AtherosclerosisPhase 2NCT00633022
A Study to Evaluate the Effects of 3 Months Dosing With GW856553, as Assessed FDG-PET/CT Imaging
A Phase 2 study testing LOSMAPIMOD 7.5 MG in people with Atherosclerosis, run by GlaxoSmithKline at 4 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- LOSMAPIMOD 7.5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 2 Jun 2008to 3 Dec 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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,
Show all 18Show fewer
- 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)
- 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.
- Either carotid or aortic TBR ³ 1.6, as measured on FDG-PET/CT, signifying active inflammation.
- 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%).
- A signed and dated written informed consent prior to admission to the study
- The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
- 1. Recent (in approximately last 12 months) echocardiogram with ejection fraction between 30 and 50%.
Who cannot join
- 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.
- History of heart failure defined as NYHA class II - IV or those with known severe LV systolic dysfunction (EF<30%) regardless of symptomatic status
- Subjects with atrial fibrillation (AF) at screening will be excluded.
- Insulin controlled Type 1 or Type 2 diabetics
- 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]
- Positive pre-study hepatitis B surface antigen or positive hepatitis C antibody results within 3 months of screening.
Show all 32Show fewer
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Renal impairment with creatinine clearance of <40 ml/min at screening, or history of kidney transplant or history of contrast nephropathy.
- Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with active chronic inflammation (e.g. Inflammatory Bowel Disease).
- 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.
- Subjects with any acute infection, symptoms suggestive of sinusitis, or significant trauma (burns, fractures)
- History of malignancy within the past 5 years, other than non-melanoma skin cancer.
- History of skeletal muscle myopathy or rhabdomyolysis
- Previous exposure to GW856553.
- Current use of steroids (inhaled or oral)
- Subjects who have donated more than 500 mL of blood within 56 days prior to the study medication administration.
- 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
- History of alcohol/drug abuse or dependence within 12 months of the study
- 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
- 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.
- QTc interval > 450 msec (using average value of triplicate ECGs)
- Subjects will be excluded if they have participated in clinical research studies involving radiation in the past three years
- 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.
- 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.
- Contraindication to MRI scanning (as assessed by local MRI safety questionnaire) which includes but not limited to:
- Intracranial aneurysm clips (except Sugita) or other metallic objects,
- History of intra- orbital metal fragments that have not been removed by an MD,
- Pacemakers, implantable cardiac defibrillators and non-MR compatible heart valves,
- Inner ear implants,
- History of claustrophobia in MR.
- Allergy to MRI contrast enhancement agent (gadolinium).
- Serum creatinine clearance < 60 mL/min (At the discretion of the physician, the subject may progress to a formal assessment based on 24 hour urine collection should serum creatinine limits fall below limits.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
GSK Investigational Site
Cambridge, CB2 2GG
GSK Investigational Site
London, E1 1B3
GSK Investigational Site
London, Se1 7EH
GSK Investigational Site
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: A Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Effects of Two Regimens of GW856553, Over a Period of 3 Month, on In-vivo Macrophage Activity, as Assessed by FDG-PET/CT Imaging, in the Carotid Arteries and Aorta of Subjects With Established Atherosclerosis
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.
- Conditions
- Atherosclerosis
- Being tested
- LOSMAPIMOD 7.5 MG, Placebo
- Keywords
- FDG-PET/CT, atherosclerosis
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOSMAPIMOD 7.5 MGDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| LOSMAPIMOD 7.5 MG TWICE DAILY | Experimental | Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks Receives: Drug: LOSMAPIMOD 7.5 MG |
| Placebo | Placebo comparator | Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks. Receives: Drug: Placebo |
| LOSMAPIMOD 7.5 MG ONCE DAILY | Experimental | 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. Receives: Drug: LOSMAPIMOD 7.5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Days -14 to -1) and up to Week 12
Secondary outcomes (9)
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.
Measured: Baseline (Days -14 to -1) and up to Week 12
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.
Measured: Baseline (Day 1) and Days 7, 14, 21, 28, 42, 56, 70, 84
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).
Measured: Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98
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).
Measured: Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98
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.
Measured: Days 1, 7, 14, 21, 28, 42, 56, 70, 84, 98
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.
Measured: Up to Follow-up (Day 98)
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.
