9 results
In subjects with T2DM, with inadequate glycemic control, who have a history or high risk of CV disease:Primary Objectives*to assess the effect of canagliflozin plus standard of care relative to placebo plus standard of care on CV risk as measured by…
In subjects with T2DM with inadequate glycemic control on combination therapy withmetformin and an SU:Primary:* To assess the effect of the addition of treatment with canagliflozin compared with theaddition of treatment with sitagliptin on HbA1c…
Primary objective:* To determine whether orteronel 300 mg twice daily (BID) plus prednisone 5 mg BID more effectively reduces serum testosterone levels, compared to placebo plus prednisone 5 mg BID, when administered to patients in JapanSecondary…
Primary:-To assess the mass balance profile (ie, excretion in urine and feces) of orteronel after a single oral dose of 400 mg orteronel containing 18.5 kBq (500 nCi) of 14[C]-orteronel-To characterize the pharmacokinetic profile of total…
Primary Objective:• To determine if orteronel plus prednisone improves overall survival (OS)Key Secondary Objectives: • To determine if orteronel plus prednisone improves radiographic progression-free survival (rPFS)• To determine if orteronel plus…
To determine if orteronel plus prednisone improves radiographic progression-freesurvival (rPFS)To determine if orteronel plus prednisone improves overall survival (OS)
Primary objectiveIn subjects with T2DM receiving standard of care but with inadequate glycemic control and at elevatedrisk of cardiovascular (CV) events to assess the effect of canagliflozin compared to placebo onprogression of albuminuria.Secondary…
The main objectives are:• To assess canagliflozin target (i.e. receptor) specific binding in vivo• To assess receptor occupancy of canagliflozin in vivo• To determine optimal scanning time in vivoTo explore the relationship between canagliflozin…
Primary Objectives:• To determine the safety of ELA026 administered IV and SC to adolescent and adult participants with sHLH.• To identify the RP3D and schedule for ELA026.Secondary Objectives:• To characterize the pharmacokinetic (PK) profile of…