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Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00246935
Recruitment Status : Completed
First Posted : November 1, 2005
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
Mitsubishi Tanabe Pharma Corporation
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on the long-term safety in patients with chronic obstructive pulmonary disease (COPD) who completed the 24-week evaluation of study APTA-2217-06. Roflumilast will be administered orally once daily. The present study consists of a 28 weeks treatment period, and is an extension of the 24-week study APTA-2217-06 (registered study). The study will provide further long-term safety and efficacy data of roflumilast.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Roflumilast Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Long-term Study of APTA-2217 in Patients With Chronic Obstructive Pulmonary Disease
Study Start Date : May 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Roflumilast




Primary Outcome Measures :
  1. Long-term safety after 28 weeks treatment of Roflumilast (total 52 weeks, 24 weeks of study APTA-2217-06 followed by 28 weeks) .

Secondary Outcome Measures :
  1. Efficacy.


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main inclusion criteria:

  • Patients with chronic obstructive pulmonary disease (COPD)
  • Written informed consent
  • Patients who completed the 24-week evaluation of study APTA-2217-06

Main exclusion criteria:

  • If patients required hospitalization or received emergency care for COPD exacerbation by the investigator (or sub-investigator) between the informed consent day and the starting day
  • Patients with long-term oxygen therapy
  • Serious diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246935


Locations
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Japan
Nycomed in Japan and Mitsubishi Tanabe Pharma Corporation
Osaka, Japan
Sponsors and Collaborators
AstraZeneca
Mitsubishi Tanabe Pharma Corporation
Investigators
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Study Director: AstraZeneca AstraZeneca AstraZeneca

Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00246935    
Other Study ID Numbers: APTA-2217-08
First Posted: November 1, 2005    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: September 2016
Keywords provided by AstraZeneca:
COPD
Phosphodiesterase 4 inhibitor
Roflumilast
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases