NCT00734032

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

Completed Phase 2 Results posted Last updated 12 January 2018

What this trial tests

Phase 2 trial testing SB480848 40mg EC Tablet in Atherosclerosis in 107 participants. Completed in 16 January 2009.

Timeline

26 August 2008

Primary endpoint
16 January 2009

16 January 2009

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	107
Start date	26 August 2008
Primary completion	16 January 2009
Estimated completion	16 January 2009
Sites	7 locations across Japan

Drugs / interventions tested

• SB480848 40mg EC Tablet — full drug profile →
• SB480848 80mg EC Tablet — full drug profile →
• SB480848 160mg EC Tablet — full drug profile →
• SB480848 Placebo Tablet — full drug profile →

Conditions studied

• Atherosclerosis — all drugs for Atherosclerosis →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 20 to 80, any sex, with Atherosclerosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity Primary · 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-PL

Group	Value	95% CI
Placebo	0.961	± 8.5
SB-480848 40 mg	0.494	± 24.6
SB-480848 80 mg	0.404	± 21.5
SB-480848 160 mg	0.313	± 24.7

Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time Secondary · 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 \[Baseline value\]).

Week 1

Group	Value	95% CI
Placebo	-4.06	± 7.025
SB-480848 40 mg	-48.25	± 15.929
SB-480848 80 mg	-55.83	± 11.031
SB-480848 160 mg	-66.03	± 7.656

Week 2

Group	Value	95% CI
Placebo	-1.96	± 8.147
SB-480848 40 mg	-49.05	± 11.094
SB-480848 80 mg	-58.95	± 8.258
SB-480848 160 mg	-67.52	± 9.402

Week 4

Group	Value	95% CI
Placebo	-3.59	± 7.822
SB-480848 40 mg	-49.05	± 13.472
SB-480848 80 mg	-58.67	± 9.438
SB-480848 160 mg	-67.73	± 8.310

Week 7 (Follow-up)

Group	Value	95% CI
Placebo	-3.16	± 9.018
SB-480848 40 mg	-7.65	± 11.408
SB-480848 80 mg	-9.40	± 8.667
SB-480848 160 mg	-13.36	± 10.244

Change From Baseline in Lp-PLA2 Activity at Week 1, 2 and Follow-up Secondary · 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

Week 1

Group	Value	95% CI
Placebo	0.957	± 7.4
SB-480848 40 mg	0.495	± 30.9
SB-480848 80 mg	0.430	± 24.1
SB-480848 160 mg	0.332	± 22.5

Week 2

Group	Value	95% CI
Placebo	0.977	± 8.4
SB-480848 40 mg	0.499	± 20.9
SB-480848 80 mg	0.403	± 19.0
SB-480848 160 mg	0.313	± 28.3

Week 7 (Follow-up)

Group	Value	95% CI
Placebo	0.964	± 9.6
SB-480848 40 mg	0.917	± 11.6
SB-480848 80 mg	0.902	± 9.8
SB-480848 160 mg	0.860	± 12.1

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events (AEs) were recorded up to Follow-up (up to Week 7).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/25 (0%)

Deaths: 0/25

SB-480848 40 mg

Serious: 1/28 (4%)

Deaths: 0/28

SB-480848 80 mg

Serious: 0/28 (0%)

Deaths: 0/28

SB-480848 160 mg

Serious: 0/26 (0%)

Deaths: 0/26

Serious adverse events (1 terms)

Reaction	System	Placebo	SB-480848 40 mg	SB-480848 80 mg	SB-480848 160 mg
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Other adverse events (10 terms — click to expand)

Reaction	System	Placebo	SB-480848 40 mg	SB-480848 80 mg	SB-480848 160 mg
Abnormal faeces	Gastrointestinal disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Urine odour abnormal	Renal and urinary disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—	—	—
Skin odour abnormal	Skin and subcutaneous tissue disorders	—	—	—	—

Most-reported serious reactions: Pulmonary embolism.

Data from ClinicalTrials.gov NCT00734032 adverse events section.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.