Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM
NCT ID: NCT00736099
Last Updated: 2014-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2122 participants
INTERVENTIONAL
2008-08-31
Brief Summary
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The treatment modalities are determined by the treatment in the blinded trial in which every patient was included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI 1356 in combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin in combination with a sulphonylurea (patients in 1218.18 study)
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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linagliptin 5 mg
open label
linagliptine 5 mg
safety and efficacy of linagliptine 5 mg open label
linagliptin 5 mg and pioglitazone 30 mg
open label
linagliptine 5 mg and pioglitazone 30 mg
efficacy and safety of the combination linagliptine and pioglitazone
Interventions
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linagliptine 5 mg
safety and efficacy of linagliptine 5 mg open label
linagliptine 5 mg and pioglitazone 30 mg
efficacy and safety of the combination linagliptine and pioglitazone
Eligibility Criteria
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Inclusion Criteria
2. Patients completing the entire treatment period as a double blind trial whether or not they have been treated with rescue medication.
Exclusion Criteria
2. Pre-menopausal women (last menstruation =\< 1 year prior to signing informed consent) who:
* are nursing or pregnant,
* or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, true sexual abstinence (when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence \[e.g. calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of birth control) and vasectomised partners. No exception will be made.
3. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation.
4. Drug abuse which, in the opinion of the investigator, would interfere with trial participation.
5. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication.
18 Years
82 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1218.40.10003 Boehringer Ingelheim Investigational Site
Chula Vista, California, United States
1218.40.10014 Boehringer Ingelheim Investigational Site
Spring Valley, California, United States
1218.40.10001 Boehringer Ingelheim Investigational Site
Walnut Creek, California, United States
1218.40.10021 Boehringer Ingelheim Investigational Site
Northglenn, Colorado, United States
1218.40.10010 Boehringer Ingelheim Investigational Site
Hollywood, Florida, United States
1218.40.10011 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1218.40.10016 Boehringer Ingelheim Investigational Site
Eugene, Oregon, United States
1218.40.10002 Boehringer Ingelheim Investigational Site
Greer, South Carolina, United States
1218.40.10004 Boehringer Ingelheim Investigational Site
Simpsonville, South Carolina, United States
1218.40.10005 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1218.40.10018 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1218.40.10007 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
1218.40.10009 Boehringer Ingelheim Investigational Site
Federal Way, Washington, United States
1218.40.54002 Boehringer Ingelheim Investigational Site
Capital Federal, , Argentina
1218.40.54010 Boehringer Ingelheim Investigational Site
Capital Federal, , Argentina
1218.40.54011 Boehringer Ingelheim Investigational Site
Mendoza, , Argentina
1218.40.54015 Boehringer Ingelheim Investigational Site
Parque Velez Sarfield, , Argentina
1218.40.43001 Boehringer Ingelheim Investigational Site
Graz, , Austria
1218.40.43005 Boehringer Ingelheim Investigational Site
Vienna, , Austria
1218.40.32005 Boehringer Ingelheim Investigational Site
Bruges, , Belgium
1218.40.32007 Boehringer Ingelheim Investigational Site
Brussels, , Belgium
1218.40.32006 Boehringer Ingelheim Investigational Site
Edegem, , Belgium
1218.40.32004 Boehringer Ingelheim Investigational Site
Genk, , Belgium
1218.40.32003 Boehringer Ingelheim Investigational Site
