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 A Study to Evaluate the Safety of 12 Weeks of Dosing With GW856553 and Its Effects on Inflammatory Markers, Infarct Size, and Cardiac Function in Subjects With Myocardial Infarction Without ST-segment Elevation (NCT00910962), a randomized phase 2 study. The primary outcome is Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00910962 |
| Phase | Phase 2 |
| Condition | Acute Coronary Syndrome |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 526 |
| Arms in the primary outcome | n/a |
| Lead sponsor | GlaxoSmithKline |
| Results posted | Yes |
2. Clinical Question
Population
Subjects with myocardial infarction without ST-segment elevation, described in the brief summary as subjects with NSTEMI. The safety population included randomized participants who took at least one dose of study medication.
Intervention
Two GW856553 dosing regimens: a 7.5 mg starting dose followed 12 hours later by 7.5mg twice daily for 12 weeks, or a 15 mg starting dose followed 12 hours later by 7.5mg twice daily for 12 weeks.
Comparator
Placebo twice daily for 12 weeks. All subjects were to continue receiving local standard of care for the duration of the study.
Primary question
What safety events were recorded through Week 14, including the number of participants with any adverse events and serious adverse events? The registry also lists inflammatory markers, infarct size and cardiac function as areas of assessment.
The study was designed to assess initial safety and efficacy in subjects with NSTEMI. The primary outcome is safety-focused: it counts participants with adverse events (AEs) and serious adverse events (SAEs) through Week 14. The registry defines an AE as an untoward medical occurrence temporally associated with use of a medicinal product, whether or not considered related to that product. An SAE is an event meeting specified seriousness criteria, including death, a life-threatening event, hospitalization or prolongation of hospitalization, disability or incapacity, congenital anomaly or birth defect, or another situation judged serious by medical or scientific judgment.
The registry lists three treatment groups: the two GW856553 regimens and placebo. The central statistical question is how to describe the observed safety counts across those groups without treating raw counts as proof of a treatment effect. The record also names secondary assessments of hsCRP, IL-6, CK-MB, cTnI, BNP, infarct size, LVEF, LVEDV and LVESV. Numerical results for those measures are not reported in the registry record.
3. Trial Design
This was a randomized, double-blind, placebo-controlled, parallel-group phase 2 study. The registry records quadruple masking and a multi-center design. The study evaluated 12 weeks of dosing with GW856553 in subjects with myocardial infarction without ST-segment elevation, with safety follow-up through Week 14 for the primary outcome.
The intervention descriptions distinguish two dosing regimens. Treatment A began with a 7.5 mg dose, followed 12 hours later by 7.5mg twice daily for 12 weeks. Treatment B began with a 15 mg dose, followed 12 hours later by 7.5mg twice daily for 12 weeks. Treatment C was placebo twice daily for 12 weeks. The brief summary states that participants continued local standard of care during the study.
The registry records enrollment of 526. Its brief summary describes randomizing up to approximately 525 subjects to meet an MRI recruitment target, with 90 subjects in a substudy. The enrollment figure and the approximate recruitment description are distinct registry statements; the record does not explain their relationship. The study is marked completed, with a start date of 2009-10-08 and primary completion date of 2012-03-06.
The intervention entries name GW856553, while the safety-group labels use the name losmapimod. The record does not explain this difference in terminology. It lists 21 outcome measures and 78 analyses, but the statistical analysis plan, allocation details beyond randomized assignment, and rationale for the sample size are not reported in the registry record. The two active regimens and placebo define the treatment structure, but the posted safety counts alone do not establish which statistical comparisons were prespecified.
