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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00736099




Registration number
NCT00736099
Ethics application status
Date submitted
14/08/2008
Date registered
15/08/2008
Date last updated
27/06/2014

Titles & IDs
Public title
Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM
Scientific title
A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 1356 (5 mg) as Monotherapy or in Combination With Other Antidiabetic Medications in Type 2 Diabetic Patients.
Secondary ID [1] 0 0
2008-000750-13
Secondary ID [2] 0 0
1218.40
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - linagliptine 5 mg
Treatment: Drugs - linagliptine 5 mg and pioglitazone 30 mg

Experimental: linagliptin 5 mg - open label

Experimental: linagliptin 5 mg and pioglitazone 30 mg - open label


Treatment: Drugs: linagliptine 5 mg
safety and efficacy of linagliptine 5 mg open label

Treatment: Drugs: linagliptine 5 mg and pioglitazone 30 mg
efficacy and safety of the combination linagliptine and pioglitazone
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency of Patients With Adverse Events (AEs)
Timepoint [1] 0 0
78 weeks
Primary outcome [2] 0 0
Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events
Timepoint [2] 0 0
78 weeks
Primary outcome [3] 0 0
Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)
Timepoint [3] 0 0
78 weeks
Primary outcome [4] 0 0
Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events
Timepoint [4] 0 0
78 weeks
Primary outcome [5] 0 0
Number of Patients With Abnormalities in Vital Signs
Timepoint [5] 0 0
78 weeks
Primary outcome [6] 0 0
Number of Patients With Abnormalities in Haematology: Eosinophils
Timepoint [6] 0 0
78 weeks
Primary outcome [7] 0 0
Number of Patients With Abnormalities in Haematology: Haemoglobin
Timepoint [7] 0 0
78 weeks
Primary outcome [8] 0 0
Number of Patients With Abnormalities in Haematology: Haematocrit
Timepoint [8] 0 0
78 weeks
Primary outcome [9] 0 0
Number of Patients With Abnormalities in Haematology: Red Blood Cell Count
Timepoint [9] 0 0
78 weeks
Primary outcome [10] 0 0
Number of Patients With Abnormalities in Haematology: White Blood Cell Count
Timepoint [10] 0 0
78 weeks
Primary outcome [11] 0 0
Number of Patients With Abnormalities in Haematology: Platelets
Timepoint [11] 0 0
78 weeks
Primary outcome [12] 0 0
Number of Patients With Abnormalities in Clinical Chemistry: Potassium
Timepoint [12] 0 0
78 weeks
Primary outcome [13] 0 0
Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid
Timepoint [13] 0 0
78 weeks
Primary outcome [14] 0 0
Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides
Timepoint [14] 0 0
78 weeks
Primary outcome [15] 0 0
Number of Patients With Abnormalities in Clinical Chemistry: Amylase
Timepoint [15] 0 0
78 weeks
Primary outcome [16] 0 0
Number of Patients With Abnormalities in Clinical Chemistry: ?-Glutamyl-transferase (GGT)
Timepoint [16] 0 0
78 weeks
Primary outcome [17] 0 0
Number of Patients With Abnormalities in Clinical Chemistry: Creatinine
Timepoint [17] 0 0
78 weeks
Primary outcome [18] 0 0
Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase
Timepoint [18] 0 0
78 weeks
Primary outcome [19] 0 0
Number of Patients With Abnormalities in Clinical Chemistry: Phosphate
Timepoint [19] 0 0
78 weeks
Primary outcome [20] 0 0
