Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00451906




Registration number
NCT00451906
Ethics application status
Date submitted
22/03/2007
Date registered
26/03/2007
Date last updated
24/05/2016

Titles & IDs
Public title
A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
Scientific title
Open-label Study of Bevacizumab (AVASTIN®) in Combination With Platinum-containing Chemotherapy as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer
Secondary ID [1] 0 0
MO19390
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Squamous Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Platinum-based chemotherapy
Treatment: Drugs - Bevacizumab [Avastin]

Experimental: Bevacizumab + Chemotherapy - Participants with advanced or recurrent NSCLC will be administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator's choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab will be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy.


Treatment: Drugs: Platinum-based chemotherapy
As prescribed

Treatment: Drugs: Bevacizumab [Avastin]
15 mg/kg IV on Day 1 of each 3 week cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events of Special Interest
Timepoint [1] 0 0
Up to 3 years
Primary outcome [2] 0 0
Number of Participants With Serious Adverse Events Related to Bevacizumab
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [1] 0 0
Duration of Overall Survival
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Time to Disease Progression
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Number of Participants With Central Nervous System Bleeding
Timepoint [3] 0 0
Up to 3 years

Eligibility
Key inclusion criteria
* adult patients, >=18 years of age;
* histologically or cytologically documented inoperable, locally advanced ( stage III), metastatic (stage IV) or recurrent NSCLC other than squamous cell (tumors of mixed histology should be categorized by the predominant cell type);
* ECOG PS status 0-2;
* life expectancy >= 12weeks;
* adequate renal, liver and hematological function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* mixed, non-small and small cell tumors, or mixed adenosquamous carcinomas with a predominant squamous component;
* hemoptysis (>=1/2 teaspoon of bright red blood) in previous 3 months;
* evidence of tumor invading major blood vessels on imaging;
* evidence of CNS metastases, even if previously treated.
* major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment, or anticipation of need for major surgery during study treatment;
* prior chemotherapy for stage IIIb/IV disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Single group
Other design features
Phase
Phase 4
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
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2009
Sample size
Target
Accrual to date
Final
2252
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
- St. Leonards
Recruitment hospital [2] 0 0
- Waratah
Recruitment hospital [3] 0 0
- Auchenflower
Recruitment hospital [4] 0 0
- Chermside
Recruitment hospital [5] 0 0
- Tugun
Recruitment hospital [6] 0 0
- Box Hill
Recruitment hospital [7] 0 0
- Geelong
Recruitment hospital [8] 0 0
- Malvern
Recruitment hospital [9] 0 0
- Wodonga
Recruitment hospital [10] 0 0
- Perth
Recruitment hospital [11] 0 0
- Sydney, New South Wales
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
4224 - Tugun
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3220 - Geelong
Recruitment postcode(s) [8] 0 0
3144 - Malvern
Recruitment postcode(s) [9] 0 0
3690 - Wodonga
Recruitment postcode(s) [10] 0 0
6008 - Perth
Recruitment postcode(s) [11] 0 0
2077 - Sydney, New South Wales
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Chaco-resistencia
Country [3] 0 0
Argentina
State/province [3] 0 0
Cordoba
Country [4] 0 0
Argentina
State/province [4] 0 0
Córdoba
Country [5] 0 0
Argentina
State/province [5] 0 0
Tucuman
Country [6] 0 0
Austria
State/province [6] 0 0
Bludesch
Country [7] 0 0
Austria
State/province [7] 0 0
Bregenz
Country [8] 0 0
Austria
State/province [8] 0 0
Feldkirch
Country [9] 0 0
Austria
State/province [9] 0 0
Graz
Country [10] 0 0
Austria
State/province [10] 0 0
Innsbruck
Country [11] 0 0
Austria
State/province [11] 0 0
Knittelfeld
Country [12] 0 0
Austria
State/province [12] 0 0
Kufstein
Country [13] 0 0
Austria
State/province [13] 0 0
Linz
Country [14] 0 0
Austria
State/province [14] 0 0
Natters
Country [15] 0 0
Austria
State/province [15] 0 0
Salzburg
Country [16] 0 0
Austria
State/province [16] 0 0
St Veit An Der Glan
Country [17] 0 0
Austria
State/province [17] 0 0
Vöcklabruck
Country [18] 0 0
Austria
State/province [18] 0 0
Wels
Country [19] 0 0
Austria
State/province [19] 0 0
Wien
Country [20] 0 0
Austria
State/province [20] 0 0
Zams
Country [21] 0 0
Bosnia and Herzegovina
State/province [21] 0 0
Banja Luka
Country [22] 0 0
Bosnia and Herzegovina
State/province [22] 0 0
Sarajevo
Country [23] 0 0
Brazil
State/province [23] 0 0
BA
Country [24] 0 0
Brazil
State/province [24] 0 0
CE
Country [25] 0 0
Brazil
State/province [25] 0 0
ES
Country [26] 0 0
Brazil
State/province [26] 0 0
GO
Country [27] 0 0
Brazil
State/province [27] 0 0
MG
Country [28] 0 0
Brazil
State/province [28] 0 0
PE
Country [29] 0 0
Brazil
State/province [29] 0 0
RJ
Country [30] 0 0
Brazil
State/province [30] 0 0
RS
Country [31] 0 0
Brazil
State/province [31] 0 0
SP
Country [32] 0 0
Canada
State/province [32] 0 0
British Columbia
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
China
State/province [34] 0 0
Beijing
Country [35] 0 0
China
State/province [35] 0 0
Guangzhou
Country [36] 0 0
China
State/province [36] 0 0
Hangzhou
Country [37] 0 0
China
State/province [37] 0 0
Shanghai
Country [38] 0 0
Colombia
State/province [38] 0 0
Bogota
Country [39] 0 0
Colombia
State/province [39] 0 0
Cali
Country [40] 0 0
Colombia
State/province [40] 0 0
Manizales
Country [41] 0 0
Czech Republic
State/province [41] 0 0
Brno
Country [42] 0 0
Czech Republic
State/province [42] 0 0
Plzen
Country [43] 0 0
Czech Republic
State/province [43] 0 0
Praha
Country [44] 0 0
Denmark
State/province [44] 0 0
Herlev
Country [45] 0 0
Denmark
State/province [45] 0 0
Hillerod
Country [46] 0 0
Denmark
State/province [46] 0 0
Naestved
Country [47] 0 0
Denmark
State/province [47] 0 0
Århus
Country [48] 0 0
Ecuador
State/province [48] 0 0
Guayaquil
Country [49] 0 0
Ecuador
State/province [49] 0 0
Quito
Country [50] 0 0
Egypt
State/province [50] 0 0
Cairo
Country [51] 0 0
Estonia
State/province [51] 0 0
Tallinn
Country [52] 0 0
Estonia
State/province [52] 0 0
Tartu
Country [53] 0 0
Finland
State/province [53] 0 0
Helsinki
Country [54] 0 0
Finland
State/province [54] 0 0
Paimio
Country [55] 0 0
Finland
State/province [55] 0 0
Pori
Country [56] 0 0
Finland
State/province [56] 0 0
Tampere
Country [57] 0 0
France
State/province [57] 0 0
Aix En Provence
Country [58] 0 0
France
State/province [58] 0 0
Avignon
Country [59] 0 0
France
State/province [59] 0 0
Besancon
Country [60] 0 0
France
State/province [60] 0 0
Beziers
Country [61] 0 0
France
State/province [61] 0 0
Bordeaux
Country [62] 0 0
France
State/province [62] 0 0
Brest
Country [63] 0 0
France
State/province [63] 0 0
Caen
Country [64] 0 0
France
State/province [64] 0 0
Chalon Sur Saone
Country [65] 0 0
France
State/province [65] 0 0
Clermont-ferrand
Country [66] 0 0
France
State/province [66] 0 0
GAP
Country [67] 0 0
France
State/province [67] 0 0
Grenoble
Country [68] 0 0
France
State/province [68] 0 0
Le Chesnay
Country [69] 0 0
France
State/province [69] 0 0
Lille
Country [70] 0 0
France
State/province [70] 0 0
Lyon
Country [71] 0 0
France
State/province [71] 0 0
Marseille
Country [72] 0 0
France
State/province [72] 0 0
Meaux
Country [73] 0 0
France
State/province [73] 0 0
Nancy
Country [74] 0 0
France
State/province [74] 0 0
Neuilly Sur Seine
Country [75] 0 0
France
State/province [75] 0 0
Paris
Country [76] 0 0
France
State/province [76] 0 0
Perpignan
Country [77] 0 0
France
State/province [77] 0 0
Reims
Country [78] 0 0
France
State/province [78] 0 0
St Julien En Genevois
Country [79] 0 0
France
State/province [79] 0 0
Strasbourg
Country [80] 0 0
France
State/province [80] 0 0
Toulon
Country [81] 0 0
France
State/province [81] 0 0
Toulouse
Country [82] 0 0
France
State/province [82] 0 0
Valenciennes
Country [83] 0 0
France
State/province [83] 0 0
Vandoeuvre Les Nancy
Country [84] 0 0
Germany
State/province [84] 0 0
Augsburg
Country [85] 0 0
Germany
State/province [85] 0 0
Bad Berka
Country [86] 0 0
Germany
State/province [86] 0 0
Bayreuth
Country [87] 0 0
Germany
State/province [87] 0 0
Berlin
Country [88] 0 0
Germany
State/province [88] 0 0
Bielefeld
Country [89] 0 0
Germany
State/province [89] 0 0
Bonn
Country [90] 0 0
Germany
State/province [90] 0 0
Coswig
Country [91] 0 0
Germany
State/province [91] 0 0
Donaustauf
Country [92] 0 0
Germany
State/province [92] 0 0
Düsseldorf
Country [93] 0 0
Germany
State/province [93] 0 0
Ebensfeld
Country [94] 0 0
Germany
State/province [94] 0 0
Erlangen
Country [95] 0 0
Germany
State/province [95] 0 0
Essen
Country [96] 0 0
Germany
State/province [96] 0 0
Frankfurt
Country [97] 0 0
Germany
State/province [97] 0 0
Freiburg
Country [98] 0 0
Germany
State/province [98] 0 0
Gauting
Country [99] 0 0
Germany
State/province [99] 0 0
Gerlingen
Country [100] 0 0
Germany
State/province [100] 0 0
Grosshansdorf
Country [101] 0 0
Germany
State/province [101] 0 0
Göttingen
Country [102] 0 0
Germany
State/province [102] 0 0
Halle (Saale)
Country [103] 0 0
Germany
State/province [103] 0 0
Hamburg
Country [104] 0 0
Germany
State/province [104] 0 0
Hannover
Country [105] 0 0
Germany
State/province [105] 0 0