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 | Placebo (P) | Losmapimod 7.5 mg (A) | Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B) |
|---|---|---|---|
| STARTED | 135 | 199 | 192 |
| COMPLETED | 92 | 121 | 116 |
| NOT COMPLETED | 43 | 78 | 76 |
Reasons for not completing this period:
| Reason | Placebo (P) | Losmapimod 7.5 mg (A) | Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B) |
|---|---|---|---|
| Adverse Event | 5 | 20 | 17 |
| Protocol Violation | 1 | 3 | 3 |
| Lost to Follow-up | 0 | 3 | 1 |
| Physician Decision | 0 | 6 | 6 |
| Withdrawal by Subject | 25 | 32 | 32 |
| Reached defined stopping criteria | 12 | 14 | 17 |
Analysis population for the primary outcome, as defined in the registry: Safety Population consisted of all participants randomized to treatment, who had taken 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: The race of one participant each in treatment A and treatment B were unknown.
| Characteristic | Unit | Placebo (P) | Losmapimod 7.5 mg (A) | Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B) | Total |
|---|---|---|---|---|---|
| Participants analysed | 135 | 199 | 192 | 526 | |
| Age, Continuous | Years | 63.4 (SD 10.29) | 62.6 (SD 11.03) | 64.6 (SD 10.50) | 63.5 (SD 10.66) |
| Sex: Female, Male: Female | Participants | 40 | 52 | 57 | 149 |
| Sex: Female, Male: Male | Participants | 95 | 147 | 135 | 377 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 3 | 0 | 3 |
| Race (NIH/OMB): Asian | Participants | 4 | 4 | 9 | 17 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 1 | 2 | 3 | 6 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 6 | 5 | 13 |
| Race (NIH/OMB): White | Participants | 128 | 183 | 174 | 485 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 1 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs), measured over Up to Week 14.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary outcome counts participants with any adverse events and serious adverse events through Week 14. It is a safety endpoint rather than a measure of infarct size, cardiac function or inflammatory response. Reporting the number of participants with events can describe the safety experience during the study period, while the registry’s definitions distinguish events by seriousness and do not require an investigator to judge an AE as caused by study medication.
For this outcome, an AE is an untoward medical occurrence temporally associated with use of a medicinal product, regardless of whether it is considered related to that product. An SAE is defined by seriousness criteria, such as death, a life-threatening event, hospitalization or prolongation of hospitalization, disability or incapacity, congenital anomaly or birth defect, or another medically or scientifically serious situation. These definitions describe how events are categorized; they do not establish causality.
The registry gives the timeframe as up to Week 14 and identifies the safety population as randomized participants who took at least one dose of study medication. The endpoint title combines AEs and SAEs, but the posted results distinguish serious events from other events and include death counts. The record does not provide a single inferential comparison for this primary outcome. The number of participants experiencing an event is useful for describing observed safety counts, but interpretation also depends on the event definitions, the observation period and how participants were included in each group.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety results give counts of participants with serious adverse events and other adverse events for placebo and the two active regimens. Placebo has 32 of 135 participants with a serious adverse event and 52 of 135 with another adverse event. Losmapimod 7.5 mg has 51 of 199 with a serious adverse event and 55 of 199 with another adverse event. Losmapimod 15 mg followed by losmapimod 7.5 mg has 43 of 192 with a serious adverse event and 49 of 192 with another adverse event. The record also reports deaths of 4, 4 and 10 in those groups, respectively.
These are descriptive counts. They do not by themselves show whether a difference between groups is compatible with chance, nor do they establish that a study medication caused or prevented an event. The counts have different group denominators, so comparing counts alone does not account for group size. No effect estimates, confidence intervals or inferential tests for these safety comparisons are reported in the registry record.
The record separately presents a combined A and B group, with 94 participants with a serious adverse event and 104 with another adverse event among 391 participants, and 14 deaths. This combined group is a registry entry, not an independent randomized arm alongside A and B: it pools the two active groups as labeled in the safety data. It should not be interpreted as an additional separately assigned treatment group.
The registry lists the most frequent serious-event terms as Myocardial infarction (5.2%), Acute myocardial infarction (3.1%), Angina pectoris (3.0%), Angina unstable (2.6%), Chest pain (2.2%) and Cardiac failure (2.1%). The denominator and calculation basis for these percentages are not reported in the registry record. The listed terms describe event coding, and the record does not establish that any event was caused by study treatment.
The study also lists outcomes related to inflammatory markers, cardiac enzymes, infarct size and cardiac function. Those outcome names indicate what was assessed, not what was observed. Numerical results for the listed secondary measures are not reported in the registry record. The safety counts therefore cannot be used to infer results for those outcomes or to characterize the overall efficacy findings.
The design was randomized and placebo-controlled, which is relevant to interpreting comparisons, but the posted counts do not include the statistical analysis needed to quantify uncertainty or account for the study’s analysis choices. The record does not report a prespecified comparison framework, adjustment for multiplicity, or confidence intervals for the safety counts. The appropriate reading is consequently limited: these are reported event counts in the specified safety groups and follow-up period, not conclusive evidence of comparative risk or treatment effect.
9. Statistical Methods Explained
Statistical interpretation starts by distinguishing a descriptive count from an estimate of a treatment contrast. A count states how many participants were recorded with an event. It does not, by itself, indicate how uncertain that observation is or whether a group difference is larger than might arise through sampling variation. The posted safety data give counts and group sizes, but the registry record does not report confidence intervals or a statistical test for the primary safety outcome.
What does a confidence interval add?
General statistical explanation: a confidence interval expresses the uncertainty around an estimated quantity using a range of values compatible with the data and the method used. A narrow interval indicates greater precision than a wide interval, while an interval that includes values representing little or no difference may leave substantial uncertainty about the direction or size of a contrast. No such intervals are reported for these safety comparisons, so their precision cannot be judged from the event counts alone.
Why do the denominators matter?
General statistical explanation: counts should be interpreted in relation to the number of participants at risk or assessed. A larger group can have more events even if its event frequency is not higher. The safety results include group denominators, so the reported counts can be read in their group context. No additional percentages or relative measures should be inferred from the counts without a defined analysis and its assumptions. The record does not report adjusted estimates for these outcomes.
The safety population is defined as randomized participants who took at least one dose of study medication. This definition describes who contributes to the safety analysis; it is not the same as an analysis of every randomized participant regardless of treatment received. The registry does not report whether participants with missing safety assessments were excluded, how missing information was handled, or whether follow-up differed across groups. Those details affect the interpretation of counts because participants must be observed for an event to have it recorded.
How should serious events be interpreted?
General statistical explanation: serious adverse events are classified by seriousness criteria, not necessarily by a judgment that the study treatment caused them. A report of an SAE therefore identifies an event meeting the definition, while attribution requires separate information. The registry definition explicitly permits AEs that are not considered related to the medicinal product. The posted counts do not report event-level causal assessments or adjusted comparisons.
Counts of deaths are also descriptive in the absence of detail about causes, timing, adjudication and the analysis plan. The registry reports 4 deaths for placebo, 4 for losmapimod 7.5 mg, 10 for losmapimod 15 mg followed by losmapimod 7.5 mg, and 14 for the combined A and B entry. The record does not report whether deaths were considered treatment-related, nor does it provide an inferential comparison for mortality. The combined entry should not be treated as a separate randomized arm because it combines the two active groups.
What do the planning illustrations mean?
General statistical explanation: sample-size planning uses assumptions about an effect, variability or event frequency, allocation and a chosen statistical procedure to illustrate how much information a future study might need. Such an illustration is not a measure of the probability that the completed study detected an effect. In this record, the planning description says the illustration is based on a fraction of the observed effect, uses a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. It also distinguishes participants per arm for most outcomes from total events for time-to-event outcomes.
Those assumptions are a planning illustration, not the trial’s documented design rationale. The record does not report the trial’s own sample-size justification or whether the design was based on the same assumptions. Planning figures should therefore be read as conditional illustrations and not as observed power or proof that an analysis was adequately powered.
The study has multiple outcomes and analyses. General statistical explanation: when many outcomes or comparisons are examined, the chance of finding at least one apparently notable result can increase unless the analysis plan accounts for multiplicity. The registry lists 21 outcome measures and 78 analyses, but does not report how hypotheses were prioritized, whether adjustments were planned, or which analyses were confirmatory. Without that information, nominal significance results, if available, would need cautious interpretation. Numerical results and tests for the listed secondary outcomes are not reported in the registry record.
Finally, randomized assignment and masking are important design features, but they do not substitute for a transparent analysis description. The registry records randomized allocation, quadruple masking and a parallel-group model. It does not report the precise statistical methods used for the primary safety outcome, handling of repeated measurements, covariate adjustment, or rules for excluding data. The posted counts are interpretable as descriptive safety summaries, while claims about comparative effects require methods and uncertainty measures that are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 21 outcome measures and 78 analyses. This breadth matters because a study that examines many outcomes, time points or contrasts can produce apparently notable findings by chance. General statistical explanation: multiplicity procedures can control or otherwise address the increased risk associated with testing many hypotheses. The registry record does not report whether any multiplicity adjustment was planned, which outcomes were designated as confirmatory beyond the listed primary safety outcome, or how the analyses were prioritized.
The primary outcome covers participants with AEs and SAEs through Week 14, while the listed secondary outcomes include inflammatory markers, cardiac enzymes, infarct size and measures of cardiac function at various times. Numerical results for those secondary outcomes are not reported in the registry record. The record also does not describe how missing measurements or incomplete follow-up were handled, including whether any imputation or sensitivity analyses were used.
The safety population is defined as randomized participants who took at least one dose of study medication. This is the stated analysis population for the safety outcome. The registry does not report an efficacy analysis population or whether efficacy analyses followed an intention-to-treat approach. Nor does it describe how participants who discontinued treatment, missed visits or lacked outcome measurements contributed to each analysis.
The study’s sample-size rationale, interim-analysis plan and detailed statistical analysis plan are not reported in the registry record. The planning description is explicitly an illustration based on the observed effect, not the trial’s own design. These omissions limit assessment of whether the reported analyses follow prespecified rules and how robust results would be to missing data or alternative analysis choices.
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 |
|---|---|---|---|
| Placebo (P) | 32 | 135 | 23.7% |
| Losmapimod 7.5 mg (A) | 51 | 199 | 25.6% |
| Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B) | 43 | 192 | 22.4% |
| A and B Comb (C) | 94 | 391 | 24.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo (P) | 4 of 135 |
| Losmapimod 7.5 mg (A) | 4 of 199 |
| Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B) | 10 of 192 |
| A and B Comb (C) | 14 of 391 |
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 |
|---|---|
| Placebo (P) | 52 of 135 |
| Losmapimod 7.5 mg (A) | 55 of 199 |
| Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B) | 49 of 192 |
| A and B Comb (C) | 104 of 391 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo (P) | Losmapimod 7.5 mg (A) | Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B) | A and B Comb (C) |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | 2 of 135 | 4 of 199 | 6 of 192 | 10 of 391 |
| Angina unstable | Cardiac disorders | 3 of 135 | 4 of 199 | 5 of 192 | 9 of 391 |
| Chest pain | General disorders | 3 of 135 | 4 of 199 | 4 of 192 | 8 of 391 |
| Myocardial infarction | Cardiac disorders | 7 of 135 | 4 of 199 | 1 of 192 | 5 of 391 |
| Angina pectoris | Cardiac disorders | 4 of 135 | 1 of 199 | 3 of 192 | 4 of 391 |
| Cardiac failure | Cardiac disorders | 0 of 135 | 2 of 199 | 4 of 192 | 6 of 391 |
| Atrial fibrillation | Cardiac disorders | 1 of 135 | 2 of 199 | 3 of 192 | 5 of 391 |
| Cardiogenic shock | Cardiac disorders | 1 of 135 | 2 of 199 | 2 of 192 | 4 of 391 |
| Cardiac failure congestive | Cardiac disorders | 0 of 135 | 2 of 199 | 1 of 192 | 3 of 391 |
