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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Atherosclerosis
Interventions: Drug: SB480848 40mg EC Tablet
Drug: SB480848 80mg EC Tablet
Drug: SB480848 160mg EC Tablet
Drug: SB480848 Placebo Tablet

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was planned in 100 dyslipidemic male or female participants, aged 20 to 80 years, undergoing statin therapy and no change in lipid-lowering medication or dose during the 4 weeks prior to randomization from 26 August 2008 to 16 January 2009 at 7 centers in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 116 participants screened, 9 were screen failures; 107 participants were randomized in a ratio of 1:1:1:1, to receive placebo or any 1 of the 3 doses of SB-480848 (40 milligram [mg], 80 mg, 160 mg), prior to which they continued their statin therapy with no change in lipid-lowering medication or dose during 4 weeks of Run-in period.

Reporting Groups
  Description
Placebo Participants received oral dose of matching placebo tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
SB-480848 40 mg Participants received oral dose of SB-480848 40 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
SB-480848 80 mg Participants received oral dose of SB-480848 80 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
SB-480848 160 mg Participants received oral dose of SB-480848 160 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.

Participant Flow:   Overall Study
    Placebo   SB-480848 40 mg   SB-480848 80 mg   SB-480848 160 mg
STARTED   25   28   28   26 
COMPLETED   25   27   28   26 
NOT COMPLETED   0   1   0   0 
Adverse Event                0                1                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Participants received oral dose of matching placebo tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
SB-480848 40 mg Participants received oral dose of SB-480848 40 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
SB-480848 80 mg Participants received oral dose of SB-480848 80 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
SB-480848 160 mg Participants received oral dose of SB-480848 160 mg enteric-coated tablet once daily, after breakfast in the morning for 4 weeks of treatment period.
Total Total of all reporting groups

Baseline Measures
   Placebo   SB-480848 40 mg   SB-480848 80 mg   SB-480848 160 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   28   28   26   107 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.5  (11.71)   59.8  (10.17)   58.3  (9.54)   58.3  (10.48)   59.0  (10.34) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      17  68.0%      17  60.7%      18  64.3%      13  50.0%      65  60.7% 
Male      8  32.0%      11  39.3%      10  35.7%      13  50.0%      42  39.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      25 100.0%      28 100.0%      28 100.0%      26 100.0%      107 100.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
White      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   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) ]

3.  Secondary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00734032     History of Changes
Other Study ID Numbers: LPL110118
First Submitted: August 12, 2008
First Posted: August 13, 2008
Results First Submitted: July 18, 2017
Results First Posted: January 12, 2018
Last Update Posted: January 12, 2018