臨床研究等提出・公開システム

Date of registration	Sept. 12, 2005
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220095

Scientific Title	A confirmatory study of APTA-2217 in patients with chronic obstructive pulmonary disease (A placebo-controlled double-blind, parallel group study)
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	AstraZeneca KK
	Address	information.center@astrazeneca.com
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Double-blind, parallel-group comparative clinical study
Study Design	Objective
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	[Inclusion criteria] Patients with chronic obstructive pulmonary disease who are 40 years old or more, current smoker or ex-smoker, 30 to 80 % of predicted FEV1 after inhalation of short acting beta stimulant. [Exclusion criteria] Patients with poorly controlled COPD, patients who need for long-term oxygen therapy, patients who have concurrent respiratory diseases such as asthma, diffuse panbronchiolitis, congenital sinobronchial syndrome, bronchiolitis obliterans, bronchiectasis, active tuberculosis, pneumoconiosis, pulmonary lymph vascular myaoma), which are considered to affect the evaluation.
	Exclusion Criteria
	Minimum Age	40age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Chronic obstructive pulmonary disease
Intervention(s)		investigational material(s) Generic name etc : APTA-2217 (roflumilast) INN of investigational material : Therapeutic category code : 229 Other agents affecting respiratory organs Dosage and Administration for Investigational material : Oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Efficacy (pulmonary function test), safety and pharmacokinetics
Secondary Outcome

Primary Sponsor	Tanabe Pharma Corporation was the original trial sponsor; however Astra Zeneca is now the Responsible Party
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-050097
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
15	Dec. 17, 2018	(this page)	Changes
14	July. 04, 2016	Detail	Changes
13	July. 04, 2016	Detail	Changes
12	Oct. 28, 2015	Detail	Changes
11	Oct. 28, 2015	Detail	Changes
10	April. 27, 2015	Detail	Changes
9	April. 27, 2015	Detail	Changes
8	July. 19, 2011	Detail	Changes
7	July. 19, 2011	Detail	Changes
6	Oct. 01, 2007	Detail	Changes
5	Oct. 01, 2007	Detail	Changes
4	April. 11, 2006	Detail	Changes
3	April. 11, 2006	Detail	Changes
2	Sept. 12, 2005	Detail	Changes
1	Sept. 12, 2005	Detail

List of change history