Integrated Biomarker And Imaging Study - 2
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00268996
First received: December 21, 2005
Last updated: May 15, 2009
Last verified: May 2009
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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:
Detailed Description:
-
Drug: SB-480848
Other Name: SB-480848
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
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 Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013