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A Phase IIb Two-cohort, Randomised, Placebo-controlled, Double-blind, Multi-centre, Dose-ranging Study of AZD5462 in Stable Patients with Chronic Heart Failure

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510148-19-00
Acronym
D9090C00008
Enrollment
235
Registered
2024-07-02
Start date
2024-07-03
Completion date
2026-01-21
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure

Brief summary

Change in echocardiographic measurements from Baseline to Week 25

Detailed description

Change in echocardiographic measurements from Baseline to Week 13 and Week 25, • Change in Health Status from Baseline to Week 3, Week 5, Week 13, and Week 25 • Change in NYHA FC from Baseline to Week 25, Change echocardiographic measurements from baseline to week 25, Change in cardiac biomarkers from Baseline to Week 5, Week 13, and Week 25, AZD5462 plasma PK concentrations

Interventions

DRUGThe AZD5462 film-coated tablet placebo contains microcrystalline cellulose
DRUGmagnesium stearate
DRUGmacrogol (polyethylene glycol) and talc. It is supplied in the same pack as the active and should be stored according to instructions on the label.

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in echocardiographic measurements from Baseline to Week 25

Secondary

MeasureTime frame
Change in echocardiographic measurements from Baseline to Week 13 and Week 25, • Change in Health Status from Baseline to Week 3, Week 5, Week 13, and Week 25 • Change in NYHA FC from Baseline to Week 25, Change echocardiographic measurements from baseline to week 25, Change in cardiac biomarkers from Baseline to Week 5, Week 13, and Week 25, AZD5462 plasma PK concentrations

Countries

Bulgaria, Czechia, Denmark, Hungary, Netherlands, Poland, Slovakia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026