Ghent, , Belgium
1218.40.32002 Boehringer Ingelheim Investigational Site
Huy, , Belgium
1218.40.32001 Boehringer Ingelheim Investigational Site
Liège, , Belgium
1218.40.01005 Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
1218.40.01010 Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
1218.40.01003 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1218.40.01011 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1218.40.01006 Boehringer Ingelheim Investigational Site
Etobicoke, Ontario, Canada
1218.40.01009 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1218.40.01002 Boehringer Ingelheim Investigational Site
London, Ontario, Canada
1218.40.01012 Boehringer Ingelheim Investigational Site
Oakville, Ontario, Canada
1218.40.01008 Boehringer Ingelheim Investigational Site
Sarnia, Ontario, Canada
1218.40.20005 Boehringer Ingelheim Investigational Site
Strathroy, Ontario, Canada
1218.40.01001 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1218.40.01004 Boehringer Ingelheim Investigational Site
Montague, Prince Edward Island, Canada
1218.40.01007 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
1218.40.86001 Boehringer Ingelheim Investigational Site
Beijing, , China
1218.40.86002 Boehringer Ingelheim Investigational Site
Beijing, , China
1218.40.86004 Boehringer Ingelheim Investigational Site
Beijing, , China
1218.40.86013 Boehringer Ingelheim Investigational Site
Chengdu, , China
1218.40.86009 Boehringer Ingelheim Investigational Site
Dalian, , China
1218.40.86011 Boehringer Ingelheim Investigational Site
Guangzhou, , China
1218.40.86014 Boehringer Ingelheim Investigational Site
Haerbin, , China
1218.40.86008 Boehringer Ingelheim Investigational Site
Qingdao, , China
1218.40.86015 Boehringer Ingelheim Investigational Site
Shanghai, , China
1218.40.86010 Boehringer Ingelheim Investigational Site
Shenyang, , China
1218.40.86007 Boehringer Ingelheim Investigational Site
Wuhan, , China
1218.40.86012 Boehringer Ingelheim Investigational Site
Wuhan, , China
1218.40.86006 Boehringer Ingelheim Investigational Site
Xi'an, , China
1218.40.38605 Boehringer Ingelheim Investigational Site
Krapinske Toplice, , Croatia
1218.40.38604 Boehringer Ingelheim Investigational Site
Slavonski Brod, , Croatia
1218.40.42004 Boehringer Ingelheim Investigational Site
Brno, , Czechia
1218.40.42007 Boehringer Ingelheim Investigational Site
Brno, , Czechia
1218.40.42009 Boehringer Ingelheim Investigational Site
Brno, , Czechia
1218.40.42006 Boehringer Ingelheim Investigational Site
Břeclav, , Czechia
1218.40.42008 Boehringer Ingelheim Investigational Site
Hodonín, , Czechia
1218.40.42003 Boehringer Ingelheim Investigational Site
Olomouc, , Czechia
1218.40.35806 Boehringer Ingelheim Investigational Site
Helsinki, , Finland
1218.40.35801 Boehringer Ingelheim Investigational Site
Kuopio, , Finland
1218.40.35803 Boehringer Ingelheim Investigational Site
Oulu, , Finland
1218.40.35805 Boehringer Ingelheim Investigational Site
Seinäjoki, , Finland
1218.40.35802 Boehringer Ingelheim Investigational Site
Turku, , Finland
1218.40.49028 Boehringer Ingelheim Investigational Site
Bad Mergentheim, , Germany
1218.40.49022 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1218.40.49024 Boehringer Ingelheim Investigational Site
Bosenheim, , Germany
1218.40.49020 Boehringer Ingelheim Investigational Site
Dresden, , Germany
1218.40.49101 Boehringer Ingelheim Investigational Site
Mainz, , Germany
1218.40.49003 Boehringer Ingelheim Investigational Site
Neuwied, , Germany
1218.40.49007 Boehringer Ingelheim Investigational Site
Nuremberg, , Germany
1218.40.49014 Boehringer Ingelheim Investigational Site
Saarbrücken, , Germany
1218.40.30004 Boehringer Ingelheim Investigational Site
Athens, , Greece
1218.40.30007 Boehringer Ingelheim Investigational Site
Athens, , Greece
1218.40.30013 Boehringer Ingelheim Investigational Site
Athens, , Greece
1218.40.30003 Boehringer Ingelheim Investigational Site
Nikaia, , Greece
1218.40.30011 Boehringer Ingelheim Investigational Site
Piraeus, , Greece
1218.40.30006 Boehringer Ingelheim Investigational Site
