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This is a randomized, double-blind, placebo-controlled, parallel group, multi-center study to evaluate initial safety and efficacy of GW856553 in subjects with NSTEMI. Up to approximately 525 subjects will be randomized to meet the MRI recruitment target (90 subjects in substudy.) All subjects will continue to receive the local standard of care for the duration of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | 7.5 mg GW856553 starting dose, followed 12 hours later by 7.5mg twice daily for 12 weeks |
|
| Treatment B | Experimental | 15 mg GW856553 starting dose, followed 12 hours later by 7.5mg twice daily for 12 weeks |
|
| Treatment C | Placebo Comparator | Placebo twice daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW856553 | Drug | 7.5 mg GW856553 starting dose, followed 12 hours later by 7.5mg BID |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE was any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. | Up to Week 14 |
| Number of Participants With Any Major Adverse Cardiovascular Events (MACE) | MACE was defined as all-cause death, adjudicated myocardial infarction, stroke/transient ischemic attack, heart failure or recurrent ischemia requiring urgent revascularization. | Up to Week 14 |
| Number of Participants With Any Pure MACE | Pure MACE was defined as all-cause death, adjudicated myocardial infarction or stroke/transient ischemic attack. | Up to Week 14 |
| Number of Participants With Hematology Data of Potential Clinical Importance (PCI) at Any Visit Post-Baseline | Hematology parameters (PCI range): Eosinophils (<0.045 or >0.605 Giga cells per liter [GI/L]), Hematocrit (<0.297 or >0.506 ratio), Hemoglobin (<85 or >200 grams per liter [g/L]), Lymphocytes (<0.765 or >4.51GI/L), Mean Corpuscle Hemoglobin (MCH) (<24.3 or >38.5 picograms [PG]), Mean Corpuscle Hemoglobin Concentration (MCHC) (<256 or >432 g/L), Mean Corpuscle Volume (MCV) (<70 or >115 femtoliter [FL]), Monocytes (<0.18 or >1.21 GI/L), Platelet count (<104 or >480 GI/L), Red Cell Distribution Width (RDW) (<7.2 or >18%), Red Blood Cell (RBC) count (<2.88 or >6.12 trillion per liter [TI/L] for females and <3.52 or >6.96 TI/L for males) , Reticulocytes (<22.5 or >93.5 10^9/L), Total Absolute Neutrophil Count (ANC) (<1.62 or >8.8 GI/L), White Blood Cell (WBC) count (<3.04 or >12 GI/L) were analyzed. The data was presented as High and low, at any visit post-Baseline. Only parameters with observed abnormal values were presented. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean hsCRP Over Hospitalization Period and Through Week 14 | Analysis of hsCRP included all participants who provided data at Baseline and at least one post-Baseline measure. The sample had a collection window of +/- 8 hours. Statistical analyses was performed to compare hsCRP levels between study drug and placebo. Log transformed ratio to Baseline hsCRP was analyzed using ANCOVA including a term for treatment, adjusting for Baseline hsCRP as a covariate, and accounting for other covariates as appropriate to the study design. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Anchorage | Alaska | 99508 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24930728 | Derived | Newby LK, Marber MS, Melloni C, Sarov-Blat L, Aberle LH, Aylward PE, Cai G, de Winter RJ, Hamm CW, Heitner JF, Kim R, Lerman A, Patel MR, Tanguay JF, Lepore JJ, Al-Khalidi HR, Sprecher DL, Granger CB; SOLSTICE Investigators. Losmapimod, a novel p38 mitogen-activated protein kinase inhibitor, in non-ST-segment elevation myocardial infarction: a randomised phase 2 trial. Lancet. 2014 Sep 27;384(9949):1187-95. doi: 10.1016/S0140-6736(14)60417-7. Epub 2014 Jun 12. | |
| 23137494 |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 111810 | Annotated Case Report Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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A total of 535 participants, with myocardial infarction without ST segment elevation, were randomized to the study of which 526 participants received at least one dose of study drug. The study was conducted at 83 centers, from 08 October 2009 to 06 March 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (P) | Eligible participants received matching placebo, orally twice daily for 12 weeks. |
| FG001 | Losmapimod 7.5 mg (A) | Eligible participants received oral losmapimod 7.5 milligrams (mg) starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| GW856553 |
| Drug |
15 mg GW856553 starting dose, followed 12 hours later by 7.5mg BID |
|
| Placebo | Drug | Placebo |
|
| Up to Week 14 |
| Number of Participants With Clinical Chemistry Data of PCI at Any Visit Post-Baseline | Clinical chemistry parameters (PCI range): Alanine Amino Transferase (ALT) (>=3x upper limit normal [ULN] units per liter [U/L]), Albumin (<25.6 or >60 g/L), Alkaline Phosphatase (>=2x ULN U/L), Aspartate Amino Transferase (AST) (>=3x ULN U/L), Calcium (<2.0776 or >2.6112 millimoles per liter [mmol/L]), Carbon dioxide content/Bicarbonate (CO2/HCO3) (<19.6 or >32.64 mmol/L), Chloride (<93.1 or >110.16 mmol/L), Creatinine (<39.6 or >136.4 micromole per liter [µmol/L]) , Glucose (<3.51 or >6.05 mmol/L), Potassium (<3.43 or >5.406 mmol/L), Sodium (<132.3 or >148.92 mmol/L), Total Bilirubin (T. bilirubin) (>=1.5xULN µmol/L) , Total Protein (<50 or >95 g/L), Urea/Blood urea nitrogen (BUN) (<2.25 or >11.55 mmol/L) and Uric acid (<135 or >495 µmol/L) were analyzed. The data was presented as High and low, at any visit post-Baseline. Only parameters with observed abnormal values were presented. | Up to Week 14 |
| Number of Participants With Liver Function Test Elevations at Any Time Post-Baseline | Liver function test parameters: Alanine aminotransferase (ALT), Total Bilirubin (T. Bilirubin), Aspartate aminotransferase (AST), Alkaline Phosphatase, Gamma glutamyl transferase (GGT) and Creatine Kinase were analyzed and presented as elevated test values at any time post-Baseline. The elevations were presented as >=2xULN, >=3xULN, >=5xULN, >=10xULN, and >=20xULN. n= number of participants with at least one non-missing result of the particular lab test post-Baseline. | Up to Week 14 |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Any Time Post-Baseline | A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT corrected (QTc) intervals. ECG findings were presented as Normal, Abnormal - Not clinically significant and Abnormal - Clinically significant at any time post-Baseline. | Up to Week 14 |
| Number of Participants With Vital Signs of PCI at Any Visit Post-Baseline | Vital signs (PCI range): Systolic blood pressure (SBP) (<75 and >200 millimeter of mercury [mmHg]), Diastolic blood pressure (DBP) (<40 and >120 mmHg) and Heart rate (<30 and >200 beats per minute [bpm]) were analyzed and were presented at any visit post-Baseline. Participants with both Normal and Low values were counted once under their worst case (Low). Participants with both Normal and High values were counted once under their worst case (High). Participants with both High and Low values were counted under both categories. All heart rate values were within normal range, hence not presented. | Up to Week 14 |
| Mean High-sensitive C-Reactive Protein (hsCRP) Value at Week 12 | Analysis of hsCRP included all participants who provided data at Baseline and at least one post-Baseline measure. Statistical analyses was performed to compare hsCRP levels between study drug and placebo. Log transformed ratio to Baseline hsCRP was analyzed using repeated measures analysis of covariance (ANCOVA) including a term for treatment, adjusting for Baseline hsCRP as a covariate, and accounting for other covariates as appropriate to the study design. | At Week 12 |
| Mean Cardiac Troponin I (cTnI) Area Under Concentration-time Curve (AUC) Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First) | cTnI AUC was the average concentration of cTnI during hospital stay. Statistical analyses was performed to compare cTnI levels between study drug and placebo, via ANCOVA. | At pre-dose and at 8, 16, 24, 32, 40, 48, 56, 64 and 72 hours |
| Up to Week 14 |
| Mean Interleukin-6 (IL-6) Value at 24 Hours Post-randomization and at Weeks 2 and 12 | Statistical analyses was performed to compare IL-6 levels between study drug and placebo. Log transformed ratio to Baseline IL-6 was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline IL-6 as a covariate, and accounting for other covariates as appropriate to the study design. | 24 hours post-randomization and at Weeks 2 and 12 |
| Mean Creatine Kinase (MB Isoenzyme) (CK-MB) AUC Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First) | Statistical analyses was performed to compare CK-MB levels between study drug and placebo. Log transformed ratio to Baseline CK-MB was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline CK-MB as a covariate, and accounting for other covariates as appropriate to the study design. | At pre-dose and at hours 8, 16, 24, 32, 40, 48, 56, 64 and 72 |
| Peak cTnI Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First) | Statistical analyses was performed to compare cTnI levels between study drug and placebo. Log transformed ratio to Baseline cTnI was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline cTnI as a covariate, and accounting for other covariates as appropriate to the study design. | Up to 72 hours |
| Mean Brain Natriuretic Peptide (BNP) at Discharge and Week 12 | Statistical analyses was performed to compare BNP levels between study drug and placebo. Log transformed ratio to Baseline BNP was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline BNP as a covariate, and accounting for other covariates as appropriate to the study design. | At discharge and Week 12 |
| Mean Infarct Size Prior to Discharge From Hospital (Approximately Day 3) and at Week 12 | Statistical analyses was performed to compare the infarct size (via MRI) at Week 12 via repeated measures ANOVA between study drug and placebo using Bayesian methods for inference. Myocardial infarct size was measured by delayed enhancement magnetic resonance imaging (MRI) as: Infarct size (% of left ventricular myocardium [% of LV]) for infarct 1. The infarct region 1 was the infarct region which the MRI interpretation process identified as the primary infarct region of the index hospitalization. Participants were included in the analyses, provided they have data for derivation of the measures of interest (MR infarct size). A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing. | Prior to discharge (visit 1) and at Week 12 |
| Mean Percent Left Ventricular Ejection Fraction (LVEF) at Week 12 | Statistical analyses of the treatment differences was performed to compare the LVEF (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing. | At Week 12 |
| Mean Left Ventricular End-diastolic Volume (LVEDV) and Left Ventricular End-systolic Volume (LVESV) at Week 12 | Statistical analyses of the treatment differences was performed to compare the LVEDV and LVESV (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing. | At Week 12 |
| Mean Left Ventricular Mass at Week 12 | Statistical analyses of the treatment differences was performed to compare the left ventricular mass (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo.Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing. | At Week 12 |
| Mean Regional Wall Motion Score Index at Week 12 | Wall motion score index is a semi-quantitative analysis of regional systolic function. Each segment is analyzed individually and scored on the basis of its motion and systolic thickening. This score is a 5-level score defines as: 1=normokinesis or hyperkinesis, 2=hypokinesi, 3=akinesis, 4=dyskinesis, 5=aneurysm. Wall motion score index is derived as a sum of all scores divided by the number of segments visualized. Larger score index indicates higher degree of abnormalities. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing. | At Week 12 |
| Mean Hyperenhancement Score Index at Week 12 | The myocardium was divided into 17 segments. A score ranging from 0 to 4 was visually attributed to each of the 17 segments according to the transmural extent of the hyperenhancement: score 0=0%, 1=>0-25%, 2=>25-50%, 3=>50-75% and 4=>75-100%. All these 17 scores were summed. The resulting summed score ranged in theory from 0 to 68 and was thereafter expressed as a percentage of the maximum possible score of 68, with higher percentages indicating hyper-enhancement in a greater percentage of the tissue in a greater number of segments. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing. Statistical analysis was performed on LS mean value using repeated measures ANCOVA. | At week 12 |
| Tucson |
| Arizona |
| 85724 |
| United States |
| GSK Investigational Site | Los Angeles | California | 90033 | United States |
| GSK Investigational Site | Mission Viejo | California | 92691 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32209 | United States |
| GSK Investigational Site | St. Petersburg | Florida | 33701 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30322 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46290 | United States |
| GSK Investigational Site | Iowa City | Iowa | 52242 | United States |
| GSK Investigational Site | Lexington | Kentucky | 40536-0284 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55407 | United States |
| GSK Investigational Site | Rochester | Minnesota | 55905 | United States |
| GSK Investigational Site | Brooklyn | New York | 11215 | United States |
| GSK Investigational Site | Stony Brook | New York | 11794 | United States |
| GSK Investigational Site | Durham | North Carolina | 27710 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27610 | United States |
| GSK Investigational Site | Elyria | Ohio | 44035 | United States |
| GSK Investigational Site | Allentown | Pennsylvania | 18103 | United States |
| GSK Investigational Site | Camp Hill | Pennsylvania | 17011 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19141 | United States |
| GSK Investigational Site | Rapid City | South Dakota | 57701 | United States |
| GSK Investigational Site | Knoxville | Tennessee | 37917 | United States |
| GSK Investigational Site | Oak Ridge | Tennessee | 37830 | United States |
| GSK Investigational Site | Amarillo | Texas | 79106 | United States |
| GSK Investigational Site | Austin | Texas | 78756 | United States |
| GSK Investigational Site | Dallas | Texas | 75216 | United States |
| GSK Investigational Site | Fort Worth | Texas | 76104 | United States |
| GSK Investigational Site | Round Rock | Texas | 78681 | United States |
| GSK Investigational Site | Victoria | Texas | 77901 | United States |
| GSK Investigational Site | Kogarah | New South Wales | 2217 | Australia |
| GSK Investigational Site | Liverpool | New South Wales | 2170 | Australia |
| GSK Investigational Site | Brisbane | Queensland | 4032 | Australia |
| GSK Investigational Site | Bedford Park | South Australia | 5042 | Australia |
| GSK Investigational Site | Woodville South | South Australia | 5011 | Australia |
| GSK Investigational Site | Launceston | Tasmania | 7250 | Australia |
| GSK Investigational Site | Fremantle | Western Australia | 6160 | Australia |
| GSK Investigational Site | Perth | Western Australia | 6000 | Australia |
| GSK Investigational Site | Calgary | Alberta | T2N 2T9 | Canada |
| GSK Investigational Site | Montreal | Quebec | H1T 1C8 | Canada |
| GSK Investigational Site | Sainte-Foy | Quebec | G1V 4G5 | Canada |
| GSK Investigational Site | Terrebonne | Quebec | J6V 2H2 | Canada |
| GSK Investigational Site | Bad Krozingen | Baden-Wurttemberg | 79189 | Germany |
| GSK Investigational Site | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| GSK Investigational Site | Rastatt | Baden-Wurttemberg | 76437 | Germany |
| GSK Investigational Site | Ulm | Baden-Wurttemberg | 89081 | Germany |
| GSK Investigational Site | Potsdam | Brandenburg | 14467 | Germany |
| GSK Investigational Site | Bad Nauheim | Hesse | 61231 | Germany |
| GSK Investigational Site | Darmstadt | Hesse | 64283 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60590 | Germany |
| GSK Investigational Site | Fulda | Hesse | 36043 | Germany |
| GSK Investigational Site | Limburg an der Lahn | Hesse | 65549 | Germany |
| GSK Investigational Site | Göttingen | Lower Saxony | 37075 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30625 | Germany |
| GSK Investigational Site | Oldenburg | Lower Saxony | 26133 | Germany |
| GSK Investigational Site | Aachen | North Rhine-Westphalia | 52074 | Germany |
| GSK Investigational Site | Bielefeld | North Rhine-Westphalia | 33604 | Germany |
| GSK Investigational Site | Bonn | North Rhine-Westphalia | 53127 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 51109 | Germany |
| GSK Investigational Site | Dortmund | North Rhine-Westphalia | 44137 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45138 | Germany |
| GSK Investigational Site | Leverkusen | North Rhine-Westphalia | 51375 | Germany |
| GSK Investigational Site | Neuss | North Rhine-Westphalia | 41464 | Germany |
| GSK Investigational Site | Wuppertal | North Rhine-Westphalia | 42117 | Germany |
| GSK Investigational Site | Worms | Rhineland-Palatinate | 67550 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01307 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04289 | Germany |
| GSK Investigational Site | Pirna | Saxony | 01796 | Germany |
| GSK Investigational Site | Halle | Saxony-Anhalt | 06120 | Germany |
| GSK Investigational Site | Magdeburg | Saxony-Anhalt | 39120 | Germany |
| GSK Investigational Site | Bad Berka | Thuringia | 99437 | Germany |
| GSK Investigational Site | Erfurt | Thuringia | 99089 | Germany |
| GSK Investigational Site | Berlin | 10117 | Germany |
| GSK Investigational Site | Berlin | 10249 | Germany |
| GSK Investigational Site | Berlin | 13353 | Germany |
| GSK Investigational Site | Berlin | 13509 | Germany |
| GSK Investigational Site | Berlin | 14165 | Germany |
| GSK Investigational Site | Hamburg | 20099 | Germany |
| GSK Investigational Site | Hamburg | 22291 | Germany |
| GSK Investigational Site | Ahmedabad | 380060 | India |
| GSK Investigational Site | Bangalore | 560052 | India |
| GSK Investigational Site | Bangalore | 560054 | India |
| GSK Investigational Site | Bangalore | 560099 | India |
| GSK Investigational Site | Calicut | 673002 | India |
| GSK Investigational Site | Pune | 411004 | India |
| GSK Investigational Site | Amsterdam | 1091 AC | Netherlands |
| GSK Investigational Site | Amsterdam | 1105 AZ | Netherlands |
| GSK Investigational Site | Arnhem | 6815 AD | Netherlands |
| GSK Investigational Site | Nieuwegein | 3435 CM | Netherlands |
| GSK Investigational Site | Tilburg | 5022 GC | Netherlands |
| GSK Investigational Site | Krakow | 30-901 | Poland |
| GSK Investigational Site | Krakow | 31-501 | Poland |
| GSK Investigational Site | Krakow | Poland |
| GSK Investigational Site | Radom | 26-617 | Poland |
| GSK Investigational Site | Warsaw | 04-628 | Poland |
| GSK Investigational Site | Alicante | 03010 | Spain |
| GSK Investigational Site | Barcelona | 08907 | Spain |
| GSK Investigational Site | Jerez (Cadiz) | 11047 | Spain |
| GSK Investigational Site | Málaga | 29010 | Spain |
| GSK Investigational Site | Santiago de Compostela | 15706 | Spain |
| GSK Investigational Site | Brighton, East Sussex | BN2 5BE | United Kingdom |
| GSK Investigational Site | Bristol | BS2 8HW | United Kingdom |
| GSK Investigational Site | Clydebank | G81 4HX | United Kingdom |
| GSK Investigational Site | Edinburgh | EH16 4SA | United Kingdom |
| GSK Investigational Site | Leicester | LE3 9QP | United Kingdom |
| GSK Investigational Site | London | SE1 7EH | United Kingdom |
| GSK Investigational Site | London | SE5 9RS | United Kingdom |
| GSK Investigational Site | Paddington, London | W2 1NY | United Kingdom |
| Derived |
| Melloni C, Sprecher DL, Sarov-Blat L, Patel MR, Heitner JF, Hamm CW, Aylward P, Tanguay JF, DeWinter RJ, Marber MS, Lerman A, Hasselblad V, Granger CB, Newby LK. The study of LoSmapimod treatment on inflammation and InfarCtSizE (SOLSTICE): design and rationale. Am Heart J. 2012 Nov;164(5):646-653.e3. doi: 10.1016/j.ahj.2012.07.030. Epub 2012 Oct 16. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111810 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111810 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111810 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111810 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111810 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111810 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG002 | Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B) | Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group). |
| COMPLETED |
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| NOT COMPLETED |
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The race of one participant each in treatment A and treatment B were unknown.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (P) | Eligible participants received matching placebo, orally twice daily for 12 weeks. |
| BG001 | Losmapimod 7.5 mg (A) | Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group). |
| BG002 | Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B) | Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE was any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. | Safety Population consisted of all participants randomized to treatment, who had taken at least one dose of study medication. | Posted | Count of Participants | Participants | Up to Week 14 |
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| Primary | Number of Participants With Any Major Adverse Cardiovascular Events (MACE) | MACE was defined as all-cause death, adjudicated myocardial infarction, stroke/transient ischemic attack, heart failure or recurrent ischemia requiring urgent revascularization. | Safety Population | Posted | Count of Participants | Participants | Up to Week 14 |
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| Primary | Number of Participants With Any Pure MACE | Pure MACE was defined as all-cause death, adjudicated myocardial infarction or stroke/transient ischemic attack. | Safety Population. | Posted | Count of Participants | Participants | Up to Week 14 |
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| Primary | Number of Participants With Hematology Data of Potential Clinical Importance (PCI) at Any Visit Post-Baseline | Hematology parameters (PCI range): Eosinophils (<0.045 or >0.605 Giga cells per liter [GI/L]), Hematocrit (<0.297 or >0.506 ratio), Hemoglobin (<85 or >200 grams per liter [g/L]), Lymphocytes (<0.765 or >4.51GI/L), Mean Corpuscle Hemoglobin (MCH) (<24.3 or >38.5 picograms [PG]), Mean Corpuscle Hemoglobin Concentration (MCHC) (<256 or >432 g/L), Mean Corpuscle Volume (MCV) (<70 or >115 femtoliter [FL]), Monocytes (<0.18 or >1.21 GI/L), Platelet count (<104 or >480 GI/L), Red Cell Distribution Width (RDW) (<7.2 or >18%), Red Blood Cell (RBC) count (<2.88 or >6.12 trillion per liter [TI/L] for females and <3.52 or >6.96 TI/L for males) , Reticulocytes (<22.5 or >93.5 10^9/L), Total Absolute Neutrophil Count (ANC) (<1.62 or >8.8 GI/L), White Blood Cell (WBC) count (<3.04 or >12 GI/L) were analyzed. The data was presented as High and low, at any visit post-Baseline. Only parameters with observed abnormal values were presented. | Safety Population. Number of participants with analyzable samples at the time of analysis were included. | Posted | Count of Participants | Participants | Up to Week 14 |
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| Primary | Number of Participants With Clinical Chemistry Data of PCI at Any Visit Post-Baseline | Clinical chemistry parameters (PCI range): Alanine Amino Transferase (ALT) (>=3x upper limit normal [ULN] units per liter [U/L]), Albumin (<25.6 or >60 g/L), Alkaline Phosphatase (>=2x ULN U/L), Aspartate Amino Transferase (AST) (>=3x ULN U/L), Calcium (<2.0776 or >2.6112 millimoles per liter [mmol/L]), Carbon dioxide content/Bicarbonate (CO2/HCO3) (<19.6 or >32.64 mmol/L), Chloride (<93.1 or >110.16 mmol/L), Creatinine (<39.6 or >136.4 micromole per liter [µmol/L]) , Glucose (<3.51 or >6.05 mmol/L), Potassium (<3.43 or >5.406 mmol/L), Sodium (<132.3 or >148.92 mmol/L), Total Bilirubin (T. bilirubin) (>=1.5xULN µmol/L) , Total Protein (<50 or >95 g/L), Urea/Blood urea nitrogen (BUN) (<2.25 or >11.55 mmol/L) and Uric acid (<135 or >495 µmol/L) were analyzed. The data was presented as High and low, at any visit post-Baseline. Only parameters with observed abnormal values were presented. | Safety Population. Number of participants with analyzable samples at the time of analysis were included. | Posted | Count of Participants | Participants | Up to Week 14 |