Karlsruhe
Country [106] 0 0
Germany
State/province [106] 0 0
Kiel
Country [107] 0 0
Germany
State/province [107] 0 0
Köln
Country [108] 0 0
Germany
State/province [108] 0 0
Leer
Country [109] 0 0
Germany
State/province [109] 0 0
Leipzig
Country [110] 0 0
Germany
State/province [110] 0 0
Leverkusen
Country [111] 0 0
Germany
State/province [111] 0 0
Löwenstein
Country [112] 0 0
Germany
State/province [112] 0 0
Magdeburg
Country [113] 0 0
Germany
State/province [113] 0 0
Mainz
Country [114] 0 0
Germany
State/province [114] 0 0
Minden
Country [115] 0 0
Germany
State/province [115] 0 0
Muenchen
Country [116] 0 0
Germany
State/province [116] 0 0
Neuruppin
Country [117] 0 0
Germany
State/province [117] 0 0
Nürnberg
Country [118] 0 0
Germany
State/province [118] 0 0
Oldenburg
Country [119] 0 0
Germany
State/province [119] 0 0
Rostock
Country [120] 0 0
Germany
State/province [120] 0 0
Treuenbrietzen
Country [121] 0 0
Germany
State/province [121] 0 0
Ulm
Country [122] 0 0
Germany
State/province [122] 0 0
Villingen-Schwenningen
Country [123] 0 0
Germany
State/province [123] 0 0
Wiesbaden
Country [124] 0 0
Germany
State/province [124] 0 0
Wolfsburg
Country [125] 0 0
Germany
State/province [125] 0 0
Wuerselen
Country [126] 0 0
Hong Kong
State/province [126] 0 0
Hong Kong
Country [127] 0 0
Hong Kong
State/province [127] 0 0
Shatin
Country [128] 0 0
Hungary
State/province [128] 0 0
Budapest
Country [129] 0 0
Hungary
State/province [129] 0 0
Mátraháza
Country [130] 0 0
Hungary
State/province [130] 0 0
Pecs
Country [131] 0 0
Hungary
State/province [131] 0 0
Szombathely
Country [132] 0 0
Hungary
State/province [132] 0 0
Torokbalint
Country [133] 0 0
Iceland
State/province [133] 0 0
Reykjavik
Country [134] 0 0
Israel
State/province [134] 0 0
Beer Sheva
Country [135] 0 0
Israel
State/province [135] 0 0
Haifa
Country [136] 0 0
Israel
State/province [136] 0 0
Jerusalem
Country [137] 0 0
Israel
State/province [137] 0 0
Kfar-Saba
Country [138] 0 0
Israel
State/province [138] 0 0
Ramat Gan
Country [139] 0 0
Israel
State/province [139] 0 0
Tel Aviv
Country [140] 0 0
Israel
State/province [140] 0 0
Zerifin
Country [141] 0 0
Italy
State/province [141] 0 0
Abruzzo
Country [142] 0 0
Italy
State/province [142] 0 0
Basilicata
Country [143] 0 0
Italy
State/province [143] 0 0
Calabria
Country [144] 0 0
Italy
State/province [144] 0 0
Campania
Country [145] 0 0
Italy
State/province [145] 0 0
Emilia-Romagna
Country [146] 0 0
Italy
State/province [146] 0 0
Friuli-Venezia Giulia
Country [147] 0 0
Italy
State/province [147] 0 0
Lazio
Country [148] 0 0
Italy
State/province [148] 0 0
Liguria
Country [149] 0 0
Italy
State/province [149] 0 0
Lombardia
Country [150] 0 0
Italy
State/province [150] 0 0
Marche
Country [151] 0 0
Italy
State/province [151] 0 0
Piemonte
Country [152] 0 0
Italy
State/province [152] 0 0
Puglia
Country [153] 0 0
Italy
State/province [153] 0 0
Sardegna
Country [154] 0 0
Italy
State/province [154] 0 0
Sicilia
Country [155] 0 0
Italy
State/province [155] 0 0
Toscana
Country [156] 0 0
Italy
State/province [156] 0 0
Veneto
Country [157] 0 0
Italy
State/province [157] 0 0
Bologna, Umbria
Country [158] 0 0
Italy
State/province [158] 0 0
Forli, Emilia-Romagna
Country [159] 0 0
Latvia
State/province [159] 0 0
Riga
Country [160] 0 0
Lebanon
State/province [160] 0 0
Beirut
Country [161] 0 0
Lithuania
State/province [161] 0 0
Kaunas
Country [162] 0 0
Lithuania
State/province [162] 0 0
Klaipeda
Country [163] 0 0
Lithuania
State/province [163] 0 0
Vilnius
Country [164] 0 0
Mexico
State/province [164] 0 0
Chihuahua
Country [165] 0 0
Mexico
State/province [165] 0 0
Leon
Country [166] 0 0
Mexico
State/province [166] 0 0
Mexico City
Country [167] 0 0
Netherlands
State/province [167] 0 0
Arnhem
Country [168] 0 0
Netherlands
State/province [168] 0 0
Breda
Country [169] 0 0
Netherlands
State/province [169] 0 0
Den Haag
Country [170] 0 0
Netherlands
State/province [170] 0 0
Eindhoven
Country [171] 0 0
Netherlands
State/province [171] 0 0
Groningen
Country [172] 0 0
Netherlands
State/province [172] 0 0
Haarlem
Country [173] 0 0
Netherlands
State/province [173] 0 0
Helmond
Country [174] 0 0
Netherlands
State/province [174] 0 0
Hoofddorp
Country [175] 0 0
Netherlands
State/province [175] 0 0
Nieuwegein
Country [176] 0 0
Netherlands
State/province [176] 0 0
Schiedam
Country [177] 0 0
Netherlands
State/province [177] 0 0
Tiel
Country [178] 0 0
Netherlands
State/province [178] 0 0
Zwolle
Country [179] 0 0
Poland
State/province [179] 0 0
Bialystok
Country [180] 0 0
Poland
State/province [180] 0 0
Krakow
Country [181] 0 0
Poland
State/province [181] 0 0
Lublin
Country [182] 0 0
Poland
State/province [182] 0 0
Poznan
Country [183] 0 0
Poland
State/province [183] 0 0
Warszawa
Country [184] 0 0
Poland
State/province [184] 0 0
Zabrze
Country [185] 0 0
Portugal
State/province [185] 0 0
Braga
Country [186] 0 0
Portugal
State/province [186] 0 0
Coimbra
Country [187] 0 0
Portugal
State/province [187] 0 0
Lisboa
Country [188] 0 0
Portugal
State/province [188] 0 0
Porto
Country [189] 0 0
Portugal
State/province [189] 0 0
Santa Maria Da Feira
Country [190] 0 0
Portugal
State/province [190] 0 0
Setubal
Country [191] 0 0
Portugal
State/province [191] 0 0
Vila Nova De Gaia
Country [192] 0 0
Romania
State/province [192] 0 0
Bucharest
Country [193] 0 0
Romania
State/province [193] 0 0
Cluj Napoca
Country [194] 0 0
Romania
State/province [194] 0 0
Timisoara
Country [195] 0 0
Russian Federation
State/province [195] 0 0
Balashikha
Country [196] 0 0
Russian Federation
State/province [196] 0 0
Engels
Country [197] 0 0
Russian Federation
State/province [197] 0 0
Irkutsk
Country [198] 0 0
Russian Federation
State/province [198] 0 0
Kislino, Kursk Region
Country [199] 0 0
Russian Federation
State/province [199] 0 0
Krasnodar
Country [200] 0 0
Russian Federation
State/province [200] 0 0
Moscow
Country [201] 0 0
Russian Federation
State/province [201] 0 0
Samara
Country [202] 0 0
Russian Federation
State/province [202] 0 0
Smolensk
Country [203] 0 0
Russian Federation
State/province [203] 0 0
Stavropol
Country [204] 0 0
Russian Federation
State/province [204] 0 0
Tumen
Country [205] 0 0
Russian Federation
State/province [205] 0 0
Tver
Country [206] 0 0
Russian Federation
State/province [206] 0 0
Ulyanovsk
Country [207] 0 0
Serbia
State/province [207] 0 0
Belgrade
Country [208] 0 0
Slovakia
State/province [208] 0 0
Bratislava
Country [209] 0 0
Slovakia
State/province [209] 0 0
