chance findings can become more likely if each is tested without an adjustment or a prespecified hierarchy. Whether that issue was addressed in the original analysis is not reported in the registry record.
Any sample-size figures framed as planning illustrations are not observed results and are not evidence of observed power. The stated illustration assumptions use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and a target effect defined as a stated fraction of the observed effect. Those are planning assumptions, not a description of the study’s actual design: the record describes a non-randomized, single-group study. The registry does not report the original sample-size justification or enough primary outcome results to assess the observed effect’s precision. Such illustrations should not be treated as confirmation that the study could detect a particular effect or as evidence about efficacy.
Overall, the registry record supports a description of the study question, design, population definition, and listed outcomes. It does not support a quantitative conclusion about the primary blood pressure change. The absence of a reported result is not evidence that the change was zero or that no analysis was conducted; it means the result is not reported in the registry record.
9. Statistical Methods Explained
The primary endpoint is continuous: it is a blood pressure measurement expressed in mm Hg, and the registry says the parameter is a mean. Continuous outcomes can take many values along a measurement scale, unlike outcomes that count events or classify people into categories. A mean gives a summary of the central value, while a standard deviation describes how spread out individual measurements are around that mean. Neither summary alone shows the uncertainty in the estimated mean; a confidence interval is commonly used to express that uncertainty.
What does change from baseline represent?
A change score compares a follow-up measurement with a participant’s baseline measurement. When individual changes are summarized, the mean change describes the average direction and size of those changes in the analyzed population. The registry names baseline and 12 weeks as the measurement period, but does not provide the mean change or its standard deviation. No further calculation or interpretation of the endpoint’s magnitude is possible from the registry record.
In general, analyzing change can account for where participants started, but it does not automatically make groups comparable. In a randomized study, random allocation can help balance participant characteristics between treatment groups on average. This study was non-randomized and is described as single-group, so a baseline-to-follow-up change does not create a randomized control contrast. Trends over time, measurement variation, and other changes occurring during follow-up can contribute to the observed change.
Why use ambulatory monitoring?
Ambulatory monitoring records blood pressure outside a single clinic measurement and the primary endpoint summarizes readings across 24 hours. As a general measurement principle, repeated readings over a broader period can describe daily blood pressure patterns differently from an individual cuff measurement. The registry separately lists daytime and nighttime ambulatory systolic pressure as secondary outcomes, as well as cuff systolic pressure for named regimen groups. These are related but distinct measures and should not be treated as interchangeable results.
What would a confidence interval communicate?
In general, a confidence interval presents a range of values compatible with the data and the statistical method used. A narrower interval indicates greater precision under that method; a wider interval indicates greater uncertainty. An interval does not correct for non-random treatment assignment, missing data, measurement limitations, or other sources of bias. The registry does not report a confidence interval for the primary endpoint, so its precision cannot be assessed.
A p-value, in general, describes how incompatible the observed data are with a specified null model, assuming the model and analysis conditions hold. It is not the probability that the treatment works, nor does it describe the size or clinical importance of an effect. The registry does not report a p-value for the primary endpoint. A p-value alone would also be insufficient to assess the result without an effect estimate and its uncertainty.
How should the planning illustrations be read?
Sample-size planning asks how many participants might be needed under chosen assumptions to detect a specified effect with a chosen statistical procedure. The record’s stated illustration assumptions include a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect target expressed as a fraction of the observed effect. These are assumptions for a planning illustration, not a report of the trial’s design. The study itself is described as non-randomized and single-group, and the registry does not report its original sample-size justification.
In general, a planning calculation depends on the effect size being targeted, outcome variability, allocation, and the chosen error and power criteria. Changing those assumptions changes the planning result. Illustrations based on a fraction of an observed effect are conditional scenarios: they do not establish that the effect is true, that the study had a particular observed power, or that a future study would reproduce the result. They are not substitutes for a reported estimate and confidence interval. The primary result needed to assess the observed effect is not reported in the registry record.
Why can over-dispersion matter?
For count outcomes, over-dispersion means that observed variability is greater than a simple statistical model expects. In general, ignoring over-dispersion can make uncertainty estimates too small and tests too optimistic. This concept does not directly describe the primary continuous blood pressure endpoint, and the registry does not report a count-model analysis. It is included as a general statistical point, not as a claim about the analysis used in this study.
The record identifies standard deviation as the dispersion measure for the primary continuous outcome, but does not give its value. It also does not specify a model, covariate adjustment, repeated-measures approach, or method for deriving uncertainty. No particular statistical test or estimation procedure should be inferred from the endpoint label alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists six outcome measures and six analyses. The primary outcome is the change from baseline in mean 24-hour ambulatory systolic blood pressure; secondary outcomes include daytime and nighttime ambulatory systolic pressure and cuff systolic pressure for named treatment regimens. Considering several outcomes creates a multiplicity issue: as a general statistical principle, making many separate tests can increase the chance of at least one chance finding if no adjustment or hierarchy is used. The registry does not report whether outcomes were tested using a multiplicity adjustment, whether a testing hierarchy was prespecified, or how the analysis distinguished confirmatory from exploratory findings. These details are not reported in the registry record.
The primary endpoint population is described as participants who received at least one dose of active study medication and had both a baseline and an end-of-study ambulatory measurement. The registry states that this subset comprised 172 participants. This definition makes availability of both measurements part of the population description. It does not explain how many otherwise eligible participants lacked measurements, why data were missing, or how missing values were handled in the analysis. The record does not report whether any imputation, sensitivity analysis, or other missing-data method was used.
The record also does not describe analysis populations for the secondary endpoints or provide a detailed statistical analysis plan. Enrollment is listed as 185, but that figure should not be assumed to be the denominator for every outcome. The registry does not state how participants who discontinued, changed treatment, or lacked a measurement were treated in each analysis. Those aspects of missing data and analysis-population definition are not reported in the registry record.
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 |
|---|---|---|---|
| Amlodipine 5 mg | 0 | 185 | 0.0% |
| Amlodipine 5mg and Olmesartan 20 mg | 0 | 180 | 0.0% |
| Amlodipine 5mg and Olmesartan 40 mg | 1 | 161 | 0.6% |
| Amlodipine 10 mg and Olmesartan 40 mg | 1 | 134 | 0.7% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Amlodipine 5 mg | 8 of 185 |
| Amlodipine 5mg and Olmesartan 20 mg | 23 of 180 |
| Amlodipine 5mg and Olmesartan 40 mg | 11 of 161 |
| Amlodipine 10 mg and Olmesartan 40 mg | 12 of 134 |
Most frequent serious adverse event terms
| Event term | Organ system | Amlodipine 5 mg | Amlodipine 5mg and Olmesartan 20 mg | Amlodipine 5mg and Olmesartan 40 mg | Amlodipine 10 mg and Olmesartan 40 mg |
|---|---|---|---|---|---|
| Limb amputation | Injury, poisoning and procedural complications | 0 of 185 | 0 of 180 | 1 of 161 | 0 of 134 |
| Transient ischemic attack | Vascular disorders | 0 of 185 | 0 of 180 | 0 of 161 | 1 of 134 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Amlodipine 5 mg | Amlodipine 5mg and Olmesartan 20 mg | Amlodipine 5mg and Olmesartan 40 mg | Amlodipine 10 mg and Olmesartan 40 mg |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 1 of 185 | 9 of 180 | 2 of 161 | 5 of 134 |
| Oedema Peripheral | General disorders | 3 of 185 | 5 of 180 | 2 of 161 | 2 of 134 |
| Upper respiratory tract infection | Infections and infestations | 1 of 185 | 4 of 180 | 3 of 161 | 1 of 134 |
| Dizziness | Nervous system disorders | 2 of 185 | 3 of 180 | 2 of 161 | 1 of 134 |
| Joint swelling | Musculoskeletal and connective tissue disorders | 1 of 185 | 2 of 180 | 2 of 161 | 3 of 134 |
Serious events with the highest arm-level rate: transient ischemic attack (0.7%), limb amputation (0.6%).
The safety record lists serious adverse events for the named regimen groups. The recorded serious-event counts are 0 for amlodipine 5 mg, 0 for amlodipine 5 mg and olmesartan 20 mg, 1 for amlodipine 5 mg and olmesartan 40 mg, and 1 for amlodipine 10 mg and olmesartan 40 mg. The corresponding at-risk counts are 185, 180, 161, and 134. These figures describe the registry’s group listings; because the study was non-randomized and does not provide a like-for-like control comparison, they should not be read as comparative estimates of treatment risk.
The registry also lists other adverse-event counts of 8, 23, 11, and 12 across those groups. It names transient ischemic attack at 0.7% and limb amputation at 0.6% among the top serious-event terms. The record does not specify the denominators or event counts associated with those listed percentages. Deaths are not reported in the registry record.
Counts alone do not communicate event timing, duration, severity beyond the registry’s classification, or whether an event was considered related to treatment. The record does not provide those details. Differences in the listed at-risk counts and non-random allocation also limit direct comparisons between groups. These figures describe reported safety events, but do not establish that one regimen is safer or less safe than another.
12. What the Result Does, and Does Not, Mean
The registry record identifies a prospective study of an amlodipine- and olmesartan-based regimen in people with stage 1 and stage 2 hypertension. It specifies a primary measurement: change from baseline to 12 weeks in mean 24-hour systolic blood pressure by ambulatory monitoring. It also identifies secondary blood pressure outcomes and reports serious and other adverse-event counts for listed treatment groups. These details clarify what the study set out to assess and what outcomes were recorded.
The record does not report the numerical primary endpoint result. It therefore cannot show the magnitude or direction of the average change, or the precision of that estimate. The absence of a reported result is not evidence of no change. It is a limit on what can be concluded from the registry record. Nor can the design establish a causal treatment effect from a change over time alone: allocation was non-randomized, masking was absent, and the record does not present a like-for-like randomized control group.
The listed safety counts are descriptive. They do not by themselves establish whether events were caused by treatment or support a reliable comparison between regimens. The registry does not provide enough information about event timing, relatedness, or the denominators behind the listed serious-event percentages to resolve those questions. Safety findings should be read within the limitations of the recorded group structure and available event details.
In general, a study can be informative about feasibility, measurement, and the pattern of outcomes observed in its participants even when it cannot establish a treatment effect. The registry record supplies useful context about the study design and endpoint definitions, but missing numerical efficacy results, unreported analysis methods, and the non-randomized design constrain interpretation. Conclusions beyond those recorded details are not supported by the available registry information.
13. Why This Trial Matters Statistically
This study illustrates why endpoint definitions and study design need to be considered together. The primary endpoint is a continuous ambulatory blood pressure measure, defined as change from baseline to 12 weeks. That definition says what was measured, in whom, and over what period. But an endpoint definition is not itself a result: without the mean change and an estimate of its uncertainty, readers cannot assess the size or precision of the finding.
The record also highlights the distinction between describing change and estimating a treatment effect. A single-group or non-randomized study can report measurements before and during treatment, but those measurements do not provide the same counterfactual comparison as randomized allocation. Here, multiple regimen groups are listed, but the registry explicitly indicates that the arms are not a like-for-like control comparison. Statistical descriptions of group outcomes cannot remove that design limitation.
Ambulatory monitoring and cuff measurements also represent different ways of assessing blood pressure. The registry distinguishes the primary 24-hour measure from daytime and nighttime ambulatory outcomes and cuff outcomes. Keeping those measures separate matters when interpreting results, choosing an endpoint, and planning later analyses.
Finally, the record lists multiple outcomes but does not explain how multiplicity, missing data, or analysis populations were handled. Those are not technical footnotes: they affect how much confidence to place in apparent patterns and how to compare results across outcomes. The study is statistically informative as an example of why complete reporting of estimates, uncertainty, allocation, and analysis methods is essential. The registry record does not report enough results or methods to support a quantitative conclusion about the primary outcome.
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 main limitation for interpreting efficacy is that the registry record does not report a numerical result for the primary endpoint. It gives the outcome definition, unit, measurement period, and dispersion type, but not the mean change, standard deviation, confidence interval, or p-value. Without these, the size and precision of the primary finding cannot be assessed.
The study was open-label and non-randomized. The registry describes a single-group model while listing several treatment regimen groups for outcomes and safety. It also states that the arms are not a like-for-like control comparison. Consequently, the group listings do not support a randomized comparison, and a before-and-after change alone cannot distinguish treatment-associated change from other influences over time.
The primary ambulatory monitoring subset is defined by receipt of at least one dose and the availability of baseline and end-of-study measurements. The record states that it comprised 172 participants, but does not describe missing measurements, discontinuations, or the handling of missing data. It also does not specify the analysis populations used for the secondary outcomes. Enrollment is listed as 185; the registry does not establish that every enrolled participant contributed to every analysis.
The record lists multiple outcomes and analyses without reporting the statistical plan or how multiplicity was addressed. It also does not report the original sample-size justification, interim-analysis procedures, covariate adjustment, or the statistical model used. Details of how regimens were assigned and adjusted are not reported in the registry record. These omissions limit assessment of both potential bias and the appropriateness of the analysis.
Safety information is also limited: the record does not report deaths, and the listed serious-event percentages lack a stated denominator and event count. Event timing and treatment relatedness are not reported. These gaps prevent detailed interpretation of the safety listings or reliable comparisons among groups.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Blood Pressure Lowering Ability and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Patients With Stage I and Stage II Hypertension — NCT00527514.
- Registry record last updated 2009-11-11; status last verified 2009-11.
- Results first posted 2009-09-23.
- 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
This completed phase 3 study examined an amlodipine- and olmesartan-based regimen in stage 1 and stage 2 hypertension. It was prospective, open-label, non-randomized, and listed as single-group. Enrollment was 185; the primary ambulatory blood pressure endpoint was defined for a subset of 172 participants with baseline and end-of-study measurements after receiving at least one dose of active study medication.
The primary outcome was change from baseline to 12 weeks in mean 24-hour systolic blood pressure measured by ambulatory monitoring. Secondary outcomes included daytime and nighttime ambulatory pressure and cuff systolic pressure for named regimen groups. The registry record does not report the numerical primary result or its uncertainty, and does not report key statistical-analysis and missing-data details. Listed safety counts are descriptive and do not establish comparative risk across the non-randomized groups.