Measured: Up to Follow-up (Day 98)
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.
Measured: Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98
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.
Measured: Up to Follow-up (Day 98)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2008 (estimated)
- Study start2 Jun 2008
- Primary completion3 Dec 2009
- Study completion3 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633022
- Sponsor's protocol ID
- PM1111138
- Status last verified
- Aug 2018
- First submitted
- 13 Feb 2008
- Last updated
- 17 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Elkhawad M, Rudd JH, Sarov-Blat L, Cai G, Wells R, Davies LC, Collier DJ, Marber MS, Choudhury RP, Fayad ZA, Tawakol A, Gleeson FV, Lepore JJ, Davis B, Willette RN, Wilkinson IB, Sprecher DL, Cheriyan J. Effects of p38 mitogen-activated protein kinase inhibition on vascular and systemic inflammation in patients with atherosclerosis. JACC Cardiovasc Imaging. 2012 Sep;5(9):911-22. doi: 10.1016/j.jcmg.2012.02.016.
PubMed 22974804
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Effects of Two Regimens of GW856553, Over a Period of 3 Month, on In-vivo Macrophage Activity, as Assessed by FDG-PET/CT Imaging, in the Carotid Arteries and Aorta of Subjects With Established Atherosclerosis
- ClinicalTrials.gov ID
- NCT00633022
- Acronym / sponsor ID
- PM1111138
- Conditions
- Atherosclerosis
- Keywords
- FDG-PET/CT, atherosclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2008 (actual)
- Primary completion
- 3 Dec 2009 (actual)
- Study completion
- 3 Dec 2009 (actual)
- First posted
- 11 Mar 2008 (estimated)
- Results
- Posted 17 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LOSMAPIMOD 7.5 MG TWICE DAILY | Experimental | Drug: LOSMAPIMOD 7.5 MGParticipants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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 | Experimental | Drug: LOSMAPIMOD 7.5 MGParticipants 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
- Subjects who have:
- 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.
- Either carotid or aortic TBR ³ 1.6, as measured on FDG-PET/CT, signifying active inflammation.
- 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%).
Key exclusion criteria (32 listed)
- 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.
- History of heart failure defined as NYHA class II - IV or those with known severe LV systolic dysfunction (EF<30%) regardless of symptomatic status
- Subjects with atrial fibrillation (AF) at screening will be excluded.
- Insulin controlled Type 1 or Type 2 diabetics
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LOSMAPIMOD 7.5 MGGW856553 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. | Drug | LOSMAPIMOD 7.5 MG ONCE DAILY, LOSMAPIMOD 7.5 MG TWICE DAILY |
| PlaceboPlacebo 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. | Drug | Placebo |
Primary outcome
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
Time frame: 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.
9 secondary outcomes
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
Time frame: Baseline (Days -14 to -1) and up to Week 12
Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP)
Time frame: Baseline (Day 1) and Days 7, 14, 21, 28, 42, 56, 70, 84
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
Time frame: Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98
Mean Heart Rate at Indicated Time Points
Time frame: Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98
Number of Participants With 12-lead Electrocardiogram (ECG) Findings
Time frame: Days 1, 7, 14, 21, 28, 42, 56, 70, 84, 98
Number of Participants With Clinical Chemistry Abnormalities of PCI
Time frame: Up to Follow-up (Day 98)
Number of Participants With Hematology Abnormalities of PCI
Time frame: Up to Follow-up (Day 98)
Number of Participants With Urinalysis Dipstick Results
Time frame: Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Follow-up (Day 98)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22974804Elkhawad M, Rudd JH, Sarov-Blat L, Cai G, Wells R, Davies LC, Collier DJ, Marber MS, Choudhury RP, Fayad ZA, Tawakol A, Gleeson FV, Lepore JJ, Davis B, Willette RN, Wilkinson IB, Sprecher DL, Cheriyan J. Effects of p38 mitogen-activated protein kinase inhibition on vascular and systemic inflammation in patients with atherosclerosis. JACC Cardiovasc Imaging. 2012 Sep;5(9):911-22. doi: 10.1016/j.jcmg.2012.02.016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Related trials for Atherosclerosis
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LOSMAPIMOD 7.5 MG in people with Atherosclerosis, run by GlaxoSmithKline at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline (Days -14 to -1) and up to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00633022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.