Last updated: 11/07/2018 17:31:00
A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients- A multicenter, randomized, double-blind, placebo-controlled study of SB-480848 to evaluate the Efficacy and Safety -
Trial description: The primary objective of this study is to examine the effects of SB-480848 on plasma lipoprotein associated phospholipase A2 (Lp-PLA2) activity in dyslipidemic patients during a 4-week treatment with SB-480848.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline to Week 4 in plasma lipoprotein-associated phospholipase A2 (Lp-PLA2) activity
Timeframe: Baseline (Week 0, Visit 2) and Week 4
Secondary outcomes:
Percent inhibition of Lp-PLA2 activity in plasma over time
Timeframe: Baseline (Week 0, Visit 2) up to Follow-up (up to Week 7)
Change from Baseline in Lp-PLA2 activity at Week 1, 2 and Follow-up
Timeframe: Baseline (Week 0, Visit 2), Week 1, Week 2 and Follow-up ( Week 7)
Interventions:
Drug: SB480848 40mg EC Tablet
Drug: SB480848 80mg EC Tablet
Drug: SB480848 160mg EC Tablet
Drug: SB480848 Placebo Tablet
Enrollment:
107
Observational study model:
Not applicable
Primary completion date:
2009-16-01
Time perspective:
Not applicable
Clinical publications:
Hiroyuki Daida, Takayuki Iwase, Shigeru Yagi, Hidekazu Ando, and Hiromu Nakajima. Effect of darapladib on plasma lipoprotein-associated phospholipase A2 activity in Japanese dyslipidemic patients with exploratory analysis on a PLA2G7 gene polymorphism of Val279Phe. Circ J. 2013;77(6):1518-25.
Medical condition
Atherosclerosis
Product
darapladib
Collaborators
Not applicable
Study date(s)
August 2008 to January 2009
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
20 - 80 years
Accepts healthy volunteers
No
- Dyslipidemic subject who is currently undergoing statin therapy and no change in lipid-lowering therapy or dose during the 4 week prior to randomization
- 1.Recent (i.e.,<6 months prior to screening) CV event and/or vascular procedure defined as:
- A)ST-elevation MI or non-ST-elevation MI
Inclusion and exclusion criteria
Inclusion criteria:
- Dyslipidemic subject who is currently undergoing statin therapy and no change in lipid-lowering therapy or dose during the 4 week prior to randomization
Exclusion criteria:
- 1.Recent (i.e.,<6 months prior to screening) CV event and/or vascular procedure defined as: A)ST-elevation MI or non-ST-elevation MI B)Unstable angina C)Coronary revascularization [(percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)] D)Stroke of any etiology E)Peripheral arterial disease with critical limb ischemia (resting pain or ischemic skin lesions, either ulcers or gangrene) F)Resuscitated cardiac arrest 2.Planned CABG or planned PCI or planned major non-cardiac surgery within study period 3.No measurable Lp-PLA2 activity in plasma (<10 nmol/min/mL) at screening 4.Change in a lipid-lowering medication, regimen or dosage during the 4 week prior to randomization 5.Poorly controlled dyslipidemia (LDL-c >=160 mg/dL) at screening
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-16-01
Actual study completion date
2009-16-01
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.
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