Tiotropium+Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)

Condition(s) targeted: Pulmonary Disease, Chronic Obstructive

Intervention: tiotropium+olodaterol FDC (Drug); tiotropium+olodaterol FDC (Drug); olodaterol (Drug); tiotropium (Drug); tiotropium (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals

Overall contact:
Boehringer Ingelheim Call Center, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com

The primary objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).

Official title: A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 µg / 5 µg; 5 µg / 5 µg) (Delivered by the Respimat® Inhaler) Compared With the Individual Components (2.5 µg and 5 µg Tiotropium, 5 µg Olodaterol) (Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD). [TOnado TM 1]

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

FEV1 AUC0-3h response

Trough FEV1 response

SGRQ total score (This endpoint will be evaluated after combining the data from this and the replicate study 1237.6)

Secondary outcome:

TDI focal score (Key secondary endpoint; This endpoint will be evaluated after combining the data from this and the replicate study 1237.6)

FVC AUC0-3h response

Trough FVC response

FEV1 AUC0-12h response [L] in sub-set of patients with 12-hour PFTs

FVC AUC0-12h response [L] in sub-set of patients with 12-hour PFTs

FEV1 peak0-3h response [L]

FEV1 response [L] at 5, 15 and 30 minutes, and at 1, 2 and 3 hours after inhalation of study medication

FVC response [L] at 5, 15 and 30 minutes, and at 1, 2 and 3 hours after inhalation of study medication

FVC peak0-3h response [L]

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria:

1. Diagnosis of chronic obstructive pulmonary disease.

2. Relatively stable airway obstruction with post FEV1< 80% predicted normal and post FEV1/FVC <70%.

3. Male or female patients, 40 years of age or older.

4. Smoking history of more than 10 pack years.

Exclusion criteria:

1. Significant disease other than COPD

2. Clinically relevant abnormal lab values.

3. History of asthma.

4. Diagnosis of thyrotoxicosis

5. Diagnosis of paroxysmal tachycardia

6. History of myocardial infarction within 1 year of screening visit

7. Unstable or life-threatening cardiac arrhythmia.

8. Hospitalization for heart failure within the past year.

9. Known active tuberculosis.

10. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years

11. History of life-threatening pulmonary obstruction.

12. History of cystic fibrosis.

13. Clinically evident bronchiectasis.

14. History of significant alcohol or drug abuse.

15. Thoracotomy with pulmonary resection

16. Oral ß-adrenergics.

17. Oral corticosteroid medication at unstable doses

18. Regular use of daytime oxygen therapy for more than one hour per day

19. Pulmonary rehabilitation program in the six weeks prior to the screening visit

20. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit

21. Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA

22. Pregnant or nursing women.

23. Women of childbearing potential not using a highly effective method of birth control

24. Patients who are unable to comply with pulmonary medication restrictions

Boehringer Ingelheim Call Center, Phone: 1-800-243-0127, Email: clintriage.rdg@boehringer-ingelheim.com

1237.5.02006 Boehringer Ingelheim Investigational Site, Quebec, Canada; Recruiting

1237.5.02003 Boehringer Ingelheim Investigational Site, Quebec, Canada; Recruiting

1237.5.42004 Boehringer Ingelheim Investigational Site, Beroun, Czech Republic; Recruiting

1237.5.42002 Boehringer Ingelheim Investigational Site, Cvikov, Czech Republic; Recruiting

1237.5.42001 Boehringer Ingelheim Investigational Site, Praha 6, Czech Republic; Recruiting

1237.5.42005 Boehringer Ingelheim Investigational Site, Rokycany, Czech Republic; Recruiting

1237.5.42003 Boehringer Ingelheim Investigational Site, Znojmo, Czech Republic; Recruiting

1237.5.45002 Boehringer Ingelheim Investigational Site, Aalborg, Denmark; Recruiting

1237.5.45009 Boehringer Ingelheim Investigational Site, Hvidovre, Denmark; Recruiting

1237.5.45007 Boehringer Ingelheim Investigational Site, Kolding, Denmark; Recruiting

1237.5.45001 Boehringer Ingelheim Investigational Site, København NV, Denmark; Recruiting

1237.5.45006 Boehringer Ingelheim Investigational Site, Odense C, Denmark; Recruiting

1237.5.45008 Boehringer Ingelheim Investigational Site, Roskilde, Denmark; Recruiting

1237.5.45010 Boehringer Ingelheim Investigational Site, Rungsted Kyst, Denmark; Not yet recruiting

1237.5.45003 Boehringer Ingelheim Investigational Site, Silkeborg, Denmark; Recruiting

1237.5.45005 Boehringer Ingelheim Investigational Site, Sønderborg, Denmark; Recruiting

1237.5.45004 Boehringer Ingelheim Investigational Site, Vaerløse, Denmark; Recruiting

1237.5.37002 Boehringer Ingelheim Investigational Site, Tallin, Estonia; Not yet recruiting

1237.5.37001 Boehringer Ingelheim Investigational Site, Tartu, Estonia; Not yet recruiting

1237.5.35801 Boehringer Ingelheim Investigational Site, Helsinki, Finland; Recruiting

1237.5.35804 Boehringer Ingelheim Investigational Site, Pori, Finland; Recruiting

1237.5.35802 Boehringer Ingelheim Investigational Site, Turku, Finland; Recruiting

1237.5.33004 Boehringer Ingelheim Investigational Site, Bethune Cedex, France; Recruiting

1237.5.33003 Boehringer Ingelheim Investigational Site, Foix cedex, France; Not yet recruiting

1237.5.33007 Boehringer Ingelheim Investigational Site, Montpellier cedex 5, France; Recruiting

1237.5.33005 Boehringer Ingelheim Investigational Site, Nantes, France; Recruiting

1237.5.33006 Boehringer Ingelheim Investigational Site, Nîmes cedex 9, France; Recruiting

1237.5.33008 Boehringer Ingelheim Investigational Site, Perpignan, France; Recruiting

1237.5.33001 Boehringer Ingelheim Investigational Site, Saint Pierre Cedex, France; Recruiting

1237.5.33002 Boehringer Ingelheim Investigational Site, Strasbourg, France; Recruiting

1237.5.49006 Boehringer Ingelheim Investigational Site, Bamberg, Germany; Not yet recruiting

1237.5.49013 Boehringer Ingelheim Investigational Site, Berlin, Germany; Not yet recruiting

1237.5.49002 Boehringer Ingelheim Investigational Site, Berlin, Germany; Not yet recruiting

1237.5.49003 Boehringer Ingelheim Investigational Site, Berlin, Germany; Not yet recruiting

1237.5.49011 Boehringer Ingelheim Investigational Site, Erfurt, Germany; Not yet recruiting

1237.5.49010 Boehringer Ingelheim Investigational Site, Hamburg, Germany; Not yet recruiting

1237.5.49005 Boehringer Ingelheim Investigational Site, Hamburg, Germany; Not yet recruiting

1237.5.49009 Boehringer Ingelheim Investigational Site, Koblenz, Germany; Not yet recruiting

1237.5.49014 Boehringer Ingelheim Investigational Site, Neu-Isenburg, Germany; Not yet recruiting

1237.5.49012 Boehringer Ingelheim Investigational Site, Oschersleben, Germany; Not yet recruiting

1237.5.49001 Boehringer Ingelheim Investigational Site, Rüdersdorf, Germany; Not yet recruiting

1237.5.49004 Boehringer Ingelheim Investigational Site, Weinheim, Germany; Not yet recruiting

1237.5.49008 Boehringer Ingelheim Investigational Site, Wiesloch, Germany; Not yet recruiting

1237.5.50207 Boehringer Ingelheim Investigational Site, Guatemala, Guatemala; Not yet recruiting

1237.5.50201 Boehringer Ingelheim Investigational Site, Guatemala, Guatemala; Not yet recruiting

1237.5.50206 Boehringer Ingelheim Investigational Site, Guatemala, Guatemala; Not yet recruiting

1237.5.50205 Boehringer Ingelheim Investigational Site, Guatemala, Guatemala; Not yet recruiting

1237.5.50204 Boehringer Ingelheim Investigational Site, Guatemala, Guatemala; Not yet recruiting

1237.5.50203 Boehringer Ingelheim Investigational Site, Guatemala, Guatemala; Not yet recruiting

1237.5.50202 Boehringer Ingelheim Investigational Site, Guatemala, Guatemala; Not yet recruiting

1237.5.36005 Boehringer Ingelheim Investigational Site, Debrecen, Hungary; Not yet recruiting

1237.5.36001 Boehringer Ingelheim Investigational Site, Deszk, Hungary; Not yet recruiting

1237.5.36006 Boehringer Ingelheim Investigational Site, Kapuvar, Hungary; Not yet recruiting

1237.5.36003 Boehringer Ingelheim Investigational Site, Szombathely, Hungary; Not yet recruiting

1237.5.36002 Boehringer Ingelheim Investigational Site, Törökbálint, Hungary; Not yet recruiting

1237.5.39008 Boehringer Ingelheim Investigational Site, Cagliari, Italy; Not yet recruiting

1237.5.39003 Boehringer Ingelheim Investigational Site, Cassano delle Murge (BA), Italy; Not yet recruiting

1237.5.39002 Boehringer Ingelheim Investigational Site, Genova, Italy; Not yet recruiting

1237.5.39007 Boehringer Ingelheim Investigational Site, Mirandola (MO), Italy; Not yet recruiting

1237.5.39006 Boehringer Ingelheim Investigational Site, Montescano (PV), Italy; Not yet recruiting

1237.5.39009 Boehringer Ingelheim Investigational Site, Monza, Italy; Not yet recruiting

1237.5.39004 Boehringer Ingelheim Investigational Site, Parma, Italy; Not yet recruiting

1237.5.39001 Boehringer Ingelheim Investigational Site, Pisa, Italy; Not yet recruiting

1237.5.81003 Boehringer Ingelheim Investigational Site, Aoba-ku, Sendai, Miyagi, Japan; Not yet recruiting

1237.5.81001 Boehringer Ingelheim Investigational Site, Asahikawa, Hokkaido, Japan; Not yet recruiting

1237.5.81006 Boehringer Ingelheim Investigational Site, Bunkyo-ku, Tokyo, Japan; Not yet recruiting

1237.5.81035 Boehringer Ingelheim Investigational Site, Gifu, Gifu, Japan; Not yet recruiting

1237.5.81017 Boehringer Ingelheim Investigational Site, Hakata-ku, Fukuoka, Fukuoka, Japan; Not yet recruiting

1237.5.81031 Boehringer Ingelheim Investigational Site, Hamamatsushi, Shizuoka, Japan; Not yet recruiting

1237.5.81014 Boehringer Ingelheim Investigational Site, Himeji, Hyogo, Japan; Not yet recruiting

1237.5.81037 Boehringer Ingelheim Investigational Site, Ikoma, Nara, Japan; Not yet recruiting

1237.5.81024 Boehringer Ingelheim Investigational Site, Inashiki-gun, Ibaraki, Japan; Not yet recruiting

1237.5.81008 Boehringer Ingelheim Investigational Site, Itabashi-ku, Tokyo, Japan; Not yet recruiting

1237.5.81016 Boehringer Ingelheim Investigational Site, Jonan-ku, Fukuoka, Fukuoka, Japan; Not yet recruiting

1237.5.81021 Boehringer Ingelheim Investigational Site, Kagoshima, Kagoshima, Japan; Not yet recruiting

1237.5.81020 Boehringer Ingelheim Investigational Site, Kagoshima, Kagoshima,, Japan; Not yet recruiting

1237.5.81005 Boehringer Ingelheim Investigational Site, Kamogawa, Chiba, Japan; Not yet recruiting

1237.5.81011 Boehringer Ingelheim Investigational Site, Kishiwada, Osaka, Japan; Not yet recruiting

1237.5.81018 Boehringer Ingelheim Investigational Site, Kitakyusyu,Fukuoka, Japan; Not yet recruiting

1237.5.81042 Boehringer Ingelheim Investigational Site, Koga, Fukuoka, Japan; Not yet recruiting

1237.5.81033 Boehringer Ingelheim Investigational Site, Komaki, Aichi, Japan; Not yet recruiting

1237.5.81032 Boehringer Ingelheim Investigational Site, Komaki, Aichi, Japan; Not yet recruiting

1237.5.81019 Boehringer Ingelheim Investigational Site, Koshi, Kumamoto, Japan; Not yet recruiting

1237.5.81027 Boehringer Ingelheim Investigational Site, koto-ku, Tokyo, Japan; Not yet recruiting

1237.5.81025 Boehringer Ingelheim Investigational Site, Kuki, Saitama, Japan; Not yet recruiting

1237.5.81044 Boehringer Ingelheim Investigational Site, Kumamoto, Kumamoto, Japan; Not yet recruiting

1237.5.81038 Boehringer Ingelheim Investigational Site, Kure, Hiroshima, Japan; Not yet recruiting

1237.5.81015 Boehringer Ingelheim Investigational Site, Kurume, Fukuoka, Japan; Not yet recruiting

1237.5.81030 Boehringer Ingelheim Investigational Site, Matsumoto, Nagano, Japan; Not yet recruiting

1237.5.81010 Boehringer Ingelheim Investigational Site, Matsusaka, Mie, Japan; Not yet recruiting

1237.5.81041 Boehringer Ingelheim Investigational Site, Minami-ku. Fukuoka, Fukuoka, Japan; Not yet recruiting

1237.5.81002 Boehringer Ingelheim Investigational Site, Morioka, Iwate, Japan; Not yet recruiting

1237.5.81034 Boehringer Ingelheim Investigational Site, Nagoya, Aichi, Japan; Not yet recruiting

1237.5.81036 Boehringer Ingelheim Investigational Site, Nagoya, Aichi, Japan; Not yet recruiting

1237.5.81004 Boehringer Ingelheim Investigational Site, Naka-gun, Ibaraki, Japan; Not yet recruiting

1237.5.81022 Boehringer Ingelheim Investigational Site, Okinawa, Urasoe, Japan; Not yet recruiting

1237.5.81023 Boehringer Ingelheim Investigational Site, Okinawa, Urasoe, Japan; Not yet recruiting

1237.5.81012 Boehringer Ingelheim Investigational Site, Sayama, Osaka, Japan; Not yet recruiting

1237.5.81045 Boehringer Ingelheim Investigational Site, Sendai, Miyagi, Japan; Not yet recruiting

1237.5.81009 Boehringer Ingelheim Investigational Site, Seto, Aichi, Japan; Not yet recruiting

1237.5.81026 Boehringer Ingelheim Investigational Site, Shinagawa, Tokyo, Japan; Not yet recruiting

1237.5.81007 Boehringer Ingelheim Investigational Site, Shinjyuku-ku, Tokyo, Japan; Not yet recruiting

1237.5.81039 Boehringer Ingelheim Investigational Site, Takamatsu, Kagawa, Japan; Not yet recruiting

1237.5.81040 Boehringer Ingelheim Investigational Site, Takamatsu-shi, Kagawa, Japan; Not yet recruiting

1237.5.81013 Boehringer Ingelheim Investigational Site, Wakayama, Wakayama, Japan; Not yet recruiting

1237.5.81043 Boehringer Ingelheim Investigational Site, Yanagawa-shi, Fukuoka,, Japan; Not yet recruiting

1237.5.81029 Boehringer Ingelheim Investigational Site, Yokohama, Kanagawa, Japan; Not yet recruiting

1237.5.81028 Boehringer Ingelheim Investigational Site, Yokohama, Kanagawa, Japan; Not yet recruiting

1237.5.82004 Boehringer Ingelheim Investigational Site, Bucheon, Korea, Republic of; Recruiting

1237.5.82008 Boehringer Ingelheim Investigational Site, Daegu, Korea, Republic of; Recruiting

1237.5.82003 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of; Recruiting

1237.5.82002 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of; Recruiting

1237.5.82007 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of; Recruiting

1237.5.82001 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of; Recruiting

1237.5.82005 Boehringer Ingelheim Investigational Site, Suwon, Korea, Republic of; Recruiting

1237.5.82006 Boehringer Ingelheim Investigational Site, Wonju, Korea, Republic of; Recruiting

1237.5.31004 Boehringer Ingelheim Investigational Site, Almelo, Netherlands; Recruiting

1237.5.31006 Boehringer Ingelheim Investigational Site, Breda, Netherlands; Recruiting

1237.5.31001 Boehringer Ingelheim Investigational Site, Eindhoven, Netherlands; Recruiting

1237.5.31008 Boehringer Ingelheim Investigational Site, Harderwijk, Netherlands; Recruiting

1237.5.31007 Boehringer Ingelheim Investigational Site, Heerlen, Netherlands; Recruiting

1237.5.31010 Boehringer Ingelheim Investigational Site, Hengelo, Netherlands; Recruiting

1237.5.31009 Boehringer Ingelheim Investigational Site, Hoorn, Netherlands; Recruiting

1237.5.31005 Boehringer Ingelheim Investigational Site, Nieuwegein, Netherlands; Not yet recruiting

1237.5.31002 Boehringer Ingelheim Investigational Site, Veldhoven, Netherlands; Recruiting

1237.5.31003 Boehringer Ingelheim Investigational Site, Zutphen, Netherlands; Recruiting

1237.5.64002 Boehringer Ingelheim Investigational Site, Dunedin, New Zealand; Not yet recruiting

1237.5.64001 Boehringer Ingelheim Investigational Site, Greenlane East Auckland NZ, New Zealand; Not yet recruiting

1237.5.35105 Boehringer Ingelheim Investigational Site, Amadora, Portugal; Not yet recruiting

1237.5.35101 Boehringer Ingelheim Investigational Site, Coimbra, Portugal; Recruiting

1237.5.35104 Boehringer Ingelheim Investigational Site, Lisboa, Portugal; Not yet recruiting

1237.5.35102 Boehringer Ingelheim Investigational Site, Lisboa, Portugal; Not yet recruiting

1237.5.35103 Boehringer Ingelheim Investigational Site, Porto, Portugal; Recruiting

1237.5.35106 Boehringer Ingelheim Investigational Site, Vila Nova de Gaia, Portugal; Not yet recruiting

1237.5.35107 Boehringer Ingelheim Investigational Site, Viseu, Portugal; Not yet recruiting

1237.5.38602 Boehringer Ingelheim Investigational Site, Golnik, Slovenia; Recruiting

1237.5.38601 Boehringer Ingelheim Investigational Site, Golnik, Slovenia; Recruiting

1237.5.01038 Boehringer Ingelheim Investigational Site, Jasper, Alabama, United States; Not yet recruiting

1237.5.01036 Boehringer Ingelheim Investigational Site, Mobile, Alabama, United States; Recruiting

1237.5.02002 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada; Not yet recruiting

1237.5.02001 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada; Recruiting

1237.5.01015 Boehringer Ingelheim Investigational Site, Boulder, Colorado, United States; Recruiting

1237.5.01024 Boehringer Ingelheim Investigational Site, Wheat Ridge, Colorado, United States; Not yet recruiting

1237.5.01034 Boehringer Ingelheim Investigational Site, Stamford, Connecticut, United States; Recruiting

1237.5.01010 Boehringer Ingelheim Investigational Site, Clearwater, Florida, United States; Recruiting

1237.5.01003 Boehringer Ingelheim Investigational Site, Clearwater, Florida, United States; Recruiting

1237.5.01027 Boehringer Ingelheim Investigational Site, Panama City, Florida, United States; Recruiting

1237.5.01031 Boehringer Ingelheim Investigational Site, O'Fallon, Illinois, United States; Recruiting

1237.5.01035 Boehringer Ingelheim Investigational Site, Opelousas, Louisiana, United States; Recruiting

1237.5.01004 Boehringer Ingelheim Investigational Site, Shreveport, Louisiana, United States; Not yet recruiting

1237.5.01017 Boehringer Ingelheim Investigational Site, Biddeford, Maine, United States; Recruiting

1237.5.02004 Boehringer Ingelheim Investigational Site, Winnipeg, Manitoba, Canada; Recruiting

1237.5.01028 Boehringer Ingelheim Investigational Site, Columbia, Maryland, United States; Recruiting

1237.5.01013 Boehringer Ingelheim Investigational Site, Livonia, Michigan, United States; Recruiting

1237.5.01019 Boehringer Ingelheim Investigational Site, Omaha, Nebraska, United States; Recruiting

1237.5.01022 Boehringer Ingelheim Investigational Site, Reno, Nevada, United States; Not yet recruiting

1237.5.01025 Boehringer Ingelheim Investigational Site, Larchmont, New York, United States; Recruiting

1237.5.01008 Boehringer Ingelheim Investigational Site, Rochester, New York, United States; Recruiting

1237.5.01023 Boehringer Ingelheim Investigational Site, Raleigh, North Carolina, United States; Recruiting

1237.5.01016 Boehringer Ingelheim Investigational Site, Tabor City, North Carolina, United States; Recruiting

1237.5.01039 Boehringer Ingelheim Investigational Site, Centerville, Ohio, United States; Recruiting

1237.5.01006 Boehringer Ingelheim Investigational Site, Cincinnati, Ohio, United States; Recruiting

1237.5.01040 Boehringer Ingelheim Investigational Site, Columbus, Ohio, United States; Not yet recruiting

1237.5.01037 Boehringer Ingelheim Investigational Site, Toledo, Ohio, United States; Recruiting

1237.5.01009 Boehringer Ingelheim Investigational Site, Oklahoma City, Oklahoma, United States; Recruiting

1237.5.02005 Boehringer Ingelheim Investigational Site, Burlington, Ontario, Canada; Recruiting

1237.5.02007 Boehringer Ingelheim Investigational Site, Grimsby, Ontario, Canada; Recruiting

1237.5.02011 Boehringer Ingelheim Investigational Site, Ottawa, Ontario, Canada; Recruiting

1237.5.01032 Boehringer Ingelheim Investigational Site, Charleston, Pennsylvania, United States; Recruiting

1237.5.02008 Boehringer Ingelheim Investigational Site, Sherbrooke, Quebec, Canada; Recruiting

1237.5.01005 Boehringer Ingelheim Investigational Site, Johnston, Rhode Island, United States; Recruiting

1237.5.02009 Boehringer Ingelheim Investigational Site, Saskatoon, Saskatchewan, Canada; Recruiting

1237.5.61003 Boehringer Ingelheim Investigational Site, Adelaide, South Australia, Australia; Not yet recruiting

1237.5.61001 Boehringer Ingelheim Investigational Site, Toorak Gardens, South Australia, Australia; Recruiting

1237.5.61002 Boehringer Ingelheim Investigational Site, Woodville, South Australia, Australia; Recruiting

1237.5.01021 Boehringer Ingelheim Investigational Site, Easley, South Carolina, United States; Recruiting

1237.5.01012 Boehringer Ingelheim Investigational Site, Gaffney, South Carolina, United States; Recruiting

1237.5.01014 Boehringer Ingelheim Investigational Site, Spartanburg, South Carolina, United States; Recruiting

1237.5.01029 Boehringer Ingelheim Investigational Site, Ft. Worth, Texas, United States; Recruiting

1237.5.01002 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States; Recruiting

1237.5.61004 Boehringer Ingelheim Investigational Site, Frankston, Victoria, Australia; Recruiting

1237.5.01026 Boehringer Ingelheim Investigational Site, Lynchburg, Virginia, United States; Recruiting

1237.5.01007 Boehringer Ingelheim Investigational Site, Spokane, Washington, United States; Recruiting

1237.5.01033 Boehringer Ingelheim Investigational Site, Tacoma, Washington, United States; Not yet recruiting

1237.5.01001 Boehringer Ingelheim Investigational Site, Morgantown, West Virginia, United States; Recruiting

Starting date: September 2011
Last updated: November 16, 2011