Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)
2016年10月3日 更新者:AstraZeneca
Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The HERMES Study
The aim of the study is to compare the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will be up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.
For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).
研究概览
研究类型
介入性
注册 (实际的)
1568
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Antigonish、加拿大、B2G2C2
- Altana Pharma/Nycomed Investigational Site
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Bridgewater、加拿大、B4V3N2
- Altana Pharma/Nycomed Investigational Site
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Calgary、加拿大、T1Y6J4
- Altana Pharma/Nycomed Investigational Site
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Corunna、加拿大、N0N1G0
- Altana Pharma/Nycomed Investigational Site
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Edmonton、加拿大、T5N4L8
- Altana Pharma/Nycomed Investigational Site
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Fort Erie、加拿大、L2A1Z3
- Altana Pharma/Nycomed Investigational Site
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Grimsby、加拿大、L3M1P3
- Altana Pharma/Nycomed Investigational Site
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Hamilton、加拿大、L8N3Z5
- Altana Pharma/Nycomed Investigational Site
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Longueuil、加拿大、J4N1E1
- Altana Pharma/Nycomed Investigational Site
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Montreal、加拿大、H2L2W5
- Altana Pharma/Nycomed Investigational Site
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Ontario、加拿大、L2R2Z9
- Altana Pharma/Nycomed Investigational Site
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Richmond Hill、加拿大、L4C2N9
- Altana Pharma/Nycomed Investigational Site
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Saint John、加拿大、E3M3W5
- Altana Pharma/Nycomed Investigational Site
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Sherbrooke、加拿大、J1H5N4
- Altana Pharma/Nycomed Investigational Site
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St Jerome、加拿大、J7Z5T3
- Altana Pharma/Nycomed Investigational Site
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St Leonard、加拿大、H1S3A9
- Altana Pharma/Nycomed Investigational Site
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Toronto、加拿大、M5G1X5
- Altana Pharma/Nycomed Investigational Site
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Winnipeg、加拿大、R2K3S8
- Altana Pharma/Nycomed Investigational Site
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Alberta
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Calgary、Alberta、加拿大、T2N 4N1
- Altana Pharma/Nycomed Investigational Site
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Calgary、Alberta、加拿大、T3C 3P1
- Altana Pharma/Nycomed Investigational Site
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Edmonton、Alberta、加拿大、T5C 0A3
- Altana Pharma/Nycomed Investigational Site
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Spruce Grove、Alberta、加拿大、T7X 2Z8
- Altana Pharma/Nycomed Investigational Site
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British Columbia
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Burnaby、British Columbia、加拿大、V5G 1T4
- Altana Pharma/Nycomed Investigational Site
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Penticton、British Columbia、加拿大、V2A 5C8
- Altana Pharma/Nycomed Investigational Site
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Vancouver、British Columbia、加拿大、V5Z 4E1
- Altana Pharma/Nycomed Investigational Site
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Nova Scotia
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Truro、Nova Scotia、加拿大、B2N 1L2
- Altana Pharma/Nycomed Investigational Site
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Ontario
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Chatham、Ontario、加拿大、N7M 1R2
- Altana Pharma/Nycomed Investigational Site
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Hamilton、Ontario、加拿大、L8M 1K7
- Altana Pharma/Nycomed Investigational Site
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London、Ontario、加拿大、N5Y 5K7
- Altana Pharma/Nycomed Investigational Site
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Mississauga、Ontario、加拿大、L5M 2V8
- Altana Pharma/Nycomed Investigational Site
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Ottawa、Ontario、加拿大、K1Y 4E9
- Altana Pharma/Nycomed Investigational Site
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Sarnia、Ontario、加拿大、N7T 4X3
- Altana Pharma/Nycomed Investigational Site
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Scarborough、Ontario、加拿大、M1B 4Z8
- Altana Pharma/Nycomed Investigational Site
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Toronto、Ontario、加拿大、M5S 2A5
- Altana Pharma/Nycomed Investigational Site
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Quebec
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Montreal、Quebec、加拿大、H1V 1X5
- Altana Pharma/Nycomed Investigational Site
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Montreal、Quebec、加拿大、H3S 2W1
- Altana Pharma/Nycomed Investigational Site
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Sainte-Foy、Quebec、加拿大、G1V4G5
- Altana Pharma/Nycomed Investigational Site
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Sherbrooke、Quebec、加拿大、J1H 4J6
- Altana Pharma/Nycomed Investigational Site
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St. Romuald、Quebec、加拿大、G6W 5M6
- Altana Pharma/Nycomed Investigational Site
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Ste-Foy、Quebec、加拿大、G1W 4R4
- Altana Pharma/Nycomed Investigational Site
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Bellville, Cape Town、南非、7530
- Altana Pharma/Nycomed Investigational Site
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Berea, Durban、南非、4000
- Altana Pharma/Nycomed Investigational Site
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Bloemfontein、南非、9301
- Altana Pharma/Nycomed Investigational Site
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C/O Netcare & Garsfontein Roads、南非、44
- Altana Pharma/Nycomed Investigational Site
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Cape Town、南非、7764
- Altana Pharma/Nycomed Investigational Site
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Cape Town、南非、8001
- Altana Pharma/Nycomed Investigational Site
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Cape Town, Tygerberg、南非、7505
- Altana Pharma/Nycomed Investigational Site
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Durban, Amanzimtoti、南非、4126
- Altana Pharma/Nycomed Investigational Site
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Durbanville / Cape Town、南非、7550
- Altana Pharma/Nycomed Investigational Site
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Mowbray, Cape Town、南非、7925
- Altana Pharma/Nycomed Investigational Site
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Paarl, Cape Town、南非、7626
- Altana Pharma/Nycomed Investigational Site
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Pretoria、南非、181
- Altana Pharma/Nycomed Investigational Site
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Somerset West、南非、7130
- Altana Pharma/Nycomed Investigational Site
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Bangalore、印度、560 002
- Altana Pharma/Nycomed Investigational Site
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Bangalore、印度、560 034
- Altana Pharma/Nycomed Investigational Site
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Bangalore, Karnataka、印度、560 029
- Altana Pharma/Nycomed Investigational Site
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Chennai、印度、600 034
- Altana Pharma/Nycomed Investigational Site
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Coimbatore、印度、641 004
- Altana Pharma/Nycomed Investigational Site
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Coimbatore、印度、641 014
- Altana Pharma/Nycomed Investigational Site
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Coimbatore, Tamilnadu、印度、641 044
- Altana Pharma/Nycomed Investigational Site
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Goa、印度、403 002
- Altana Pharma/Nycomed Investigational Site
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Hyderabad、印度、12
- Altana Pharma/Nycomed Investigational Site
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Indore, South Tukuganj、印度、452001
- Altana Pharma/Nycomed Investigational Site
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Mangalore、印度、574 160
- Altana Pharma/Nycomed Investigational Site
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Mangalore、印度、575 001
- Altana Pharma/Nycomed Investigational Site
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Mumbai、印度、400022
- Altana Pharma/Nycomed Investigational Site
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Mumbai, Byculla、印度、400 008
- Altana Pharma/Nycomed Investigational Site
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Mumbai, Dadar (E)、印度、400 014
- Altana Pharma/Nycomed Investigational Site
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Mysore、印度、570004
- Altana Pharma/Nycomed Investigational Site
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Nagpur、印度、440 012
- Altana Pharma/Nycomed Investigational Site
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Nagpur、印度、440 013
- Altana Pharma/Nycomed Investigational Site
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Nagpur、印度、440012
- Altana Pharma/Nycomed Investigational Site
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Pune、印度、411 014
- Altana Pharma/Nycomed Investigational Site
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Pune、印度、411033
- Altana Pharma/Nycomed Investigational Site
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Shastri Nagar, Jaipur、印度、302 016
- Altana Pharma/Nycomed Investigational Site
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Berlin、德国、10559
- Altana Pharma/Nycomed Investigational Site
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Berlin、德国、10717
- Altana Pharma/Nycomed Investigational Site
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Berlin、德国、10965
- Altana Pharma/Nycomed Investigational Site
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Berlin、德国、10969
- Altana Pharma/Nycomed Investigational Site
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Berlin、德国、12165
- Altana Pharma/Nycomed Investigational Site
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Berlin、德国、12203
- Altana Pharma/Nycomed Investigational Site
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Berlin、德国、13507
- Altana Pharma/Nycomed Investigational Site
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Berlin、德国、13597
- Altana Pharma/Nycomed Investigational Site
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Donaustauf、德国、93093
- Altana Pharma/Nycomed Investigational Site
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Großhansdorf、德国、22927
- Altana Pharma/Nycomed Investigational Site
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Halle、德国、6108
- Altana Pharma/Nycomed Investigational Site
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Hamburg、德国、20535
- Altana Pharma/Nycomed Investigational Site
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Landsberg/Lech、德国、86899
- Altana Pharma/Nycomed Investigational Site
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Neuruppin、德国、16816
- Altana Pharma/Nycomed Investigational Site
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Oschersleben、德国、39387
- Altana Pharma/Nycomed Investigational Site
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Potsdam、德国、14464
- Altana Pharma/Nycomed Investigational Site
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Potsdam、德国、14467
- Altana Pharma/Nycomed Investigational Site
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Regensburg、德国、93059
- Altana Pharma/Nycomed Investigational Site
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Rüdersdorf、德国、15562
- Altana Pharma/Nycomed Investigational Site
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Ulm、德国、89073
- Altana Pharma/Nycomed Investigational Site
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Bergamo、意大利、24100
- Altana Pharma/Nycomed Investigational Site
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Bologna、意大利、40136
- Altana Pharma/Nycomed Investigational Site
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Cassano Murge、意大利、70020
- Altana Pharma/Nycomed Investigational Site
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Firenze、意大利、50134
- Altana Pharma/Nycomed Investigational Site
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Milano、意大利、20142
- Altana Pharma/Nycomed Investigational Site
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Parma、意大利、43100
- Altana Pharma/Nycomed Investigational Site
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Pavia、意大利、27100
- Altana Pharma/Nycomed Investigational Site
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Roma、意大利、135
- Altana Pharma/Nycomed Investigational Site
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Trieste、意大利、34100
- Altana Pharma/Nycomed Investigational Site
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Verona、意大利、37100
- Altana Pharma/Nycomed Investigational Site
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Veruno、意大利、28010
- Altana Pharma/Nycomed Investigational Site
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Chrzanów、波兰、32500
- Altana Pharma/Nycomed Investigational Site
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Czestochowa、波兰、42200
- Altana Pharma/Nycomed Investigational Site
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Dzialdowo、波兰、13-200
- Altana Pharma/Nycomed Investigational Site
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Katowice、波兰、40-752
- Altana Pharma/Nycomed Investigational Site
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Kraków、波兰、31-202
- Altana Pharma/Nycomed Investigational Site
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Kraków、波兰、31202
- Altana Pharma/Nycomed Investigational Site
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Lublin、波兰、20-718
- Altana Pharma/Nycomed Investigational Site
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Poznan、波兰、60-569
- Altana Pharma/Nycomed Investigational Site
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Warsawa、波兰、01-138
- Altana Pharma/Nycomed Investigational Site
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Warszawa、波兰、1140
- Altana Pharma/Nycomed Investigational Site
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Wodzislaw Slaski、波兰、44300
- Altana Pharma/Nycomed Investigational Site
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Zgierz、波兰、95100
- Altana Pharma/Nycomed Investigational Site
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Alabama
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Bayou La Batre、Alabama、美国、36509
- Altana Pharma/Nycomed Investigational Site
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Birmingham、Alabama、美国、35249
- Altana Pharma/Nycomed Investigational Site
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Birmingham、Alabama、美国、35294
- Altana Pharma/Nycomed Investigational Site
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Huntsville、Alabama、美国、35801
- Altana Pharma/Nycomed Investigational Site
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Arizona
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Bullhead City、Arizona、美国、85442
- Altana Pharma/Nycomed Investigational Site
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Phoenix、Arizona、美国、85012
- Altana Pharma/Nycomed Investigational Site
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Phoenix、Arizona、美国、85023
- Altana Pharma/Nycomed Investigational Site
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Arkansas
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Fort Smith、Arkansas、美国、72917
- Altana Pharma/Nycomed Investigational Site
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Little Rock、Arkansas、美国、72205
- Altana Pharma/Nycomed Investigational Site
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California
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Anaheim、California、美国、92801
- Altana Pharma/Nycomed Investigational Site
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Burbank、California、美国、91505
- Altana Pharma/Nycomed Investigational Site
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Carlsbad、California、美国、92008
- Altana Pharma/Nycomed Investigational Site
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Fresno、California、美国、93720
- Altana Pharma/Nycomed Investigational Site
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Lakewood、California、美国、90712
- Altana Pharma/Nycomed Investigational Site
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Long Beach、California、美国、90822
- Altana Pharma/Nycomed Investigational Site
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Los Alamitos、California、美国、90720
- Altana Pharma/Nycomed Investigational Site
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Los Angeles、California、美国、90033
- Altana Pharma/Nycomed Investigational Site
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Roseville、California、美国、95678
- Altana Pharma/Nycomed Investigational Site
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Sacramento、California、美国、95831
- Altana Pharma/Nycomed Investigational Site
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San Diego、California、美国、92120
- Altana Pharma/Nycomed Investigational Site
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San Diego、California、美国、92103
- Altana Pharma/Nycomed Investigational Site
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Sepulveda、California、美国、91343
- Altana Pharma/Nycomed Investigational Site
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Stockton、California、美国、95207
- Altana Pharma/Nycomed Investigational Site
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Colorado
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Denver、Colorado、美国、80206
- Altana Pharma/Nycomed Investigational Site
