Integrated Biomarker And Imaging Study - 2

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00268996
First received: December 21, 2005
Last updated: May 15, 2009
Last verified: May 2009
  Purpose

IBIS-2 is a study using SB-480848 versus placebo in subjects with angiographically documented coronary heart disease. Endpoints include coronary imaging, endothelial function, biomarkers, safety and tolerability.


Condition Intervention Phase
Coronary Artery Disease
Drug: SB-480848
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • IVUS (Intravascular Ultrasound) -based palpography and high sensitivity C-reactive protein

Secondary Outcome Measures:
  • Endothelial function plaque volume by quantitative coronary angiography and intravascular ultrasound circulating biomarkers

Estimated Enrollment: 300
Study Start Date: November 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SB-480848
    Other Name: SB-480848
Detailed Description:

Integrated Biomarker and Imaging Study -2 (IBIS-2): An International, Multicenter, Randomized, Placebo-controlled, Parallel-group, 1 Year Treatment, Integrated Biomarkers and Imaging Study in Subjects with Angiographically Documented Coronary Heart Disease (CHD) to Examine the Effects of the Novel Lipoprotein-associated Phospholipase A2 (Lp-PLA2) inhibitor SB-480848 on Intermediate Cardiovascular Endpoints, Patient Safety and Tolerability.

  Eligibility

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

Inclusion criteria:

  • Successful PCI (Percutaneous Coronary Intervention) or uncomplicated diagnostic catheterization
  • Suitable non-intervened coronary artery with IVUS
  • Antiplatelet therapy

Exclusion criteria:

  • Clinical instability
  • Previous CABG (Coronary Artery By-pass Graft) surgery
  • Planned major surgery
  • Recent stroke
  • Abnormal QTc
  • Renal or hepatic impairment
  • Uncontrolled hypertension
  • Use of corticosteroids
  • Class III or IV heart failure
  • Asthma
  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: NCT00268996

Locations
Austria
GSK Investigational Site
Vienna, Austria, A-1140
Belgium
GSK Investigational Site
Aalst, Belgium, 9300
GSK Investigational Site
Antwerpen, Belgium, 2020
GSK Investigational Site
Liège, Belgium, 4000
Czech Republic
GSK Investigational Site
Praha 2, Czech Republic, 128 08
Denmark
GSK Investigational Site
Aarhus N, Denmark, DK-8200
Germany
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89081
GSK Investigational Site
Muenchen, Bayern, Germany, 80336
GSK Investigational Site
Bad Nauheim, Hessen, Germany, 61231
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45122
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany, 23795
GSK Investigational Site
Hamburg, Germany, 22527
Netherlands
GSK Investigational Site
Eindhoven, Netherlands, 5623 EJ
GSK Investigational Site
Enschede, Netherlands, 7511JX
GSK Investigational Site
Leeuwarden, Netherlands, 8934 AD
GSK Investigational Site
Rotterdam, Netherlands, 3015 GD
GSK Investigational Site
Rotterdam, Netherlands, 3075 EA
Norway
GSK Investigational Site
Bergen, Norway, 5053
Poland
GSK Investigational Site
Katowice, Poland, 40-635
GSK Investigational Site
Krakow, Poland, 31-501
Spain
GSK Investigational Site
Marid, Spain, 28040
GSK Investigational Site
Santander, Spain, 38008
Switzerland
GSK Investigational Site
Luzern 16, Switzerland, 6000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00268996     History of Changes
Other Study ID Numbers: SB-480848/026
Study First Received: December 21, 2005
Last Updated: May 15, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
Lipoprotein-associated Phospholipase A2
palpography
hs-CRP
Coronary artery disease
endothelial function
intravascular ultrasound

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

ClinicalTrials.gov processed this record on October 20, 2014