| Cerebrovascular accident | Nervous system disorders | 0 of 135 | 1 of 199 | 2 of 192 | 3 of 391 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo (P) | Losmapimod 7.5 mg (A) | Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B) | A and B Comb (C) |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | 11 of 135 | 15 of 199 | 13 of 192 | 28 of 391 |
| Chest pain | General disorders | 7 of 135 | 13 of 199 | 9 of 192 | 22 of 391 |
| Dizziness | Nervous system disorders | 10 of 135 | 11 of 199 | 7 of 192 | 18 of 391 |
| Haematoma | Vascular disorders | 8 of 135 | 11 of 199 | 6 of 192 | 17 of 391 |
| Nausea | Gastrointestinal disorders | 8 of 135 | 7 of 199 | 4 of 192 | 11 of 391 |
| Fatigue | General disorders | 10 of 135 | 4 of 199 | 5 of 192 | 9 of 391 |
| Diarrhoea | Gastrointestinal disorders | 7 of 135 | 4 of 199 | 6 of 192 | 10 of 391 |
| Nasopharyngitis | Infections and infestations | 7 of 135 | 1 of 199 | 9 of 192 | 10 of 391 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 7 of 135 | 5 of 199 | 4 of 192 | 9 of 391 |
| Atrial fibrillation | Cardiac disorders | 7 of 135 | 3 of 199 | 5 of 192 | 8 of 391 |
Serious events with the highest arm-level rate: myocardial infarction (5.2%), acute myocardial infarction (3.1%), angina pectoris (3.0%), angina unstable (2.6%), chest pain (2.2%).
The registry reports serious adverse event counts, other adverse event counts and deaths for each safety group through the study’s safety follow-up. For placebo, the figures are 32 of 135 participants with a serious adverse event, 52 of 135 with another adverse event and 4 deaths. For losmapimod 7.5 mg, they are 51 of 199, 55 of 199 and 4 deaths. For losmapimod 15 mg followed by losmapimod 7.5 mg, they are 43 of 192, 49 of 192 and 10 deaths.
The combined A and B entry reports 94 of 391 participants with a serious adverse event, 104 of 391 with another adverse event and 14 deaths. It represents a combined registry group, not a separate randomized arm. The registry’s top serious-event terms include Myocardial infarction (5.2%), Acute myocardial infarction (3.1%), Angina pectoris (3.0%), Angina unstable (2.6%), Chest pain (2.2%) and Cardiac failure (2.1%). The basis for these percentages is not reported in the registry record.
These figures describe events recorded in the safety population; they do not establish treatment causation or a statistically reliable difference between groups. The record does not provide confidence intervals, tests of comparison, causes of death or treatment-relatedness assessments for these counts.
12. What the Result Does, and Does Not, Mean
The registry supports a limited, descriptive reading of the safety outcome. It reports participants with serious and other adverse events in the placebo and active-treatment groups, along with deaths. Those figures describe what was recorded in the defined safety population up to Week 14. They do not, on their own, estimate a causal treatment effect, quantify uncertainty or establish that one regimen has a different safety profile from another.
That distinction is important because an adverse event is defined by its occurrence in temporal association with medicinal product use, whether or not it is considered related to the product. Seriousness is classified using clinical criteria such as death, life-threatening events or hospitalization. Neither classification alone proves that the study medication caused the event. The registry does not report causal assessments for the listed counts.
The study’s randomized, double-blind, placebo-controlled design provides a framework for comparing assigned groups, but credible interpretation still depends on the prespecified analysis, complete outcome ascertainment and uncertainty measures. The statistical analysis plan, confidence intervals and inferential tests for this safety outcome are not reported in the registry record. Nor are numerical results for the named inflammatory, infarct-size or cardiac-function outcomes.
The trial therefore should not be read as demonstrating efficacy or lack of efficacy from the safety figures. Its registry record identifies those efficacy-related domains as secondary outcomes, but their numerical findings are not reported. Similarly, the count of deaths in a group is not a mortality comparison unless the analysis accounts for the follow-up, group size and statistical uncertainty. The record does not report causes of death or a mortality analysis.
