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Discover 14,456 clinical trials near Minneapolis, Minnesota. Find research studies in your area.
Showing 10641-10660 of 14,456 trials
NCT01711723
In accordance with the recently revised FDA draft renal impairment guidance (March 2010) which advises the conduct of renal impairment study in drugs that are not predominately eliminated through the renal route, the proposed study will be conducted to formally assess the pharmacokinetics (PK) of darapladib in severely renally impaired subjects. In this is an open-label, non-randomized study eight subjects with severe renal impairment will be recruited along with 8 healthy control subjects matched to the severe renal impairment subjects based on gender, body mass index (plus or minus 20%) and age (plus or minus 10 years). All subjects will receive repeat oral doses of darapladib 160 milligram (mg) for 10 consecutive days. The pharmacokinetics of darapladib and its metabolites; and safety and tolerability will be evaluated. All the subjects will be admitted to the clinic on the evening of Day -1. Subjects may check out of the clinic on Day 2 after all assessments are complete, but must return to the clinic each day (Days 3-8) for dosing and assessments. Subjects will be admitted to the clinic again on the evening of Day 9. After the last dose of the study drug, there will be a follow-up period which will include 2 visits (Day 20-24 and Day 38-52). The total study duration for each subject including the screening, treatment and follow-up periods will be approximately 11 weeks.
NCT01007435
This randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A) tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks.