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Comparison of Different Algorithms for Predicting Clinical Drug-Drug Interactions, Based on the Use of CYP3A4 in Vitro Data: Predictions of Compounds as Precipitants of Interaction
Cytochrome P450 3A4 (CYP3A4) is the most important enzyme in drug metabolism and because it is the most frequent target for pharmacokinetic drug-drug interactions (DDIs) it is highly desirable to beExpand
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Application of CYP3A4 in vitro data to predict clinical drug-drug interactions; predictions of compounds as objects of interaction.
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT Numerous retrospective analyses have shown the utility of in vitro systems for predicting potential drug-drug interactions (DDIs). Prediction of DDIs from inExpand
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Effect of ertugliflozin on glucose control, body weight, blood pressure and bone density in type 2 diabetes mellitus inadequately controlled on metformin monotherapy (VERTIS MET)
We evaluated the efficacy and safety of ertugliflozin, an SGLT2 inhibitor, in type 2 diabetes mellitus (T2DM) inadequately controlled (HbA1c, 7.0%‐10.5%) with metformin monotherapy (≥1500 mg/d for ≥8Expand
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Evaluation of Cognitive Function in Healthy Older Subjects Treated with Fesoterodine
Abstract Objective: To evaluate the cognitive effects of fesoterodine 4 and 8 mg versus placebo in healthy older adults. Methods: This was an active– and placebo–controlled, double–blind,Expand
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Flexible‐Dose Fesoterodine in Elderly Adults with Overactive Bladder: Results of the Randomized, Double‐Blind, Placebo‐Controlled Study of Fesoterodine in an Aging Population Trial
To assess the efficacy and safety of flexible‐dose fesoterodine in elderly adults with overactive bladder (OAB).
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Phase III, efficacy and safety study of ertugliflozin monotherapy in people with type 2 diabetes mellitus inadequately controlled with diet and exercise alone
To conduct a phase III study to evaluate the efficacy and safety of ertugliflozin monotherapy in people with type 2 diabetes.
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Cognitive testing in early-phase clinical trials: Development of a rapid computerized test battery and application in a simulated Phase I study
Abstract Background Inclusion of cognitive assessment in Phase I trials of novel pharmaceutical agents may help identify subtle yet meaningful CNS effects early in clinical development, and lead to aExpand
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Long‐term safety, tolerability and efficacy of flexible‐dose fesoterodine in elderly patients with overactive bladder: Open‐label extension of the SOFIA trial
To assess the long‐term safety, tolerability, and efficacy of flexible‐dose fesoterodine in elderly patients with OAB.
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Long‐term efficacy and safety of ertugliflozin monotherapy in patients with inadequately controlled T2DM despite diet and exercise: VERTIS MONO extension study
This phase III, multicentre, randomized study (ClinicalTrials.gov; NCT01958671) evaluated the efficacy and safety of ertugliflozin monotherapy in adults with inadequately controlled type 2 diabetesExpand
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