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| Primary | Number of Participants With Liver Function Test Elevations at Any Time Post-Baseline | Liver function test parameters: Alanine aminotransferase (ALT), Total Bilirubin (T. Bilirubin), Aspartate aminotransferase (AST), Alkaline Phosphatase, Gamma glutamyl transferase (GGT) and Creatine Kinase were analyzed and presented as elevated test values at any time post-Baseline. The elevations were presented as >=2xULN, >=3xULN, >=5xULN, >=10xULN, and >=20xULN. n= number of participants with at least one non-missing result of the particular lab test post-Baseline. | Safety Population. Number of participants with analyzable samples at the time of analysis were included. | Posted | Count of Participants | Participants | Up to Week 14 |
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| Primary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Any Time Post-Baseline | A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT corrected (QTc) intervals. ECG findings were presented as Normal, Abnormal - Not clinically significant and Abnormal - Clinically significant at any time post-Baseline. | Safety Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Count of Participants | Participants | Up to Week 14 |
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| Primary | Number of Participants With Vital Signs of PCI at Any Visit Post-Baseline | Vital signs (PCI range): Systolic blood pressure (SBP) (<75 and >200 millimeter of mercury [mmHg]), Diastolic blood pressure (DBP) (<40 and >120 mmHg) and Heart rate (<30 and >200 beats per minute [bpm]) were analyzed and were presented at any visit post-Baseline. Participants with both Normal and Low values were counted once under their worst case (Low). Participants with both Normal and High values were counted once under their worst case (High). Participants with both High and Low values were counted under both categories. All heart rate values were within normal range, hence not presented. | Safety Population. Number of participants with analyzable samples at the time of analysis were included. | Posted | Count of Participants | Participants | Up to Week 14 |
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| Primary | Mean High-sensitive C-Reactive Protein (hsCRP) Value at Week 12 | Analysis of hsCRP included all participants who provided data at Baseline and at least one post-Baseline measure. Statistical analyses was performed to compare hsCRP levels between study drug and placebo. Log transformed ratio to Baseline hsCRP was analyzed using repeated measures analysis of covariance (ANCOVA) including a term for treatment, adjusting for Baseline hsCRP as a covariate, and accounting for other covariates as appropriate to the study design. | Intent-to-treat (ITT) Population comprised all randomized participants who received at least one dose of study medication and at least one on treatment assessment. Only those participants with data available at Week 12 were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg per liter (mg/L) | At Week 12 |
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| Primary | Mean Cardiac Troponin I (cTnI) Area Under Concentration-time Curve (AUC) Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First) | cTnI AUC was the average concentration of cTnI during hospital stay. Statistical analyses was performed to compare cTnI levels between study drug and placebo, via ANCOVA. | ITT Population. Only those participants available at 72 hours were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | nonograms*hour per milliliter (ng*hr/mL) | At pre-dose and at 8, 16, 24, 32, 40, 48, 56, 64 and 72 hours |
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| Secondary | Mean hsCRP Over Hospitalization Period and Through Week 14 | Analysis of hsCRP included all participants who provided data at Baseline and at least one post-Baseline measure. The sample had a collection window of +/- 8 hours. Statistical analyses was performed to compare hsCRP levels between study drug and placebo. Log transformed ratio to Baseline hsCRP was analyzed using ANCOVA including a term for treatment, adjusting for Baseline hsCRP as a covariate, and accounting for other covariates as appropriate to the study design. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/L | Up to Week 14 |
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| Secondary | Mean Interleukin-6 (IL-6) Value at 24 Hours Post-randomization and at Weeks 2 and 12 | Statistical analyses was performed to compare IL-6 levels between study drug and placebo. Log transformed ratio to Baseline IL-6 was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline IL-6 as a covariate, and accounting for other covariates as appropriate to the study design. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | picograms per milliliter (pg/mL) | 24 hours post-randomization and at Weeks 2 and 12 |
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| Secondary | Mean Creatine Kinase (MB Isoenzyme) (CK-MB) AUC Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First) | Statistical analyses was performed to compare CK-MB levels between study drug and placebo. Log transformed ratio to Baseline CK-MB was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline CK-MB as a covariate, and accounting for other covariates as appropriate to the study design. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | At pre-dose and at hours 8, 16, 24, 32, 40, 48, 56, 64 and 72 |
