Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure
Tracking Information
Start Date ICMJE | May 2009 |
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Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: May 6, 2009) | To evaluate the effect of vildagliptin on left ventricular function in patients with T2DM and CHF (NYHA class I-III) by showing that vildagliptin is at least not inferior to placebo with respect to change in left ventricular ejection fraction (LVEF). [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00894868 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: May 6, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure |
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Official Title ICMJE | A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of 52 Weeks Treatment With Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure |
Brief Summary | This study will assess the effect of vildagliptin on left ventricular function in patients with type 2 diabetes and congestive heart failure (NYHA Class I-III). Effect on HbA1c and overall safety and tolerability will also be assessed. |
Detailed Description | |
Study Phase | Phase IV |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 490 | ||||
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Completion Date | |||||
Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 85 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Czech Republic, Estonia, India, Italy, Latvia, Lithuania, Poland, Romania, Russian Federation, Slovakia |
Administrative Information
NCT ID ICMJE | NCT00894868 |
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Responsible Party | External Affairs, Novartis Pharma AG |
Study ID Numbers ICMJE | CLAF237A23118, EUDRACT number:2008-005012-41 |
Study Sponsor ICMJE | Novartis Pharmaceuticals |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Novartis |
Source: http://clinicaltrials.gov/