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Completed

NCT Number: NCT00246935

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 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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nycomed in Japan and Mitsubishi Tanabe Pharma Corporation

Osaka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Roflumilast

Drug

Primary outcomes

  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 outcomes

  1. Efficacy.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Tanabe Pharma Corporation

Registry information

Official study title

A Long-term Study of APTA-2217 in Patients With Chronic Obstructive Pulmonary Disease

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Nov 1, 2005
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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