Protocol Summary for 112670
| Protocol Id: | 112670 |
| Secondary Ids: |
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| Title: | A multi-center, placebo-controlled study to evaluate the safety of GSK716155 and its effects on myocardial metabolism, myocardial function, and exercise capacity in patients with NYHA Class II/III congestive heart failure |
| Phase: | phase 2 |
| Acronym: | |
| FDA Regulated Intervention?: | Yes |
| Section 801 Clinical Trial?: | Yes |
| Delayed Posting: | No |
| IND/IDE Protocol?: | yes |
| IND/IDE Grantor: | CBER |
| IND/IDE Number: | 65,177 |
| IND/IDE Serial Number: | TBD |
| Has Expanded Access?: | no |
| Study Type: | Interventional |
| Oversight Authority: |
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| Brief Summary: | This exploratory proof of concept study will be conducted in patients with stable New York Heart Association (NYHA) Class II-III heart failure. The focus of the efficacy endpoints is to test the hypothesis that GSK716155 administration will increase glucose uptake and utilization in the myocardium, resulting in increased myocardial efficiency and increased exercise capacity. A positive result, defined as either statistically significant effects on one or more of the efficacy endpoints or as an overall signal suggesting a clinically relevant effect on myocardial physiology, would provide evidence for potential progression into further development in a chronic heart failure population. |
| Detailed Description: | |
| Record Verification Date: | April 2013 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | September 2010 |
| Study Completion Date: | August 2012 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | August 2012 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | basic |
| Allocation: | Randomized |
| Masking: | Double Blind |
| Masked Subject: | yes |
| Masked Caregiver: | yes |
| Masked Investigator: | yes |
| Masked Assessor: | no |
| Study Design (Assignment): | Parallel Assignment |
| Study Classification (Endpoint): | Safety/Efficacy Study |
| Primary Outcomes: |
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| Keywords: |
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| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 21 Year |
| Maximum Age: | 75 Year |
| Enrollment: | 70 |
| Enrollment Type: | Actual |
| Healthy Volunteers?: | none |
| Central Contact: | Call Center |
| Central Contact Phone: | 877-379-3718 |
| Central Contact Email: | GSKClinicalSupportHD@gsk.com |
| Backup Central Contact: | |
| Backup Central Contact Phone: | |
| Backup Central Contact Email: | |
| Overall Study Official: | GSK Clinical Trials |
| Overall Study Official Affiliation: | GlaxoSmithKline |
| Overall Study Official Role: | Study Director |
| Responsible Party Name/Official Title: | Cheri Hudson; Clinical Disclosure Advisor |
| Responsible Party Organization: | GSK Clinical Disclosure |
| Location and Contact Information: |
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Click to view inclusion/exclusion criteria