Number of Patients With Abnormalities in Clinical Chemistry: Calcium
Timepoint [20] 0 0
78 weeks
Primary outcome [21] 0 0
Number of Patients With Abnormalities in Clinical Chemistry: Sodium
Timepoint [21] 0 0
78 weeks
Primary outcome [22] 0 0
Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT)
Timepoint [22] 0 0
78 weeks
Primary outcome [23] 0 0
Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST)
Timepoint [23] 0 0
78 weeks
Primary outcome [24] 0 0
Number of Patients With Abnormalities in Clinical Chemistry: Glucose
Timepoint [24] 0 0
78 weeks
Primary outcome [25] 0 0
Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin
Timepoint [25] 0 0
78 weeks
Primary outcome [26] 0 0
Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP)
Timepoint [26] 0 0
78 weeks
Primary outcome [27] 0 0
Number of Patients With Abnormalities in Clinical Chemistry: Albumin
Timepoint [27] 0 0
78 weeks
Primary outcome [28] 0 0
Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH)
Timepoint [28] 0 0
78 weeks
Primary outcome [29] 0 0
Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol
Timepoint [29] 0 0
78 weeks
Secondary outcome [1] 0 0
Change in HbA1c From Baseline to Week 6
Timepoint [1] 0 0
Baseline and week 6
Secondary outcome [2] 0 0
Change in HbA1c From Baseline to Week 18
Timepoint [2] 0 0
Baseline and week 18
Secondary outcome [3] 0 0
Change in HbA1c From Baseline to Week 30
Timepoint [3] 0 0
Baseline and week 30
Secondary outcome [4] 0 0
Change in HbA1c From Baseline to Week 42
Timepoint [4] 0 0
Baseline and week 42
Secondary outcome [5] 0 0
Change in HbA1c From Baseline to Week 54
Timepoint [5] 0 0
Baseline and week 54
Secondary outcome [6] 0 0
Change in HbA1c From Baseline to Week 66
Timepoint [6] 0 0
Baseline and week 66
Secondary outcome [7] 0 0
Change in HbA1c From Baseline to Week 78
Timepoint [7] 0 0
Baseline and week 78
Secondary outcome [8] 0 0
Number of Patients With HbA1c<7.0% Over Time
Timepoint [8] 0 0
78 weeks
Secondary outcome [9] 0 0
Number of Patients With HbA1c<6.5% Over Time
Timepoint [9] 0 0
78 weeks
Secondary outcome [10] 0 0
Number of Patients With Lowered HbA1c by at Least 0.5% Over Time
Timepoint [10] 0 0
78 weeks
Secondary outcome [11] 0 0
Change in FPG From Baseline to Week 6
Timepoint [11] 0 0
Baseline and week 6
Secondary outcome [12] 0 0
Change in FPG From Baseline to Week 18
Timepoint [12] 0 0
Baseline and week 18
Secondary outcome [13] 0 0
Change in FPG From Baseline to Week 30
Timepoint [13] 0 0
Baseline and week 30
Secondary outcome [14] 0 0
Change in FPG From Baseline to Week 42
Timepoint [14] 0 0
Baseline and week 42
Secondary outcome [15] 0 0
Change in FPG From Baseline to Week 54
Timepoint [15] 0 0
Baseline and week 54
Secondary outcome [16] 0 0
Change in FPG From Baseline to Week 66
Timepoint [16] 0 0
Baseline and week 66
Secondary outcome [17] 0 0
Change in FPG From Baseline to Week 78
Timepoint [17] 0 0
Baseline and week 78

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Signed and dated written informed consent in accordance with the GCP and local legislation.
2. Patients completing the entire treatment period as a double blind trial whether or not they have been treated with rescue medication.
Minimum age
18 Years
Maximum age
82 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Patients who meet one or more of the withdrawal criteria of the treatment period of the previous trial.
