A Phase 2 interventional study of GSK249320 100/mg and Placebo in Cerebrovascular Accident, sponsored by GlaxoSmithKline. Terminated at 36 sites in 4 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-11-17.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
Study MAG104615, a Proof of Concept Study for GSK249320 versus placebo in Stroke Patients.
Myelin-associated glycoprotein (MAG) is one of the key proteins known to inhibit neuronal regeneration when released from oligodendrocytes in conditions of neuronal injury, such as stroke. GSK249320 is a humanised monoclonal antibody (mAb) that binds with high specificity to MAG and antagonises or neutralises MAG-mediated inhibition and has been shown to improve functional recovery after stroke in pre-clinical models, possibly by promoting neuroregeneration and plasticity. The present study (MAG104615) is designed to establish Proof of Concept (PoC) for GSK249320 in ischemic stroke patients. MAG104615 will be a placebo-controlled, double-blind, multicenter, randomized, repeat dose, Bayesian design study. PoC will be achieved by demonstrating a clinically meaningful improvement in lower limb motor recovery, specifically by evaluating changes in gait velocity from baseline to Day 90/Month 3. Subjects will also be followed out to Day 180/Month 6 to further evaluate longer term motor recovery and safety. Additional secondary efficacy measures of motor recovery will be evaluated to further demonstrate and characterize the extent and duration of overall motor recovery after treatment with GSK249320. Changes in disability and neurological impairment will be characterized after treatment with GSK249320 and explored for how they relate to motor recovery. This PoC study will also further characterize the safety, PK, and immunogenicity of GSK249320 will explore pharmacodynamic (PD) markers, and will explore use of actigraphy to measure motor recovery. Subjects will be stratified by gait velocity at baseline for randomization (1:1 allocation) into one of two treatment groups: 15mg/kg GSK249320, or placebo. Each subject will receive 2 repeat IV doses of GSK249320 or placebo.
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's enrollment of 134 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo is a clear, colorless solution (50mM acetate buffer, pH 5.5 containing 0.02% (w/v) polysorbate-80 and made isotonic with 111.2 mM sodium chloride). Placebo is for intravenous (IV) use only.
Drug: Placebo
Clear to opalescent, colorless to pale yellow or pale brown, and is supplied as a sterile, concentrated solution (1000mg/vial). GSK249320 is for IV use only.
Drug: GSK249320 100/mg
Clear to opalescent, colorless to pale yellow or pale brown, and is supplied as a sterile, concentrated solution (1000mg/vial). GSK249320 is for IV use only.
Placebo is a clear, colorless solution (50mM acetate buffer, pH 5.5 containing 0.02% (w/v) polysorbate-80 and made isotonic with 111.2 mM sodium chloride). Placebo is for intravenous (IV) use only.
Mean Change From Baseline (BL) to Month 3/ Day 90 in Gait Velocity
Gait is the way or manner in which a person walks. Gait velocity (walking speed) is an objective, quantitative measure of lower extremity motor recovery in individuals who have had a stroke. Participants were asked to walk at their usual pace over a level, indoor 10 meter (m) distance and were allowed to use their normal assistive devices. The time (seconds\[s\]) taken by the participants to travel the 10 m distance was recorded. Gait velocity (m/s) as assessed by study personnel was derived as: 10 divided by time to walk 10 m. Two trials of gait velocity were conducted at each time point. Change from BL was calculated as the mean Month 3/Day 90 value minus the mean BL value. BL was defined as Day 1. The measure type displayed are posterior means.
Time frame: BL (Day 1) and Month 3/Day 90
Mean Change From BL to Month 6/ Day 180 in Gait Velocity
Gait is the way or manner in which a person walks. Gait velocity (walking speed) is an objective, quantitative measure of lower extremity motor recovery in individuals who have had a stroke. Participants were asked to walk at their usual pace over a level, indoor 10 m distance and were allowed to use their normal assistive devices. The time (s) taken by the participants to travel the 10 m distance was recorded. Gait velocity (m/s) as assessed by study personnel was derived as: 10 divided by time to walk 10 m. Two trials of gait velocity were conducted at each time point. Change from BL was calculated as the mean Month 3/Day 90 value minus the mean BL value. BL was defined as Day 1. The measure type displayed are posterior means.
Time frame: BL (Day 1) and Month 6/Day 180
Number of Participants With Indicated Transition From One Gait Velocity Category to Another Category at the Indicated Time Points
Participants were categorized at each visit into the following gait velocity categories: 0 m/s, \>0 to \<0.4 m/s, \>=0.4 m/s to 0.8 m/s and \>0.8m/s. A distinction was made between participants who are too incapacitated to walk (i.e., gait velocity = 0m/s) and participants for whom the gait velocity assessment was not performed due to another reason (i.e., truly missing data). Participants were asked to walk at their usual or normal pace and using their normal assistive devices. Two trials of gait velocity were conducted at each time point. The number of participants transitioning from one gait velocity category to another category was assessed at each post-Baseline visit and was presented in terms of the following transition categories: worsened, no change, improved 1 level, improved 2 levels and improved 3 levels. By-visit sample sizes vary due to missing data or early termination of the study, missing data was not imputed.
Time frame: BL (Day 1), Month 1/Day 30, Month 2/Day 60, Month 3/Day 90 and Month 6/Day 180.
Change From BL in Dexterity as Measured by Box and Blocks Test
Dexterity is ability of person to use hands skillfully in performing a task. Box and Blocks test is an objective, gross manual dexterity test in individuals with upper limb impairments. Participants were asked to move small wooden blocks from one side of a partitioned box to other. The score was determined by number of blocks transferred within a 60 second time period. Both affected and unaffected arms were tested, starting with the unaffected arm. Change from BL was calculated as the individual post- BL value minus BL value. A higher number of displaced blocks indicated a better gross dexterity and a low number of displaced blocks indicated poor gross dexterity. It was analyzed using fixed effects for treatment, visit, treatment by visit interaction, sex, age, Baseline National Institute of Health stroke scale (NIHSS) total score, BL number of blocks transferred by the affected and unaffected arms, country and presence of concomitant medications that potentially impact recovery.
Time frame: BL (Day 1), Month 1/Day 30, Month 2/Day 60, Month 3/Day 90 and Month 6/Day 180
Number of Participants Experiencing Falls
The number of participants who experienced at least one fall between BL to Day 90 and BL to Day 180 is summarized.
Time frame: BL (Day 1) Day 90 and Day 180
Number of Falls Over Time
The number of participants who experienced 1, 2, 3 or \>=4 falls between BL to Day 90 and BL to Day 180 is summarized. By-visit sample sizes vary due to missing data or early termination of the study. The participants who experienced atleast one-fall were reported
Time frame: BL (Day 1), Day 90 and Day 180
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or all events of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment is exercised in other situations.
Time frame: Up to 14 months
Number of Participants With Events Common to Stroke
Events common to stroke were those events that commonly occurred after a stroke and are generally associated with the underlying stroke or the progression of stroke. These included joint or soft tissue pain, bladder incontinence, depression/mood disorder, urinary tract infection, dysphagia, bowel incontinence, dysarthia, confusion, spasticity, limb edema, aspiration pneumonia, hemorrhagic transformation (symptomatic or asymptomatic), pressure ulcers, progression of stroke, malnutrition, deep vein thrombosis, brain herniation, pulmonary embolism, seizures, and falls.
Time frame: From Day 1 until early withdrawal, death, Month 6/Day 180
Change From BL in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Safety was measured by monitoring vital signs including blood pressure. The BL for DBP and SBP was the value of pre-dose assessment on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.
Time frame: BL (Day 1) , Day 6, Day 180 and early withdrawal (EW) visit
Change From BL in Vitals Signs-Heart Rate
Safety was measured by monitoring vital signs including heart rate. The BL for heart rate was the value of pre-dose assessment on Day 1. Change from BL was calculated as the individual post-BL value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study. BL was defined as Day 1.
Time frame: Day 1, Day 6, Day 180 and EW visit
Change From BL in ECG Parameter-Heart Rate
A single 12-lead ECG was obtained at each time point that measured heart rate. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.
Time frame: BL (Day 1) Day 6, Day 30 and EW visit
Change From BL in ECG Parameters
A single 12-lead ECG was obtained at each time point and the following ECG intervals were determined: PR, QRS, QT, RR and corrected QT (QTc), QT interval corrected by Bazett's formula (QTcB), QT interval corrected by Fridericia's formula (QTcF). BL for ECG parameters was the value of Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.
Time frame: BL (Day 1), Day 6, Day 30 and EW visit
Change From BL in Clinical Chemistry- Albumin and Total Protein
ALB and TP were measured at BL, Day 6, Day 30, Day 90 and Day 180. Baseline was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.
Time frame: BL (Day 1), Day 6, Day 30, Day 90 and Day 180
Change From BL in Clinical Chemistry-urea/Blood Urea Nitrogen (BUN), Sodium (Na), Potassium (K), Glucose (Gluc), Chloride (Cl), Calcium (Ca)
Ca, Cl, Gluc, K, Na and BUN were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.
Time frame: BL (Day 1), Day 6, Day 30, Day 90 and Day 180
Change From BL in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALP, ALT and AST were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.
Time frame: BL (Day 1), Day 6, Day 30, Day 90 and Day 180
Change From BL in Clinical Chemistry- Direct Bilirubin, Total Bilirubin, Creatinine
Direct bilirubin, total bilirubin and creatinine were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.
Time frame: BL (Day 1), Day 6, Day 30, Day 90 and Day 180
Change From BL in Eosinophils (EOS), Lymphocytes (LYM), Total Absolute Neutrophil Count (ANC), Platelet (PLT) Count, White Blood Cell (WBC) Count
EOS, LYM, Total ANC, PLT count and WBC count were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value.By-visit sample sizes vary due to missing data or early termination of the study.
Time frame: BL (Day 1), Day 6, Day 30, Day 90 and Day 180
Change From BL in Hematology- Hemoglobin
Hemoglobin was measured at BL Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. . By-visit sample sizes vary due to missing data or early termination of the study.
Time frame: BL (Day 1), Day 6, Day 30, Day 90 and Day 180
Change From Baseline in Hematology- Hematocrit
Hematocrit was measured at Baseline, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value.By-visit sample sizes vary due to missing data or early termination of the study.
Time frame: BL (Day 1), Day 6, Day 30, Day 90 and Day 180
Change From BL in NIHSS Total Score
The NIHSS is a 15 item, standardized, disease-specific, deficit scale which measures neurological impairment (level of consciousness, eye movements, visual fields, facial symmetry, motor strength (arm and leg), coordination, sensation, language (aphasia and dysarthria), and neglect) and is used to quantify participant status by measuring the severity of the stroke as assessed by NIHSS certified study personnel. The total NIHSS score is calculated as the sum of responses to the 15 items. The total NIHSS score ranges from 0-42, with a higher score indicative of a more severe impairment. By-visit sample sizes vary due to missing data or early termination of the study. Change from BL was calculated as the individual post-Baseline value minus the BL value. BL was defined as the value at Day 1.
Time frame: BL (Day 1), Day 30, Day 90 and Day 180
Number of Participants With Suicidal Ideation Via Columbia Suicide Severity Rating Scale (CSSRS)
C-SSRS is a clinician-rated scale that evaluates severity and change of suicidality by integrating both suicidality behavior and ideation. For Suicidal Ideation (SI), participants were scored non-suicidal:0, wish to be dead:1, non-specific active suicidal thoughts:2, active suicidal ideation with associated thoughts of methods without intent:3, active suicidal ideation with some intent to act on suicidal thoughts without clear plan:4, active suicidal ideation with plan and intent:5 (most severe). SI intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore, the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation.
Time frame: Da y 1, Da y 6, Day 30, Day 60, Day 90 and Day 180
Maximum Observed Plasma Concentration (Cmax) for GSK249320
Cmax is the maximum observed concentration of GSK249320 obtained at the end of infusion post dose on Day 6. Due to early termination of the study, this data was not collected.
Time frame: Pre-dose and post-dose up to Day 180
Time to Reach Maximum Observed Plasma Concentration (Tmax) GSK249320
Tmax is the time of the occurrence of Cmax. The Cmax is defined as the maximum observed concentration of GSK249320 obtained at the end of infusion post dose on day 6. Due to early termination of the study data for Tmax was not collected.
Time frame: Pre-dose and post-dose up to Day 180
PK as Measured by Plasma Decay Half-life (t1/2) GSK249320
Blood samples were collected for determination of plasma concentrations of GSK249320. Terminal phase half-life was derived from the plasma concentration-time data. Only participants in the GSK249320 15 mg/kg group were analyzed.
Time frame: Up to Day 180
Area Under the Concentration-time Curve From 0 to 5 Days [AUC(0-5d)] and Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC(0-inf)] for GSK249320
Blood samples were collected for determination of plasma concentrations of GSK249320. AUC (0-5d) and AUC (0-inf) were derived from the plasma concentration-time data. AUC(0-5d) is the model predicted AUC over the planned TAU of 5 days. Only participants in the GSK249320 15 mg/kg group were analyzed.
Time frame: Pre-dose and post-dose up to Day 180
Clearance (CL) for GSK249320
Blood samples were collected for determination of plasma concentrations of GSK249320. CL was derived from the plasma concentration-time data. Analysis was performed for PK Population that comprised of all participants in the Safety Population who had at least one PK sample with a concentration above the non-quantifiable limit. Only participants in the GSK249320 15 mg/kg group were analyzed.
Time frame: Up to Day 180
Volume of Distribution (V1 and V2) and Volume at Steady State (Vss) for GSK249320
Blood samples were collected for determination of plasma concentrations of GSK249320. V1, V2 and Vss were derived from the plasma concentration-time data. Analysis was performed for PK Population that comprised of all participants in the Safety Population who had at least one PK sample with a concentration above the non-quantifiable limit. Only participants in the GSK249320 15 mg/kg group were analyzed.
Time frame: Up to Day 180
Antibodies Against GSK249320, Assessed Using Electrochemi-luminescent Assay (ECL) Assay
Blood samples were collected and the presence of antibodies against GSK249320 was assessed using ECL assays. Positive result indicated presence of antibodies and negative result indicated absence of antibodies. Confirmed samples with presence of antibodies were further characterized for neutralizing activity as binding antibody (BAb) and neutralising antibody (NAb) by a neutralization assay.By-visit sample sizes vary due to missing data or early termination of the study.
Time frame: Day 1, Day 30, Day 180, EW visit and Follow-up visit
A total of 134 participants with Stroke, were randomized to the study. The study was conducted from 18 May 2013 to 28 July 2014 at 30 centers; with 5 in United States, 5 in Canada, 8 in United Kingdom, and 12 in Germany. The ITT population consisted of total 120 participants and the Per Protocol consisted of 104 participants.
| Milestone | Placebo | GSK249320 15 mg/kg |
|---|---|---|
| Started | 68 | 65 |
| Completed | 32 | 32 |
| Not completed | 36 | 33 |
| Withdrew: Physician decision | 0 | 2 |
| Withdrew: Study closed/terminated | 25 | 23 |
| Withdrew: Adverse event, non-fatal | 2 | 0 |
| Withdrew: Consent withdrawn by subject | 6 | 7 |
| Withdrew: Lost to follow-up | 3 | 1 |
Gait is the way or manner in which a person walks. Gait velocity (walking speed) is an objective, quantitative measure of lower extremity motor recovery in individuals who have had a stroke. Participants were asked to walk at their usual pace over a level, indoor 10 meter (m) distance and were allowed to use their normal assistive devices. The time (seconds\[s\]) taken by the participants to travel the 10 m distance was recorded. Gait velocity (m/s) as assessed by study personnel was derived as: 10 divided by time to walk 10 m. Two trials of gait velocity were conducted at each time point. Change from BL was calculated as the mean Month 3/Day 90 value minus the mean BL value. BL was defined as Day 1. The measure type displayed are posterior means.
| m/s | Placebo | GSK249320 15 mg/kg |
|---|---|---|
| Mean Change From Baseline (BL) to Month 3/ Day 90 in Gait Velocity | 0.5417 ± 0.062 | 0.5859 ± 0.0535 |
Gait is the way or manner in which a person walks. Gait velocity (walking speed) is an objective, quantitative measure of lower extremity motor recovery in individuals who have had a stroke. Participants were asked to walk at their usual pace over a level, indoor 10 m distance and were allowed to use their normal assistive devices. The time (s) taken by the participants to travel the 10 m distance was recorded. Gait velocity (m/s) as assessed by study personnel was derived as: 10 divided by time to walk 10 m. Two trials of gait velocity were conducted at each time point. Change from BL was calculated as the mean Month 3/Day 90 value minus the mean BL value. BL was defined as Day 1. The measure type displayed are posterior means.
| m/s | Placebo | GSK249320 15 mg/kg |
|---|---|---|
| Mean Change From BL to Month 6/ Day 180 in Gait Velocity | 0.5442 ± 0.0665 | 0.6236 ± 0.0556 |
Participants were categorized at each visit into the following gait velocity categories: 0 m/s, \>0 to \<0.4 m/s, \>=0.4 m/s to 0.8 m/s and \>0.8m/s. A distinction was made between participants who are too incapacitated to walk (i.e., gait velocity = 0m/s) and participants for whom the gait velocity assessment was not performed due to another reason (i.e., truly missing data). Participants were asked to walk at their usual or normal pace and using their normal assistive devices. Two trials of gait velocity were conducted at each time point. The number of participants transitioning from one gait velocity category to another category was assessed at each post-Baseline visit and was presented in terms of the following transition categories: worsened, no change, improved 1 level, improved 2 levels and improved 3 levels. By-visit sample sizes vary due to missing data or early termination of the study, missing data was not imputed.
| Participants | Placebo - PP | GSK249320 15 mg/kg - PP |
|---|---|---|
| Day 30, Worsened | 1 | 0 |
| Day 30, No Change | 19 | 18 |
| Day 30, Improved 1 Levels | 11 | 11 |
| Day 30, Improved 2 Levels | 9 | 9 |
| Day 30, Improved 3 Levels | 8 | 11 |
| Day 60, Worsened | 0 | 0 |
| Day 60, No Change | 13 | 14 |
| Day 60, Improved 1 Level | 14 | 11 |
| Day 60, Improved 2 Levels | 6 | 7 |
| Day 60, Improved 3 Levels | 9 | 10 |
| Day 90, Worsened | 1 | 0 |
| Day 90, No Change | 9 | 8 |
| Day 90, Improved 1 Level | 12 | 14 |
| Day 90, Improved 2 Levels | 10 | 7 |
| Day 90, Improved 3 Levels | 10 | 12 |
| Day 180, Worsened | 1 | 0 |
| Day 180, No Change | 7 | 6 |
| Day 180, Improved 1 Level | 9 | 14 |
| Day 180, Improved 2 Levels | 11 | 5 |
| Day 180, Improved 3 Levels | 8 | 14 |
Dexterity is ability of person to use hands skillfully in performing a task. Box and Blocks test is an objective, gross manual dexterity test in individuals with upper limb impairments. Participants were asked to move small wooden blocks from one side of a partitioned box to other. The score was determined by number of blocks transferred within a 60 second time period. Both affected and unaffected arms were tested, starting with the unaffected arm. Change from BL was calculated as the individual post- BL value minus BL value. A higher number of displaced blocks indicated a better gross dexterity and a low number of displaced blocks indicated poor gross dexterity. It was analyzed using fixed effects for treatment, visit, treatment by visit interaction, sex, age, Baseline National Institute of Health stroke scale (NIHSS) total score, BL number of blocks transferred by the affected and unaffected arms, country and presence of concomitant medications that potentially impact recovery.
| Number of blocks | Placebo - PP | GSK249320 15 mg/kg - PP |
|---|---|---|
| Day 30 | 10.130 ± 2.195 | 12.538 ± 1.587 |
| Day 60 | 11.469 ± 2.345 | 14.484 ± 1.6 |
| Day 90 | 15.196 ± 2.962 | 17.631 ± 1.926 |
| Day 180 | 14.869 ± 2.839 | 18.813 ± 2.11 |
The number of participants who experienced at least one fall between BL to Day 90 and BL to Day 180 is summarized.
| Participants | Placebo - Safety | GSK249320 15 mg/kg - Safety |
|---|---|---|
| Baseline to Day 90 | 15 | 12 |
| Baseline to Day 180 | 18 | 16 |
The number of participants who experienced 1, 2, 3 or \>=4 falls between BL to Day 90 and BL to Day 180 is summarized. By-visit sample sizes vary due to missing data or early termination of the study. The participants who experienced atleast one-fall were reported
| Participants | Placebo - Safety | GSK249320 15 mg/kg - Safety |
|---|---|---|
| Baseline to Day 90, 1 Fall | 8 | 6 |
| Baseline to Day 90, 2 Falls | 3 | 3 |
| Baseline to Day 90, 3 Falls | 0 | 2 |
| Baseline to Day 90, >=4 Falls | 4 | 1 |
| Baseline to Day 180, 1 Fall | 7 | 9 |
| Baseline to Day 180, 2 Falls | 6 | 2 |
| Baseline to Day 180, 3 Falls | 1 | 2 |
| Baseline to Day 180, >=4 Falls | 4 | 3 |
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or all events of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment is exercised in other situations.
| Participants | Placebo | GSK249320 15/mg |
|---|---|---|
| Any AE | 57 | 49 |
| Any SAE | 16 | 9 |
Events common to stroke were those events that commonly occurred after a stroke and are generally associated with the underlying stroke or the progression of stroke. These included joint or soft tissue pain, bladder incontinence, depression/mood disorder, urinary tract infection, dysphagia, bowel incontinence, dysarthia, confusion, spasticity, limb edema, aspiration pneumonia, hemorrhagic transformation (symptomatic or asymptomatic), pressure ulcers, progression of stroke, malnutrition, deep vein thrombosis, brain herniation, pulmonary embolism, seizures, and falls.
| Participants | Placebo | GSK249320 15/mg |
|---|---|---|
| Joint or soft tissue pain | 19 | 22 |
| Bladder Incontinence | 11 | 23 |
| Depression/Mood Disorder | 17 | 16 |
| Urinary tract infection | 17 | 13 |
| Dysphagia | 12 | 12 |
| Bowel Incontinence | 11 | 12 |
| Dysarthia | 11 | 11 |
| Confusion | 8 | 13 |
| Spasticity | 9 | 9 |
| Limb edema | 5 | 12 |
| Aspiration Pneumonia | 5 | 3 |
| Hemorrhagic Transformation | 4 | 4 |
| Pressure Ulcers | 3 | 2 |
| Progression of Stroke | 2 | 2 |
| Malnutrition | 1 | 2 |
| Deep vein thrombosis | 2 | 0 |
| Brain Herniation | 0 | 1 |
| Pulmonary embolism | 1 | 0 |
| Seizures | 0 | 1 |
| Falls | 18 | 16 |
Safety was measured by monitoring vital signs including blood pressure. The BL for DBP and SBP was the value of pre-dose assessment on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.
| Millimeters of mercury | Placebo - Safety | GSK249320 15 mg/kg - Safety |
|---|---|---|
| DBP, Day 1 Post-dose | 1.7 ± 10.58 | 0.5 ± 10.14 |
| DBP, Day 6 Pre-dose | 0.2 ± 16.52 | -1.1 ± 11.98 |
| DBP, Day 6 Post-dose | 2.4 ± 15.06 | 1.9 ± 16.36 |
| DBP, Day 180 | 8.1 ± 13.97 | 5.0 ± 14.60 |
| DBP, EW visit | -5.0 ± 15.55 | 1.8 ± 15.05 |
| SBP, Day 1 Post-dose | 3.1 ± 16.15 | 0.7 ± 11.81 |
| SBP, Day 6 Pre-dose | -3.5 ± 26.46 | -6.0 ± 20.13 |
| SBP, Day 6 Post-dose | -0.9 ± 24.59 | -2.0 ± 20.14 |
| SBP, Day 180 | -6.4 ± 22.96 | -6.4 ± 27.79 |
| SBP, EW visit | -15.2 ± 29.08 | -0.0 ± 25.42 |
Safety was measured by monitoring vital signs including heart rate. The BL for heart rate was the value of pre-dose assessment on Day 1. Change from BL was calculated as the individual post-BL value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study. BL was defined as Day 1.
| Beats per minute | Placebo - Safety | GSK249320 15 mg/kg - Safety |
|---|---|---|
| Day 1 Post-dose | 0.9 ± 8.68 | 0.7 ± 7.98 |
| Day 6 Pre-dose | -1.8 ± 13.03 | -0.4 ± 17.47 |
| Day 6 Post-dose | -3.9 ± 12.09 | -3.1 ± 15.30 |
| Day 180 | -0.3 ± 17.50 | -3.0 ± 15.48 |
| EW visit | 3.3 ± 15.47 | -2.1 ± 15.40 |
A single 12-lead ECG was obtained at each time point that measured heart rate. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.
| Beats per minute | Placebo - Safety | GSK249320 15 mg/kg - Safety |
|---|---|---|
| Day 6, n=60, 58 | -3.4 ± 17.57 | -4.9 ± 15.37 |
| Day 30, n=46, 50 | -3.4 ± 19.81 | 0.9 ± 16 |
| EW Visit, n=16, 16 | -5.4 ± 16.82 | -10.3 ± 29.58 |
A single 12-lead ECG was obtained at each time point and the following ECG intervals were determined: PR, QRS, QT, RR and corrected QT (QTc), QT interval corrected by Bazett's formula (QTcB), QT interval corrected by Fridericia's formula (QTcF). BL for ECG parameters was the value of Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.
| Milliseconds | Placebo - Safety | GSK249320 15 mg/kg - Safety |
|---|---|---|
| PR, Day 6 | -1.0 ± 30.47 | -0.8 ± 20.02 |
| PR, Day 30 | -5.9 ± 36.05 | -3.5 ± 42.08 |
| PR, EW Visit | -0.4 ± 21.01 | 3.1 ± 33.96 |
| QRS, Day 6 | 4.9 ± 15.75 | -4.0 ± 44.11 |
| QRS, Day 30 | 3.4 ± 10.97 | 1.1 ± 17.74 |
| QRS, EW Visit | 2.6 ± 27.47 | -23.7 ± 81.24 |
| RR, Day 6 | 61.1 ± 246.84 | 12.9 ± 154.09 |
| RR, Day 30 | 80.5 ± 245.31 | -21.8 ± 181.99 |
| RR, EW Visit | -21.6 ± 164.19 | 85.6 ± 349.82 |
| QT, Day 6 | 10.4 ± 40.86 | 9.4 ± 36.46 |
| QT, Day 30 | 4.1 ± 43.59 | -12.1 ± 42.06 |
| QT, EW Visit | 20.8 ± 37.16 | 43.7 ± 93.85 |
| QTc, Day 6 | 2.9 ± 30.70 | 6.8 ± 43.87 |
| QTc, Day 30 | -1.3 ± 32.92 | -2.2 ± 39.49 |
| QTc, EW Visit | 7.1 ± 27.75 | 8.9 ± 69.58 |
| QTcB, Day 6 | 2.2 ± 124.73 | 4.5 ± 46.49 |
| QTcB, Day 30 | -31.9 ± 120.26 | -13.9 ± 79.33 |
| QTcB, EW Visit | 28.2 ± 37.06 | 6.9 ± 52.02 |
| QTcF, Day 6 | 4.3 ± 74.12 | 5.7 ± 33.25 |
| QTcF, Day 30 | -16.9 ± 75.41 | -12.0 ± 58.16 |
| QTcF, EW Visit | 26.0 ± 31.85 | 18.3 ± 62.78 |
ALB and TP were measured at BL, Day 6, Day 30, Day 90 and Day 180. Baseline was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.
