Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT02678312
Pre Assignment Details:
The low and high doses for Group 3 0.4 mg/kg and 1.6 mg/kg, respectively. 26 patients received either one or two single doses of LCZ696 in Pt 1. In Pt 2, patients were randomized to receive either LCZ696 or enalapril. 377 patients were randomized and 375 received study drug (2 did not receive drug). 11 of 26 Pt 1 patients rolled into Pt 2; however, 1 patient had two ID numbers; so only 10 unique patients were in Pt 1 \& 2.
Recruitment Details:
2-Part (Pt) Study: Pt 1 a single dose PK/PD study with 2 dose levels; Pt 2 is a 52-week, double blind, active controlled, randomized, safety \& efficacy study. In Pt 1, there were 3 age groups: 6 to \<18 yrs, 1 to \<6 yrs and 1 month to \<1 yr. Each received either a single low dose LCZ696 (Cohort 1), a single high dose LCZ696 (Cohort 2) or both. Cohort S included patients receiving a single low dose after having received a single high dose. The low/high doses for groups 1/2 were 0.8 \& 3.1 (mg/kg).
Study:
NCT02678312
Study Brief:
Results Section:
NCT02678312