Kosice
Country [210] 0 0
Slovakia
State/province [210] 0 0
Nitra
Country [211] 0 0
Slovakia
State/province [211] 0 0
Poprad
Country [212] 0 0
Slovenia
State/province [212] 0 0
Golnik
Country [213] 0 0
Slovenia
State/province [213] 0 0
Ljubljana
Country [214] 0 0
Spain
State/province [214] 0 0
Alicante
Country [215] 0 0
Spain
State/province [215] 0 0
Barcelona
Country [216] 0 0
Spain
State/province [216] 0 0
Cantabria
Country [217] 0 0
Spain
State/province [217] 0 0
Islas Baleares
Country [218] 0 0
Spain
State/province [218] 0 0
Madrid
Country [219] 0 0
Spain
State/province [219] 0 0
Navarra
Country [220] 0 0
Spain
State/province [220] 0 0
Tenerife
Country [221] 0 0
Spain
State/province [221] 0 0
Vizcaya
Country [222] 0 0
Spain
State/province [222] 0 0
Girona
Country [223] 0 0
Spain
State/province [223] 0 0
Huesca
Country [224] 0 0
Spain
State/province [224] 0 0
La Coruña
Country [225] 0 0
Spain
State/province [225] 0 0
Lugo
Country [226] 0 0
Spain
State/province [226] 0 0
Murcia
Country [227] 0 0
Spain
State/province [227] 0 0
Salamanca
Country [228] 0 0
Spain
State/province [228] 0 0
Valencia
Country [229] 0 0
Spain
State/province [229] 0 0
Zaragoza
Country [230] 0 0
Sweden
State/province [230] 0 0
Gothenburg
Country [231] 0 0
Sweden
State/province [231] 0 0
Lund
Country [232] 0 0
Sweden
State/province [232] 0 0
Malmoe
Country [233] 0 0
Sweden
State/province [233] 0 0
Oerebro
Country [234] 0 0
Sweden
State/province [234] 0 0
Stokholm, Solna
Country [235] 0 0
Sweden
State/province [235] 0 0
Umea
Country [236] 0 0
Sweden
State/province [236] 0 0
Uppsala
Country [237] 0 0
Switzerland
State/province [237] 0 0
Aarau
Country [238] 0 0
Switzerland
State/province [238] 0 0
Baden
Country [239] 0 0
Switzerland
State/province [239] 0 0
Genolier
Country [240] 0 0
Switzerland
State/province [240] 0 0
Locarno
Country [241] 0 0
Taiwan
State/province [241] 0 0
Taichung
Country [242] 0 0
Taiwan
State/province [242] 0 0
Tainan
Country [243] 0 0
Taiwan
State/province [243] 0 0
Taipei
Country [244] 0 0
Taiwan
State/province [244] 0 0
Taoyuan
Country [245] 0 0
Turkey
State/province [245] 0 0
Ankara
Country [246] 0 0
Turkey
State/province [246] 0 0
Gaziantep
Country [247] 0 0
Turkey
State/province [247] 0 0
Istanbul
Country [248] 0 0
Turkey
State/province [248] 0 0
Izmir
Country [249] 0 0
Turkey
State/province [249] 0 0
Sihhiye, ANKARA
Country [250] 0 0
United Kingdom
State/province [250] 0 0
Aberdeen
Country [251] 0 0
United Kingdom
State/province [251] 0 0
Belfast
Country [252] 0 0
United Kingdom
State/province [252] 0 0
Birmingham
Country [253] 0 0
United Kingdom
State/province [253] 0 0
Cambridge
Country [254] 0 0
United Kingdom
State/province [254] 0 0
Cardiff
Country [255] 0 0
United Kingdom
State/province [255] 0 0
Manchester
Country [256] 0 0
United Kingdom
State/province [256] 0 0
Nottingham
Country [257] 0 0
United Kingdom
State/province [257] 0 0
Suffolk
Country [258] 0 0
Venezuela
State/province [258] 0 0
Barcelona
Country [259] 0 0
Venezuela
State/province [259] 0 0
Barquisimeto
Country [260] 0 0
Venezuela
State/province [260] 0 0
Porlamar

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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/NCT00451906