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Connecticut
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Waterbury、Connecticut、美国、6708
- Altana Pharma/Nycomed Investigational Site
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District of Columbia
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Washington、District of Columbia、美国、20017
- Altana Pharma/Nycomed Investigational Site
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Florida
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Clearwater、Florida、美国、33756
- Altana Pharma/Nycomed Investigational Site
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Deland、Florida、美国、32720
- Altana Pharma/Nycomed Investigational Site
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Fort Lauderdale、Florida、美国、33316
- Altana Pharma/Nycomed Investigational Site
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Jacksonville、Florida、美国、32204
- Altana Pharma/Nycomed Investigational Site
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Miami、Florida、美国、33176
- Altana Pharma/Nycomed Investigational Site
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Miami、Florida、美国、33173
- Altana Pharma/Nycomed Investigational Site
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Miami Beach、Florida、美国、33140
- Altana Pharma/Nycomed Investigational Site
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Ocala、Florida、美国、34471
- Altana Pharma/Nycomed Investigational Site
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Ormand Beach、Florida、美国、32174
- Altana Pharma/Nycomed Investigational Site
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Port Orange、Florida、美国、33127
- Altana Pharma/Nycomed Investigational Site
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Tamarac、Florida、美国、33321
- Altana Pharma/Nycomed Investigational Site
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Vero Beach、Florida、美国、32960
- Altana Pharma/Nycomed Investigational Site
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Georgia
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Atlanta、Georgia、美国、30342
- Altana Pharma/Nycomed Investigational Site
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Blue Ridge、Georgia、美国、30513
- Altana Pharma/Nycomed Investigational Site
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Columbus、Georgia、美国、31901
- Altana Pharma/Nycomed Investigational Site
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Decatur、Georgia、美国、30033
- Altana Pharma/Nycomed Investigational Site
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Ft. Gordon、Georgia、美国、30905
- Altana Pharma/Nycomed Investigational Site
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Marietta、Georgia、美国、30060
- Altana Pharma/Nycomed Investigational Site
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Rincon、Georgia、美国、594
- Altana Pharma/Nycomed Investigational Site
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Savannah、Georgia、美国、31406
- Altana Pharma/Nycomed Investigational Site
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Idaho
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Twin Falls、Idaho、美国、83301
- Altana Pharma/Nycomed Investigational Site
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Illinois
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Champaign、Illinois、美国、61820
- Altana Pharma/Nycomed Investigational Site
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Chicago、Illinois、美国、60611
- Altana Pharma/Nycomed Investigational Site
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Elk Grove Village、Illinois、美国、60007
- Altana Pharma/Nycomed Investigational Site
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North Chicago、Illinois、美国、60064
- Altana Pharma/Nycomed Investigational Site
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Peoria、Illinois、美国、61603
- Altana Pharma/Nycomed Investigational Site
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River Forest、Illinois、美国、60305
- Altana Pharma/Nycomed Investigational Site
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Indiana
-
Elkhart、Indiana、美国、46514
- Altana Pharma/Nycomed Investigational Site
-
Indianapolis、Indiana、美国、46202
- Altana Pharma/Nycomed Investigational Site
-
Indianapolis、Indiana、美国、46254
- Altana Pharma/Nycomed Investigational Site
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New Albany、Indiana、美国、47150
- Altana Pharma/Nycomed Investigational Site
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Iowa
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Dubuque、Iowa、美国、52001
- Altana Pharma/Nycomed Investigational Site
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Fort Dodge、Iowa、美国、50501
- Altana Pharma/Nycomed Investigational Site
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Iowa City、Iowa、美国、52242
- Altana Pharma/Nycomed Investigational Site
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Waterloo、Iowa、美国、50702
- Altana Pharma/Nycomed Investigational Site
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Kansas
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Olathe、Kansas、美国、66061
- Altana Pharma/Nycomed Investigational Site
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Topeka、Kansas、美国、66606
- Altana Pharma/Nycomed Investigational Site
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Kentucky
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Campbellsville、Kentucky、美国、42718
- Altana Pharma/Nycomed Investigational Site
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Hazard、Kentucky、美国、41701
- Altana Pharma/Nycomed Investigational Site
-
Louisville、Kentucky、美国、40207
- Altana Pharma/Nycomed Investigational Site
-
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Louisiana
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Metairie、Louisiana、美国、70006
- Altana Pharma/Nycomed Investigational Site
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West Monroe、Louisiana、美国、71291
- Altana Pharma/Nycomed Investigational Site
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Maryland
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Columbia、Maryland、美国、21044
- Altana Pharma/Nycomed Investigational Site
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Massachusetts
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Boston、Massachusetts、美国、02114
- Altana Pharma/Nycomed Investigational Site
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Michigan
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Brighton、Michigan、美国、48114
- Altana Pharma/Nycomed Investigational Site
-
Interlochen、Michigan、美国、49643
- Altana Pharma/Nycomed Investigational Site
-
Livonia、Michigan、美国、48152
- Altana Pharma/Nycomed Investigational Site
-
Portage、Michigan、美国、49002
- Altana Pharma/Nycomed Investigational Site
-
Saginaw、Michigan、美国、48602
- Altana Pharma/Nycomed Investigational Site
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Minnesota
-
Duluth、Minnesota、美国、55805
- Altana Pharma/Nycomed Investigational Site
-
Edina、Minnesota、美国、55435
- Altana Pharma/Nycomed Investigational Site
-
Minneapolis、Minnesota、美国、55407
- Altana Pharma/Nycomed Investigational Site
-
Rochester、Minnesota、美国、55905
- Altana Pharma/Nycomed Investigational Site
-
-
Missouri
-
Chesterfield、Missouri、美国、63017
- Altana Pharma/Nycomed Investigational Site
-
Jefferson City、Missouri、美国、65101
- Altana Pharma/Nycomed Investigational Site
-
Kansas City、Missouri、美国、64111
- Altana Pharma/Nycomed Investigational Site
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Kansas City (-1453)、Missouri、美国、64106
- Altana Pharma/Nycomed Investigational Site
-
St. Louis、Missouri、美国、63122
- Altana Pharma/Nycomed Investigational Site
-
St. Louis、Missouri、美国、63141
- Altana Pharma/Nycomed Investigational Site
-
Sunset、Missouri、美国、70584
- Altana Pharma/Nycomed Investigational Site
-
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Montana
-
Bozeman、Montana、美国、59718
- Altana Pharma/Nycomed Investigational Site
-
Butte、Montana、美国、59701
- Altana Pharma/Nycomed Investigational Site
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Nebraska
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Omaha、Nebraska、美国、68131
- Altana Pharma/Nycomed Investigational Site
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-
Nevada
-
Las Vegas、Nevada、美国、89123
- Altana Pharma/Nycomed Investigational Site
-
Las Vegas、Nevada、美国、89176
- Altana Pharma/Nycomed Investigational Site
-
-
New Jersey
-
Absecon、New Jersey、美国、08201
- Altana Pharma/Nycomed Investigational Site
-
Hamilton、New Jersey、美国、08610
- Altana Pharma/Nycomed Investigational Site
-
South Bound Brook、New Jersey、美国、08880
- Altana Pharma/Nycomed Investigational Site
-
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New York
-
Camillus、New York、美国、13031
- Altana Pharma/Nycomed Investigational Site
-
Corning、New York、美国、14830
- Altana Pharma/Nycomed Investigational Site
-
Cortland、New York、美国、13045
- Altana Pharma/Nycomed Investigational Site
-
New Hyde Park、New York、美国、11040
- Altana Pharma/Nycomed Investigational Site
-
New Hyde Park、New York、美国、11042
- Altana Pharma/Nycomed Investigational Site