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| Secondary | Peak cTnI Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First) | Statistical analyses was performed to compare cTnI levels between study drug and placebo. Log transformed ratio to Baseline cTnI was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline cTnI as a covariate, and accounting for other covariates as appropriate to the study design. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Up to 72 hours |
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| Secondary | Mean Brain Natriuretic Peptide (BNP) at Discharge and Week 12 | Statistical analyses was performed to compare BNP levels between study drug and placebo. Log transformed ratio to Baseline BNP was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline BNP as a covariate, and accounting for other covariates as appropriate to the study design. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | At discharge and Week 12 |
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| Secondary | Mean Infarct Size Prior to Discharge From Hospital (Approximately Day 3) and at Week 12 | Statistical analyses was performed to compare the infarct size (via MRI) at Week 12 via repeated measures ANOVA between study drug and placebo using Bayesian methods for inference. Myocardial infarct size was measured by delayed enhancement magnetic resonance imaging (MRI) as: Infarct size (% of left ventricular myocardium [% of LV]) for infarct 1. The infarct region 1 was the infarct region which the MRI interpretation process identified as the primary infarct region of the index hospitalization. Participants were included in the analyses, provided they have data for derivation of the measures of interest (MR infarct size). A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing. | MRI ITT Population was subset of participants in the ITT Population who had at least one MRI scan. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Percent of left ventricle | Prior to discharge (visit 1) and at Week 12 |
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| Secondary | Mean Percent Left Ventricular Ejection Fraction (LVEF) at Week 12 | Statistical analyses of the treatment differences was performed to compare the LVEF (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing. | MRI ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | Percent | At Week 12 |
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| Secondary | Mean Left Ventricular End-diastolic Volume (LVEDV) and Left Ventricular End-systolic Volume (LVESV) at Week 12 | Statistical analyses of the treatment differences was performed to compare the LVEDV and LVESV (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing. | MRI ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | mL | At Week 12 |
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| Secondary | Mean Left Ventricular Mass at Week 12 | Statistical analyses of the treatment differences was performed to compare the left ventricular mass (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo.Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing. | MRI ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | grams (gm) | At Week 12 |
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| Secondary | Mean Regional Wall Motion Score Index at Week 12 | Wall motion score index is a semi-quantitative analysis of regional systolic function. Each segment is analyzed individually and scored on the basis of its motion and systolic thickening. This score is a 5-level score defines as: 1=normokinesis or hyperkinesis, 2=hypokinesi, 3=akinesis, 4=dyskinesis, 5=aneurysm. Wall motion score index is derived as a sum of all scores divided by the number of segments visualized. Larger score index indicates higher degree of abnormalities. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing. | MRI ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | At Week 12 |
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| Secondary | Mean Hyperenhancement Score Index at Week 12 | The myocardium was divided into 17 segments. A score ranging from 0 to 4 was visually attributed to each of the 17 segments according to the transmural extent of the hyperenhancement: score 0=0%, 1=>0-25%, 2=>25-50%, 3=>50-75% and 4=>75-100%. All these 17 scores were summed. The resulting summed score ranged in theory from 0 to 68 and was thereafter expressed as a percentage of the maximum possible score of 68, with higher percentages indicating hyper-enhancement in a greater percentage of the tissue in a greater number of segments. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing. Statistical analysis was performed on LS mean value using repeated measures ANCOVA. | MRI ITT Population. Only those participants with data available at week 12 were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | At week 12 |
|
SAEs and nSAEs were collected from start of study medication up to Week 14.