The sound conclusion is bounded by what is posted: there are descriptive event counts for the stated safety groups and a list of frequently reported serious-event terms. The record does not support a definitive conclusion about comparative safety, treatment causation, or effects on inflammatory markers, infarct size or cardiac function.
13. Why This Trial Matters Statistically
This trial is statistically notable for the combination of a randomized, masked, placebo-controlled design and a safety outcome reported primarily as participant counts. Such counts are a direct way to describe the observed safety experience, but their meaning depends on group denominators, event definitions, follow-up and the analysis used to compare groups. The record gives some of that context, including the safety population and follow-up period, while leaving important inferential details unreported.
The three treatment groups also make it important to distinguish a randomized arm from a combined summary. The record reports a pooled A and B safety entry in addition to the separate placebo and active-regimen entries. That combined entry can summarize the active groups together, but it is not an additional randomized group. Careful reading prevents double-counting or misrepresenting the design.
The study lists many outcome measures and analyses, ranging from inflammatory markers to imaging and cardiac-function measures. This breadth raises a general statistical issue: interpretation across multiple endpoints depends on which comparisons were planned and how multiplicity was handled. Neither the detailed analysis plan nor numerical results for the listed secondary outcomes are reported in the registry record.
Finally, the trial’s planning description is explicitly an illustration based on the observed effect, not documentation of the original design rationale. Keeping planning illustrations separate from observed power avoids treating a post-study calculation as evidence about what the trial was designed to detect. Together, these points make the record useful for learning how to separate reported counts, analysis choices and conclusions that the available information can support.
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 registry record does not include a detailed statistical analysis plan for the primary safety outcome. It does not report the inferential tests, confidence intervals, adjustment methods or prespecified contrasts used to compare treatment groups. As a result, the posted event counts can be described, but their comparative precision and statistical interpretation cannot be assessed from the record.
The record defines the safety population as randomized participants who took at least one dose, but does not describe missing safety data, incomplete follow-up, discontinuations or sensitivity analyses. It also does not report whether the analysis accounted for differences in observation time. These omissions matter when interpreting event counts accumulated during follow-up.
Although death counts and serious-event terms are listed, causes of death, event-level adjudication and treatment-relatedness assessments are not reported in the registry record. The percentage basis for the listed serious-event terms is also not stated. The combined A and B safety entry is reported alongside separate arm entries, but the record does not explain its presentation or specify a formal pooled comparison.
The registry lists a substantial set of secondary outcomes, but numerical results for them are not reported. The multiplicity strategy, interim-analysis plan and trial-specific sample-size justification are not reported in the registry record. In addition, the intervention entries use the name GW856553 while the safety group labels use losmapimod; the record does not explain that terminology difference. These limitations restrict interpretation to the posted descriptions and counts rather than broader conclusions about comparative safety or efficacy.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Evaluate the Safety of 12 Weeks of Dosing With GW856553 and Its Effects on Inflammatory Markers, Infarct Size, and Cardiac Function in Subjects With Myocardial Infarction Without ST-segment Elevation — NCT00910962.
- Registry record last updated 2017-12-07; status last verified 2017-09.
- Results first posted 2017-10-27.
- 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
NCT00910962 is a completed phase 2 randomized, double-blind, placebo-controlled, parallel-group study of GW856553 in subjects with myocardial infarction without ST-segment elevation. The registry records quadruple masking and enrollment of 526. The brief summary describes up to approximately 525 subjects and an MRI substudy target of 90 subjects.
The study compared two GW856553 dosing regimens with placebo, with dosing for 12 weeks and the primary safety outcome assessed through Week 14. The primary outcome counted participants with adverse events and serious adverse events. The safety population included randomized participants who took at least one dose.
The record reports event counts for placebo, each active regimen and a combined active-group entry. It also lists inflammatory, cardiac-enzyme, imaging and cardiac-function outcomes, but their numerical results are not reported in the registry record. Detailed statistical methods, multiplicity handling, missing-data procedures and the trial’s sample-size rationale are also not reported.