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Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Roflumilast
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Roflumilast, COPD, Chronic obstructive pulmonary disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Altana Pharma/Nycomed Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Roflumilast

Placebo

Arm Description

500 mcg, once daily, oral administration in the morning

once daily

Outcomes

Primary Outcome Measures

Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]
COPD Exacerbation Rate (Moderate or Severe)
Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].

Secondary Outcome Measures

Post-bronchodilator FEV1 [L]
Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]
Time to Mortality Due to Any Reason
Natural Log-transformed C-reactive Protein (CRP)
Mean change from baseline to the last post randomization measurement in natural log-transformed CRP
Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period
The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9.

Full Information

First Posted
February 27, 2006
Last Updated
October 3, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00297115
Brief Title
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)
Official Title
Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The HERMES Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Roflumilast, COPD, Chronic obstructive pulmonary disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1568 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Roflumilast
Arm Type
Active Comparator
Arm Description
500 mcg, once daily, oral administration in the morning
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
once daily
Intervention Type
Drug
Intervention Name(s)
Roflumilast
Intervention Description
500 mcg, once daily, oral administration in the morning
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
once daily
Primary Outcome Measure Information:
Title
Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
Description
Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]
Time Frame
Change from baseline over 52 weeks of treatment
Title
COPD Exacerbation Rate (Moderate or Severe)
Description
Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].
Time Frame
52 weeks treatment period
Secondary Outcome Measure Information:
Title
Post-bronchodilator FEV1 [L]
Description
Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]
Time Frame
Change from baseline over 52 weeks of treatment
Title
Time to Mortality Due to Any Reason
Time Frame
52 weeks treatment period
Title
Natural Log-transformed C-reactive Protein (CRP)
Description
Mean change from baseline to the last post randomization measurement in natural log-transformed CRP
Time Frame
Change from baseline to last post randomization measurement (52 weeks)
Title
Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period
Description
The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9.
Time Frame
Change from baseline over 52 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca AstraZeneca
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bayou La Batre
State/Province
Alabama
ZIP/Postal Code
36509
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bullhead City
State/Province
Arizona
ZIP/Postal Code
85442
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72917
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Carlsbad
State/Province
California
ZIP/Postal Code
92008
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Roseville
State/Province
California
ZIP/Postal Code
95678
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95831
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Sepulveda
State/Province
California
ZIP/Postal Code
91343
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
6708
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20017
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Ormand Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
33127
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31901
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Ft. Gordon
State/Province
Georgia
ZIP/Postal Code
30905
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Rincon
State/Province
Georgia
ZIP/Postal Code
594
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Twin Falls
State/Province
Idaho
ZIP/Postal Code
83301
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Dubuque
State/Province
Iowa
ZIP/Postal Code
52001
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Fort Dodge
State/Province
Iowa
ZIP/Postal Code
50501
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50702
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Campbellsville
State/Province
Kentucky
ZIP/Postal Code
42718
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48114
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Interlochen
State/Province
Michigan
ZIP/Postal Code
49643
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Portage
State/Province
Michigan
ZIP/Postal Code
49002
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65101
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Kansas City (-1453)
State/Province
Missouri
ZIP/Postal Code
64106
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63122
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Sunset
State/Province
Missouri
ZIP/Postal Code
70584
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89176
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Absecon
State/Province
New Jersey
ZIP/Postal Code
08201
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08610
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
South Bound Brook
State/Province
New Jersey
ZIP/Postal Code
08880
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Camillus
State/Province
New York
ZIP/Postal Code
13031
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Corning
State/Province
New York
ZIP/Postal Code
14830
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Cortland
State/Province
New York
ZIP/Postal Code
13045
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28070
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15221
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Stoneboro
State/Province
Pennsylvania
ZIP/Postal Code
16153
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Swarthmore
State/Province
Pennsylvania
ZIP/Postal Code
19081
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
2919
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Union
State/Province
South Carolina
ZIP/Postal Code
29379
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Williamston
State/Province
South Carolina
ZIP/Postal Code
29697
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
New Tazewell
State/Province
Tennessee
ZIP/Postal Code
37825
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76109
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Seguin
State/Province
Texas
ZIP/Postal Code
78155
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53212
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3C 3P1
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5C 0A3
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Spruce Grove
State/Province
Alberta
ZIP/Postal Code
T7X 2Z8
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5G 1T4
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 5C8
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E1
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Truro
State/Province
Nova Scotia
ZIP/Postal Code
B2N 1L2
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7M 1R2
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N5Y 5K7
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2V8
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1B 4Z8
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2A5
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1V 1X5
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3S 2W1
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4J6
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
St. Romuald
State/Province
Quebec
ZIP/Postal Code
G6W 5M6
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Antigonish
ZIP/Postal Code
B2G2C2
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bridgewater
ZIP/Postal Code
B4V3N2
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Calgary
ZIP/Postal Code
T1Y6J4
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Corunna
ZIP/Postal Code
N0N1G0
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Edmonton
ZIP/Postal Code
T5N4L8
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Fort Erie
ZIP/Postal Code
L2A1Z3
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Grimsby
ZIP/Postal Code
L3M1P3
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Hamilton
ZIP/Postal Code
L8N3Z5
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Longueuil
ZIP/Postal Code
J4N1E1
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Montreal
ZIP/Postal Code
H2L2W5
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Ontario
ZIP/Postal Code
L2R2Z9
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Richmond Hill
ZIP/Postal Code
L4C2N9
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Saint John
ZIP/Postal Code
E3M3W5
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Sherbrooke
ZIP/Postal Code
J1H5N4
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
St Jerome
ZIP/Postal Code
J7Z5T3
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
St Leonard
ZIP/Postal Code
H1S3A9
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Toronto
ZIP/Postal Code
M5G1X5
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Winnipeg
ZIP/Postal Code
R2K3S8
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Berlin
ZIP/Postal Code
10559
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Berlin
ZIP/Postal Code
10717
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Berlin
ZIP/Postal Code
10965
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Berlin
ZIP/Postal Code
10969
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Berlin
ZIP/Postal Code
12165
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Berlin
ZIP/Postal Code
13507
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Berlin
ZIP/Postal Code
13597
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Donaustauf
ZIP/Postal Code
93093
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Halle
ZIP/Postal Code
6108
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Hamburg
ZIP/Postal Code
20535
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Landsberg/Lech
ZIP/Postal Code
86899
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Neuruppin
ZIP/Postal Code
16816
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Oschersleben
ZIP/Postal Code
39387
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Potsdam
ZIP/Postal Code
14464
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Regensburg
ZIP/Postal Code
93059
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Rüdersdorf
ZIP/Postal Code
15562
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Ulm
ZIP/Postal Code
89073
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bangalore, Karnataka
ZIP/Postal Code
560 029
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bangalore
ZIP/Postal Code
560 002
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bangalore
ZIP/Postal Code
560 034
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Chennai
ZIP/Postal Code
600 034
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Coimbatore, Tamilnadu
ZIP/Postal Code
641 044
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Coimbatore
ZIP/Postal Code
641 004
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Coimbatore
ZIP/Postal Code
641 014
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Goa
ZIP/Postal Code
403 002
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Hyderabad
ZIP/Postal Code
12
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Indore, South Tukuganj
ZIP/Postal Code
452001
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Mangalore
ZIP/Postal Code
574 160
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Mangalore
ZIP/Postal Code
575 001
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Mumbai, Byculla
ZIP/Postal Code
400 008
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Mumbai, Dadar (E)
ZIP/Postal Code
400 014
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Mumbai
ZIP/Postal Code
400022
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Mysore
ZIP/Postal Code
570004
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Nagpur
ZIP/Postal Code
440 012
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Nagpur
ZIP/Postal Code
440 013
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Nagpur
ZIP/Postal Code
440012
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Pune
ZIP/Postal Code
411 014
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Pune
ZIP/Postal Code
411033
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Shastri Nagar, Jaipur
ZIP/Postal Code
302 016
Country
India
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bergamo
ZIP/Postal Code
24100
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Cassano Murge
ZIP/Postal Code
70020
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Roma
ZIP/Postal Code
135
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Trieste
ZIP/Postal Code
34100
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Verona
ZIP/Postal Code
37100
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Veruno
ZIP/Postal Code
28010
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Chrzanów
ZIP/Postal Code
32500
Country
Poland
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Czestochowa
ZIP/Postal Code
42200
Country
Poland
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Dzialdowo
ZIP/Postal Code
13-200
Country
Poland
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Kraków
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Kraków
ZIP/Postal Code
31202
Country
Poland
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Warsawa
ZIP/Postal Code
01-138
Country
Poland
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Warszawa
ZIP/Postal Code
1140
Country
Poland
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Wodzislaw Slaski
ZIP/Postal Code
44300
Country
Poland
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Zgierz
ZIP/Postal Code
95100
Country
Poland
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bellville, Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Berea, Durban
ZIP/Postal Code
4000
Country
South Africa
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Altana Pharma/Nycomed Investigational Site
City
C/O Netcare & Garsfontein Roads
ZIP/Postal Code
44
Country
South Africa
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Cape Town, Tygerberg
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Cape Town
ZIP/Postal Code
7764
Country
South Africa
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Cape Town
ZIP/Postal Code
8001
Country
South Africa
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Durban, Amanzimtoti
ZIP/Postal Code
4126
Country
South Africa
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Durbanville / Cape Town
ZIP/Postal Code
7550
Country
South Africa
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Mowbray, Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Paarl, Cape Town
ZIP/Postal Code
7626
Country
South Africa
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Pretoria
ZIP/Postal Code
181
Country
South Africa
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Badajoz
ZIP/Postal Code
6080
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Calde (Lugo)
ZIP/Postal Code
27210
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Cartagena
ZIP/Postal Code
30203
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Elda
ZIP/Postal Code
3600
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Getafe
ZIP/Postal Code
28905
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Merida (Badajoz)
ZIP/Postal Code
6800
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Partida de Bacarot (Alicante)
ZIP/Postal Code
3114
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Requena
ZIP/Postal Code
46340
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Talavera de la Reina (Toledo)
ZIP/Postal Code
45600
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Tarrasa (Barcelona)
ZIP/Postal Code
8221
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Toldeo
ZIP/Postal Code
45004
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Valencia
ZIP/Postal Code
46017
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
19716960
Citation
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.
Results Reference
result
PubMed Identifier
28419462
Citation
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.
Results Reference
derived
PubMed Identifier
24120253
Citation
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.
Results Reference
derived
PubMed Identifier
23117188
Citation
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.
Results Reference
derived
PubMed Identifier
20102307
Citation
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.
Results Reference
derived

Learn more about this trial

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)

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