Atherosclerosis
Conditions
Keywords
FDG-PET/CT, atherosclerosis
Brief summary
This study is being conducted to assess the potential anti-inflammatory effects of a 3-month treatment with GW856553, on the inflammatory activity within the aorta and carotid plaques, as assessed by FDG-PET/CT.
Interventions
DRUGLOSMAPIMOD 7.5 MG
GW856553 tablets (wet granulation formulation) are available as white, film coated, round, convex tablets manufactured using micronised GW856553X active substance. Tablets are available containing 7.5 mg of GW856553X and are packed into high-density polyethylene (HDPE) bottles.
DRUGPlacebo
Placebo tablets (wet granulation formulation) are available as white, film coated, round, convex tablets manufactured using micronised substance to visually match the active GW856553 tablets are also available. Tablets are packed into high-density polyethylene (HDPE) bottles.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
for Main Study: 1. Adult male and female subjects, between 50 and 80 years of age, inclusive, with a body weight \> 50 kg and body mass index (BMI) between 19 and 35 kg/m2 2. Subjects who have: * experienced a CV event (acute coronary syndrome, unstable angina, CABG, PCI, stroke, MI, TIA, carotid endarterectomy), but have been clinically stable for at least 6 months since that event, * or, have peripheral vascular disease (PVD), as indicated by * symptoms of claudication and either a positive imaging/treadmill test, or * reduced ankle branchial pressure index, * or, have a diagnosis of CAD corroborated by stress testing (exercise or pharmacological) or any other confirmed diagnosis of atherosclerotic arterial disease * Individuals who have experienced a CV event or have PVD will be given preference for enrolment in the study, if they also have one of the following: * metabolic syndrome, as defined by NCEP ATP III * Framingham score \> 20 * Current smokers (at least 1pack/day) * Well-controlled diabetes, defined for the purposes of this study as HbA1c \<= 8%, or fasting blood glucose \<= 126mg/dL (7mmol/L) 3. Subjects must be on a stable dose of statin for at least 3 months prior to first dose of study medication. Subjects must be capable of continuing statin therapy from screening until the final follow up visit. 4. Either carotid or aortic TBR ³ 1.6, as measured on FDG-PET/CT, signifying active inflammation. 5. AST and ALT \< 2xULN at screening; alkaline phosphatase and bilirubin \<= 1.5xULN at screening (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). 6. A signed and dated written informed consent prior to admission to the study 7. The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Exclusion criteria
for Main Study: 1. Any medical history or clinically relevant abnormality identified on the screening medical examination, vital sign measurement, 12-lead ECG recording and/or clinical laboratory examination that is deemed by the principal investigator and/or medical monitor to make the subject ineligible for inclusion because of a safety concern. 2. History of heart failure defined as NYHA class II - IV or those with known severe LV systolic dysfunction (EF\<30%) regardless of symptomatic status 3. Subjects with atrial fibrillation (AF) at screening will be excluded. 4. Insulin controlled Type 1 or Type 2 diabetics 5. Diabetics with fasting glucose \> 126mg/dL (7mmol/L) or HbAc1 levels \> 8%, at screening. \[note: fasting glucose to be checked again at first FDG-PET scan, and if glucose \> 11mmol/L at that visit, subject will be excluded from study\] 6. Positive pre-study hepatitis B surface antigen or positive hepatitis C antibody results within 3 months of screening. 7. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). 8. Renal impairment with creatinine clearance of \<40 ml/min at screening, or history of kidney transplant or history of contrast nephropathy. 9. Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with active chronic inflammation (e.g. Inflammatory Bowel Disease). 10. Subjects with chronic infections such as HIV, gingivitis, periodonitis, prostatitis, gastritis, and urinary tract infections, or any active diseases, including active tuberculosis or a history of active tuberculosis. 11. Subjects with any acute infection, symptoms suggestive of sinusitis, or significant trauma (burns, fractures) 12. History of malignancy within the past 5 years, other than non-melanoma skin cancer. 13. History of skeletal muscle myopathy or rhabdomyolysis 14. Previous exposure to GW856553. 15. Current use of steroids (inhaled or oral) 16. Subjects who have donated more than 500 mL of blood within 56 days prior to the study medication administration. 17. Participation in a clinical study where the subject has received a drug or new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of the drug (whichever is longer) prior to the first dose of study medication 18. History of alcohol/drug abuse or dependence within 12 months of the study 19. The subject has a three month prior history of regular alcohol consumption exceeding an average weekly intake of \>28 units (or an average daily intake of greater than 3 units) for males, or an average weekly intake of \> 21 units (or an average daily intake of greater than 2 units) for females. 1 unit is equivalent to a half-pint (284mL) of beer/lager; 25mL measure of spirits or 125mL of wine; or a positive alcohol breath test at the screening visit 20. A positive urine test for drugs of abuse (not related to known medications the subject is taking, e.g. codeine for pain management) or alcohol at screening or prior to study medication administration. 21. QTc interval \> 450 msec (using average value of triplicate ECGs) 22. Subjects will be excluded if they have participated in clinical research studies involving radiation in the past three years 23. Women must be of non-childbearing potential \[i.e. either postmenopausal or documented hysterectomy - tubal ligation is not sufficient\]. For the purposes of this study, post menopausal is defined as being amenorrhoeic for greater than 2 years with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms. Postmenopausal status will be confirmed by serum or urine FSH and oestradiol concentrations at screening, if appropriate. Surgical sterility will be defined as females who have had a hysterectomy and/or bilateral oophorectomy. 24. An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women; or an unwillingness of the subject to use a condom/spermicide in addition to having their female partner use another form of contraception such as an IUD, diaphragm with spermicide, injectable progesterone, sub-dermal implants or a tubal ligation if the women could become pregnant from the time of the first dose of the study medication until 3 months after administration of last dose of study medication. Inclusion Criteria for Subjects in MRI Sub-study 1\. Recent (in approximately last 12 months) echocardiogram with ejection fraction between 30 and 50%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline of Mean of Maximum Tissue to Background Ratio (TBR) in the Qualifying Artery, Following 12 Weeks of Treatment in the Setting of Chronic Statin Therapy | Baseline (Days -14 to -1) and up to Week 12 | Qualifying artery was defined as the artery (left or right carotid or ascending aorta) with the highest segmental mean of maximum (max) TBR at Baseline. The TBR of the qualifying segment was to be ≥ 1.6. If more than one artery qualified, the hottest (greatest mean of max TBR) artery was the qualifying artery. Baseline was defined as the value between Days -14 to -1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-treatment values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Baseline (Day 1) and Days 7, 14, 21, 28, 42, 56, 70, 84 | CRP is a protein that the liver makes when there is inflammation in the body. It's also called a marker of inflammation, and can be measured with an hs-CRP test. Blood samples were collected to analyze hs-CRP. Baseline was defined as the value on Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-treatment values. |
| Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98 | Blood pressure measurements were taken to observe vital signs and included SBP and DBP. SBP and DBP measurements were obtained at Day 1, 7, 14, 21, 28, 42, 56, 70, 84 and follow-up (1-2 weeks post last dose on Day 84). |
| Mean Heart Rate at Indicated Time Points | Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98 | Vital sign monitoring included heart rate measurement. Heart rate measurements were obtained at Day 1, 7, 14, 21, 28, 42, 56, 70, 84 and follow-up (1-2 weeks post last dose on Day 84). |
| Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Days 1, 7, 14, 21, 28, 42, 56, 70, 84, 98 | All 12-lead ECGs were obtained after the participant had rested in the supine position for at least 15 minutes. All ECGs were evaluated by the principal investigator or designee for any other abnormality of potential clinical importance (PCI). Data for abnormal ECG findings have been reported under abnormal - Not clinically significant (NCS) and Abnormal - Clinically significant (CS) categories. Data only for categories with values have been presented. |
| Change From Baseline of the 'Most Diseased Segment (MSD)' Average Maximum TBR in the Qualifying Artery Following 12 Weeks of Treatment With GW856553 or Placebo in the Setting of Chronic Statin Therapy | Baseline (Days -14 to -1) and up to Week 12 | Most diseased segment (MDS) mean of max TBR was mean of all the slice max TBR that compose the most diseased segment. TBR was derived by dividing the arterial vessel wall SUV (tissue) by the background venous blood pool SUV. Unless noted otherwise, the tissue max SUV value for each ROI was used as inputs to the TBR. Baseline was defined as the value between Days -14 to -1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-treatment values. |
| Number of Participants With Hematology Abnormalities of PCI | Up to Follow-up (Day 98) | Hematology range for PCI was: white blood cell count (WBC) low \< 1.1 x109/ L; hemoglobin low \<71 (age: 18-99) grams per litre (g/L), high \>199 (age: 18-99) g/L; hematocrit low 0.201 (age: 18-99) ratio of 1 high 0.599 (age: 18-99) ratio of 1 and platelet count low \< 80 x109/ L, high \> 500 x109/ L. Categories with values have been presented. |
| Number of Participants With Urinalysis Dipstick Results | Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98 | A urine dipstick test is a basic diagnostic tool used to determine pathological changes in a participant's urine in standard urinalysis. Data was analyzed for urine occult blood, urine glucose, urine ketones and urine protein ranging from 2+, trace, 1+, 3+, 1+or 1/4, 3+ or 1 and trace or 1/10, indicating proportional concentrations in the urine sample. Data has been presented for categories with values for positive findings. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Follow-up (Day 98) | An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. |
| Number of Participants With Clinical Chemistry Abnormalities of PCI | Up to Follow-up (Day 98) | Clinical chemistry range for PCI was calcium low \<1.5 mill mole per litre (mmol/L), high \> 3.24 mmol/L; creatinine high 155 mmol/L; glucose low \< 2.2 (age: 13-99) mmol/L, high \> 27.8 (age: 13-99) mmol/L; phosphorus low \< 2.8 mmol/L, high \> 6.5 mmol/L; sodium low \< 125 mmol/L, high \> 150 mmol/L. Categories with values have been presented. |
Countries
United Kingdom
Participant flow
Recruitment details
Participants with established atherosclerosis were planned to be enrolled across 4 sites in the United Kingdom from 02 June 2008 to 03 December 2009. Participants were screened within 45 days prior to the first dose and underwent radiological scan within 14 days prior to the first dose.
Pre-assignment details
Participants were randomized in the study to receive oral dose of Losmapimod 7.5 milligram (mg) twice daily, Losmapimod 7.5 mg once daily or placebo.
Participants by arm
| Arm | Count |
|---|---|
| Losmapimod 7.5 mg Twice Daily Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks. | 34 |
| Losmapimod 7.5 mg Once Daily Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks. | 33 |
| Placebo Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks. | 32 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 5 |
| Overall Study | Physician Decision | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Losmapimod 7.5 mg Twice Daily | Losmapimod 7.5 mg Once Daily | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 62.3 Years STANDARD_DEVIATION 5.9 | 65.3 Years STANDARD_DEVIATION 5.94 | 63.7 Years STANDARD_DEVIATION 6.37 | 63.8 Years STANDARD_DEVIATION 6.13 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 30 Participants | 30 Participants | 92 Participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 4 Participants | 14 Participants |
| Sex: Female, Male Male | 29 Participants | 28 Participants | 28 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 33 | 1 / 32 |
| other Total, other adverse events | 25 / 34 | 24 / 33 | 28 / 32 |
| serious Total, serious adverse events | 4 / 34 | 1 / 33 | 3 / 32 |
Outcome results
Primary
Change From Baseline of Mean of Maximum Tissue to Background Ratio (TBR) in the Qualifying Artery, Following 12 Weeks of Treatment in the Setting of Chronic Statin Therapy
Qualifying artery was defined as the artery (left or right carotid or ascending aorta) with the highest segmental mean of maximum (max) TBR at Baseline. The TBR of the qualifying segment was to be ≥ 1.6. If more than one artery qualified, the hottest (greatest mean of max TBR) artery was the qualifying artery. Baseline was defined as the value between Days -14 to -1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-treatment values.
Time frame: Baseline (Days -14 to -1) and up to Week 12
Population: Pharmacodynamic (PD) Population comprised of all participants who provided PD data. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Losmapimod 7.5 mg Twice Daily | Change From Baseline of Mean of Maximum Tissue to Background Ratio (TBR) in the Qualifying Artery, Following 12 Weeks of Treatment in the Setting of Chronic Statin Therapy | -0.146 Maximum tissue to background ratio | Standard Deviation 0.2483 |
| Losmapimod 7.5 mg Once Daily | Change From Baseline of Mean of Maximum Tissue to Background Ratio (TBR) in the Qualifying Artery, Following 12 Weeks of Treatment in the Setting of Chronic Statin Therapy | -0.122 Maximum tissue to background ratio | Standard Deviation 0.1839 |
| Placebo | Change From Baseline of Mean of Maximum Tissue to Background Ratio (TBR) in the Qualifying Artery, Following 12 Weeks of Treatment in the Setting of Chronic Statin Therapy | -0.070 Maximum tissue to background ratio | Standard Deviation 0.1632 |
Comparison: Losmapimod 7.5 mg BID versus Placebop-value: 0.451995% CI: [-0.14, 0.06]ANCOVA
Comparison: Losmapimod 7.5 mg once daily versus Placebop-value: 0.578995% CI: [-0.11, 0.06]ANCOVA
Secondary
Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP)
CRP is a protein that the liver makes when there is inflammation in the body. It's also called a marker of inflammation, and can be measured with an hs-CRP test. Blood samples were collected to analyze hs-CRP. Baseline was defined as the value on Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-treatment values.
Time frame: Baseline (Day 1) and Days 7, 14, 21, 28, 42, 56, 70, 84
Population: PD Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Losmapimod 7.5 mg Twice Daily | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 7 | -2.293 milligram per litre (mg/L) | Standard Deviation 6.0389 |
| Losmapimod 7.5 mg Twice Daily | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 14 | -0.756 milligram per litre (mg/L) | Standard Deviation 4.8068 |
| Losmapimod 7.5 mg Twice Daily | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 21 | -2.250 milligram per litre (mg/L) | Standard Deviation 5.9883 |
| Losmapimod 7.5 mg Twice Daily | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 28 | -1.394 milligram per litre (mg/L) | Standard Deviation 3.9276 |
| Losmapimod 7.5 mg Twice Daily | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 56 | 0.012 milligram per litre (mg/L) | Standard Deviation 6.0287 |
| Losmapimod 7.5 mg Twice Daily | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 70 | 1.313 milligram per litre (mg/L) | Standard Deviation 2.8216 |
| Losmapimod 7.5 mg Twice Daily | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 84 | -0.100 milligram per litre (mg/L) | Standard Deviation 1.5281 |
| Losmapimod 7.5 mg Twice Daily | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 42 | -0.085 milligram per litre (mg/L) | Standard Deviation 10.3631 |
| Losmapimod 7.5 mg Once Daily | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 42 | -0.145 milligram per litre (mg/L) | Standard Deviation 0.6186 |
| Losmapimod 7.5 mg Once Daily | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 7 | -0.446 milligram per litre (mg/L) | Standard Deviation 0.5547 |
| Losmapimod 7.5 mg Once Daily | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 84 | 1.452 milligram per litre (mg/L) | Standard Deviation 5.3392 |
| Losmapimod 7.5 mg Once Daily | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 70 | 0.086 milligram per litre (mg/L) | Standard Deviation 0.9118 |
| Losmapimod 7.5 mg Once Daily | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 14 | -0.617 milligram per litre (mg/L) | Standard Deviation 2.08 |
| Losmapimod 7.5 mg Once Daily | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 56 | 0.077 milligram per litre (mg/L) | Standard Deviation 4.6724 |
| Losmapimod 7.5 mg Once Daily | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 28 | 1.953 milligram per litre (mg/L) | Standard Deviation 13.6807 |
| Losmapimod 7.5 mg Once Daily | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 21 | 0.130 milligram per litre (mg/L) | Standard Deviation 1.1586 |
| Placebo | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 84 | -0.313 milligram per litre (mg/L) | Standard Deviation 1.9369 |
| Placebo | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 28 | 0.197 milligram per litre (mg/L) | Standard Deviation 3.7474 |
| Placebo | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 42 | -0.009 milligram per litre (mg/L) | Standard Deviation 0.8105 |
| Placebo | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 56 | 0.563 milligram per litre (mg/L) | Standard Deviation 5.027 |
| Placebo | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 21 | 0.242 milligram per litre (mg/L) | Standard Deviation 1.3125 |
| Placebo | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 7 | 0.079 milligram per litre (mg/L) | Standard Deviation 0.6886 |
| Placebo | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 14 | -0.352 milligram per litre (mg/L) | Standard Deviation 1.9871 |
| Placebo | Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP) | Day 70 | -0.657 milligram per litre (mg/L) | Standard Deviation 1.3011 |
Secondary
Change From Baseline of the 'Most Diseased Segment (MSD)' Average Maximum TBR in the Qualifying Artery Following 12 Weeks of Treatment With GW856553 or Placebo in the Setting of Chronic Statin Therapy
Most diseased segment (MDS) mean of max TBR was mean of all the slice max TBR that compose the most diseased segment. TBR was derived by dividing the arterial vessel wall SUV (tissue) by the background venous blood pool SUV. Unless noted otherwise, the tissue max SUV value for each ROI was used as inputs to the TBR. Baseline was defined as the value between Days -14 to -1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-treatment values.
Time frame: Baseline (Days -14 to -1) and up to Week 12
Population: PD Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Losmapimod 7.5 mg Twice Daily | Change From Baseline of the 'Most Diseased Segment (MSD)' Average Maximum TBR in the Qualifying Artery Following 12 Weeks of Treatment With GW856553 or Placebo in the Setting of Chronic Statin Therapy | -0.294 Ratio | Standard Deviation 0.3169 |
| Losmapimod 7.5 mg Once Daily | Change From Baseline of the 'Most Diseased Segment (MSD)' Average Maximum TBR in the Qualifying Artery Following 12 Weeks of Treatment With GW856553 or Placebo in the Setting of Chronic Statin Therapy | -0.250 Ratio | Standard Deviation 0.2892 |
| Placebo | Change From Baseline of the 'Most Diseased Segment (MSD)' Average Maximum TBR in the Qualifying Artery Following 12 Weeks of Treatment With GW856553 or Placebo in the Setting of Chronic Statin Therapy | -0.221 Ratio | Standard Deviation 0.2132 |
Comparison: Losmapimod 7.5 mg twice daily versus placebop-value: 0.698695% CI: [-0.15, 0.1]ANCOVA
Comparison: Losmapimod 7.5 mg once daily versus Placebop-value: 0.948695% CI: [-0.13, 0.12]ANCOVA
Secondary
Mean Heart Rate at Indicated Time Points
Vital sign monitoring included heart rate measurement. Heart rate measurements were obtained at Day 1, 7, 14, 21, 28, 42, 56, 70, 84 and follow-up (1-2 weeks post last dose on Day 84).
Time frame: Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Losmapimod 7.5 mg Twice Daily | Mean Heart Rate at Indicated Time Points | Heart rate: Day 56 | 58.6 beats per minute (bpm) | Standard Deviation 11.48 |
| Losmapimod 7.5 mg Twice Daily | Mean Heart Rate at Indicated Time Points | Heart rate: Day 14 | 57.7 beats per minute (bpm) | Standard Deviation 11.8 |
| Losmapimod 7.5 mg Twice Daily | Mean Heart Rate at Indicated Time Points | Heart rate: Day 70 | 57.3 beats per minute (bpm) | Standard Deviation 7.67 |
| Losmapimod 7.5 mg Twice Daily | Mean Heart Rate at Indicated Time Points | Heart rate: Day 84 | 58.7 beats per minute (bpm) | Standard Deviation 12.07 |
| Losmapimod 7.5 mg Twice Daily | Mean Heart Rate at Indicated Time Points | Heart rate: Day 98 | 61.5 beats per minute (bpm) | Standard Deviation 12.09 |
| Losmapimod 7.5 mg Twice Daily | Mean Heart Rate at Indicated Time Points | Heart rate: Day 1 | 57.6 beats per minute (bpm) | Standard Deviation 11.39 |
| Losmapimod 7.5 mg Twice Daily | Mean Heart Rate at Indicated Time Points | Heart rate: Day 21 | 63.9 beats per minute (bpm) | Standard Deviation 12.44 |
| Losmapimod 7.5 mg Twice Daily | Mean Heart Rate at Indicated Time Points | Heart rate: Day 7 | 60.8 beats per minute (bpm) | Standard Deviation 13.97 |
| Losmapimod 7.5 mg Twice Daily | Mean Heart Rate at Indicated Time Points | Heart rate: Day 28 | 58.7 beats per minute (bpm) | Standard Deviation 12.25 |
| Losmapimod 7.5 mg Twice Daily | Mean Heart Rate at Indicated Time Points | Heart rate: Day 42 | 60.1 beats per minute (bpm) | Standard Deviation 9.31 |
| Losmapimod 7.5 mg Once Daily | Mean Heart Rate at Indicated Time Points | Heart rate: Day 56 | 56.1 beats per minute (bpm) | Standard Deviation 10.12 |
| Losmapimod 7.5 mg Once Daily | Mean Heart Rate at Indicated Time Points | Heart rate: Day 21 | 54.3 beats per minute (bpm) | Standard Deviation 6.59 |
| Losmapimod 7.5 mg Once Daily | Mean Heart Rate at Indicated Time Points | Heart rate: Day 42 | 52.1 beats per minute (bpm) | Standard Deviation 6.46 |
| Losmapimod 7.5 mg Once Daily | Mean Heart Rate at Indicated Time Points | Heart rate: Day 70 | 53.8 beats per minute (bpm) | Standard Deviation 5.26 |
| Losmapimod 7.5 mg Once Daily | Mean Heart Rate at Indicated Time Points | Heart rate: Day 14 | 56.7 beats per minute (bpm) | Standard Deviation 7.66 |
| Losmapimod 7.5 mg Once Daily | Mean Heart Rate at Indicated Time Points | Heart rate: Day 1 | 56.3 beats per minute (bpm) | Standard Deviation 9.84 |
| Losmapimod 7.5 mg Once Daily | Mean Heart Rate at Indicated Time Points | Heart rate: Day 84 | 59.2 beats per minute (bpm) | Standard Deviation 10.35 |
| Losmapimod 7.5 mg Once Daily | Mean Heart Rate at Indicated Time Points | Heart rate: Day 28 | 56.4 beats per minute (bpm) | Standard Deviation 9.17 |
| Losmapimod 7.5 mg Once Daily | Mean Heart Rate at Indicated Time Points | Heart rate: Day 98 | 58.2 beats per minute (bpm) | Standard Deviation 9 |
| Losmapimod 7.5 mg Once Daily | Mean Heart Rate at Indicated Time Points | Heart rate: Day 7 | 52.5 beats per minute (bpm) | Standard Deviation 6.81 |
| Placebo | Mean Heart Rate at Indicated Time Points | Heart rate: Day 98 | 56.1 beats per minute (bpm) | Standard Deviation 9.76 |
| Placebo | Mean Heart Rate at Indicated Time Points | Heart rate: Day 1 | 56.5 beats per minute (bpm) | Standard Deviation 9.79 |
| Placebo | Mean Heart Rate at Indicated Time Points | Heart rate: Day 7 | 54.6 beats per minute (bpm) | Standard Deviation 6.11 |
| Placebo | Mean Heart Rate at Indicated Time Points | Heart rate: Day 14 | 55.4 beats per minute (bpm) | Standard Deviation 10.32 |
| Placebo | Mean Heart Rate at Indicated Time Points | Heart rate: Day 21 | 54.8 beats per minute (bpm) | Standard Deviation 8.97 |
| Placebo | Mean Heart Rate at Indicated Time Points | Heart rate: Day 28 | 57.2 beats per minute (bpm) | Standard Deviation 10.91 |
| Placebo | Mean Heart Rate at Indicated Time Points | Heart rate: Day 42 | 56.8 beats per minute (bpm) | Standard Deviation 10.8 |
| Placebo | Mean Heart Rate at Indicated Time Points | Heart rate: Day 56 | 56.5 beats per minute (bpm) | Standard Deviation 10.73 |
| Placebo | Mean Heart Rate at Indicated Time Points | Heart rate: Day 70 | 54.3 beats per minute (bpm) | Standard Deviation 9.52 |
| Placebo | Mean Heart Rate at Indicated Time Points | Heart rate: Day 84 | 55.8 beats per minute (bpm) | Standard Deviation 11.53 |
Secondary
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
Blood pressure measurements were taken to observe vital signs and included SBP and DBP. SBP and DBP measurements were obtained at Day 1, 7, 14, 21, 28, 42, 56, 70, 84 and follow-up (1-2 weeks post last dose on Day 84).
Time frame: Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98
Population: Safety Population comprised of all participants who received at least one dose of study drug. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Losmapimod 7.5 mg Twice Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 28 | 131.7 millimeter of mercury (mm/Hg) | Standard Deviation 21.94 |
| Losmapimod 7.5 mg Twice Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 70 | 76.3 millimeter of mercury (mm/Hg) | Standard Deviation 4.54 |
| Losmapimod 7.5 mg Twice Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 1 | 78.9 millimeter of mercury (mm/Hg) | Standard Deviation 8.67 |
| Losmapimod 7.5 mg Twice Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 21 | 136.9 millimeter of mercury (mm/Hg) | Standard Deviation 15.12 |
| Losmapimod 7.5 mg Twice Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 84 | 75.6 millimeter of mercury (mm/Hg) | Standard Deviation 8.68 |
| Losmapimod 7.5 mg Twice Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 21 | 77.9 millimeter of mercury (mm/Hg) | Standard Deviation 8.44 |
| Losmapimod 7.5 mg Twice Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 14 | 128.2 millimeter of mercury (mm/Hg) | Standard Deviation 17.08 |
| Losmapimod 7.5 mg Twice Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 98 | 78.0 millimeter of mercury (mm/Hg) | Standard Deviation 9.81 |
| Losmapimod 7.5 mg Twice Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 98 | 131.2 millimeter of mercury (mm/Hg) | Standard Deviation 18.06 |
| Losmapimod 7.5 mg Twice Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 7 | 132.4 millimeter of mercury (mm/Hg) | Standard Deviation 19.4 |
| Losmapimod 7.5 mg Twice Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 1 | 134.9 millimeter of mercury (mm/Hg) | Standard Deviation 16.67 |
| Losmapimod 7.5 mg Twice Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 70 | 136.3 millimeter of mercury (mm/Hg) | Standard Deviation 11.46 |
| Losmapimod 7.5 mg Twice Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 28 | 77.4 millimeter of mercury (mm/Hg) | Standard Deviation 9.64 |
| Losmapimod 7.5 mg Twice Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 84 | 129.5 millimeter of mercury (mm/Hg) | Standard Deviation 17.78 |
| Losmapimod 7.5 mg Twice Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 56 | 130.1 millimeter of mercury (mm/Hg) | Standard Deviation 17.88 |
| Losmapimod 7.5 mg Twice Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 42 | 80.6 millimeter of mercury (mm/Hg) | Standard Deviation 11.12 |
| Losmapimod 7.5 mg Twice Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 14 | 76.6 millimeter of mercury (mm/Hg) | Standard Deviation 9.01 |
| Losmapimod 7.5 mg Twice Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 42 | 140.7 millimeter of mercury (mm/Hg) | Standard Deviation 19.78 |
| Losmapimod 7.5 mg Twice Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 56 | 77.5 millimeter of mercury (mm/Hg) | Standard Deviation 10.95 |
| Losmapimod 7.5 mg Twice Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 7 | 79.4 millimeter of mercury (mm/Hg) | Standard Deviation 8 |
| Losmapimod 7.5 mg Once Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 70 | 122.8 millimeter of mercury (mm/Hg) | Standard Deviation 14.56 |
| Losmapimod 7.5 mg Once Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 1 | 76.7 millimeter of mercury (mm/Hg) | Standard Deviation 11.08 |
| Losmapimod 7.5 mg Once Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 7 | 73.6 millimeter of mercury (mm/Hg) | Standard Deviation 11.04 |
| Losmapimod 7.5 mg Once Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 14 | 76.1 millimeter of mercury (mm/Hg) | Standard Deviation 10.55 |
| Losmapimod 7.5 mg Once Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 21 | 73.8 millimeter of mercury (mm/Hg) | Standard Deviation 12.05 |
| Losmapimod 7.5 mg Once Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 28 | 76.5 millimeter of mercury (mm/Hg) | Standard Deviation 9.63 |
| Losmapimod 7.5 mg Once Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 42 | 72.8 millimeter of mercury (mm/Hg) | Standard Deviation 8.96 |
| Losmapimod 7.5 mg Once Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 56 | 75.7 millimeter of mercury (mm/Hg) | Standard Deviation 9.09 |
| Losmapimod 7.5 mg Once Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 70 | 73.8 millimeter of mercury (mm/Hg) | Standard Deviation 10.71 |
| Losmapimod 7.5 mg Once Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 84 | 75.4 millimeter of mercury (mm/Hg) | Standard Deviation 9.51 |
| Losmapimod 7.5 mg Once Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 98 | 76.6 millimeter of mercury (mm/Hg) | Standard Deviation 10.58 |
| Losmapimod 7.5 mg Once Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 1 | 132.6 millimeter of mercury (mm/Hg) | Standard Deviation 16 |
| Losmapimod 7.5 mg Once Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 7 | 123.1 millimeter of mercury (mm/Hg) | Standard Deviation 13.58 |
| Losmapimod 7.5 mg Once Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 14 | 133.3 millimeter of mercury (mm/Hg) | Standard Deviation 19.05 |
| Losmapimod 7.5 mg Once Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 21 | 132.8 millimeter of mercury (mm/Hg) | Standard Deviation 20.8 |
| Losmapimod 7.5 mg Once Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 28 | 132.3 millimeter of mercury (mm/Hg) | Standard Deviation 17.79 |
| Losmapimod 7.5 mg Once Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 42 | 126.5 millimeter of mercury (mm/Hg) | Standard Deviation 17.94 |
| Losmapimod 7.5 mg Once Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 56 | 130.5 millimeter of mercury (mm/Hg) | Standard Deviation 16.91 |
| Losmapimod 7.5 mg Once Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 84 | 128.1 millimeter of mercury (mm/Hg) | Standard Deviation 14.32 |
| Losmapimod 7.5 mg Once Daily | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 98 | 130.9 millimeter of mercury (mm/Hg) | Standard Deviation 17.61 |
| Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 7 | 73.9 millimeter of mercury (mm/Hg) | Standard Deviation 6.81 |
| Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 21 | 126.6 millimeter of mercury (mm/Hg) | Standard Deviation 15.76 |
| Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 56 | 75.9 millimeter of mercury (mm/Hg) | Standard Deviation 7.5 |
| Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 98 | 125.1 millimeter of mercury (mm/Hg) | Standard Deviation 15.87 |
| Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 28 | 128.5 millimeter of mercury (mm/Hg) | Standard Deviation 18.76 |
| Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 42 | 74.6 millimeter of mercury (mm/Hg) | Standard Deviation 7.94 |
| Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 84 | 126.4 millimeter of mercury (mm/Hg) | Standard Deviation 19.84 |
| Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 42 | 128.3 millimeter of mercury (mm/Hg) | Standard Deviation 20.1 |
| Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 28 | 76.4 millimeter of mercury (mm/Hg) | Standard Deviation 8.96 |
| Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 1 | 75.8 millimeter of mercury (mm/Hg) | Standard Deviation 7.64 |
| Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 56 | 127.4 millimeter of mercury (mm/Hg) | Standard Deviation 16.69 |
| Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 21 | 74.5 millimeter of mercury (mm/Hg) | Standard Deviation 7.6 |
| Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 1 | 129.5 millimeter of mercury (mm/Hg) | Standard Deviation 19.22 |
| Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 98 | 73.6 millimeter of mercury (mm/Hg) | Standard Deviation 8.26 |
| Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 14 | 76.4 millimeter of mercury (mm/Hg) | Standard Deviation 9.03 |
| Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 7 | 122.4 millimeter of mercury (mm/Hg) | Standard Deviation 13.99 |
| Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 84 | 76.2 millimeter of mercury (mm/Hg) | Standard Deviation 8.9 |
| Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 70 | 135.4 millimeter of mercury (mm/Hg) | Standard Deviation 19.48 |
| Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | SBP: Day 14 | 130.3 millimeter of mercury (mm/Hg) | Standard Deviation 17.87 |
| Placebo | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points | DBP: Day 70 | 75.0 millimeter of mercury (mm/Hg) | Standard Deviation 6.3 |
Secondary
Number of Participants With 12-lead Electrocardiogram (ECG) Findings
All 12-lead ECGs were obtained after the participant had rested in the supine position for at least 15 minutes. All ECGs were evaluated by the principal investigator or designee for any other abnormality of potential clinical importance (PCI). Data for abnormal ECG findings have been reported under abnormal - Not clinically significant (NCS) and Abnormal - Clinically significant (CS) categories. Data only for categories with values have been presented.
Time frame: Days 1, 7, 14, 21, 28, 42, 56, 70, 84, 98
Population: Safety Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Losmapimod 7.5 mg Twice Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 1 pre-dose 1: Abnormal-NCS | 19 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 1 pre-dose 2:Abnormal-NCS | 19 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 1 pre-dose 3: Abnormal-NCS | 18 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 7 pre-dose 1: Abnormal-NCS | 8 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 14 pre-dose 1: Abnormal-NCS | 16 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 28 pre-dose 1: Abnormal-NCS | 16 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 28 pre-dose 1: Abnormal-CS | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 56 pre-dose 1: Abnormal-NCS | 17 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 70 pre-dose 1: Abnormal-NCS | 4 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 84 pre-dose 1: Abnormal-NCS | 15 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 98: Abnormal-NCS | 15 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 98: Abnormal-CS | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 98: Abnormal-CS | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 1 pre-dose 1: Abnormal-NCS | 17 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 28 pre-dose 1: Abnormal-CS | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 70 pre-dose 1: Abnormal-NCS | 4 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 1 pre-dose 2:Abnormal-NCS | 16 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 28 pre-dose 1: Abnormal-NCS | 14 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 98: Abnormal-NCS | 18 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 1 pre-dose 3: Abnormal-NCS | 16 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 56 pre-dose 1: Abnormal-NCS | 15 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 14 pre-dose 1: Abnormal-NCS | 17 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 7 pre-dose 1: Abnormal-NCS | 8 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 84 pre-dose 1: Abnormal-NCS | 17 Participants |
| Placebo | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 7 pre-dose 1: Abnormal-NCS | 7 Participants |
| Placebo | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 14 pre-dose 1: Abnormal-NCS | 16 Participants |
| Placebo | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 84 pre-dose 1: Abnormal-NCS | 11 Participants |
| Placebo | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 28 pre-dose 1: Abnormal-NCS | 13 Participants |
| Placebo | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 28 pre-dose 1: Abnormal-CS | 1 Participants |
| Placebo | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 56 pre-dose 1: Abnormal-NCS | 12 Participants |
| Placebo | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 98: Abnormal-NCS | 13 Participants |
| Placebo | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 1 pre-dose 1: Abnormal-NCS | 15 Participants |
| Placebo | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 1 pre-dose 2:Abnormal-NCS | 15 Participants |
| Placebo | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 70 pre-dose 1: Abnormal-NCS | 4 Participants |
| Placebo | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 1 pre-dose 3: Abnormal-NCS | 15 Participants |
| Placebo | Number of Participants With 12-lead Electrocardiogram (ECG) Findings | Day 98: Abnormal-CS | 1 Participants |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Time frame: Up to Follow-up (Day 98)
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 29 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 4 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 28 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 1 Participants |
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 31 Participants |
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAE | 3 Participants |
Secondary
Number of Participants With Clinical Chemistry Abnormalities of PCI
Clinical chemistry range for PCI was calcium low \<1.5 mill mole per litre (mmol/L), high \> 3.24 mmol/L; creatinine high 155 mmol/L; glucose low \< 2.2 (age: 13-99) mmol/L, high \> 27.8 (age: 13-99) mmol/L; phosphorus low \< 2.8 mmol/L, high \> 6.5 mmol/L; sodium low \< 125 mmol/L, high \> 150 mmol/L. Categories with values have been presented.
