A Pharmacokinetic Study Of SB-681323 In Subjects With Coronary Heart Disease Undergoing Percutaneous Intervention
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00291902
First received: February 13, 2006
Last updated: May 31, 2012
Last verified: September 2011
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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
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 Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013