Thessaloniki, , Greece
1218.40.30016 Boehringer Ingelheim Investigational Site
Thessaloniki, , Greece
1218.40.36003 Boehringer Ingelheim Investigational Site
Budapest, , Hungary
1218.40.36004 Boehringer Ingelheim Investigational Site
Budapest, , Hungary
1218.40.36006 Boehringer Ingelheim Investigational Site
Budapest, , Hungary
1218.40.36008 Boehringer Ingelheim Investigational Site
Debrecen, , Hungary
1218.40.36005 Boehringer Ingelheim Investigational Site
Győr, , Hungary
1218.40.36002 Boehringer Ingelheim Investigational Site
Szombathely, , Hungary
1218.40.91010 Boehringer Ingelheim Investigational Site
Andhra Pradesh, , India
1218.40.91002 Boehringer Ingelheim Investigational Site
Bangalore, , India
1218.40.91005 Boehringer Ingelheim Investigational Site
Bangalore, , India
1218.40.91012 Boehringer Ingelheim Investigational Site
Chennai, , India
1218.40.91014 Boehringer Ingelheim Investigational Site
Chennai, , India
1218.40.91009 Boehringer Ingelheim Investigational Site
Hyderabad, Andra Pradesh, , India
1218.40.91006 Boehringer Ingelheim Investigational Site
Jaipur, , India
1218.40.91001 Boehringer Ingelheim Investigational Site
Kerala, , India
1218.40.91011 Boehringer Ingelheim Investigational Site
Maharashtra, , India
1218.40.91008 Boehringer Ingelheim Investigational Site
Mangalore, , India
1218.40.91007 Boehringer Ingelheim Investigational Site
Manipal, , India
1218.40.91004 Boehringer Ingelheim Investigational Site
Mumbai, , India
1218.40.91003 Boehringer Ingelheim Investigational Site
Nashik, , India
1218.40.91013 Boehringer Ingelheim Investigational Site
Uttar Pradesh, , India
1218.40.97274 Boehringer Ingelheim Investigational Site
Afula, , Israel
1218.40.97273 Boehringer Ingelheim Investigational Site
Haifa, , Israel
1218.40.97275 Boehringer Ingelheim Investigational Site
Holon, , Israel
1218.40.97271 Boehringer Ingelheim Investigational Site
Jerusalem, , Israel
1218.40.97272 Boehringer Ingelheim Investigational Site
Nahariya, , Israel
1218.40.97276 Boehringer Ingelheim Investigational Site
Safed, , Israel
1218.40.97278 Boehringer Ingelheim Investigational Site
Tel Aviv, , Israel
1218.40.39008 Boehringer Ingelheim Investigational Site
Genova, , Italy
1218.40.39002 Boehringer Ingelheim Investigational Site
Milan, , Italy
1218.40.39001 Boehringer Ingelheim Investigational Site
Pisa, , Italy
1218.40.39006 Boehringer Ingelheim Investigational Site
Roma, , Italy
1218.40.81001 Boehringer Ingelheim Investigational Site
Amagasaki, Hyogo, , Japan
1218.40.81005 Boehringer Ingelheim Investigational Site
Koganei, Tokyo, , Japan
1218.40.81002 Boehringer Ingelheim Investigational Site
Osaka, Osaka, , Japan
1218.40.81004 Boehringer Ingelheim Investigational Site
Shinjyuku-ku,Tokyo, , Japan
1218.40.81003 Boehringer Ingelheim Investigational Site
Suita, Osaka,, , Japan
1218.40.60007 Boehringer Ingelheim Investigational Site
George Town, , Malaysia
1218.40.60003 Boehringer Ingelheim Investigational Site
Kelantan, , Malaysia
1218.40.60001 Boehringer Ingelheim Investigational Site
Kuala Lumpur, , Malaysia
1218.40.60002 Boehringer Ingelheim Investigational Site
Kuala Lumpur, , Malaysia
1218.40.60004 Boehringer Ingelheim Investigational Site
Perak, , Malaysia
1218.40.60005 Boehringer Ingelheim Investigational Site
Perak, , Malaysia
1218.40.52007 Boehringer Ingelheim Investigational Site
Aguascalientes, Ags., , Mexico
1218.40.52010 Boehringer Ingelheim Investigational Site
Col.Americana, Guadalajara, Jalisco, , Mexico
1218.40.52008 Boehringer Ingelheim Investigational Site
Colonia Tlalpan, Mexico, , Mexico
1218.40.52006 Boehringer Ingelheim Investigational Site
Faccionamiento Lomas de Campestre,AGUASCAL, , Mexico
1218.40.52009 Boehringer Ingelheim Investigational Site
León, , Mexico
1218.40.52002 Boehringer Ingelheim Investigational Site
México, , Mexico
1218.40.52004 Boehringer Ingelheim Investigational Site
México, , Mexico
1218.40.52005 Boehringer Ingelheim Investigational Site
México, , Mexico
1218.40.52003 Boehringer Ingelheim Investigational Site
Monterrey, , Mexico
