Baseline Characteristics Module
The Baseline Characteristics Module provides demographic and baseline characteristics information for participants in a clinical trial. This module includes data such as population descriptions and the types of units analyzed, helping researchers understand the baseline characteristics of study participants.
Baseline Characteristics Module path is as follows:
Study -> Results Section -> Baseline Characteristics Module
Baseline Characteristics Module
Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 1:05 AM
NCT ID:
NCT03610334
Population Description:
the trial is divided into 2 phases (SAD and MAD). SAD included a total of 6 cohorts (total of 48 volunteers), with 36 (6x6) volunteers receiving the verum at dose ranging from 2.5mg to 60.0mg/day, and 12 (6x2) receiving the equivalent placebo. MAD included a total of 3 cohorts (total of 24 volunteeres), with 18 (3x6) receiving the verum at dose ranging from 15 to 50mg/day, and 6 (3x2) receiving the equivalent placebo for 14 days.
All patients were healthy French caucasian male above 18 years.
Study:
NCT03610334
Study Brief:
Results Section:
NCT03610334