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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00734032
First received: August 12, 2008
Last updated: June 21, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Dyslipidaemia
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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 -

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline to week 4 in plasma Lp-PLA2 activity [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • •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 [ Time Frame: 4 weeks ]

Enrollment: 107
Study Start Date: August 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734032

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00734032     History of Changes
Other Study ID Numbers: LPL110118
Study First Received: August 12, 2008
Last Updated: June 21, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
SB-480848
Dyslipidaemia

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Dyslipidemias
Arterial Occlusive Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014