1218.40.52001 Boehringer Ingelheim Investigational Site
Monterrey N.L., , Mexico
1218.40.31006 Boehringer Ingelheim Investigational Site
Deurne, , Netherlands
1218.40.31001 Boehringer Ingelheim Investigational Site
Ewijk, , Netherlands
1218.40.31010 Boehringer Ingelheim Investigational Site
Losser, , Netherlands
1218.40.31008 Boehringer Ingelheim Investigational Site
Roelofarendsveen, , Netherlands
1218.40.31002 Boehringer Ingelheim Investigational Site
Wildervank, , Netherlands
1218.40.64004 Boehringer Ingelheim Investigational Site
Christchurch, , New Zealand
1218.40.64003 Boehringer Ingelheim Investigational Site
Dunedin, , New Zealand
1218.40.64002 Boehringer Ingelheim Investigational Site
Otahuhu, , New Zealand
1218.40.64001 Boehringer Ingelheim Investigational Site
Tauranga, , New Zealand
1218.40.64005 Boehringer Ingelheim Investigational Site
Wellington, , New Zealand
1218.40.63003 Boehringer Ingelheim Investigational Site
Greenhills, San Juan, , Philippines
1218.40.63005 Boehringer Ingelheim Investigational Site
Manila, , Philippines
1218.40.63002 Boehringer Ingelheim Investigational Site
Marikina City, , Philippines
1218.40.63001 Boehringer Ingelheim Investigational Site
Pasig, , Philippines
1218.40.63004 Boehringer Ingelheim Investigational Site
Quezon City, , Philippines
1218.40.48603 Boehringer Ingelheim Investigational Site
Lublin, , Poland
1218.40.48601 Boehringer Ingelheim Investigational Site
Warsaw, , Poland
1218.40.48604 Boehringer Ingelheim Investigational Site
Zabrze, , Poland
1218.40.40504 Boehringer Ingelheim Investigational Site
Alba Iulia, , Romania
1218.40.40604 Boehringer Ingelheim Investigational Site
Brasov, , Romania
1218.40.40501 Boehringer Ingelheim Investigational Site
Bucharest, , Romania
1218.40.40502 Boehringer Ingelheim Investigational Site
Bucharest, , Romania
1218.40.40603 Boehringer Ingelheim Investigational Site
Galati, , Romania
1218.40.40503 Boehringer Ingelheim Investigational Site
Sibiu, , Romania
1218.40.40505 Boehringer Ingelheim Investigational Site
Târgu Mureş, , Romania
1218.40.70014 Boehringer Ingelheim Investigational Site
Arkhangelsk, , Russia
1218.40.70001 Boehringer Ingelheim Investigational Site
Moscow, , Russia
1218.40.70002 Boehringer Ingelheim Investigational Site
Moscow, , Russia
1218.40.70003 Boehringer Ingelheim Investigational Site
Moscow, , Russia
1218.40.70012 Boehringer Ingelheim Investigational Site
Moscow, , Russia
1218.40.70005 Boehringer Ingelheim Investigational Site
Novosibirsk, , Russia
1218.40.70006 Boehringer Ingelheim Investigational Site
Perm, , Russia
1218.40.70013 Boehringer Ingelheim Investigational Site
Rostov-on-Don, , Russia
1218.40.70015 Boehringer Ingelheim Investigational Site
Saint Petersburg, , Russia
1218.40.70016 Boehringer Ingelheim Investigational Site
Samara, , Russia
1218.40.70004 Boehringer Ingelheim Investigational Site
Tomsk, , Russia
1218.40.42103 Boehringer Ingelheim Investigational Site
Banská Bystrica, , Slovakia
1218.40.42102 Boehringer Ingelheim Investigational Site
Bratislava, , Slovakia
1218.40.42104 Boehringer Ingelheim Investigational Site
Bratislava, , Slovakia
1218.40.42105 Boehringer Ingelheim Investigational Site
Bratislava, , Slovakia
1218.40.42101 Boehringer Ingelheim Investigational Site
Nové Mesto, , Slovakia
1218.40.42106 Boehringer Ingelheim Investigational Site
Šamorín, , Slovakia
1218.40.82002 Boehringer Ingelheim Investigational Site
Busan, , South Korea
1218.40.82011 Boehringer Ingelheim Investigational Site
Daegu, , South Korea
1218.40.82008 Boehringer Ingelheim Investigational Site
Incheon, , South Korea
1218.40.82010 Boehringer Ingelheim Investigational Site
Jeonju, , South Korea
1218.40.82004 Boehringer Ingelheim Investigational Site
Pusan, , South Korea
1218.40.82001 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1218.40.82005 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1218.40.82006 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1218.40.82007 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1218.40.82009 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1218.40.82003 Boehringer Ingelheim Investigational Site
