Impact of Ramadan on Achieving Joint National Committee (JNC) 7 Treatment Goals in CV Risk Patients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Impact of Ramadan on Achieving Joint National Committee (JNC) 7 Treatment Goals in CV Risk Patients (NCT01853839), a registered phase not stated study. The primary outcome is Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52.

2. Clinical Question

3. Trial Design

This was an outpatient-based, prospective, multicentre, observational post-marketing surveillance study involving internists and cardiologists. It enrolled patients with essential hypertension and at least one additional risk factor. The registry lists planned enrollment of 1674 and identifies hypertension as the condition under study. The study status is completed.

Treatment was not assigned by the study according to the registry description. Patients could receive any antihypertensive treatment approved for cardiovascular protection, including Micardis 80 mg or Micardis Plus. The record does not state an allocation method, and it does not describe a randomized treatment comparison. The listed treatment options therefore should not be read as randomized study arms or as a direct comparison of those medications.

Patients were to be followed over one year, with four visits from baseline to endpoint and an additional visit before and after Ramadan. The primary endpoint was assessed at week 52. The record also lists outcomes concerning JNC 7 goal achievement after Ramadan and during the whole study, cardiovascular events, assessments by patients and physicians at 52 weeks, and patient compliance before, during, after Ramadan and throughout the study.

The registry lists 13 outcome measures but no analyses. It does not report the primary endpoint estimate, uncertainty interval, hypothesis test, or detailed statistical analysis plan. Consequently, the design and intended measurements can be described, but the posted record does not establish how the observed data were analyzed or what the primary result was.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: ITT dataset which included all patients, who received at least one dose of study medication.

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.

Population: All subjects included in the study according to the study protocol i.e. patients who did not violate any inclusion or exclusion criteria

6. Primary Endpoint

The registry lists the primary outcome as Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52, measured over Up to 52 weeks.

The primary endpoint is the percentage of participants who achieved the JNC 7 treatment goal at week 52, up to 52 weeks. To count as achieving the goal, a participant had to meet both blood-pressure criteria: systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg. The endpoint was derived from mean sitting blood pressure assessed by investigators.

Using both criteria makes the endpoint a joint threshold outcome: meeting only one of the two blood-pressure targets would not satisfy the registry’s definition. Expressing the result as a percentage describes how common goal achievement was in the defined study population. In general, a binary endpoint records whether each participant meets a specified condition, and a percentage summarizes the proportion who do.

The registry identifies the primary population as the ITT dataset, defined there as all patients who received at least one dose of study medication. The record does not report the observed percentage, its confidence interval, or a statistical test. It also does not explain how missing week-52 blood-pressure measurements were handled. Without those results and analysis details, the endpoint definition is available, but the degree of goal achievement in the enrolled population cannot be quantified from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical methods that were actually used are not reported in the registry record. The distinction between a planned endpoint and an analysis result is important: an endpoint definition specifies what is to be measured, whereas an estimate, uncertainty interval, and test require reported data and analysis procedures. The primary endpoint is defined, but its observed value and the analysis details are absent.

What does a percentage endpoint represent?

The primary outcome is a percentage of participants meeting a binary definition. Each participant either satisfies both blood-pressure thresholds or does not, according to the endpoint definition. In general, a percentage provides an easily interpretable description of the frequency of an outcome in a population. It does not, by itself, show why the outcome occurred or whether one factor caused it.

Because the goal requires both systolic and diastolic criteria, a participant who meets only one criterion would not meet the combined definition. The registry says the measure was derived from mean sitting blood pressure assessed by investigators. It does not report the number with evaluable week-52 measurements, the resulting percentage, or how observations missing one or both measures were treated.

What would an uncertainty interval add?

In general, a confidence interval describes uncertainty around an estimated quantity under the assumptions of the statistical method. A narrower interval indicates greater precision, while a wider interval indicates more uncertainty. For a percentage, the interval would help readers distinguish a relatively precise estimate from one based on limited information. No confidence interval for the primary result is reported, so its precision cannot be assessed from the registry record.

A hypothesis test and its p-value address a different question: whether the observed data are inconsistent with a specified null hypothesis under the test’s assumptions. A p-value is not the probability that a treatment works, nor does it measure the size or clinical importance of an effect. The record gives no primary endpoint p-value, test, or defined hypothesis comparison. There is therefore no reported statistical test to interpret.

Why is the observational design relevant to analysis?

In general, random allocation can help balance measured and unmeasured characteristics between comparison groups, on average. In an observational study, treatment and other exposures are not assigned by the study, so groups or time periods may differ for reasons related to participants or clinical care. Statistical adjustment can sometimes address measured differences, but it cannot automatically remove unmeasured confounding. The registry does not report an adjusted analysis, covariates, or a model used to estimate the primary result.

The record also does not describe a randomized comparison of Ramadan fasting with a non-fasting control. It gives a schedule that includes visits before and after Ramadan, but does not report how within-person or between-period comparisons were analyzed. A before-and-after pattern, if reported, would need interpretation in light of other changes over time; the timing alone would not establish that Ramadan caused a change.

What can be said about the analysis population?

The primary outcome population is called the ITT dataset and is defined in the record as all patients who received at least one dose of study medication. The term ITT is commonly associated with randomized studies, but its use does not make this observational study randomized. The registry does not report the number included in that endpoint analysis or whether any enrolled participants were excluded from it.

It also does not state whether analyses used all available observations, imputation, complete cases, or another method for missing data. In general, missing-data methods matter because the participants with observed follow-up may differ from those without it. Without information about missingness and its handling, the direction or magnitude of any resulting bias cannot be assessed.

What do the safety counts mean?

The safety record gives counts of subjects affected and numbers at risk for serious and other events. Counts describe reported events or affected subjects as recorded; they do not, on their own, estimate a causal treatment effect. In general, a comparison of safety risk requires clearly defined groups, observation periods, and methods for handling differences in follow-up and patient characteristics. Those details and a controlled safety comparison are not reported in the registry record.

The adverse-event listing includes percentages for selected serious-event terms, but does not supply a statistical comparison or an attribution analysis. The death field has no numerical value reported. No conclusions about relative safety, causality, or the statistical significance of event differences can be drawn from these entries alone.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 13 outcome measures, including the primary goal-achievement endpoint and secondary outcomes concerning post-Ramadan and full-study goal achievement, cardiovascular events, patient and physician assessments, and compliance. It reports no analyses. The statistical plan for handling multiple outcomes or multiple comparisons is not reported in the registry record.

In general, when several outcomes or comparisons are examined, the chance of at least one apparently unusual result can increase if each is tested separately without accounting for multiplicity. Methods for addressing this may include prespecifying a hierarchy or adjusting inferential thresholds. The record does not say whether any such approach was planned or used. Without analysis results, it is also not possible to determine which outcomes were tested or how many comparisons were made.

The registry does not report the handling of missing data for the primary or secondary outcomes. It does not state how many participants completed follow-up, had evaluable blood pressure at week 52, or contributed to each secondary analysis. It also does not describe imputation, exclusions, or sensitivity analyses. Missing-data handling can affect estimates when the availability of measurements is related to participant characteristics or outcomes; the amount and consequences of missingness cannot be assessed from the posted information.

The primary population is described as an ITT dataset consisting of all patients who received at least one dose of study medication. The registry does not report the number actually included in the primary analysis or explain how this population label was applied to the observational study. These omissions limit assessment of population flow, completeness of follow-up, multiplicity, and the robustness of any outcome estimate.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: acute myocardial infarction (0.8%), cerebrovascular accident (0.1%), accidental death (0.0%), sudden death (0.0%).

The registry safety entry lists 2090 subjects at risk for serious events and 21 affected, alongside 2090 at risk for other events and 0 affected. These are the counts recorded in the registry; the record does not state the observation window or provide a treatment-group comparison. The number at risk should not be assumed to match the planned enrollment, since the record does not explain the difference.

Selected serious-event terms are listed with their recorded percentages: acute myocardial infarction, 0.8%; cerebrovascular accident, 0.1%; accidental death, 0.0%; and sudden death, 0.0%. These term-level entries do not establish causality or show whether risks differed between treatments or groups. The deaths field has no numerical value reported, so it should not be read as a reported count of zero deaths.

In general, adverse-event counts are descriptive unless accompanied by clear definitions, follow-up information, comparison groups, and an appropriate analysis. The registry does not report those details sufficiently to estimate a comparative safety effect. These figures therefore describe the entries recorded, not proof that an event was caused by a treatment or that a treatment is safer or less safe.

12. What the Result Does, and Does Not, Mean

The registry record documents a prospective observational study of treatment-goal achievement among cardiovascular-risk patients with hypertension, with follow-up that included visits around Ramadan. It defines a primary endpoint based on meeting both systolic and diastolic JNC 7 thresholds at week 52. Those design details clarify the question the study set out to address.

The record does not report the observed primary endpoint percentage, an uncertainty interval, or a statistical test. It therefore cannot establish from the posted results how often participants achieved the goal, how precise that estimate was, or whether goal achievement changed across the study. Secondary outcome results are not reported either.

Even if outcome values were available, the observational design would require caution about causal interpretation. Treatment was not assigned by the study, and the registry does not describe a randomized comparator. Associations or changes observed over time would not, by themselves, show that Ramadan fasting or a particular antihypertensive treatment caused the outcome. Other clinical and participant factors could influence both treatment and blood pressure.

The safety entries provide recorded counts and selected serious-event percentages, but no controlled comparison or causal assessment. They do not show that any treatment caused or prevented an event. The registry also does not provide a numerical death count in the deaths field.

The appropriate conclusion is therefore limited: the registry states the study purpose, design, endpoint definition, and selected safety data, but does not provide the result needed to answer the primary clinical question. The study objective should not be mistaken for a finding, and the available record does not support a claim that any treatment or fasting pattern did or did not achieve a particular outcome.

13. Why This Trial Matters Statistically

This study is statistically notable for asking a clinically framed question through a prospective observational design rather than a randomized comparison. The registry description makes clear that investigators observed patients receiving treatments available in daily practice and followed them across a period that included Ramadan. That kind of design can describe outcomes in a clinical setting, but causal interpretation depends on more than the timing of measurements.

The primary endpoint is also a combined threshold: participants had to meet both systolic and diastolic blood-pressure criteria. This definition is important when interpreting a percentage because it is not enough to satisfy only one component. The endpoint is tied to investigator-assessed mean sitting blood pressure at week 52, which identifies the measurement basis and timing.

Statistical transparency is a central issue in this record. The registry lists 13 outcome measures but no analyses, and it does not report the primary estimate, uncertainty, or missing-data approach. These omissions prevent readers from judging the magnitude and precision of the main result, the completeness of endpoint data, or whether multiple outcomes were addressed in a prespecified way.

The mismatch between planned enrollment and the safety population count is not explained in the registry record. That does not establish an error, but it leaves the relationship between enrolled participants and those at risk for safety outcomes unclear. Overall, the record illustrates why endpoint definitions and study design must be considered alongside actual estimates, analysis methods, and participant flow. Without those elements, a well-defined question remains unanswered by the posted results.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The most consequential limitation of the registry record is that it does not report the primary outcome result. There is no week-52 percentage for participants meeting both blood-pressure criteria, and no confidence interval or test is reported. The record therefore does not allow assessment of the observed level of goal achievement or the precision of an estimate.

The study is described as observational, with treatment not assigned by the study. The registry does not state an allocation method or identify a randomized control comparison. Any observed relationship between treatment, Ramadan timing, and blood-pressure goals would consequently need cautious interpretation; the record does not report adjustment methods or analyses addressing confounding.

Although the planned enrollment is 1674, the safety entry lists 2090 subjects at risk. The registry does not explain how these populations relate, and the difference should not be resolved by assumption. The record also does not report participant flow, endpoint-specific analysis counts, or the number with evaluable week-52 blood pressure.

Missing-data methods, outcome-analysis methods, and the approach to multiple outcomes are not reported. The record lists 13 outcome measures and no analyses, leaving unclear which measures were analyzed and how any inferential findings were handled. The deaths field has no numerical value. Adverse-event observation periods, attribution, and comparative safety analyses are also not stated. These limitations apply to what can be concluded from the registry record; they do not establish how analyses may have been conducted elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Impact of Ramadan on Achieving Joint National Committee (JNC) 7 Treatment Goals in CV Risk Patients — NCT01853839.
• Registry record last updated 2015-08-10; status last verified 2015-07.
• Results first posted 2015-08-10.
• 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.

18. Record Summary

NCT01853839 is a completed prospective, multicentre, outpatient observational post-marketing surveillance study sponsored by Boehringer Ingelheim. It concerns patients with essential hypertension and at least one additional risk factor, with planned enrollment of 1674. Patients could receive antihypertensive treatment approved for cardiovascular protection. Follow-up was planned over one year, with visits including periods before and after Ramadan.

The primary endpoint was the percentage achieving both JNC 7 blood-pressure thresholds at week 52. The registry lists 13 outcome measures and no analyses. It does not report the primary endpoint result, confidence interval, p-value, or missing-data methods. The safety entry lists 21 affected among 2090 at risk for serious events and 0 affected among 2090 at risk for other events; the deaths field has no numerical value. The registry record describes the study question and selected safety data but does not provide the analysis needed to answer the primary question.