AtherosclerosisPhase 2NCT00695305
An Imaging Study in Patients With Atherosclerosis Taking Rilapladib or Placebo for 12 Weeks
A Phase 2 study testing rilapladib and 18F Fluorodeoxylucose (FDG)-PET in people with Atherosclerosis, run by GlaxoSmithKline at 10 sites in United States.
Trial summary
A study in patients with atherosclerosis to assess safety, effect and PK of rilapladib vs. placebo over 12 weeks of dosing. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- rilapladib and 18F Fluorodeoxylucose (FDG)-PET
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 10 sitesUnited States
- Study dates
- Nov 2008to May 2010
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving written informed consent and able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
- Male or female, aged 50 to 80 years inclusive, at screening.
- Females must be of non-childbearing potential
- Body weight ≥ 50 kg and BMI within the range 19-35 kg/m2
- Documented atherosclerotic vascular disease (e.g. prior MI, prior revascularization, peripheral arterial disease, carotid disease, or cerebrovascular disease) and clinically stable for at least 6 months
- If diabetic, have well controlled diabetes, defined for the purpose of this study as HbA1c ≤8% or FPG ≤200 mg/dL
- Evidence of plaque inflammation [carotid artery or ascending aorta plaque inflammation defined as a tissue to background ratio (TBR) ≥ 1.6]
- On a stable dose of a statin for 3 months prior to screening with no evidence of statin intolerance
Who cannot join
- Recent (i.e., <6 months from Screening Visit) CV event defined as ST-elevation MI or non-ST-elevation MI, confirmed by cardiac enzyme elevation and ECG changes, coronary revascularization (PCI or CABG), stroke of any etiology, resuscitated sudden death, prior carotid surgery or stenting procedure
- Evidence of clinical instability or abnormal clinical laboratory findings prior to randomization that, in the opinion of the Investigator, makes the subject unsuitable for the study.
- Exposure to substantial radiation within the past 12 months
- Planned cardiac surgery (e.g., CABG, valve repair or replacement, or aneurysmectomy), PCI or major non-cardiac surgery within the study period
- Current inadequately controlled hypertension (blood pressure ≥160 mmHg systolic or ≥100 mmHg diastolic) on a stable dose of anti-hypertensive medication
- Diabetics taking injectable insulin at screening
Show all 27Show fewer
- Serum triglycerides >400 mg/dL, LDLc >130 mg/dL
- Recent (<1 month) or ongoing acute infection.
- History of chronic inflammatory disease
- Recently received (<1 month) or currently receiving oral or injectable corticosteroids, or regular use of nasal, inhaled or topical corticosteroids.
- Subjects who will commence, or who are likely to commence regular treatment with oral, non-steroidal anti-inflammatory drugs (NSAIDs) from screening until study completion
- Currently receiving oral or injectable potent CYP3A4 inhibitor(s)
- History of chronic viral hepatitis or other chronic hepatic disorders; or ALT or AST >1.5 x ULN, or alkaline phosphatase or total bilirubin >1.5 x ULN of laboratory reference range at Screen
- Renal impairment with serum creatinine >2.0 mg/dl or history of kidney transplant or status post nephrectomy.
- History of myopathy or inflammatory muscle disease, or elevated total CPK at screening
- History of severe heart failure defined as NYHA class III or IV or those with known severe left ventricular dysfunction (ejection fraction<30%) regardless of symptomatic status
- History of adult asthma (or reactive airway disease) manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s)
- History of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions or severe allergic responses
- History of malignancy within the past 2 years.
- A history of glaucoma or any other findings in the baseline eye exam
- Current life-threatening condition other than vascular disease that may prevent a subject from completing the study
- QTc interval ≥450msec at screening or ≥480 msec for subjects with bundle branch block
- History of drug abuse within the past 6 months
- Previous exposure to rilapladib.
- Contraindication to MRI scanning
- Use of an investigational drug within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of study medication
- Any other subject the Investigator deems unsuitable for the study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
GSK Investigational Site
Boston, Massachusetts, 02114
GSK Investigational Site
Brockton, Massachusetts, 02301
GSK Investigational Site
Haverhill, Massachusetts, 01830
GSK Investigational Site
Linden, New Jersey, 07036
GSK Investigational Site
New York, New York, 10001
GSK Investigational Site
New York, New York, 10029
GSK Investigational Site
New York, New York, 10035
GSK Investigational Site
New York, New York, 10065
GSK Investigational Site
North Massapequa, New York, 11758
GSK Investigational Site
Warwick, Rhode Island, 02886
About this study
Official title: A Multicenter, Randomized, 12 Week, Double-blind, Placebo-controlled, Parallel-group, Phase IIa Study Using 18F Fluorodeoxyglucose (FDG)-PET to Measure the Effects of Rilapladib on Macrophage Activity in Subjects With Atherosclerosis
A study in patients with atherosclerosis to assess safety, effect and PK of rilapladib vs. placebo over 12 weeks of dosing.
Read the detailed description
Study LP2105521 is a randomized, double-blind, placebo-controlled, parallel-group study to examine the safety, tolerability, and effects of rilapladib on plasma Lp-PLA2 activity, plaque inflammation, and PAF (if feasible). Subjects will receive placebo or rilapladib once daily for 12 weeks. The study will be conducted in subjects with established atherosclerosis.