Time frame: Up to Follow-up (Day 98)
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Clinical Chemistry Abnormalities of PCI | Calcium low | 2 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Clinical Chemistry Abnormalities of PCI | Calcium high | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Clinical Chemistry Abnormalities of PCI | Glucose low | 1 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Clinical Chemistry Abnormalities of PCI | Glucose high | 7 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Clinical Chemistry Abnormalities of PCI | Potassium low | 1 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Clinical Chemistry Abnormalities of PCI | Sodium low | 1 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Clinical Chemistry Abnormalities of PCI | Creatinine high | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Clinical Chemistry Abnormalities of PCI | Chloride low | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Clinical Chemistry Abnormalities of PCI | Glucose low | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Clinical Chemistry Abnormalities of PCI | Creatinine high | 2 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Clinical Chemistry Abnormalities of PCI | Glucose high | 2 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Clinical Chemistry Abnormalities of PCI | Potassium low | 2 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Clinical Chemistry Abnormalities of PCI | Sodium low | 3 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Clinical Chemistry Abnormalities of PCI | Calcium low | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Clinical Chemistry Abnormalities of PCI | Calcium high | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Clinical Chemistry Abnormalities of PCI | Chloride low | 2 Participants |
| Placebo | Number of Participants With Clinical Chemistry Abnormalities of PCI | Glucose low | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Abnormalities of PCI | Calcium high | 1 Participants |
| Placebo | Number of Participants With Clinical Chemistry Abnormalities of PCI | Calcium low | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Abnormalities of PCI | Glucose high | 3 Participants |
| Placebo | Number of Participants With Clinical Chemistry Abnormalities of PCI | Creatinine high | 4 Participants |
| Placebo | Number of Participants With Clinical Chemistry Abnormalities of PCI | Sodium low | 3 Participants |
| Placebo | Number of Participants With Clinical Chemistry Abnormalities of PCI | Potassium low | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Abnormalities of PCI | Chloride low | 0 Participants |
Secondary
Number of Participants With Hematology Abnormalities of PCI
Hematology range for PCI was: white blood cell count (WBC) low \< 1.1 x109/ L; hemoglobin low \<71 (age: 18-99) grams per litre (g/L), high \>199 (age: 18-99) g/L; hematocrit low 0.201 (age: 18-99) ratio of 1 high 0.599 (age: 18-99) ratio of 1 and platelet count low \< 80 x109/ L, high \> 500 x109/ L. Categories with values have been presented.
Time frame: Up to Follow-up (Day 98)
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Hematology Abnormalities of PCI | Monocytes high | 1 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Hematology Abnormalities of PCI | Reticulocytes low | 4 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Hematology Abnormalities of PCI | Eosinophils low | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Hematology Abnormalities of PCI | WBC count low | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Hematology Abnormalities of PCI | Reticulocytes high | 18 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Hematology Abnormalities of PCI | Eosinophils high | 3 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Hematology Abnormalities of PCI | Platelet count low | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Hematology Abnormalities of PCI | MCH high | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Hematology Abnormalities of PCI | Haemoglobin low | 1 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Hematology Abnormalities of PCI | Neutrophils high | 3 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Hematology Abnormalities of PCI | Lymphocytes high | 1 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Hematology Abnormalities of PCI | Lymphocytes low | 4 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Hematology Abnormalities of PCI | RBC count low | 1 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Hematology Abnormalities of PCI | Neutrophils low | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Hematology Abnormalities of PCI | Reticulocytes low | 4 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Hematology Abnormalities of PCI | Eosinophils high | 1 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Hematology Abnormalities of PCI | Eosinophils low | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Hematology Abnormalities of PCI | Haemoglobin low | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Hematology Abnormalities of PCI | RBC count low | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Hematology Abnormalities of PCI | Neutrophils high | 1 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Hematology Abnormalities of PCI | Reticulocytes high | 10 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Hematology Abnormalities of PCI | Platelet count low | 1 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Hematology Abnormalities of PCI | WBC count low | 1 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Hematology Abnormalities of PCI | Lymphocytes low | 2 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Hematology Abnormalities of PCI | Lymphocytes high | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Hematology Abnormalities of PCI | MCH high | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Hematology Abnormalities of PCI | Monocytes high | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Hematology Abnormalities of PCI | Neutrophils low | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormalities of PCI | RBC count low | 1 Participants |
| Placebo | Number of Participants With Hematology Abnormalities of PCI | Monocytes high | 1 Participants |
| Placebo | Number of Participants With Hematology Abnormalities of PCI | Lymphocytes low | 2 Participants |
| Placebo | Number of Participants With Hematology Abnormalities of PCI | Haemoglobin low | 1 Participants |
| Placebo | Number of Participants With Hematology Abnormalities of PCI | Eosinophils high | 1 Participants |
| Placebo | Number of Participants With Hematology Abnormalities of PCI | Lymphocytes high | 2 Participants |
| Placebo | Number of Participants With Hematology Abnormalities of PCI | Eosinophils low | 1 Participants |
| Placebo | Number of Participants With Hematology Abnormalities of PCI | Reticulocytes high | 13 Participants |
| Placebo | Number of Participants With Hematology Abnormalities of PCI | Neutrophils high | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormalities of PCI | Platelet count low | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormalities of PCI | Reticulocytes low | 9 Participants |
| Placebo | Number of Participants With Hematology Abnormalities of PCI | Neutrophils low | 1 Participants |
| Placebo | Number of Participants With Hematology Abnormalities of PCI | WBC count low | 0 Participants |
| Placebo | Number of Participants With Hematology Abnormalities of PCI | MCH high | 1 Participants |
Secondary
Number of Participants With Urinalysis Dipstick Results
A urine dipstick test is a basic diagnostic tool used to determine pathological changes in a participant's urine in standard urinalysis. Data was analyzed for urine occult blood, urine glucose, urine ketones and urine protein ranging from 2+, trace, 1+, 3+, 1+or 1/4, 3+ or 1 and trace or 1/10, indicating proportional concentrations in the urine sample. Data has been presented for categories with values for positive findings.
Time frame: Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 7: Urine Occult Blood, 3+ | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 70: Urine Protein, 2+ | 1 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 21: Urine Protein, 1+ | 1 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 1: Urine Occult Blood, 3+ | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 70: Urine Occult Blood, trace | 1 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 28: Urine Occult Blood, 2+ | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 1: Urine Occult Blood, trace | 1 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 70: Urine Occult Blood, 2+ | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 28: Urine Occult Blood, trace | 1 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 7: Urine Protein, trace | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Protein, 1+ | 3 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 28: Urine Protein, trace | 2 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Glucose, 3+ OR 1 | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Protein, trace | 2 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 28: Urine Protein, 1+ | 3 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Occult Blood, 2+ | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Ketones, trace | 1 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 42: Urine Occult Blood, 2+ | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 7: Urine Protein, 1+ | 1 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Glucose, Trace or 1/10 | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 42: Urine Protein, trace | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 1: Urine Protein, trace | 4 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Occult Blood, 1+ | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 42: Urine Protein, 1+ | 1 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Protein, 1+ | 3 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Occult Blood, trace | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Occult Blood, 2+ | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 14: Urine Occult Blood, 2+ | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Protein, 1+ | 3 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Protein, trace | 2 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 14: Urine Occult Blood, trace | 1 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Occult Blood, 3+ | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Protein, 2+ | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 14: Urine Occult Blood, 1+ | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 1: Urine Protein, 1+ | 2 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Ketones, trace | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 14: Urine Ketones, trace | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Protein, trace | 2 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Occult Blood, 1+ | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 14: Urine Protein, trace | 1 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Occult Blood, 1+ | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Occult Blood, trace | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 14: Urine Protein, 1+ | 3 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 7: Urine Occult Blood, 1+ | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Occult Blood, 2+ | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 21: Urine Occult Blood, trace | 1 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 1: Urine Glucose, 1+ | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 70: Urine Protein, 1+ | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 21: Urine Ketones, trace | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Occult Blood, trace | 1 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 70: Urine Protein, trace | 0 Participants |
| Losmapimod 7.5 mg Twice Daily | Number of Participants With Urinalysis Dipstick Results | Day 21: Urine Protein, trace | 1 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Occult Blood, 2+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 1: Urine Occult Blood, trace | 1 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 1: Urine Occult Blood, 3+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 1: Urine Glucose, 1+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 1: Urine Protein, trace | 1 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 1: Urine Protein, 1+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 7: Urine Occult Blood, 1+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 7: Urine Occult Blood, 3+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 7: Urine Protein, trace | 1 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 7: Urine Protein, 1+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 14: Urine Occult Blood, 2+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 14: Urine Occult Blood, trace | 2 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 14: Urine Occult Blood, 1+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 14: Urine Ketones, trace | 1 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 14: Urine Protein, trace | 1 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 14: Urine Protein, 1+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 21: Urine Occult Blood, trace | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 21: Urine Ketones, trace | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 21: Urine Protein, trace | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 21: Urine Protein, 1+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 28: Urine Occult Blood, 2+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 28: Urine Occult Blood, trace | 1 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 28: Urine Protein, trace | 3 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 28: Urine Protein, 1+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 42: Urine Occult Blood, 2+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 42: Urine Protein, trace | 1 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 42: Urine Protein, 1+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Occult Blood, 2+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Occult Blood, trace | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Occult Blood, 1+ | 1 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Glucose, Trace or 1/10 | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Ketones, trace | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Protein, trace | 2 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Protein, 1+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 70: Urine Occult Blood, 2+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 70: Urine Occult Blood, trace | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 70: Urine Protein, 2+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 70: Urine Protein, trace | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 70: Urine Protein, 1+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Occult Blood, 2+ | 1 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Occult Blood, trace | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Occult Blood, 1+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Ketones, trace | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Protein, 2+ | 1 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Protein, trace | 3 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Protein, 1+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Occult Blood, trace | 1 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Occult Blood, 1+ | 1 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Occult Blood, 3+ | 0 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Glucose, 3+ OR 1 | 1 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Protein, trace | 1 Participants |
| Losmapimod 7.5 mg Once Daily | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Protein, 1+ | 0 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 70: Urine Occult Blood, trace | 0 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 21: Urine Protein, trace | 3 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Occult Blood, trace | 0 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 70: Urine Protein, 2+ | 0 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 21: Urine Ketones, trace | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 1: Urine Protein, 1+ | 5 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 70: Urine Protein, trace | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 21: Urine Occult Blood, trace | 0 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Protein, 1+ | 3 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 70: Urine Protein, 1+ | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 14: Urine Protein, 1+ | 2 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Occult Blood, 1+ | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Occult Blood, 2+ | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 14: Urine Protein, trace | 3 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 1: Urine Protein, trace | 2 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Occult Blood, trace | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 14: Urine Ketones, trace | 0 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Protein, trace | 3 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Occult Blood, 1+ | 2 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 14: Urine Occult Blood, 1+ | 3 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Occult Blood, 3+ | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Ketones, trace | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 14: Urine Occult Blood, trace | 0 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 1: Urine Glucose, 1+ | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Protein, 2+ | 0 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 14: Urine Occult Blood, 2+ | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 1: Urine Occult Blood, trace | 2 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Protein, trace | 5 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Occult Blood, 2+ | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 42: Urine Protein, 1+ | 0 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 7: Urine Protein, 1+ | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Occult Blood, trace | 2 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 42: Urine Protein, trace | 2 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Glucose, 3+ OR 1 | 0 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Occult Blood, 1+ | 2 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 42: Urine Occult Blood, 2+ | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 84: Urine Protein, 1+ | 0 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Glucose, Trace or 1/10 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 28: Urine Protein, 1+ | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 7: Urine Protein, trace | 3 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Ketones, trace | 0 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 28: Urine Protein, trace | 5 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 7: Urine Occult Blood, 3+ | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Protein, trace | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 28: Urine Occult Blood, trace | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 98: Urine Occult Blood, 2+ | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 56: Urine Protein, 1+ | 2 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 28: Urine Occult Blood, 2+ | 2 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 7: Urine Occult Blood, 1+ | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 70: Urine Occult Blood, 2+ | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 21: Urine Protein, 1+ | 1 Participants |
| Placebo | Number of Participants With Urinalysis Dipstick Results | Day 1: Urine Occult Blood, 3+ | 1 Participants |