Pediatric Research Studies
Study Title: A Phase III, Multicenter, Double-Blind, Randomized, Placebo and Metformin-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Sitagliptin in Pediatric Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control.
Study Purpose: The purpose of the study is to assess the safety of the addition of sitagliptin, and its effect on hemoglobin A1c (A1C) in pediatric participants 10-17 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control.
Priincipal Investigator: Jeffrey L. Blumer, Ph.D., M.D.
Study Coordinator: Bonnie Rosolowski, RRT, CCRC, for more information please contact 419-291-2191
Study Title: A Double-blind, Randomized, Stratified Multi-center Trial Evaluating Conventional and High Dose Oseltamivir in the Treatment of Immunocompromised Patients With Influenza
Study Purpose: This 2-arm study will investigate the safety and tolerability of twice daily conventional and high dose Tamiflu (oseltamivir) for the treatment of influenza in immunocompromised patients. Eligible immunocompromised patients with laboratory-confirmed influenza will be randomized to receive either conventional dose (30mg-75mg twice daily po, depending on age and weight) or high dose (60mg-150mg twice daily po depending on age and weight) Tamiflu for 10 days. Nasal and throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study treatment is 10 days.
Priincipal Investigator: Jeffrey L. Blumer, Ph.D., M.D.
Study Coordinator: Bonnie Rosolowski, RRT, CCRC, for more information please contact 419-291-2191
Study Title: A Randomized, Multi-Center, Parallel Group, Single-Dose, Pharmacokinetics and Pharmacodynamics Study of Dapagliflozin in Children and Adolescents Aged 10 to 17 Years With Type 2 Diabetes Mellitus
Study Purpose: The purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin in pediatric subjects with type 2 diabetes mellitus (T2DM)
Priincipal Investigator: Jeffrey L. Blumer, Ph.D., M.D.
Study Coordinator: Bonnie Rosolowski, RRT, CCRC, for more information please contact 419-291-2191
Study Title: A Multicenter, Double-blind, Randomized, 52-week, Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age
Study Purpose: The purpose of this study is to evaluate in a randomized, double-blind fashion, the long-term safety, tolerability and efficacy profile of aliskiren compared to the active comparator enalapril in children, 6 - 17 years old with hypertension (msSBP ≥ 95th percentile for age, gender and height, at baseline in study CSPP100A2365). Patients will be randomized to receive either aliskiren or enalapril. Weight-group based doses of aliskiren or enalapril will be administered once daily and children will receive study medication in a double-blind manner. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in pediatric patients 6-17 years of age (age at baseline in Study CSPP100A2365).
Priincipal Investigator: Jeffrey L. Blumer, Ph.D., M.D.
Study Coordinator: Bonnie Rosolowski, RRT, CCRC, for more information please contact 419-291-2191
Study Title: A Multicenter, Randomized, Double-blind, 8 Week Study to Evaluate the Dose Response, Efficacy and Safety of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age
Study Purpose: This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight-based doses. The low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid dose ranges from 37.5 mg to 150 mg of aliskiren and the high dose ranges from 150 mg to 600 mg of aliskiren. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in children 6-17 years of age.
Priincipal Investigator: Jeffrey L. Blumer, Ph.D., M.D.
Study Coordinator: Bonnie Rosolowski, RRT, CCRC, for more information please contact 419-291-2191