| Grams per liter | Placebo - Safety | GSK249320 15 mg/kg - Safety |
|---|---|---|
| ALB, Day 6 | 0.0 ± 3.02 | -0.2 ± 3.67 |
| ALB, Day 30 | 1.0 ± 3.44 | 3.0 ± 5.50 |
| ALB, Day 90 | 2.3 ± 3.23 | 4.4 ± 5.14 |
| ALB, Day 180 | 2.3 ± 3.80 | 5.3 ± 3.86 |
| TP, Day 6 | 1.0 ± 4.64 | 0.9 ± 5.90 |
| TP, Day 30 | 2.7 ± 5.13 | 5.6 ± 8.11 |
| TP, Day 90 | 3.1 ± 4.92 | 6.5 ± 7.34 |
| TP, Day 180 | 4.4 ± 5.07 | 7.6 ± 5.89 |
Ca, Cl, Gluc, K, Na and BUN were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.
| Millimoles per liter | Placebo - Safety | GSK249320 15 mg/kg - Safety |
|---|---|---|
| Ca, Day 6 | 0.042 ± 0.1163 | 0.059 ± 0.1564 |
| Ca, Day 30 | 0.091 ± 0.1254 | 0.158 ± 0.1985 |
| Ca, Day 90 | 0.093 ± 0.1092 | 0.186 ± 0.1960 |
| Ca, Day 180 | 0.087 ± 0.1053 | 0.182 ± 0.1315 |
| Cl, Day 6 | -0.9 ± 3.13 | -1.4 ± 4.08 |
| Cl, Day 30 | -1.6 ± 3.72 | -3.1 ± 5.01 |
| Cl, Day 90 | -1.3 ± 3.02 | -2.7 ± 4.67 |
| Cl, Day 180 | -1.4 ± 2.48 | -3.4 ± 3.93 |
| Gluc, Day 6 | 0.21 ± 3.123 | -0.35 ± 2.619 |
| Gluc, Day 30 | -0.93 ± 2.611 | -0.45 ± 2.476 |
| Gluc, Day 90 | -1.12 ± 2.075 | -0.38 ± 2.170 |
| Gluc, Day 180 | -1.09 ± 3.045 | -1.02 ± 2.136 |
| K, Day 6 | 0.17 ± 0.384 | 0.21 ± 0.452 |
| K, Day 30 | 0.37 ± 0.487 | 0.30 ± 0.429 |
| K, Day 90 | 0.36 ± 0.477 | 0.39 ± 0.404 |
| K, Day 180 | 0.33 ± 0.517 | 0.54 ± 0.472 |
| Na, Day 6 | 0.1 ± 2.82 | 0.0 ± 2.83 |
| Na, Day 30 | -0.3 ± 2.64 | -0.8 ± 3.21 |
| Na, Day 90 | 0.4 ± 1.87 | -0.7 ± 2.91 |
| Na, Day 180 | 0.5 ± 2.04 | -1.2 ± 2.90 |
| Urea/BUN, Day 6 | 1.57 ± 2.392 | 1.61 ± 2.541 |
| Urea/BUN, Day 30 | 1.09 ± 2.673 | 2.19 ± 5.436 |
| Urea/BUN, Day 90 | 1.02 ± 2.310 | 1.04 ± 2.655 |
| Urea/BUN, Day 180 | 0.51 ± 2.364 | 1.04 ± 3.502 |
ALP, ALT and AST were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.
| International units per liter | Placebo - Safety | GSK249320 15 mg/kg - Safety |
|---|---|---|
| ALP, Day 6 | 7.7 ± 20.05 | 6.2 ± 16.4 |
| ALP, Day 30 | 11.7 ± 21.47 | 19.5 ± 35.87 |
| ALP, Day 90 | 8.6 ± 27.18 | 6.7 ± 18.01 |
| ALP, Day 180 | 8.9 ± 12.73 | 4.0 ± 17.63 |
| ALT, Day 6 | 11.4 ± 25.92 | 10.7 ± 16.22 |
| ALT, Day 30 | 7.9 ± 19.02 | 10.6 ± 27.84 |
| ALT, Day 90 | -0.8 ± 16.14 | 3.2 ± 11.21 |
| ALT, Day 180 | -2.0 ± 12.83 | 1.4 ± 10.66 |
| AST, Day 6 | 7.9 ± 26.39 | 2.5 ± 15.52 |
| AST, Day 30 | 0.2 ± 14.24 | -0.9 ± 13.18 |
| AST, Day 90 | -6.1 ± 11.78 | -5.2 ± 13.33 |
| AST, Day 180 | -3.2 ± 7.13 | -5.0 ± 9.70 |
Direct bilirubin, total bilirubin and creatinine were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.
| Micromoles per liter | Placebo - Safety | GSK249320 15 mg/kg - Safety |
|---|---|---|
| direct bilirubin, Day 6 | 0.3 ± 3.81 | -0.0 ± 1.58 |
| direct bilirubin, Day 30 | -1.0 ± 1.93 | -0.4 ± 1.48 |
| direct bilirubin, Day 90 | -1.5 ± 1.92 | -0.5 ± 1.62 |
| direct bilirubin, Day 180 | -1.2 ± 1.59 | -0.1 ± 1.38 |
| total bilirubin, Day 6 | -1.5 ± 3.76 | -1.8 ± 5.90 |
| total bilirubin, Day 30 | -4.6 ± 4.90 | -3.0 ± 4.85 |
| total bilirubin, Day 90 | -4.9 ± 4.75 | -3.5 ± 5.59 |
| total bilirubin, Day 180 | -4.6 ± 4.83 | -3.8 ± 5.28 |
| creatinine, Day 6 | 2.35 ± 20.520 | 3.48 ± 16.778 |
| creatinine, Day 30 | 4.94 ± 31.767 | 9.79 ± 28.329 |
| creatinine, Day 90 | 6.69 ± 18.980 | 3.09 ± 15.387 |
| creatinine, Day 180 | 5.07 ± 12.925 | 0.24 ± 13.857 |
EOS, LYM, Total ANC, PLT count and WBC count were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value.By-visit sample sizes vary due to missing data or early termination of the study.
