Status:
COMPLETED
Study to Determine the Effect of 14 Days Dosing With Darapladib (SB-480848) on Carotid Plague Composition in Patients With Planned Carotid Endarterectomy
Lead Sponsor:
GlaxoSmithKline
Conditions:
Atherosclerosis
Eligibility:
All Genders
35+ years
Phase:
PHASE2
Brief 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 determinatio...
Eligibility Criteria
Inclusion
- 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
- 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 ≥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 opinion, would preclude completion of a safe surgical procedure and/or completion of the study
- Use of an investigational drugs within 30 days or 5 half-lives of their last dose prior to starting the study, whichever is the longest
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2003
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT01916720
Start Date
January 1 2003
End Date
July 1 2003
Last Update
December 5 2016
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.