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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00291902
First received: February 13, 2006
Last updated: May 31, 2012
Last verified: September 2011
  Purpose

Study of SB-681323 (a novel p38 MAPkinase inhibitor) in subjects with documented coronary heart disease (CHD) undergoing elective percutaneous coronary intervention (PCI).


Condition Intervention Phase
Coronary Heart Disease
Drug: SB-681323
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

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

Estimated Enrollment: 80
Study Start Date: March 2006
Intervention Details:
    Drug: SB-681323
    Other Name: SB-681323
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291902

Locations
Denmark
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
Poland
GSK Investigational Site
Bialystok, Poland, 15-276
GSK Investigational Site
Poznan, Poland, 60-355
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00291902     History of Changes
Other Study ID Numbers: PMK103351
Study First Received: February 13, 2006
Last Updated: May 31, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by GlaxoSmithKline:
CHD
coronary heart disease
atherosclerosis
inflammation

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

ClinicalTrials.gov processed this record on October 30, 2014