SAEs and nSAEs were reported for safety Population which consisted of all participants randomized to treatment, who had taken at least one dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (P) | Eligible participants received matching placebo, orally twice daily for 12 weeks. | 4 | 135 | 32 | 135 | 52 | 135 |
| EG001 | Losmapimod 7.5 mg (A) | Eligible participants received oral losmapimod 7.5 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as non-loading dose group). | 4 | 199 | 51 | 199 | 55 | 199 |
| EG002 | Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B) | Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group). | 10 | 192 | 43 | 192 | 49 | 192 |
| EG003 | A and B Comb (C) | A combined data for eligible participants from arm A and arm B were presented. | 14 | 391 | 94 | 391 | 104 | 391 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dressler's syndrome | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Intracardiac thrombus | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ventricular asystole | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ventricular dysfunction | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Thrombosis in device | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Post procedural myocardial infarction | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| In-stent coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Postoperative thoracic procedure complication | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Arterial haemorrhage | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Arterial thrombosis limb | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Subclavian artery stenosis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Myeloproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Rectal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ischaemic hepatitis | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided
| ID | Term |
|---|---|
| C543534 | 6-(5-((cyclopropylamino)carbonyl)-3-fluoro-2-methylphenyl)-N-(2,2-dimethylprpyl)-3-pyridinecarboxamide |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Any SAE |
|
A combined data for eligible participants from arm A and arm B were presented.
|
|
|
|
|
|
| OG002 | Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B) | Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group). |
| OG003 | A and B Combined (C) | A combined data for eligible participants from arm A and arm B were presented. |
|
|
| OG002 | Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B) | Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group). |
| OG003 | A and B Combined (C) | A combined data for eligible participants from arm A and arm B were presented. |
|
|
| OG003 | A and B Combined (C) | A combined data for eligible participants from arm A and arm B were presented. |
|
|
| OG003 | A and B Combined (C) | A combined data for eligible participants from arm A and arm B were presented. |
|
|
Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group). |
| OG003 | A and B Combined (C) | A combined data for eligible participants from arm A and arm B were presented. |
|
|
Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group). |
| OG003 | A and B Combined (C) | A combined data for eligible participants from arm A and arm B were presented. |
|
|
|
| OG003 | A and B Combined (C) | A combined data for eligible participants from arm A and arm B were presented. |
|
|
|
| OG003 | A and B Combined (C) | A combined data for eligible participants from arm A and arm B were presented. |
|
|
|
| OG003 | A and B Combined (C) | A combined data for eligible participants from arm A and arm B were presented. |
|
|
|
| OG003 | A and B Combined (C) | A combined data for eligible participants from arm A and arm B were presented. |
|
|
|
| OG003 | A and B Combined (C) | A combined data for eligible participants from arm A and arm B were presented. |
|
|
|
| OG003 | A and B Combined (C) | A combined data for eligible participants from arm A and arm B were presented. |
|
|
|
| OG002 | Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B) | Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group). |
| OG003 | A and B Combined (C) | A combined data for eligible participants from arm A and arm B were presented. |
|
|
|
Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
| OG003 | A and B Combined (C) | A combined data for eligible participants from arm A and arm B were presented. |
|
|
|
Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group).
| OG003 | A and B Combined (C) | A combined data for eligible participants from arm A and arm B were presented. |
|
|
|
| OG003 | A and B Combined (C) | A combined data for eligible participants from arm A and arm B were presented. |
|
|
|
| OG002 | Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B) | Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group). |
| OG003 | A and B Combined (C) | A combined data for eligible participants from arm A and arm B were presented. |
|
|
|
| OG002 | Losmapimod 15 mg Followed by Losmapimod 7.5 mg (B) | Eligible participants received oral losmapimod 15 mg starting dose, followed 12+/-4 hours, later by losmapimod 7.5 mg twice daily maintenance dose for 12 weeks (referred to as loading dose group). |
| OG003 | A and B Combined (C) | A combined data for eligible participants from arm A and arm B were presented. |
|
|
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