-
Syracuse、New York、美国、13210
- Altana Pharma/Nycomed Investigational Site
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North Carolina
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Charlotte、North Carolina、美国、28207
- Altana Pharma/Nycomed Investigational Site
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Huntersville、North Carolina、美国、28070
- Altana Pharma/Nycomed Investigational Site
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Winston Salem、North Carolina、美国、27103
- Altana Pharma/Nycomed Investigational Site
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Ohio
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Canton、Ohio、美国、44718
- Altana Pharma/Nycomed Investigational Site
-
Cincinnati、Ohio、美国、45231
- Altana Pharma/Nycomed Investigational Site
-
Columbus、Ohio、美国、43215
- Altana Pharma/Nycomed Investigational Site
-
Sylvania、Ohio、美国、43560
- Altana Pharma/Nycomed Investigational Site
-
Toledo、Ohio、美国、43614
- Altana Pharma/Nycomed Investigational Site
-
Toledo、Ohio、美国、43608
- Altana Pharma/Nycomed Investigational Site
-
Toledo、Ohio、美国、43617
- Altana Pharma/Nycomed Investigational Site
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Oklahoma
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Oklahoma City、Oklahoma、美国、73120
- Altana Pharma/Nycomed Investigational Site
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Oregon
-
Medford、Oregon、美国、97504
- Altana Pharma/Nycomed Investigational Site
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Portland、Oregon、美国、97220
- Altana Pharma/Nycomed Investigational Site
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Pennsylvania
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Erie、Pennsylvania、美国、16506
- Altana Pharma/Nycomed Investigational Site
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Hershey、Pennsylvania、美国、17033
- Altana Pharma/Nycomed Investigational Site
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Philadelphia、Pennsylvania、美国、19140
- Altana Pharma/Nycomed Investigational Site
-
Philadelphia、Pennsylvania、美国、19107
- Altana Pharma/Nycomed Investigational Site
-
Pittsburgh、Pennsylvania、美国、15221
- Altana Pharma/Nycomed Investigational Site
-
Stoneboro、Pennsylvania、美国、16153
- Altana Pharma/Nycomed Investigational Site
-
Swarthmore、Pennsylvania、美国、19081
- Altana Pharma/Nycomed Investigational Site
-
-
Rhode Island
-
Johnston、Rhode Island、美国、2919
- Altana Pharma/Nycomed Investigational Site
-
-
South Carolina
-
Charleston、South Carolina、美国、29406
- Altana Pharma/Nycomed Investigational Site
-
Greenville、South Carolina、美国、29605
- Altana Pharma/Nycomed Investigational Site
-
Greenville、South Carolina、美国、29615
- Altana Pharma/Nycomed Investigational Site
-
Greer、South Carolina、美国、29651
- Altana Pharma/Nycomed Investigational Site
-
Union、South Carolina、美国、29379
- Altana Pharma/Nycomed Investigational Site
-
Williamston、South Carolina、美国、29697
- Altana Pharma/Nycomed Investigational Site
-
-
Tennessee
-
Johnson City、Tennessee、美国、37604
- Altana Pharma/Nycomed Investigational Site
-
Knoxville、Tennessee、美国、37920
- Altana Pharma/Nycomed Investigational Site
-
Memphis、Tennessee、美国、38163
- Altana Pharma/Nycomed Investigational Site
-
Nashville、Tennessee、美国、37203
- Altana Pharma/Nycomed Investigational Site
-
New Tazewell、Tennessee、美国、37825
- Altana Pharma/Nycomed Investigational Site
-
-
Texas
-
Boerne、Texas、美国、78006
- Altana Pharma/Nycomed Investigational Site
-
Corsicana、Texas、美国、75110
- Altana Pharma/Nycomed Investigational Site
-
Fort Worth、Texas、美国、76109
- Altana Pharma/Nycomed Investigational Site
-
Houston、Texas、美国、77005
- Altana Pharma/Nycomed Investigational Site
-
Houston、Texas、美国、77024
- Altana Pharma/Nycomed Investigational Site
-
Hurst、Texas、美国、76054
- Altana Pharma/Nycomed Investigational Site
-
McKinney、Texas、美国、75069
- Altana Pharma/Nycomed Investigational Site
-
San Antonio、Texas、美国、78205
- Altana Pharma/Nycomed Investigational Site
-
San Antonio、Texas、美国、78229
- Altana Pharma/Nycomed Investigational Site
-
Seguin、Texas、美国、78155
- Altana Pharma/Nycomed Investigational Site
-
Tyler、Texas、美国、75708
- Altana Pharma/Nycomed Investigational Site
-
-
Utah
-
Salt Lake City、Utah、美国、84107
- Altana Pharma/Nycomed Investigational Site
-
Salt Lake City、Utah、美国、84124
- Altana Pharma/Nycomed Investigational Site
-
-
Virginia
-
Lynchburg、Virginia、美国、24501
- Altana Pharma/Nycomed Investigational Site
-
-
Washington
-
Seattle、Washington、美国、98104
- Altana Pharma/Nycomed Investigational Site
-
Spokane、Washington、美国、99216
- Altana Pharma/Nycomed Investigational Site
-
-
West Virginia
-
Charleston、West Virginia、美国、25304
- Altana Pharma/Nycomed Investigational Site
-
-
Wisconsin
-
Glendale、Wisconsin、美国、53212
- Altana Pharma/Nycomed Investigational Site
-
Glendale、Wisconsin、美国、53217
- Altana Pharma/Nycomed Investigational Site
-
-
-
-
-
Badajoz、西班牙、6080
- Altana Pharma/Nycomed Investigational Site
-
Calde (Lugo)、西班牙、27210
- Altana Pharma/Nycomed Investigational Site
-
Cartagena、西班牙、30203
- Altana Pharma/Nycomed Investigational Site
-
Elda、西班牙、3600
- Altana Pharma/Nycomed Investigational Site
-
Getafe、西班牙、28905
- Altana Pharma/Nycomed Investigational Site
-
Guadalajara、西班牙、19002
- Altana Pharma/Nycomed Investigational Site
-
Madrid、西班牙、28006
- Altana Pharma/Nycomed Investigational Site
-
Madrid、西班牙、28041
- Altana Pharma/Nycomed Investigational Site
-
Merida (Badajoz)、西班牙、6800
- Altana Pharma/Nycomed Investigational Site
-
Partida de Bacarot (Alicante)、西班牙、3114
- Altana Pharma/Nycomed Investigational Site
-
Pontevedra、西班牙、36071
- Altana Pharma/Nycomed Investigational Site
-
Requena、西班牙、46340
- Altana Pharma/Nycomed Investigational Site
-
Santiago de Compostela、西班牙、15706
- Altana Pharma/Nycomed Investigational Site
-
Talavera de la Reina (Toledo)、西班牙、45600
- Altana Pharma/Nycomed Investigational Site
-
Tarrasa (Barcelona)、西班牙、8221
- Altana Pharma/Nycomed Investigational Site
-
Toldeo、西班牙、45004
- Altana Pharma/Nycomed Investigational Site
-
Valencia、西班牙、46015
- Altana Pharma/Nycomed Investigational Site
-
Valencia、西班牙、46017
- Altana Pharma/Nycomed Investigational Site
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Main Inclusion Criteria:
- COPD patients having at least one exacerbation within last year
- FEV1/FVC ratio (post-bronchodilator) ≤ 70%
- FEV1 (post-bronchodilator) ≤ 50% of predicted
Main Exclusion Criteria:
- COPD exacerbation not resolved at first baseline visit
- Diagnosis of asthma and/or other relevant lung disease
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
安慰剂比较:安慰剂
每天一次
|
每天一次
|
有源比较器:罗氟司特
500 mcg,每天一次,早上口服
|
500 mcg,每天一次,早上口服
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
支气管扩张剂前第一秒用力呼气量 (FEV1)
大体时间:在 52 周的治疗期间从基线的变化
|
支气管扩张剂前 FEV1 [L] 治疗期间相对于基线的平均变化
|
在 52 周的治疗期间从基线的变化
|
COPD 恶化率(中度或重度)
大体时间:52周治疗期
|
每名患者每年需要口服或肠胃外糖皮质激素(=中度 COPD 恶化)或需要住院治疗或导致死亡(=重度 COPD 恶化)的 COPD 恶化的平均发生率。
COPD 恶化是疾病自然病程中的事件,其特征是患者基线呼吸困难、咳嗽和/或咳痰的变化超过日常变异性,足以保证改变管理 [美国胸科学会 (ATS) /欧洲呼吸学会 (ERS) 2005]。
|
52周治疗期
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
支气管扩张剂后 FEV1 [L]
大体时间:在 52 周的治疗期间从基线的变化
|
支气管扩张剂后 FEV1 [L] 治疗期间相对于基线的平均变化
|
在 52 周的治疗期间从基线的变化
|
因任何原因死亡的时间
大体时间:52周治疗期
|
52周治疗期
|
|
天然对数转化的 C 反应蛋白 (CRP)
大体时间:从基线到最后一次随机化后测量的变化(52 周)
|
自然对数转换 CRP 中从基线到最后一次随机化后测量的平均变化
|
从基线到最后一次随机化后测量的变化(52 周)
|
治疗期间平均过渡性呼吸困难指数 (TDI) 焦点评分
大体时间:在 52 周的治疗期间从基线的变化
|
TDI 是公认的问卷,用于测量门诊 COPD 患者的呼吸困难。
在基线时,呼吸困难的 3 个组成部分,每个组成部分有 4 个问题,被问到: - 功能障碍 - 任务量级 - 努力量级 在每次随机化后访问中,来自 TDI 的问题被问到与 3 个组成部分相关的问题:变化 -功能障碍 - 任务强度 - 努力强度 TDI 中的每个问题都从 -3(严重恶化)到 +3(重大改善)分级。
这导致 TDI 焦点得分范围从 -9 到 +9。
|
在 52 周的治疗期间从基线的变化
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Cazzola M, Picciolo S, Matera MG. Roflumilast in chronic obstructive pulmonary disease: evidence from large trials. Expert Opin Pharmacother. 2010 Feb;11(3):441-9. doi: 10.1517/14656560903555201.
- Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):685-94. doi: 10.1016/S0140-6736(09)61255-1. Erratum In: Lancet. 2010 Oct 2;376(9747):1146.
- Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.
- Hanania NA, Calverley PM, Dransfield MT, Karpel JP, Brose M, Zhu H, Goehring UM, Rowe P. Pooled subpopulation analyses of the effects of roflumilast on exacerbations and lung function in COPD. Respir Med. 2014 Feb;108(2):366-75. doi: 10.1016/j.rmed.2013.09.018. Epub 2013 Sep 30.
- Wedzicha JA, Rabe KF, Martinez FJ, Bredenbroker D, Brose M, Goehring UM, Calverley PMA. Efficacy of roflumilast in the COPD frequent exacerbator phenotype. Chest. 2013 May;143(5):1302-1311. doi: 10.1378/chest.12-1489.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2006年3月1日
初级完成 (实际的)
2008年4月1日
研究完成 (实际的)
2008年8月1日
研究注册日期
首次提交
2006年2月27日
首先提交符合 QC 标准的
2006年2月27日
首次发布 (估计)
2006年2月28日
研究记录更新
最后更新发布 (估计)
2016年11月6日
上次提交的符合 QC 标准的更新
2016年10月3日
最后验证
2016年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
安慰剂的临床试验
-
City of Hope Medical CenterNational Cancer Institute (NCI)主动,不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病,BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病,BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
-
Mila (bMotion Technologies)完全的
-
Universidad Autonoma de MadridCentro Universitario La Salle完全的