LUMINARA
A Phase IIb Two-Cohort, Randomised, Placebo-controlled, Double-blind, Multi-centre, Dose-ranging Study of AZD5462 in Stable Patients With Chronic Heart Failure
Patient / Population Intervention / Exposition Comparaison Critère de jugement
In 375 patients with chronic heart failure, AZD5462, an oral relaxin agonist was compared with placebo on the change in LV end-systolic volume index or systemic vascular resistance at 24 weeks.
N
375
Schéma
phase 2b, randomised 1:1:1:1 (stratified by cohort), double-blind, placebo-controlled, multicentre (57 sites in 10 countries), dose-ranging; two cohorts — A: LVEF ≤35 % (≈220 planned), B: LVEF 41–55 % (≈140 planned); three once-daily oral doses of AZD5462 vs placebo for 24 weeks, plus 4-week follow-up
Critère
Cohort A — change from baseline in left ventricular end-systolic volume index after 24 weeks of treatment; Cohort B — change from baseline in systemic vascular resistance index after 24 weeks of treatment (echocardiographic, week 25 visit)