Study identifier:D6582C00001
ClinicalTrials.gov identifier:NCT05492877
EudraCT identifier:2022-002441-18
CTIS identifier:N/A
A Phase IIa Randomised, Double Blind, Placebo Controlled, Parallel Arm, Multi-Centre Study to Evaluate the Efficacy and Safety of Mitiperstat (AZD4831), for 12-24 weeks, in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Chronic obstructive pulmonary disease (COPD)
Phase 2
No
Mitiperstat (AZD4831)
All
381
Interventional
40 Years - 80 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Nov 2024 by AstraZeneca
AstraZeneca
-
This is a research study to evaluate the efficacy and safety of the investigational drug Mitiperstat (AZD4831) in adult patients with chronic obstructive pulmonary disease.
Study D6582C00001 is a phase IIa randomised, double blind, placebo controlled, parallel arm study to evaluate the efficacy and safety of Mitiperstat (AZD4831) in adult participants with moderate to severe chronic obstructive pulmonary disease. Approximately 100 sites globally will participate in this study. Approximately 406 participants will be randomised to two treatment groups; Mitiperstat (AZD4831) vs placebo in a 1:1 ratio.
Location
Location
Bradford, United Kingdom, BD9 6RJ
Location
Groningen, Netherlands, 9713 GH
Location
Szczecin, Poland, 70-111
Location
Wakefield, United Kingdom, WF1 4DG
Location
Glasgow, United Kingdom, G12 0YN
Location
Ksawerów, Poland, 95-054
Location
Kraków, Poland, 31-011
Location
Karczew, Poland, 05-480
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Placebo Approximately 203 participants will be randomised to receive placebo. | Other: Placebo Oral dosage, once daily. Other Name: N/A |
Experimental: Mitiperstat (AZD4831) Approximately 203 participants will be randomised to receive mitiperstat (AZD4831). | Drug: Mitiperstat (AZD4831) Oral dosage, once daily. Other Name: N/A |
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