| Giga (10^9 cells) per liter | Placebo - Safety | GSK249320 15 mg/kg - Safety |
|---|---|---|
| EOS, Day 6 | 0.049 ± 0.1153 | 0.082 ± 0.1692 |
| EOS, Day 30 | 0.058 ± 0.2207 | 0.086 ± 0.1318 |
| EOS, Day 90 | 0.058 ± 0.1175 | 0.058 ± 0.1149 |
| EOS, Day 180 | 0.045 ± 0.1314 | 0.048 ± 0.1206 |
| LYM, Day 6 | -0.046 ± 0.3904 | -0.030 ± 0.6750 |
| LYM, Day 30 | 0.026 ± 0.4666 | -0.002 ± 0.5728 |
| LYM, Day 90 | 0.066 ± 0.4110 | 0.236 ± 0.5854 |
| LYM, Day 180 | 0.017 ± 0.5005 | 0.075 ± 0.5919 |
| Total ANC, Day 6 | -0.375 ± 2.2795 | -0.756 ± 2.5842 |
| Total ANC, Day 30 | -1.486 ± 2.4578 | -0.581 ± 4.7282 |
| Total ANC, Day 90 | -1.469 ± 2.1498 | -1.455 ± 2.3515 |
| Total ANC, Day 180 | -2.202 ± 2.7396 | -0.579 ± 1.6956 |
| PLT Count, Day 6 | 17.4 ± 37.57 | 32.4 ± 41.01 |
| PLT Count, Day 30 | 40.5 ± 62.89 | 47.6 ± 44.23 |
| PLT Count, Day 90 | 33.2 ± 53.36 | 60.4 ± 56.30 |
| PLT Count, Day 180 | 19.9 ± 35.91 | 35.9 ± 39.15 |
| WBC Count,Day 6 | -0.40 ± 2.294 | -0.78 ± 2.288 |
| WBC Count, Day 30 | -1.46 ± 2.524 | -0.54 ± 4.819 |
| WBC Count, Day 90 | -1.45 ± 2.017 | -1.28 ± 2.119 |
| WBC Count, Day 180 | -2.15 ± 2.496 | -0.55 ± 1.943 |
Hemoglobin was measured at BL Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. . By-visit sample sizes vary due to missing data or early termination of the study.
| Grams per liter | Placebo - Safety | GSK249320 15 mg/kg - Safety |
|---|---|---|
| Day 6 | -0.1 ± 9.55 | 2.4 ± 10.21 |
| Day 30 | -1.0 ± 13.19 | 3.8 ± 14.84 |
| Day 90 | -4.1 ± 16.61 | 4.7 ± 15.91 |
| Day 180 | -6.2 ± 17.70 | 7.6 ± 13.45 |
Hematocrit was measured at Baseline, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value.By-visit sample sizes vary due to missing data or early termination of the study.
| Ratio | Placebo - Safety | GSK249320 15 mg/kg - Safety |
|---|---|---|
| Day 6 | 0.00096 ± 0.032094 | 0.00896 ± 0.032858 |
| Day 30 | -0.00350 ± 0.040669 | 0.01116 ± 0.046146 |
| Day 90 | -0.01446 ± 0.053418 | 0.01329 ± 0.049054 |
| Day 180 | -0.02455 ± 0.056181 | 0.01909 ± 0.043139 |
The NIHSS is a 15 item, standardized, disease-specific, deficit scale which measures neurological impairment (level of consciousness, eye movements, visual fields, facial symmetry, motor strength (arm and leg), coordination, sensation, language (aphasia and dysarthria), and neglect) and is used to quantify participant status by measuring the severity of the stroke as assessed by NIHSS certified study personnel. The total NIHSS score is calculated as the sum of responses to the 15 items. The total NIHSS score ranges from 0-42, with a higher score indicative of a more severe impairment. By-visit sample sizes vary due to missing data or early termination of the study. Change from BL was calculated as the individual post-Baseline value minus the BL value. BL was defined as the value at Day 1.
| Scores on a scale | Placebo - Safety | GSK249320 15 mg/kg - Safety |
|---|---|---|
| Day 1 | 10.0 ± 4.40 | 9.8 ± 3.79 |
| Day 30 | 6.4 ± 4.40 | 5.7 ± 4.66 |
| Day 90 | 5.0 ± 3.83 | 4.8 ± 4.89 |
| Day 180 | 3.9 ± 3.22 | 4.2 ± 3.87 |
C-SSRS is a clinician-rated scale that evaluates severity and change of suicidality by integrating both suicidality behavior and ideation. For Suicidal Ideation (SI), participants were scored non-suicidal:0, wish to be dead:1, non-specific active suicidal thoughts:2, active suicidal ideation with associated thoughts of methods without intent:3, active suicidal ideation with some intent to act on suicidal thoughts without clear plan:4, active suicidal ideation with plan and intent:5 (most severe). SI intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore, the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation.
| Participants | Placebo - Safety | GSK249320 15 mg/kg - Safety |
|---|---|---|
| Number of Participants With Suicidal Ideation Via Columbia Suicide Severity Rating Scale (CSSRS) | 10 | 3 |
Cmax is the maximum observed concentration of GSK249320 obtained at the end of infusion post dose on Day 6. Due to early termination of the study, this data was not collected.
No measurements were reported for this outcome.
Tmax is the time of the occurrence of Cmax. The Cmax is defined as the maximum observed concentration of GSK249320 obtained at the end of infusion post dose on day 6. Due to early termination of the study data for Tmax was not collected.
No measurements were reported for this outcome.
Blood samples were collected for determination of plasma concentrations of GSK249320. Terminal phase half-life was derived from the plasma concentration-time data. Only participants in the GSK249320 15 mg/kg group were analyzed.
| Days | GSK249320 15 mg/kg - PK |
|---|---|
| PK as Measured by Plasma Decay Half-life (t1/2) GSK249320 | 23.09 (13.5 to 42.9) |
Blood samples were collected for determination of plasma concentrations of GSK249320. AUC (0-5d) and AUC (0-inf) were derived from the plasma concentration-time data. AUC(0-5d) is the model predicted AUC over the planned TAU of 5 days. Only participants in the GSK249320 15 mg/kg group were analyzed.
| Milligrams/milliliter*hour | GSK249320 15 mg/kg - PK |
|---|---|
| AUC(0-5 d) | 28.2273 ± 10.9 |
| AUC(0-inf) | 120.6895 ± 20.4 |
Blood samples were collected for determination of plasma concentrations of GSK249320. CL was derived from the plasma concentration-time data. Analysis was performed for PK Population that comprised of all participants in the Safety Population who had at least one PK sample with a concentration above the non-quantifiable limit. Only participants in the GSK249320 15 mg/kg group were analyzed.
| Milligrams/kilograms/hour | GSK249320 15 mg/kg - PK |
|---|---|
| Clearance (CL) for GSK249320 | 0.1243 ± 20.4 |
Blood samples were collected for determination of plasma concentrations of GSK249320. V1, V2 and Vss were derived from the plasma concentration-time data. Analysis was performed for PK Population that comprised of all participants in the Safety Population who had at least one PK sample with a concentration above the non-quantifiable limit. Only participants in the GSK249320 15 mg/kg group were analyzed.
| milliliters/kilogram | GSK249320 15 mg/kg - PK |
|---|---|
| V1 | 43.6992 ± 6.7 |
| V2 | 41.4193 ± 17.8 |
| Vss | 85.2892 ± 11.5 |
Blood samples were collected and the presence of antibodies against GSK249320 was assessed using ECL assays. Positive result indicated presence of antibodies and negative result indicated absence of antibodies. Confirmed samples with presence of antibodies were further characterized for neutralizing activity as binding antibody (BAb) and neutralising antibody (NAb) by a neutralization assay.By-visit sample sizes vary due to missing data or early termination of the study.
| Participants | Placebo - Safety | GSK249320 15 mg/kg - Safety |
|---|---|---|
| Day 1, BAb Positive | 7 | 5 |
| Day 1, BAb Negative | 60 | 59 |
| Day 1, NAb Negative | 0 | 2 |
| Day 30, BAb Positive | 4 | 4 |
| Day 30, BAb Negative | 44 | 46 |
| Day 30, NAb Negative | 1 | 1 |
| Day 180, BAb Positive | 0 | 5 |
| Day 180, BAb Negative | 24 | 19 |
| EW visit, BAb Positive | 1 | 4 |
| EW visit, BAb Negative | 22 | 18 |
| EW visit, NAb Negative | 1 | 4 |
| FU visit, BAb Positive | 0 | 1 |
| FU visit, NAb Negative | 0 | 1 |
Collected over Up to 14 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 5/68 (7.4%) | 16/68 (23.5%) | 25/68 (36.8%) |
| GSK249320 15 mg/kg | 2/65 (3.1%) | 9/65 (13.8%) | 32/65 (49.2%) |
| Event | Placebo | GSK249320 15 mg/kg |
|---|---|---|
| Pneumonia aspirationRespiratory, thoracic and mediastinal disorders | 2/68 | 0/65 |
| Acute myocardial infarctionCardiac disorders | 0/68 | 1/65 |
| Atrial fibrillationCardiac disorders | 0/68 | 1/65 |
| Cardiac failure congestiveCardiac disorders | 0/68 | 1/65 |
| Cardio-respiratory arrestCardiac disorders | 0/68 | 1/65 |
| Sick sinus syndromeCardiac disorders | 0/68 | 1/65 |
| Anal ulcerGastrointestinal disorders | 0/68 | 1/65 |
| Haemorrhagic transformation strokeNervous system disorders | 0/68 | 1/65 |
| Ischemic cerebral infarctionNervous system disorders | 0/68 | 1/65 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 0/68 | 1/65 |
| Event | Placebo | GSK249320 15 mg/kg |
|---|---|---|
| ConstipationGastrointestinal disorders | 6/68 | 13/65 |
| HeadacheNervous system disorders | 7/68 | 12/65 |
| InsomniaPsychiatric disorders | 4/68 | 5/65 |
| NauseaGastrointestinal disorders | 3/68 | 5/65 |
| Atrial fibrillationCardiac disorders | 0/68 | 4/65 |
| RashSkin and subcutaneous tissue disorders | 3/68 | 4/65 |
| HypertensionVascular disorders | 4/68 | 3/65 |
| HypotensionVascular disorders | 4/68 | 2/65 |
| Urinary tract infectionGastrointestinal disorders | 4/68 | 0/65 |
| Age, Continuous(years) | Placebo | GSK249320 15 mg/kg | Total |
|---|---|---|---|
| Mean | 67.1 ± 11.2 | 68.2 ± 11.92 | 67.6 ± 11.53 |
| Sex: Female, Male(Participants) | Placebo | GSK249320 15 mg/kg | Total |
|---|---|---|---|
| Female | 29 | 31 | 60 |
| Male | 39 | 34 | 73 |
| Race (NIH/OMB)(Participants) | Placebo | GSK249320 15 mg/kg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 2 | 6 |
| White | 62 | 62 | 124 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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