311
Participants
Start Date
June 6, 2019
Primary Completion Date
January 14, 2021
Study Completion Date
April 15, 2021
LOU064 Arm 1
10 mg LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85
LOU064 Arm 2
35 mg of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85
LOU064 Arm 3
100 mg of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85
LOU064 Arm 4
10mg bid of LOU064 orally, twice daily from Day 1 to 85
LOU064 Arm 5
25 mg bid of LOU064 orally, twice daily from Day 1 to 85
LOU064 Arm 6
100 mg bid of LOU064 orally, twice daily from Day 1 to 85
Placebo arm
Matching placebo, orally, twice daily from Day 1 to 85
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Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY