A Phase 4 interventional study of vildagliptin and placebo of vildagliptin in Congestive Heart Failure and Type II Diabetes Mellitus, sponsored by Novartis Pharmaceuticals. Completed at 94 sites in 15 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 798 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: vildagliptin
Drug: placebo of vildagliptin
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
To evaluate the overall safety of vildagliptin versus placebo in patients with T2DM and CHF (NYHA class I - III) over 52 weeks of treatment with special regard to signs and symptoms of heart failure.
Time frame: 52 weeks
To evaluate the efficacy of vildagliptin in patients with T2DM and CHF (NYHA class I-III) by assessing the HbA1c reduction with vildagliptin compared to placebo after 16 weeks of treatment.
Time frame: 52 weeks
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals