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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Drug: SB480848 40mg EC Tablet Drug: SB480848 80mg EC Tablet Drug: SB480848 160mg EC Tablet Drug: SB480848 Placebo Tablet Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 -
Actual Study Start Date : August 26, 2008
Actual Primary Completion Date : January 16, 2009
Actual Study Completion Date : January 16, 2009

Arm Intervention/treatment
Placebo Comparator: Placebo Group
Matched Placebo
Drug: SB480848 Placebo Tablet
1 tablet once a day
Experimental: SB480848 40mg Group
SB480848 40mg/day
Drug: SB480848 40mg EC Tablet
1 tablet once a day
Other Name: Darapladib
Experimental: SB480848 80mg Group
SB480848 80mg/day
Drug: SB480848 80mg EC Tablet
1 tablet once a day
Experimental: SB480848 160mg Group
SB480848 160mg/day
Drug: SB480848 160mg EC Tablet
1 tablet once a day



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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]).

  2. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00734032


Locations
Japan
GSK Investigational Site
Fukuoka, Japan, 812-0025
GSK Investigational Site
Fukuoka, Japan, 818-0036
GSK Investigational Site
Fukuoka, Japan, 819-1102
GSK Investigational Site
Tokyo, Japan, 105-0004
GSK Investigational Site
Tokyo, Japan, 154-0024
GSK Investigational Site
Tokyo, Japan, 160-0017
GSK Investigational Site
Tokyo, Japan, 174-0051
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: LPL110118
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: LPL110118
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: LPL110118
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: LPL110118
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: LPL110118
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: LPL110118
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00734032     History of Changes
Other Study ID Numbers: LPL110118
First Posted: August 13, 2008    Key Record Dates
Results First Posted: January 12, 2018
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
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://

Keywords provided by GlaxoSmithKline:
SB-480848
Dyslipidaemia

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases