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A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients

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ClinicalTrials.gov Identifier: NCT00734032
Recruitment Status : Completed
First Posted : August 13, 2008
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

August 12, 2008
August 13, 2008
July 18, 2017
January 12, 2018
January 12, 2018
August 26, 2008
January 16, 2009   (Final data collection date for primary outcome measure)
Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity [ Time Frame: Baseline (Week 0, Visit 2) and Week 4 ]
Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Change from Baseline was calculated as the post-Baseline (Week 4) assessment value minus the Baseline assessment value. If either value was missing, then the change from Baseline was set to be missing. The natural logarithm (log) was used for transformation in Lp-PLA2 activity. In case of zero values, an offset of 0.0001 was added to the zero values to ensure that the log transformation was successfully applied. The log transformation was conducted on the original value and then taken the change from Baseline on that log original value, calculated as log (post-Baseline value [week 4]) minus log (Baseline value).
Change from baseline to week 4 in plasma Lp-PLA2 activity
Complete list of historical versions of study NCT00734032 on ClinicalTrials.gov Archive Site
  • Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time [ Time Frame: Baseline (Week 0, Visit 2) up to Follow-up (up to Week 7) ]
    Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Percentage inhibition of Lp-PLA2 activity relative to a Baseline value was calculated as: 100 multiplied by (post-Baseline values (Week 1, 2, 4 and Follow-up-Baseline value) divided by [Baseline value]).
  • Change From Baseline in Lp-PLA2 Activity at Week 1, 2 and Follow-up [ Time Frame: Baseline (Week 0, Visit 2), Week 1, Week 2 and Follow-up ( Week 7) ]
    Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Change from Baseline was calculated as the post-Baseline (Week 1, Week 2 and Follow-up) assessment values minus the Baseline assessment value. If either value was missing, then the change from Baseline was set to be missing. The log was used for transformation in Lp-PLA2 activity. In case of zero values, an offset of 0.0001 was added to the zero values to ensure that the log transformation was successfully applied. The log transformation was conducted on the original value and then taken change from Baseline on that log original value, calculated as log (post-Baseline [Week 1, Week 2 and Follow-up] values) minus log (Baseline value).
•Percent inhibition of Lp-PLA2 activity in plasma at week 4•Overtime changes of Lp-PLA2 activity and the inhibition rate of Lp-PLA2 activity in plasma from baseline
Not Provided
Not Provided
 
A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients
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 -
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Atherosclerosis
  • Drug: SB480848 40mg EC Tablet
    1 tablet once a day
    Other Name: Darapladib
  • Drug: SB480848 80mg EC Tablet
    1 tablet once a day
  • Drug: SB480848 160mg EC Tablet
    1 tablet once a day
  • Drug: SB480848 Placebo Tablet
    1 tablet once a day
  • Placebo Comparator: Placebo Group
    Matched Placebo
    Intervention: Drug: SB480848 Placebo Tablet
  • Experimental: SB480848 40mg Group
    SB480848 40mg/day
    Intervention: Drug: SB480848 40mg EC Tablet
  • Experimental: SB480848 80mg Group
    SB480848 80mg/day
    Intervention: Drug: SB480848 80mg EC Tablet
  • Experimental: SB480848 160mg Group
    SB480848 160mg/day
    Intervention: Drug: SB480848 160mg EC Tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
100
January 16, 2009
January 16, 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00734032
LPL110118
Not Provided
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP