Status:
COMPLETED
A Pharmacokinetic Study Of SB-681323 In Subjects With Coronary Heart Disease Undergoing Percutaneous Intervention
Lead Sponsor:
GlaxoSmithKline
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Study of SB-681323 (a novel p38 MAPkinase inhibitor) in subjects with documented coronary heart disease (CHD) undergoing elective percutaneous coronary intervention (PCI).
Eligibility Criteria
Inclusion
- Females must be of non-child-bearing potential.
- Female subjects must have a negative pregnancy test.
- Subjects scheduled to undergo elective single vessel PCI to be performed within the 6 weeks of diagnostic coronary angiography.
- Must be on stable dose of statin for = 6 weeks prior to screening, with statin tolerability and LDL \<130 mg/dL (3.4 mmol/L) at Screening visit.
- Must be capable of providing informed consent.
- Have an hsCRP concentration of \>2 mg/L, but \< 10 mg/L at screening.
Exclusion
- Women who are pregnant or breast feeding.
- Planned PCI with multi-vessel stenting.
- Planned PCI with additional revascularization procedures staged at different days during the study period.
- Planned PCI other than stenting (e.g., atherectomy, PTCA without stenting, etc).
- Planned PCI of any bypass graft.
- History of CABG surgery.
- Planned cardiac or major non-cardiac surgery within the study period.
- Disabling stroke in the past 6 months.
- History of chronic viral hepatitis or other chronic hepatic disorders.
- History of Gilbert's syndrome or elevated bilirubin concentrations at screening.
- History of increased liver function tests (ALT, AST) due to acute or chronic liver conditions, above the upper limit of normal at screening or in the past 6 months.
- Renal impairment with serum creatinine \>2.0 mg/dl (177umol/L) at Screening, or history of kidney transplant, or a history of contrast nephropathy.
- Current inadequately controlled hypertension (blood pressure \>160 mmHg systolic and/or \>100 mmHg diastolic) on a stable dose of antihypertensive medication.
- Current poorly controlled diabetes mellitus, defined as HbA1c \>10% at Screening.
- History of severe heart failure defined as NYHA class III or IV or those with known severe LV dysfunction (EF\<30%) regardless of symptomatic status.
- History of malignancy within the past 5 years, other than non-melanoma skin cancer.
- Current life-threatening condition other than vascular disease that may prevent a subject from completing the study.
- Alcohol or drug abuse within the past 6 months.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00291902
Start Date
March 1 2006
Last Update
June 4 2012
Active Locations (7)
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1
GSK Investigational Site
Esbjerg, Denmark, 6700
2
GSK Investigational Site
Haderslev, Denmark, 6100
3
GSK Investigational Site
Hellerup, Denmark, 2900
4
GSK Investigational Site
Herning, Denmark, 7400