Study to Determine the Effect of 14 Days Dosing With Darapladib (SB-480848) on Carotid Plague Com⦠(NCT01916720) | Clinical Trial Compass
CompletedPhase 2
Study to Determine the Effect of 14 Days Dosing With Darapladib (SB-480848) on Carotid Plague Composition in Patients With Planned Carotid Endarterectomy
103 participantsStarted 2003-01
Plain-language summary
The primary objective is to determine Lp-PLA2 activity in atherosclerotic carotid plaques after 14 (+/-4) days treatment with darapladib, compared to placebo. Secondary objectives include determination of the change in Lp-PLA2 activity in blood, Lp-PLA2 mass in blood and plaque, specified biomarkers in blood and plaque and their respective correlation's with Lp-PLA2. In addition, the study aims to characterise the PK/PD of repeat oral doses of SB-480848, and safety and tolerability in this population.
Who can participate
Age range35 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, \>35 years of age
* Females of childbearing potential must be using approved contraceptive measures
* Male patients must be willing to abstain from sexual intercourse or use a form of contraception if engaging in sexual intercourse with a woman who could become pregnant
* Planned carotid endarterectomy within a timeframe compatible with recruitment for the study and able to comply with the requirements of the study, as deemed by the investigator
* Written, informed consent to participate
Exclusion Criteria:
* Recent myocardial infarction (within the previous 4 weeks)
* Currently taking corticosteroids, warfarin, digoxin or a potent CYP3A4 inhibitor
* Recent (\<3 months) or ongoing acute infection or significant trauma associated with bruising and/or taking antibiotics. Prophylactic antibiotics for surgery are allowed
* Change in dose of lipid-lowering therapy during the previous 4 weeks from randomisation
* History of chronic liver disease (e.g. cirrhosis, hepatitis) OR ALT OR AST ā„1.5 times the upper limit of normal (ULN) at screening
* Diagnosis of systemic lupus erythematosis (SLE) or rheumatoid arthritis (RA)
* Clinically significant anaemia
* History of severe renal impairment (serum creatinine \>1.8mg/dL)
* Unstable angina
* History of asthma , anaphylaxis or anaphylactoid reactions, severe allergic responses
* Abuse of alcohol or drugs within the last 6 months
* Any factor or clinical disease state that, in the investigator's opā¦
What they're measuring
1
Lp-PLA2 activity in the atherosclerotic plaque removed during carotid endarterectomy