A Pharmacokinetic Study Of SB-681323 In Subjects With Coronary Heart Disease Undergoing Percutaneous Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00291902
Recruitment Status : Completed
First Posted : February 15, 2006
Last Update Posted : June 4, 2012
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Drug: SB-681323 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A 28-day, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Anti-inflammatory Effect and Steady-state Pharmacokinetics of SB-681323 (7.5 mg) in Subjects With Coronary Heart Disease (CHD) Undergoing Elective Percutaneous Coronary Interventions (PCI)
Study Start Date : March 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Patient safety Tolerability Anti-inflammatory effect (high sensitivity C-reactive Protein) [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Anti-inflammatory effect (biomarkers) Endothelial function (peripheral artery tonometry) Pharmacokinetics [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00291902

GSK Investigational Site
Esbjerg, Denmark, 6700
GSK Investigational Site
Haderslev, Denmark, 6100
GSK Investigational Site
Hellerup, Denmark, 2900
GSK Investigational Site
Herning, Denmark, 7400
GSK Investigational Site
Viborg, Denmark, 8800
GSK Investigational Site
Bialystok, Poland, 15-276
GSK Investigational Site
Poznan, Poland, 60-355
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: GlaxoSmithKline Identifier: NCT00291902     History of Changes
Other Study ID Numbers: PMK103351
First Posted: February 15, 2006    Key Record Dates
Last Update Posted: June 4, 2012
Last Verified: September 2011

Keywords provided by GlaxoSmithKline:
coronary heart disease

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases