Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-01-05 @ 7:25 PM
Study NCT ID:
NCT00917150
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2009-06-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Investigate the Efficacy and Safety of OPC-6535 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase 2, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm, Dose-comparison Trial of OPC-6535 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate the efficacy and safety of OPC-6535 in COPD patients, using the measurement of trough FEV1 over time as the primary endpoint.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| JapicCTI-090770 | None | None | View |