This is a randomised, double-blind, placebo-controlled, therapeutic confirmatory multicentre
trial with 4 parallel treatment groups. The design is adaptive group-sequential with two
interim analyses, possible sample size re-estimation after the first or second interim
analysis and drop-the-loser approach. The study design was primarily chosen to show superior
efficacy of Tepilta® compared to the single components and to placebo. Evaluation of safety
is a secondary objective.
Phase:
Phase 3
Details
Lead Sponsor:
MEDA Pharma GmbH & Co. KG
Collaborators:
Clinipace Worldwide ICON plc Trium Analysis Online GmbH