Last updated: 11/07/2018 14:28:00
Study to determine the effect of 14 days dosing with darapladib (SB-480848) on carotid plague composition in patients with planned carotid endarterectomy
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A multi-centre, randomised, double-blind, placebo-controlled, parallel-group study to investigate the effect of the Lp-PLA2 inhibitor SB-480848 (40, 80mg od) on carotid plaque composition in patients with carotid artery disease and planned carotid endarterectomy, stratified for statin use and gender, after 14+/-4 days treatment
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Lp-PLA2 activity in the atherosclerotic plaque removed during carotid endarterectomy
Timeframe: 14 +/- 4 days
Secondary outcomes:
Lp-PLA2 mass in plaque removed during the carotid endarterectomy
Timeframe: 14 +/- 4 days
Lp-PLA2 mass and activity in blood
Timeframe: 14 +/- days
Lipid and Non-Lipid Biomarkers in Plasma
Timeframe: 14 +/- days
Oxidised Lipids and Their Metabolites, and Biomarkers in Plaque
Timeframe: 14 +/- 4 days
Interventions:
Drug: SB-480848 40 mg
Drug: SB-480848 80 mg
Drug: Placebo
Enrollment:
103
Observational study model:
Not applicable
Primary completion date:
2003-31-07
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Atherosclerosis
Product
darapladib
Collaborators
Not applicable
Study date(s)
January 2003 to July 2003
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
35+ years
Accepts healthy volunteers
No
- Male or female, >35 years of age
- Females of childbearing potential must be using approved contraceptive measures
- Recent myocardial infarction (within the previous 4 weeks)
- Currently taking corticosteroids, warfarin, digoxin or a potent CYP3A4 inhibitor
Inclusion and exclusion criteria
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 ≥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
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2003-31-07
Actual study completion date
2003-31-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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