AtherosclerosisPhase 2NCT00269048
SB-480848 In Subjects With Coronary Heart Disease
A Phase 2 study testing SB-480848 in people with Atherosclerosis, run by GlaxoSmithKline at 119 sites in 16 countries.
Trial summary
This trial of SB-480848 in approximately 920 subjects with Coronary Heart Disease (CHD) or CHD-risk equivalent will examine whether SB-480848 produces sustained inhibition of plasma Lp-PLA2 activity, explore the effects of SB-480848 on other circulating biomarkers associated with cardiovascular risk, and evaluate the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- SB-480848
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 969 participants
- Where
- 119 sitesin 16 countries
- Study dates
- Nov 2005to Sep 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects must be of non-childbearing potential.
- Stable CHD or CHD-risk equivalent.
- Must have been on a stable dose of a statin for =4 weeks with LDL <130 mg/dL (3.4 mmol/L) or off statin therapy for =4 weeks with LDL <160 mg/dL (4.1 mmol/L).
- On a stable dose of at least one oral antiplatelet agent (e.g., aspirin, clopidogrel, or ticlopidine).
Who cannot join
- Recent cardiovascular event and / or vascular procedure.
- History of difficult to manage dyslipidemia.
- Planned cardiac surgery or PCI (percutaneous coronary intervention) or planned major non-cardiac surgery.
- Inadequately controlled hypertension.
- Poorly controlled diabetes mellitus.
- Serum triglycerides >400 mg/dL (4.52 mmol/L).
Show all 21Show fewer
- Recent or ongoing acute infection.
- History of chronic inflammatory disease.
- Receiving topical, oral, inhaled or injectable corticosteroids.
- History of chronic viral hepatitis, or other chronic hepatic disorders.
- History of kidney transplant.
- History of myopathy or inflammatory muscle disease, or elevated total serum CK (3 x ULN).
- Severe heart failure (NYHA class III or IV), or severe left ventricular dysfunction (ejection fraction <30%).
- Asthma manifested by bronchospasm in the past 6 months, or currently taking inhaled bronchodilator on regular basis.
- History of anaphylaxis, anaphylactoid reactions or severe allergic responses within the past 6 months.
- Malignancy within the past 2 years, other than non-melanoma skin cancer.
- Current life-threatening condition other than vascular disease that may prevent a subject from completing the study.
- QTc interval >440 msec (males) or >450 msec (females).
- Alcohol or drug abuse within the past 6 months.
- Previous exposure to SB-480848.
- Use of an investigational drug within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of study medication (blinded atorvastatin).
Trial locations and contacts
119 sites in 16 countries.
119 sites in 16 countries
United States28 sites
GSK Investigational Site
Auburn, Maine, 04210
GSK Investigational Site
Birmingham, Alabama, 35294
GSK Investigational Site
Bryan, Texas, 77802
GSK Investigational Site
Camp Hill, Pennsylvania, 17011
GSK Investigational Site
Chicago, Illinois, 60607
GSK Investigational Site
Chicago, Illinois, 60610
GSK Investigational Site
Cincinnati, Ohio, 45219
GSK Investigational Site
Fort Lauderdale, Florida, 33308
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Indianapolis, Indiana, 46260
GSK Investigational Site
Jacksonville, Florida, 32205
GSK Investigational Site
Lacombe, Louisiana, 70445
GSK Investigational Site
New York, New York, 10016
GSK Investigational Site
Norfolk, Virginia, 23502
GSK Investigational Site
Northport, Alabama, 35476
GSK Investigational Site
Oklahoma City, Oklahoma, 73132
GSK Investigational Site
Pembroke Pines, Florida, 33024
GSK Investigational Site
Philadelphia, Pennsylvania, 19104
GSK Investigational Site
Phoenix, Arizona, 85014
GSK Investigational Site
Richmond, Virginia, 23294
GSK Investigational Site
Salt Lake City, Utah, 84143
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Slidell, Louisiana, 70458
GSK Investigational Site
Spring Valley, California, 91978
GSK Investigational Site
Statesville, North Carolina, 28677
GSK Investigational Site
Torrance, California, 90509
GSK Investigational Site
Tucson, Arizona, 85715
GSK Investigational Site
Walnut Creek, California, 94598
Germany24 sites
GSK Investigational Site
Berlin, State of Berlin, 10249
GSK Investigational Site
Berlin, State of Berlin, 10367
GSK Investigational Site
Berlin, State of Berlin, 12163
GSK Investigational Site
Berlin, State of Berlin, 13125
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44787
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51069
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574
GSK Investigational Site
Haag, Bavaria, 83527
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 20249
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22041
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22143
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22335
GSK Investigational Site
Kippenheim, Baden-Wurttemberg, 77971
GSK Investigational Site
Künzing, Bavaria, 94550
GSK Investigational Site
Leipzig, Saxony, 04229
GSK Investigational Site
Leipzig, Saxony, 04315
GSK Investigational Site
Munich, Bavaria, 81241
GSK Investigational Site
Nuremberg, Bavaria, 90402
GSK Investigational Site
Rednitzhembach, Bavaria, 91126
GSK Investigational Site
Rhaunen, Rhineland-Palatinate, 55624
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19055
GSK Investigational Site
Witten, North Rhine-Westphalia, 58455
Spain18 sites
GSK Investigational Site
Alicante, 03114
GSK Investigational Site
Barcelona, 080018
GSK Investigational Site
Barcelona, 08022
GSK Investigational Site
Cáceres, 10004
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Madrid, 28035
GSK Investigational Site
Madrid, 28037
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Móstoles/Madrid, 28935
GSK Investigational Site
Oviedo, 33006
GSK Investigational Site
Palma de Mallorca, 07014
GSK Investigational Site
Quart de Poblet, Valencia, 46930
GSK Investigational Site
Sant Joan d'Alacant, 3550
GSK Investigational Site
Santa Coloma de Gramanet/Barcelona, 08923
GSK Investigational Site
Santiago de Compostela, 15706
GSK Investigational Site
Santiago de Compostela/La Coruña, 15706
GSK Investigational Site
Tarrasa, Barcelona, 08221
France9 sites
GSK Investigational Site
Anzin, 59410
GSK Investigational Site
Bron, 69677
GSK Investigational Site
Créteil, 94000
GSK Investigational Site
Dommartin-lès-Toul, 54201
GSK Investigational Site
Gières, 38610
GSK Investigational Site
Montbrison, 42600
GSK Investigational Site
Montpellier, 34295
GSK Investigational Site
Pessac, 33604
GSK Investigational Site
Toulouse, 31300
Netherlands8 sites
GSK Investigational Site
Den Helder, 1782 GZ
GSK Investigational Site
Ede, 6716 RP
GSK Investigational Site
Enschede, 7511JX
GSK Investigational Site
Haarlem, 2035 RC
GSK Investigational Site
Hoofddorp, 2130 AT
GSK Investigational Site
Rotterdam, 3011 TD
GSK Investigational Site
Sneek, 8601 ZK
GSK Investigational Site
Zeist, 3707 HL
Hungary5 sites
GSK Investigational Site
Budapest, 1032
GSK Investigational Site
Budapest, 1135
GSK Investigational Site
Debrecen, 4004
GSK Investigational Site
Szeged, 6720
GSK Investigational Site
Szolnok, 5000
Bulgaria4 sites
GSK Investigational Site
Pleven, 5800
GSK Investigational Site
Sofia, 1000
GSK Investigational Site
Sofia, 1309
GSK Investigational Site
Sofia, 1572
Canada4 sites
GSK Investigational Site
Oakville, Ontario, L6H 3P1
GSK Investigational Site
Ottawa, Ontario, K1Y 4W7
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G2
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G5
Argentina3 sites
GSK Investigational Site
Buenos Aires, Buenos Aires, 1425
GSK Investigational Site
Buenos Aires, Buenos Aires, 1704
GSK Investigational Site
Buenos Aires, C1408INH
Australia3 sites
GSK Investigational Site
Caulfield, Victoria, 3162
GSK Investigational Site
Geelong, Victoria, 3220
GSK Investigational Site
Kippa-Ring, Queensland, 4021
Estonia3 sites
GSK Investigational Site
Tallinn, 1162
GSK Investigational Site
Tallinn, 13419
GSK Investigational Site
Tartu, 51014
India3 sites
GSK Investigational Site
Banglore
GSK Investigational Site
Hyderabad, 500034
GSK Investigational Site
New Delhi, 110044
New Zealand2 sites
GSK Investigational Site
Hamilton, 2001
GSK Investigational Site
Takapuna
Pakistan2 sites
GSK Investigational Site
Karachi, 74800
GSK Investigational Site
Karachi, 75510
Romania2 sites
GSK Investigational Site
Bucharest
GSK Investigational Site
Târgu Mureş
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study of SB-480848, an Oral Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Inhibitor, in Subjects With Stable Coronary Heart Disease (CHD) or CHD-risk Equivalent to Examine Chronic Inhibition of Lp-PLA2 Effects on Circulating Biomarkers Associated With Cardiovascular Risk, Safety and Tolerability Over 12 Weeks
This trial of SB-480848 in approximately 920 subjects with Coronary Heart Disease (CHD) or CHD-risk equivalent will examine whether SB-480848 produces sustained inhibition of plasma Lp-PLA2 activity, explore the effects of SB-480848 on other circulating biomarkers associated with cardiovascular risk, and evaluate the pharmacokinetics, safety and tolerability of SB-480848 over 12 weeks of once-daily oral dosing. Subjects will first be randomized 1:1 to double-blind atorvastatin 20 mg or 80 mg once daily for a minimum of 3 weeks. Subjects will then be randomized 1:1:1:1 to oral doses of SB-480848 40 mg, 80 mg, 160 mg or placebo once daily for 12 weeks. Blood samples will be collected at various timepoints. Vital signs, electrocardiograms, clinical laboratory safety tests and adverse event assessments will be performed to evaluate the safety and tolerability of SB-480848.
Read the detailed description
A multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study of SB-480848, an oral lipoprotein-associated phospholipase A2 (Lp-PLA2) inhibitor, in subjects with stable coronary heart disease (CHD) or CHD-risk equivalent to examine chronic inhibition of Lp-PLA2, effects on circulating biomarkers associated with cardiovascular risk, safety and tolerability over 12 weeks
- Conditions
- Atherosclerosis
- Being tested
- SB-480848, placebo
- Keywords
- CHD, Lp-PLA2, SB-480848
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-480848Drug
SB-480848
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | SB-480848 Receives: Drug: SB-480848 |
| Arm 2 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
On treatment sustained inhibition of plasma Lp-PLA2 activity.
Measured: 12 Weeks
Secondary outcomes (1)
Difference in dose-dependent effects of SB-480848 on plasma Lp-PLA2 activity, other biomarkers, and safety.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startNov 2005
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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, Care provider
- Enrolment
- 969 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
- NCT00269048
- Sponsor's protocol ID
- LPL104884
- Status last verified
- Aug 2016
- First submitted
- 21 Dec 2005
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Mohler ER 3rd, Ballantyne CM, Davidson MH, Hanefeld M, Ruilope LM, Johnson JL, Zalewski A; Darapladib Investigators. The effect of darapladib on plasma lipoprotein-associated phospholipase A2 activity and cardiovascular biomarkers in patients with stable coronary heart disease or coronary heart disease risk equivalent: the results of a multicenter, randomized, double-blind, placebo-controlled study. J Am Coll Cardiol. 2008 Apr 29;51(17):1632-41. doi: 10.1016/j.jacc.2007.11.079.
PubMed 18436114
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study of SB-480848, an Oral Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Inhibitor, in Subjects With Stable Coronary Heart Disease (CHD) or CHD-risk Equivalent to Examine Chronic Inhibition of Lp-PLA2 Effects on Circulating Biomarkers Associated With Cardiovascular Risk, Safety and Tolerability Over 12 Weeks
- ClinicalTrials.gov ID
- NCT00269048
- Acronym / sponsor ID
- LPL104884
- Conditions
- Atherosclerosis
- Keywords
- CHD, Lp-PLA2, SB-480848
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 969 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 23 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial of SB-480848 in approximately 920 subjects with Coronary Heart Disease (CHD) or CHD-risk equivalent will examine whether SB-480848 produces sustained inhibition of plasma Lp-PLA2 activity, explore the effects of SB-480848 on other circulating biomarkers associated with cardiovascular risk, and evaluate the pharmacokinetics, safety and tolerability of SB-480848 over 12 weeks of once-daily oral dosing. Subjects will first be randomized 1:1 to double-blind atorvastatin 20 mg or 80 mg once daily for a minimum of 3 weeks. Subjects will then be randomized 1:1:1:1 to oral doses of SB-480848 40 mg, 80 mg, 160 mg or placebo once daily for 12 weeks. Blood samples will be collected at various timepoints. Vital signs, electrocardiograms, clinical laboratory safety tests and adverse event assessments will be performed to evaluate the safety and tolerability of SB-480848.
Detailed description
A multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study of SB-480848, an oral lipoprotein-associated phospholipase A2 (Lp-PLA2) inhibitor, in subjects with stable coronary heart disease (CHD) or CHD-risk equivalent to examine chronic inhibition of Lp-PLA2, effects on circulating biomarkers associated with cardiovascular risk, safety and tolerability over 12 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: SB-480848SB-480848 |
| Arm 2 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female subjects must be of non-childbearing potential.
- Stable CHD or CHD-risk equivalent.
- Must have been on a stable dose of a statin for =4 weeks with LDL <130 mg/dL (3.4 mmol/L) or off statin therapy for =4 weeks with LDL <160 mg/dL (4.1 mmol/L).
- On a stable dose of at least one oral antiplatelet agent (e.g., aspirin, clopidogrel, or ticlopidine).
Key exclusion criteria (21 listed)
- Recent cardiovascular event and / or vascular procedure.
- History of difficult to manage dyslipidemia.
- Planned cardiac surgery or PCI (percutaneous coronary intervention) or planned major non-cardiac surgery.
- Inadequately controlled hypertension.
- Poorly controlled diabetes mellitus.
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 |
|---|---|---|
| SB-480848SB-480848 | Drug | Arm 1 |
| placeboplacebo | Drug | Arm 2 |
Primary outcome
On treatment sustained inhibition of plasma Lp-PLA2 activity.
Time frame: 12 Weeks
1 secondary outcome
Difference in dose-dependent effects of SB-480848 on plasma Lp-PLA2 activity, other biomarkers, and safety.
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- Derived from this study: PubMed 18436114Mohler ER 3rd, Ballantyne CM, Davidson MH, Hanefeld M, Ruilope LM, Johnson JL, Zalewski A; Darapladib Investigators. The effect of darapladib on plasma lipoprotein-associated phospholipase A2 activity and cardiovascular biomarkers in patients with stable coronary heart disease or coronary heart disease risk equivalent: the results of a multicenter, randomized, double-blind, placebo-controlled study. J Am Coll Cardiol. 2008 Apr 29;51(17):1632-41. doi: 10.1016/j.jacc.2007.11.079.
- 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.
Related trials for Atherosclerosis
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
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
119 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB-480848 in people with Atherosclerosis, run by GlaxoSmithKline at 119 sites in 16 countries.
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 4 inclusion and 21 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 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 119 sites in United States, Germany, Spain, France, Netherlands and 11 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
On treatment sustained inhibition of plasma Lp-PLA2 activity. (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00269048, which also lists 1 linked publication.
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 8 Aug 2016.