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Not Yet RecruitingNCT07198347

Efficacy and Safety of AG2001 in Patients With Acute Bronchitis

A Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2001 in Patients With Acute Bronchitis

Status
Not Yet Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
300 (estimated)
Sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd · Industry
Sex
All
Age
19 Years – 64 Years
Healthy volunteers
Not accepted

Summary

This is a Phase 3, randomized, double-blind, active-controlled clinical trial designed to evaluate the efficacy and safety of AG2001 in patients with acute bronchitis. The primary objective is to demonstrate the superiority of AG2001 over two active comparators based on the change in Bronchitis Severity Score (BSS) at Day 4.

Conditions

Interventions

TypeNameDescription
DRUGAG2001Oral administration, three times daily for 7 days.
DRUGAG20011Oral administration, three times daily for 7 days.
DRUGAG20012Oral administration, three times daily for 7 days.

Timeline

Start date
2025-11-01
Primary completion
2026-03-31
Completion
2026-10-31
First posted
2025-09-30
Last updated
2025-09-30

Source: ClinicalTrials.gov record NCT07198347. Inclusion in this directory is not an endorsement.

Efficacy and Safety of AG2001 in Patients With Acute Bronchitis (NCT07198347) · Clinical Trials Directory