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
2122
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Colorado
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United States of America
State/province [3] 0 0
Florida
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United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
United States of America
State/province [5] 0 0
South Carolina
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United States of America
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Texas
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United States of America
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Washington
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Argentina
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Capital Federal
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Argentina
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Mendoza
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Argentina
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Parque Velez Sarfield
Country [11] 0 0
Austria
State/province [11] 0 0
Graz
Country [12] 0 0
Austria
State/province [12] 0 0
Wien
Country [13] 0 0
Belgium
State/province [13] 0 0
Brugge
Country [14] 0 0
Belgium
State/province [14] 0 0
Brussel
Country [15] 0 0
Belgium
State/province [15] 0 0
Edegem
Country [16] 0 0
Belgium
State/province [16] 0 0
Genk
Country [17] 0 0
Belgium
State/province [17] 0 0
Gent
Country [18] 0 0
Belgium
State/province [18] 0 0
Huy
Country [19] 0 0
Belgium
State/province [19] 0 0
Liège
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Prince Edward Island
Country [24] 0 0
Canada
State/province [24] 0 0
Saskatchewan
Country [25] 0 0
China
State/province [25] 0 0
Beijing
Country [26] 0 0
China
State/province [26] 0 0
Chengdu
Country [27] 0 0
China
State/province [27] 0 0
Dalian
Country [28] 0 0
China
State/province [28] 0 0
Guangzhou
Country [29] 0 0
China
State/province [29] 0 0
Haerbin
Country [30] 0 0
China
State/province [30] 0 0
Qingdao
Country [31] 0 0
China
State/province [31] 0 0
Shanghai
Country [32] 0 0
China
State/province [32] 0 0
Shenyang
Country [33] 0 0
China
State/province [33] 0 0
Wuhan
Country [34] 0 0
China
State/province [34] 0 0
Xi'An
Country [35] 0 0
Croatia
State/province [35] 0 0
Krapinske Toplice
Country [36] 0 0
Croatia
State/province [36] 0 0
Slavonski Brod
Country [37] 0 0
Czech Republic
State/province [37] 0 0
Breclav
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Czech Republic
State/province [38] 0 0
Brno
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Czech Republic
State/province [39] 0 0
Hodonin
Country [40] 0 0
Czech Republic
State/province [40] 0 0
Olomouc
Country [41] 0 0
Finland
State/province [41] 0 0
Helsinki
Country [42] 0 0
Finland
State/province [42] 0 0
Kuopio
Country [43] 0 0
Finland
State/province [43] 0 0
Oulu
Country [44] 0 0
Finland
State/province [44] 0 0
Seinäjoki
Country [45] 0 0
Finland
State/province [45] 0 0
Turku
Country [46] 0 0
Germany
State/province [46] 0 0
Bad Mergentheim
Country [47] 0 0
Germany
State/province [47] 0 0
Berlin
Country [48] 0 0
Germany
State/province [48] 0 0
Bosenheim
Country [49] 0 0
Germany
State/province [49] 0 0
Dresden
Country [50] 0 0
Germany
State/province [50] 0 0
Mainz
Country [51] 0 0
Germany
State/province [51] 0 0
Neuwied
Country [52] 0 0
Germany
State/province [52] 0 0
Nürnberg
Country [53] 0 0
Germany
State/province [53] 0 0
Saarbrücken
Country [54] 0 0
Greece
State/province [54] 0 0
Athens
Country [55] 0 0
Greece
State/province [55] 0 0
Nikaia
Country [56] 0 0
Greece
State/province [56] 0 0
Piraeus
Country [57] 0 0
Greece
State/province [57] 0 0
Thessaloniki
Country [58] 0 0
Hungary
State/province [58] 0 0
Budapest
Country [59] 0 0
Hungary
State/province [59] 0 0
Debrecen
Country [60] 0 0
Hungary
State/province [60] 0 0
Györ
Country [61] 0 0
Hungary
State/province [61] 0 0
Szombathely
Country [62] 0 0
India
State/province [62] 0 0
Andhra Pradesh
Country [63] 0 0
India
State/province [63] 0 0
Bangalore
Country [64] 0 0
India
State/province [64] 0 0
Chennai
Country [65] 0 0
India
State/province [65] 0 0
Hyderabad, Andra Pradesh
Country [66] 0 0
India
State/province [66] 0 0
Jaipur
Country [67] 0 0
India
State/province [67] 0 0
Kerala
Country [68] 0 0
India
State/province [68] 0 0
Maharashtra
Country [69] 0 0
India
State/province [69] 0 0
Mangalore
Country [70] 0 0
India
State/province [70] 0 0
Manipal
Country [71] 0 0
India
State/province [71] 0 0
Mumbai
Country [72] 0 0
India
State/province [72] 0 0
Nasik
Country [73] 0 0
India
State/province [73] 0 0
Uttar Pradesh
Country [74] 0 0
Israel
State/province [74] 0 0
Afula
Country [75] 0 0
Israel
State/province [75] 0 0
Haifa
Country [76] 0 0
Israel
State/province [76] 0 0
Holon
Country [77] 0 0
Israel
State/province [77] 0 0
Jerusalem
Country [78] 0 0
Israel
State/province [78] 0 0
Nahariya
Country [79] 0 0
Israel
State/province [79] 0 0
Safed
Country [80] 0 0
Israel
State/province [80] 0 0
Tel Aviv
Country [81] 0 0
Italy
State/province [81] 0 0
Genova
Country [82] 0 0
Italy
State/province [82] 0 0
Milano
Country [83] 0 0
Italy
State/province [83] 0 0
Pisa
Country [84] 0 0
Italy
State/province [84] 0 0
Roma
Country [85] 0 0
Japan
State/province [85] 0 0
Amagasaki, Hyogo
Country [86] 0 0
Japan
State/province [86] 0 0
Koganei, Tokyo
Country [87] 0 0
Japan
State/province [87] 0 0
Osaka, Osaka
Country [88] 0 0
Japan
State/province [88] 0 0
Shinjyuku-ku,Tokyo
Country [89] 0 0
Japan
State/province [89] 0 0
Suita, Osaka,
Country [90] 0 0
Korea, Republic of
State/province [90] 0 0
Busan
Country [91] 0 0
Korea, Republic of
State/province [91] 0 0
Daegu
Country [92] 0 0
Korea, Republic of
State/province [92] 0 0
Incheon
Country [93] 0 0
Korea, Republic of
State/province [93] 0 0
Jeonju
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Pusan
Country [95] 0 0
Korea, Republic of
State/province [95] 0 0
Seoul
Country [96] 0 0
Korea, Republic of
State/province [96] 0 0
Suwon
Country [97] 0 0
Malaysia
State/province [97] 0 0
Kelantan
Country [98] 0 0
Malaysia
State/province [98] 0 0
Kuala Lumpur
Country [99] 0 0
Malaysia
State/province [99] 0 0
Penang
Country [100] 0 0
Malaysia
State/province [100] 0 0
Perak
Country [101] 0 0
Mexico
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Aguascalientes, Ags.
Country [102] 0 0
Mexico
State/province [102] 0 0
Col.Americana, Guadalajara, Jalisco
Country [103] 0 0
Mexico
State/province [103] 0 0
Colonia Tlalpan, mexico
Country [104] 0 0
Mexico
State/province [104] 0 0
Faccionamiento Lomas de Campestre,AGUASCAL
Country [105] 0 0
Mexico
State/province [105] 0 0
León
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Mexico
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Monterrey N.L.
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Mexico
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Monterrey
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Mexico
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México
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Netherlands
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Deurne
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Netherlands
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Ewijk
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Netherlands
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Losser
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Netherlands
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Roelofarendsveen
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Netherlands
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Wildervank
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New Zealand
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Christchurch
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New Zealand
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Dunedin
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New Zealand
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Otahuhu
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New Zealand
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Tauranga
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New Zealand
State/province [118] 0 0
Wellington
Country [119] 0 0
Philippines
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Greenhills, San Juan
Country [120] 0 0
Philippines
State/province [120] 0 0
Manila
Country [121] 0 0
Philippines
State/province [121] 0 0
Marikina
Country [122] 0 0
Philippines
State/province [122] 0 0
Pasig
Country [123] 0 0
Philippines
State/province [123] 0 0
Quezon City
Country [124] 0 0
Poland
State/province [124] 0 0
Lublin
Country [125] 0 0
Poland
State/province [125] 0 0
Warsaw
Country [126] 0 0
Poland
State/province [126] 0 0
Zabrze
Country [127] 0 0
Romania
State/province [127] 0 0
Alba Iulia
Country [128] 0 0
Romania
State/province [128] 0 0
Brasov
Country [129] 0 0
Romania
State/province [129] 0 0
Bucharest
Country [130] 0 0
Romania
State/province [130] 0 0
Galati
Country [131] 0 0
Romania
State/province [131] 0 0
Sibiu
Country [132] 0 0
Romania
State/province [132] 0 0
Targu-Mures
Country [133] 0 0
Russian Federation
State/province [133] 0 0
Arkhangelsk
Country [134] 0 0
Russian Federation
State/province [134] 0 0
Moscow
Country [135] 0 0
Russian Federation
State/province [135] 0 0
Novosibirsk
Country [136] 0 0
Russian Federation
State/province [136] 0 0
Perm
Country [137] 0 0
Russian Federation
State/province [137] 0 0
Rostov-on-Don
Country [138] 0 0
Russian Federation
State/province [138] 0 0
Samara
Country [139] 0 0
Russian Federation
State/province [139] 0 0
St. Petersburg
Country [140] 0 0
Russian Federation
State/province [140] 0 0
Tomsk
Country [141] 0 0
Slovakia
State/province [141] 0 0
Banska Bystrica
Country [142] 0 0
Slovakia
State/province [142] 0 0
Bratislava
Country [143] 0 0
Slovakia
State/province [143] 0 0
Nove Mesto
Country [144] 0 0
Slovakia
State/province [144] 0 0
Samorin
Country [145] 0 0
Spain
State/province [145] 0 0
Badalona
Country [146] 0 0
Spain
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Badia del Vallés
Country [147] 0 0
Spain
State/province [147] 0 0
Borges del Camp
Country [148] 0 0
Spain
State/province [148] 0 0
Centelles
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Spain
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Granada
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Spain
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L'Hospitalet de Llobregat (Barcelona)
Country [151] 0 0
Spain
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Madrid
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Spain
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Sant Adrià del Besós (Barcelona)
Country [153] 0 0
Spain
State/province [153] 0 0
Sevilla
Country [154] 0 0
Spain
State/province [154] 0 0
Vic (Barcelona)
Country [155] 0 0
Sweden
State/province [155] 0 0
Härnösand
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Sweden
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Malmö
Country [157] 0 0
Sweden
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Uddevalla
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Sweden
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Uppsala
Country [159] 0 0
Taiwan
State/province [159] 0 0
ChangHua
Country [160] 0 0
Taiwan
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Taichung
Country [161] 0 0
Taiwan
State/province [161] 0 0
Tainan
Country [162] 0 0
Taiwan
State/province [162] 0 0
Taipei
Country [163] 0 0
Taiwan
State/province [163] 0 0
Taoyuan
Country [164] 0 0
Thailand
State/province [164] 0 0
Bangkok
Country [165] 0 0
Thailand
State/province [165] 0 0
Khon Kaen
Country [166] 0 0
Ukraine
State/province [166] 0 0
Dnepropetrovsk
Country [167] 0 0
Ukraine
State/province [167] 0 0
Kharkov
Country [168] 0 0
Ukraine
State/province [168] 0 0
Kiev
Country [169] 0 0
Ukraine
State/province [169] 0 0
Lvov
Country [170] 0 0
Ukraine
State/province [170] 0 0
Vinnitsa
Country [171] 0 0
Ukraine
State/province [171] 0 0
Zaporizhzhya
Country [172] 0 0
United Kingdom
State/province [172] 0 0
Ashford
Country [173] 0 0
United Kingdom
State/province [173] 0 0
Baillieston, Glasgow
Country [174] 0 0
United Kingdom
State/province [174] 0 0
Bath
Country [175] 0 0
United Kingdom
State/province [175] 0 0
Burbage
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Bury St Edmonds
Country [177] 0 0
United Kingdom
State/province [177] 0 0
Cardiff
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Penarth
Country [179] 0 0
United Kingdom
State/province [179] 0 0
Reading
Country [180] 0 0
United Kingdom
State/province [180] 0 0
Waterloo, Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Boehringer Ingelheim
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Boehringer Ingelheim
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Contact person for public queries
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Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00736099