Suwon, , South Korea
1218.40.34002 Boehringer Ingelheim Investigational Site
Badalona, , Spain
1218.40.34011 Boehringer Ingelheim Investigational Site
Badia Del Vallés, , Spain
1218.40.34012 Boehringer Ingelheim Investigational Site
Borges Del Camp, , Spain
1218.40.34013 Boehringer Ingelheim Investigational Site
Centelles, , Spain
1218.40.34007 Boehringer Ingelheim Investigational Site
Granada, , Spain
1218.40.34008 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat (Barcelona), , Spain
1218.40.34009 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat (Barcelona), , Spain
1218.40.34004 Boehringer Ingelheim Investigational Site
Madrid, , Spain
1218.40.34006 Boehringer Ingelheim Investigational Site
Madrid, , Spain
1218.40.34010 Boehringer Ingelheim Investigational Site
Sant Adrià Del Besós (Barcelona), , Spain
1218.40.34005 Boehringer Ingelheim Investigational Site
Seville, , Spain
1218.40.34014 Boehringer Ingelheim Investigational Site
Vic (Barcelona), , Spain
1218.40.46013 Boehringer Ingelheim Investigational Site
Härnösand, , Sweden
1218.40.46001 Boehringer Ingelheim Investigational Site
Malmo, , Sweden
1218.40.46012 Boehringer Ingelheim Investigational Site
Uddevalla, , Sweden
1218.40.46004 Boehringer Ingelheim Investigational Site
Uppsala, , Sweden
1218.40.88605 Boehringer Ingelheim Investigational Site
Changhua, , Taiwan
1218.40.88604 Boehringer Ingelheim Investigational Site
Taichung, , Taiwan
1218.40.88606 Boehringer Ingelheim Investigational Site
Tainan City, , Taiwan
1218.40.88601 Boehringer Ingelheim Investigational Site
Taipei, , Taiwan
1218.40.88602 Boehringer Ingelheim Investigational Site
Taipei, , Taiwan
1218.40.88603 Boehringer Ingelheim Investigational Site
Taipei, , Taiwan
1218.40.88607 Boehringer Ingelheim Investigational Site
Taipei, , Taiwan
1218.40.88608 Boehringer Ingelheim Investigational Site
Taoyuan District, , Taiwan
1218.40.66001 Boehringer Ingelheim Investigational Site
Bangkok, , Thailand
1218.40.66002 Boehringer Ingelheim Investigational Site
Khon Kaen, , Thailand
1218.40.38011 Boehringer Ingelheim Investigational Site
Dnipro, , Ukraine
1218.40.38002 Boehringer Ingelheim Investigational Site
Kharkiv, , Ukraine
1218.40.38004 Boehringer Ingelheim Investigational Site
Kharkiv, , Ukraine
1218.40.38010 Boehringer Ingelheim Investigational Site
Kharkiv, , Ukraine
1218.40.38001 Boehringer Ingelheim Investigational Site
Kiev, , Ukraine
1218.40.38005 Boehringer Ingelheim Investigational Site
Kiev, , Ukraine
1218.40.38008 Boehringer Ingelheim Investigational Site
Kiev, , Ukraine
1218.40.38009 Boehringer Ingelheim Investigational Site
Kiev, , Ukraine
1218.40.38012 Boehringer Ingelheim Investigational Site
Kiev, , Ukraine
1218.40.38003 Boehringer Ingelheim Investigational Site
Lviv, , Ukraine
1218.40.38006 Boehringer Ingelheim Investigational Site
Vinnitsa, , Ukraine
1218.40.38007 Boehringer Ingelheim Investigational Site
Zaporizhzhya, , Ukraine
1218.40.44005 Boehringer Ingelheim Investigational Site
Ashford, , United Kingdom
1218.40.44004 Boehringer Ingelheim Investigational Site
Baillieston, Glasgow, , United Kingdom
1218.40.44001 Boehringer Ingelheim Investigational Site
Bath, , United Kingdom
1218.40.44003 Boehringer Ingelheim Investigational Site
Burbage, , United Kingdom
1218.40.44010 Boehringer Ingelheim Investigational Site
Bury Saint Edmonds, , United Kingdom
1218.40.44009 Boehringer Ingelheim Investigational Site
Cardiff, , United Kingdom
1218.40.44002 Boehringer Ingelheim Investigational Site
Penarth, , United Kingdom
1218.40.44006 Boehringer Ingelheim Investigational Site
Reading, , United Kingdom
1218.40.44007 Boehringer Ingelheim Investigational Site
Waterloo, Liverpool, , United Kingdom
Countries
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Other Identifiers
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2008-000750-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1218.40
Identifier Type: -
Identifier Source: org_study_id
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