- Conditions
- Atherosclerosis
- Being tested
- rilapladib, placebo, 18F Fluorodeoxylucose (FDG)-PET
- Keywords
- rilapladib,, Lp-PLA2,, atherosclerosis, SB-659032,, FDG-PET,
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rilapladibDrug
Also called SB-659032
250 mg oral dose once daily
placeboDrug
placebo
18F Fluorodeoxylucose (FDG)-PETOther
Also called FDG marker
FDG-PET
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo to match Receives: Drug: placebo |
| rilapladib | Active comparator | 250 mg/day Receives: Drug: rilapladib; Other: 18F Fluorodeoxylucose (FDG)-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety from AE reporting, vital signs, clinical labs, ECGs, slit lamp eye exams and electron microscopy of peripheral blood lymphocytes.
Measured: 12 weeks
LP-PLA2 activity;
Measured: 12 weeks
changes in mean standard values of 18 FDG uptake as assessed by PET and MRI imaging
Measured: 12 weeks
Secondary outcomes (4)
Estimation of PK parameters (such as: apparent volume of distribution, apparent clearance, etc.) of rilapladib and their associated variability, appropriate to the final model
Measured: 12 weeks
Estimation of PK/PD parameters (such as: IC50, Eo) and their associated variability, appropriate to the final model
Measured: 12 weeks
24 hour ambulatory blood pressure monitoring
Measured: 12 weeks
PAF levels in human plasma as feasible
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 posted11 Jun 2008 (estimated)
- Study startNov 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 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
- NCT00695305
- Sponsor's protocol ID
- LP2105521
- Status last verified
- Nov 2016
- First submitted
- 9 Jun 2008
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, 12 Week, Double-blind, Placebo-controlled, Parallel-group, Phase IIa Study Using 18F Fluorodeoxyglucose (FDG)-PET to Measure the Effects of Rilapladib on Macrophage Activity in Subjects With Atherosclerosis
- ClinicalTrials.gov ID
- NCT00695305
- Acronym / sponsor ID
- LP2105521
- Conditions
- Atherosclerosis
- Keywords
- rilapladib,, Lp-PLA2,, atherosclerosis, SB-659032,, FDG-PET,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 11 Jun 2008 (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.
A study in patients with atherosclerosis to assess safety, effect and PK of rilapladib vs. placebo over 12 weeks of dosing.
Detailed description
Study LP2105521 is a randomized, double-blind, placebo-controlled, parallel-group study to examine the safety, tolerability, and effects of rilapladib on plasma Lp-PLA2 activity, plaque inflammation, and PAF (if feasible). Subjects will receive placebo or rilapladib once daily for 12 weeks. The study will be conducted in subjects with established atherosclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placeboplacebo to match |
| rilapladib | Active comparator | Drug: rilapladib, Other: 18F Fluorodeoxylucose (FDG)-PET250 mg/day |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Capable of giving written informed consent and able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
- Male or female, aged 50 to 80 years inclusive, at screening.
- Females must be of non-childbearing potential
- Body weight ≥ 50 kg and BMI within the range 19-35 kg/m2
- Documented atherosclerotic vascular disease (e.g. prior MI, prior revascularization, peripheral arterial disease, carotid disease, or cerebrovascular disease) and clinically stable for at least 6 months
Key exclusion criteria (27 listed)
- Recent (i.e., <6 months from Screening Visit) CV event defined as ST-elevation MI or non-ST-elevation MI, confirmed by cardiac enzyme elevation and ECG changes, coronary revascularization (PCI or CABG), stroke of any etiology, resuscitated sudden death, prior carotid surgery or stenting procedure
- Evidence of clinical instability or abnormal clinical laboratory findings prior to randomization that, in the opinion of the Investigator, makes the subject unsuitable for the study.
- Exposure to substantial radiation within the past 12 months
- Planned cardiac surgery (e.g., CABG, valve repair or replacement, or aneurysmectomy), PCI or major non-cardiac surgery within the study period
- Current inadequately controlled hypertension (blood pressure ≥160 mmHg systolic or ≥100 mmHg diastolic) on a stable dose of anti-hypertensive medication
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 |
|---|---|---|
| rilapladibAlso: SB-659032250 mg oral dose once daily | Drug | rilapladib |
| placeboplacebo | Drug | placebo |
| 18F Fluorodeoxylucose (FDG)-PETAlso: FDG markerFDG-PET | Other | rilapladib |
Primary outcome
Safety from AE reporting, vital signs, clinical labs, ECGs, slit lamp eye exams and electron microscopy of peripheral blood lymphocytes.
Time frame: 12 weeks
LP-PLA2 activity;
Time frame: 12 weeks
changes in mean standard values of 18 FDG uptake as assessed by PET and MRI imaging
Time frame: 12 weeks
4 secondary outcomes
Estimation of PK parameters (such as: apparent volume of distribution, apparent clearance, etc.) of rilapladib and their associated variability, appropriate to the final model
Time frame: 12 weeks
Estimation of PK/PD parameters (such as: IC50, Eo) and their associated variability, appropriate to the final model
Time frame: 12 weeks
24 hour ambulatory blood pressure monitoring
Time frame: 12 weeks
PAF levels in human plasma as feasible
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 1 Dec 2016.
- 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
10 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 rilapladib and 18F Fluorodeoxylucose (FDG)-PET in people with Atherosclerosis, run by GlaxoSmithKline at 10 sites in United States.
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 8 inclusion and 27 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 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
Safety from AE reporting, vital signs, clinical labs, ECGs, slit lamp eye exams and electron microscopy of peripheral blood lymphocytes. (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 1 Dec 2016.