A Study to Evaluate the Effects of 3 Months Dosing With GW856553, as Assessed FDG-PET/CT Imaging
- Registration Number
- NCT00633022
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LOSMAPIMOD 7.5 MG TWICE DAILY LOSMAPIMOD 7.5 MG Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks Placebo Placebo Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks. LOSMAPIMOD 7.5 MG ONCE DAILY LOSMAPIMOD 7.5 MG 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
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.
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧London, United Kingdom