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A Study to Evaluate the Safety and Effectiveness of Crinecerfont in Adults with Classic Congenital Adrenal Hyperplasia
Rochester, MN
The purpose of this study is to evaluate the effectiveness of NBI-74788 (100 mg twice daily [bid]), compared with placebo, in reducing daily glucocorticoid dosage while maintaining adrenal androgen control, in reducing adrenal steroid levels following an initial 4-week treatment period, on clinical endpoints associated with supraphysiologic (greater than normal) glucocorticoid dosing, to evaluate plasma concentrations of NBI-74788 and metabolites, and to assess the safety and tolerability of NBI-74788.
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A Study to Evaluate the Safety and Effectiveness of SPR001 in Adults with Classic Congenital Adrenal Hyperplasia
Rochester, MN
The purpose of this study is to evaluate the effect of Tildacerfont in reducing androstenedione (hormone, A4) in subjects with Classic Adrenal Hyperplasia (CAH) over approximately 86 weeks.
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A Study of ATR-101 for the Treatment of Congenital Adrenal Hyperplasia
Rochester, MN
This is a Phase 2 multicenter, single-blind, multiple dose study to evaluate the safety and efficacy of orally administered ATR-101 in subjects with classic congenital adrenal hyperplasia (CAH). Treatment duration will range from a minimum of approximately 2 months to 6 months per subject. A subject may receive a minimum of one dose level or up to a maximum of 5 dose levels, in sequentially increasing dose strengths. Each dose level will last 28 days.
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A Study to Evaluate the Safety and Effectiveness of Tildacerfont to Reduce Glucocorticoid Use in Classic Congenital Adrenal Hyperplasia
Rochester, MN
The purpose of this study is to evaluate the potential of Tildacerfont to reduce glucocorticoid (GC) burden in adult subjects with classic Classic Congenital Adrenal Hyperplasia (CAH) who have lower limit of detection (LLD) ≤ A4 ≤ 1.5 x upper limit of normal (ULN) and are on supraphysiologic doses of GC therapy.
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Chronocort Versus Standard Hydrocortisone Replacement Therapy to Treat Congenital Adrenal Hyperplasia in Participants Aged 16 Years and Over
Rochester, MN
The purpose of this study is to compare the effectiveness, safety, and tolerability of Chronocort (study drug) with standard of care medication, Immediate-Release Hydrocortisone (IRHC-Cortef) on subjects and their condition (CAH) to find out which is better.
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Newborn Screening and Outcomes for Congenital Adrenal Hyperplasia
Rochester, MN
The objective of this study is to evaluate the role of molecular testing to improve newborn screening (NBS) for congenital adrenal Hyperplasia (CAH).
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Prospective Study of Adrenal Disorders: Clinical Registry, Imaging Analysis and Biomaterial Collection
Rochester, MN
The purpose of this research is to follow people with adrenal disorders in order to make conclusions about the natural history of a particular adrenal disease as well as effect of various therapies and interventions decided on by you and your medical team. In addition, we will collect biomaterial from you at times you are being evaluated which will be used to discover novel biomarkers which can potentially improve the accuracy of current diagnostic tests and affect the management of patients with adrenal disorders. We will also include a control group (without known adrenal disease) to compare to the volunteers ...