Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
ALTANA Pharma |
---|---|
Information provided by: | ALTANA Pharma |
ClinicalTrials.gov Identifier: | NCT00242320 |
The aim of the study is to compare the effect of roflumilast on lung function in patients with COPD. Roflumilast will be administered orally once daily in the morning at one dose level. The study duration consists of a baseline period (4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of roflumilast.
Condition | Intervention | Phase |
---|---|---|
COPD |
Drug: Roflumilast Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | The JADE Study: A 12-Week, Double-Blind, Randomized Study to Investigate the Effect of 500 Mcg Roflumilast Tablets Once Daily Versus Placebo on Pulmonary Function in Patients With Chronic Obstructive Pulmonary Disease |
Enrollment: | 551 |
Study Start Date: | August 2005 |
Study Completion Date: | August 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Roflumilast 500 µg
|
Drug: Roflumilast
to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo
|
2: Placebo Comparator
Placebo
|
Drug: Roflumilast
to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo
Drug: Placebo
|
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Hong Kong | |
Altana Pharma/Nycomed | |
Shatin, NT, Hong Kong, Hong Kong | |
Altana Pharma/Nycomed | |
Hong Kong, Hong Kong, 852 | |
Korea, Republic of | |
Altana Pharma/Nycomed | |
Seoul, Korea, Republic of, 135-720 | |
Altana Pharma/Nycomed | |
Seoul, Korea, Republic of, 136-705 | |
Altana Pharma/Nycomed | |
Seoul, Korea, Republic of, 137-701 | |
Altana Pharma/Nycomed | |
Seoul, Korea, Republic of, 138-736 | |
Altana Pharma/Nycomed | |
Seoul, Korea, Republic of, 140-757 | |
Altana Pharma/Nycomed | |
Seoul, Korea, Republic of, 158-710 | |
Altana Pharma/Nycomed | |
Jiniu-Si. Gveongsangnam-Do, Korea, Republic of, 660-702 | |
Altana Pharma/Nycomed | |
Gangwon-Do, Korea, Republic of, 220-711 | |
Altana Pharma/Nycomed | |
Chungbuk, Korea, Republic of, 361-711 | |
Altana Pharma/Nycomed | |
Gyeonggi-do, Korea, Republic of, 420-767 | |
Altana Pharma/Nycomed | |
Anvang-Si, Gveonggi-Do, Korea, Republic of, 431-070 | |
Altana Pharma/Nycomed | |
Uijongbu-city, Gveonggi-Do, Korea, Republic of, 480-130 | |
Altana Pharma/Nycomed | |
Gwangju, Korea, Republic of, 501-757 | |
Altana Pharma/Nycomed | |
Gangwon-do, Korea, Republic of, 220-701 | |
Altana Pharma/Nycomed | |
Ulsan, Korea, Republic of, 682-060 | |
Malaysia | |
Altana Pharma/Nycomed | |
Kota Bharu / Kelantan, Malaysia, 16150 | |
Altana Pharma/Nycomed | |
Kuala Lumpur, Malaysia, 50590 | |
Altana Pharma/Nycomed | |
Kuala Lumpur, Malaysia, 56000 | |
Altana Pharma/Nycomed | |
Kuala Lumpur, Malaysia, 59100 | |
Altana Pharma/Nycomed | |
Jalan Rasah, Seremban, Malaysia, 70300 | |
Altana Pharma/Nycomed | |
Kota Kinabalu, Sabah, Malaysia, 88586 | |
Philippines | |
Altana Pharma/Nycomed | |
Manila, Philippines, 1000 | |
Altana Pharma/Nycomed | |
Quezon City, Philippines, 1100 | |
Altana Pharma/Nycomed | |
Quezon City, Philippines, 1102 | |
Altana Pharma/Nycomed | |
Quezon City, Philippines, 850 | |
Altana Pharma/Nycomed | |
Quezon City, Philippines, 870 | |
Taiwan | |
Altana Pharma/Nycomed | |
Taipei, Taiwan | |
Altana Pharma/Nycomed | |
Kaohsiung, Taiwan, 886-807 | |
Altana Pharma/Nycomed | |
Taipei City 114, Taiwan, 886-114 | |
Altana Pharma/Nycomed | |
Tau-Yuan, Taiwan, 886-333 | |
Altana Pharma/Nycomed | |
Taipei, Taiwan, 886-114 |
Principal Investigator: | Sang-Do Lee, Prof. | University of Ulsan, College of Medicine, Seoul, Korea |
Responsible Party: | Nycomed ( Nycomed ) |
Study ID Numbers: | BY217/M2-119 |
Study First Received: | October 19, 2005 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00242320 History of Changes |
Health Authority: | Malaysia: Ministry of Health |
COPD chronic obstructive pulmonary disease Roflumilast |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Pulmonary Disease, Chronic Obstructive |