AtherosclerosisPhase 2NCT00734032
A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients
A Phase 2 study testing SB480848 40mg EC Tablet, SB480848 80mg EC Tablet and SB480848 160mg EC Tablet in people with Atherosclerosis, run by GlaxoSmithKline at 7 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- SB480848 40mg EC Tablet, SB480848 80mg EC Tablet and SB480848 160mg EC Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 7 sitesJapan
- Study dates
- 26 Aug 2008to 16 Jan 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dyslipidemic subject who is currently undergoing statin therapy and no change in lipid-lowering therapy or dose during the 4 week prior to randomization
Who cannot join
- 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
- Planned CABG or planned PCI or planned major non-cardiac surgery within study period
- No measurable Lp-PLA2 activity in plasma (<10 nmol/min/mL) at screening
- Change in a lipid-lowering medication, regimen or dosage during the 4 week prior to randomization
- Poorly controlled dyslipidemia (LDL-c >=160 mg/dL) at screening
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
GSK Investigational Site
Fukuoka, 812-0025
GSK Investigational Site
Fukuoka, 818-0036
GSK Investigational Site
Fukuoka, 819-1102
GSK Investigational Site
Tokyo, 105-0004
GSK Investigational Site
Tokyo, 154-0024
GSK Investigational Site
Tokyo, 160-0017
GSK Investigational Site
Tokyo, 174-0051
About this study
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 -
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.
- Conditions
- Atherosclerosis
- Being tested
- SB480848 40mg EC Tablet, SB480848 80mg EC Tablet, SB480848 160mg EC Tablet, SB480848 Placebo Tablet
- Keywords
- SB-480848, Dyslipidaemia
- Medical subject headings
- Atherosclerosis, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB480848 40mg EC TabletDrug
Also called Darapladib
1 tablet once a day
SB480848 80mg EC TabletDrug
1 tablet once a day
SB480848 160mg EC TabletDrug
1 tablet once a day
SB480848 Placebo TabletDrug
1 tablet once a day
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Matched Placebo Receives: Drug: SB480848 Placebo Tablet |
| SB480848 40mg Group | Experimental | SB480848 40mg/day Receives: Drug: SB480848 40mg EC Tablet |
| SB480848 80mg Group | Experimental | SB480848 80mg/day Receives: Drug: SB480848 80mg EC Tablet |
| SB480848 160mg Group | Experimental | SB480848 160mg/day Receives: Drug: SB480848 160mg EC Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity
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).
Measured: Baseline (Week 0, Visit 2) and Week 4
Secondary outcomes (2)
Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time
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]).
Measured: Baseline (Week 0, Visit 2) up to Follow-up (up to Week 7)
Change From Baseline in Lp-PLA2 Activity at Week 1, 2 and Follow-up
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).
Measured: Baseline (Week 0, Visit 2), Week 1, Week 2 and Follow-up ( Week 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study start26 Aug 2008
- Primary completion16 Jan 2009
- Study completion16 Jan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734032
- Sponsor's protocol ID
- LPL110118
- Status last verified
- Jan 2018
- First submitted
- 12 Aug 2008
- Last updated
- 12 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 -
- ClinicalTrials.gov ID
- NCT00734032
- Acronym / sponsor ID
- LPL110118
- Conditions
- Atherosclerosis
- Keywords
- SB-480848, Dyslipidaemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2008 (actual)
- Primary completion
- 16 Jan 2009 (actual)
- Study completion
- 16 Jan 2009 (actual)
- First posted
- 13 Aug 2008 (estimated)
- Results
- Posted 12 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Drug: SB480848 Placebo TabletMatched Placebo |
| SB480848 40mg Group | Experimental | Drug: SB480848 40mg EC TabletSB480848 40mg/day |
| SB480848 80mg Group | Experimental | Drug: SB480848 80mg EC TabletSB480848 80mg/day |
| SB480848 160mg Group | Experimental | Drug: SB480848 160mg EC TabletSB480848 160mg/day |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dyslipidemic subject who is currently undergoing statin therapy and no change in lipid-lowering therapy or dose during the 4 week prior to randomization
Key exclusion criteria (6 listed)
- 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
- Planned CABG or planned PCI or planned major non-cardiac surgery within study period
- No measurable Lp-PLA2 activity in plasma (<10 nmol/min/mL) at screening
- Change in a lipid-lowering medication, regimen or dosage during the 4 week prior to randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB480848 40mg EC TabletAlso: Darapladib1 tablet once a day | Drug | SB480848 40mg Group |
| SB480848 80mg EC Tablet1 tablet once a day | Drug | SB480848 80mg Group |
| SB480848 160mg EC Tablet1 tablet once a day | Drug | SB480848 160mg Group |
| SB480848 Placebo Tablet1 tablet once a day | Drug | Placebo Group |
Primary outcome
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).
2 secondary outcomes
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB480848 40mg EC Tablet, SB480848 80mg EC Tablet and SB480848 160mg EC Tablet in people with Atherosclerosis, run by GlaxoSmithKline at 7 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.