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| Sponsored by: |
University of Alberta |
| Information provided by: | University of Alberta |
| ClinicalTrials.gov Identifier: | NCT00325910 |
Purpose
To conduct a pilot study to evaluate the feasibility of a large randomized controlled trial (RCT) of metformin in patients with heart failure and type 2 diabetes and to generate initial morbidity and mortality estimates in this patient population. The primary hypothesis is that subjects with heart failure and type 2 diabetes who receive metformin will have a significant reduction in the combined endpoint of all-cause mortality and all-cause hospitalization as compared to subjects who receive placebo therapy.
| Condition | Intervention | Phase |
|
Diabetes Mellitus, Type 2 Heart Failure, Congestive |
Drug: Metformin |
Phase III |
| MedlinePlus related topics: | Diabetes Heart Failure |
| ChemIDplus related topics: | Metformin Metformin hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
| Official Title: | Patients With Heart Failure ANd Type 2 Diabetes Treated With Placebo Or Metformin (PHANTOM) Pilot Study |
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2006 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A diagnosis of type 2 diabetes defined as:
Exclusion Criteria:
Contacts and Locations| Canada, Alberta | |||||
| University of Alberta Hospital | |||||
| Edmonton, Alberta, Canada, T6G 2B7 | |||||
| Misericordia Hospital | |||||
| Edmonton, Alberta, Canada, T5R 4H5 | |||||
| University of Alberta |
| Principal Investigator: | Jeffrey A Johnson, PhD | University Of Alberta, Alberta, Canada |
More Information
| Study ID Numbers: | Approval J-2865, Ethics 6002 |
| First Received: | May 12, 2006 |
| Last Updated: | May 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00325910 |
| Health Authority: | Canada: Ethics Review Committee |
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