Abstract

The primary objective of this trial is: 1. To evaluate the long-term safety and the tolerability (adverse experiences) of oral ridogrel 2.5 mg or 5.0 mg given for 24 months to pediatric patients with ulcerative colitis. The secondary objectives are: 1. To evaluate the pharmacokinetics of a single oral dose of 2.5 or 5.0 mg ridogrel in pediatric patients age >8 to <18 with active U.C. 2. To evaluate/document the long-term efficacy of oral ridogrel on endoscopic and clinical activity scores in pediatric patients with ulcerative colitis. 3. If possible, to evaluate the impact of the disease state (active versus non-active) on the pharmacokinetics of ridogrel. In December 1998 the Mallinckrodt General Clinical Research Center was notified by the principal investigator that the sponsor, Pharmaceutical Research Associates, Inc., had been notified by Jansen Research Foundation that enrollment has been suspended for both SPID 0395 and SPID 0396. This decision has been made as a result of data received from the pivotal trials.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR001066-22S3
Application #
6265467
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
22
Fiscal Year
1999
Total Cost
Indirect Cost

  Institution

Name
Massachusetts General Hospital
Department
Type
DUNS #
City
Boston
State
MA
Country
United States
Zip Code
02199

  Publications

Fourman, Lindsay T; Czerwonka, Natalia; Shaikh, Sofia D et al. (2018) Insulin-like growth factor 1 inversely relates to monocyte/macrophage activation markers in HIV. AIDS 32:927-932
Berkowitz, Robert I; Marcus, Marsha D; Anderson, Barbara J et al. (2018) Adherence to a lifestyle program for youth with type 2 diabetes and its association with treatment outcome in the TODAY clinical trial. Pediatr Diabetes 19:191-198
Arslanian, Silva; El Ghormli, Laure; Kim, Joon Young et al. (2018) The Shape of the Glucose Response Curve During an Oral Glucose Tolerance Test: Forerunner of Heightened Glycemic Failure Rates and Accelerated Decline in ?-Cell Function in TODAY. Diabetes Care :
Kriska, Andrea; El Ghormli, Laure; Copeland, Kenneth C et al. (2018) Impact of lifestyle behavior change on glycemic control in youth with type 2 diabetes. Pediatr Diabetes 19:36-44
Venditti, E M; Tan, K; Chang, N et al. (2018) Barriers and strategies for oral medication adherence among children and adolescents with Type 2 diabetes. Diabetes Res Clin Pract 139:24-31
Foldyna, Borek; Fourman, Lindsay T; Lu, Michael T et al. (2018) Sex Differences in Subclinical Coronary Atherosclerotic Plaque Among Individuals With HIV on Antiretroviral Therapy. J Acquir Immune Defic Syndr 78:421-428
Gidding, Samuel S; Bacha, Fida; Bjornstad, Petter et al. (2018) Cardiac Biomarkers in Youth with Type 2 Diabetes Mellitus: Results from the TODAY Study. J Pediatr 192:86-92.e5
Srinivasa, Suman; Lu, Michael T; Fitch, Kathleen V et al. (2018) Epicardial adipose tissue volume and cardiovascular risk indices among asymptomatic women with and without HIV. Antivir Ther 23:1-9
Schorr, Melanie; Dichtel, Laura E; Gerweck, Anu V et al. (2018) Sex differences in body composition and association with cardiometabolic risk. Biol Sex Differ 9:28
Srinivasan, Shylaja; Kaur, Varinderpal; Chamarthi, Bindu et al. (2018) TCF7L2 Genetic Variation Augments Incretin Resistance and Influences Response to a Sulfonylurea and Metformin: The Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans (SUGAR-MGH). Diabetes Care 41:554-561

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