5 results
Primary: To demonstrate the superiority of NVA237 50 *g o.d. compared to placebo in addition to background therapy with long acting B2 agonist/ inhaled corticosteroid (* 800 *g/day of budesonide or equivalent) in terms of trough FEV1 after 26 weeks…
Determine whether temozolomide given during radiation therapy followed by the combination of temozolomide and CCNU as adjuvant therapy results in an improvement in event-free survival compared to historical control cohorts.To further assess the…
The primary objective is to investigate the safety and tolerability of inhalation of glycopyrronium inhalation powder using different dosing regimens. The second objectives are to determine the decrease in drooling by using different dosing regimens…
Primary Objectives• Safety and tolerability• PK of OCA and its conjugates o SD PK Phase: To assess the PK of OCA and its conjugates after a single low dose of OCA on Day 1 and determine subject eligibility for the MD Phase o MD Phase: To assess the…
The primary objective is to assess the effects of the combination of OCA and BZF on alkaline phosphatase(ALP) in comparison to BZF alone in subjects with primary biliary cholangitis (PBC)To assess the effects of the combination of OCA and BZF in…