Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy

NCT ID: NCT00364351

Last Updated: 2018-01-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1574 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2016-11-30

Brief Summary

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To determine if ZD6474 a new investigational drug, is effective in treating Non Small Lung Cancer and if so, how it compares with another type of anti cancer therapy chemotherapy, Erlotinib

Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Erlotinib

Group Type ACTIVE_COMPARATOR

Erlotinib

Intervention Type DRUG

oral dose

2

Vandetanib

Group Type EXPERIMENTAL

Vandetanib

Intervention Type DRUG

once daily oral tablet

Interventions

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Vandetanib

once daily oral tablet

Intervention Type DRUG

Erlotinib

oral dose

Intervention Type DRUG

Other Intervention Names

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ZD6474 ZACTIMA™ Tarceva®

Eligibility Criteria

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Inclusion Criteria

* Confirmed locally advanced or metastatic NSCLC
* Failure of at least one but not more than two prior chemotherapy regimens

Exclusion Criteria

* Prior treatment with erlotinib (Tarceva), gefitinib (IRESSA), sunitinib (Sutent), sorafenib (Nexavar)
* Chemotherapy or other type of anti cancer therapy within 4 weeks of study start
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Berkeley, California, United States

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Los Angeles, California, United States

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Santa Rosa, California, United States

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Boynton Beach, Florida, United States

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Fort Myers, Florida, United States

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Jacksonville, Florida, United States

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Port Saint Lucie, Florida, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Metairie, Louisiana, United States

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Baltimore, Maryland, United States

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Columbia, Missouri, United States

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St Louis, Missouri, United States

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Latham, New York, United States

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Hickory, North Carolina, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Greenville, South Carolina, United States

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Chattanooga, Tennessee, United States

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Nashville, Tennessee, United States

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Amarillo, Texas, United States

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Garland, Texas, United States

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Webster, Texas, United States

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Fairfax, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Burien, Washington, United States

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Yakima, Washington, United States

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Ciudad de Buenos Aires, , Argentina

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Córdoba, , Argentina

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Manuel B. Gonnet, , Argentina

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Ramos Mejía, , Argentina

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Rosario, , Argentina

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Santa Fe, , Argentina

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Ashford, , Australia

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Bedford Park, , Australia

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Chermside, , Australia

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Geelong, , Australia

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Hornsby, , Australia

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Kogarah, , Australia

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Malvern, , Australia

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Prahran, , Australia

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Wodonga, , Australia

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Belo Horizonte, , Brazil

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Caxias do Sul, , Brazil

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Curitiba, , Brazil

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Goiânia, , Brazil

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Porto Alegre, , Brazil

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Santo André, , Brazil

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São Paulo, , Brazil

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Kelowna, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Oshawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Sault Ste. Marie, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Toronto, Ontario, Canada

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York, Ontario, Canada

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Charlottetown, Prince Edward Island, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Beijing, , China

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Dalian, , China

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Hangzhou, , China

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Nanjing, , China

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Nanning, , China

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Shanghai, , China

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Shenyang, , China

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Wuhan, , China

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Herlev, , Denmark

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København Ø, , Denmark

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Næstved, , Denmark

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Caen, , France

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Clermont-Ferrand, , France

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Marseille, , France

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Paris, , France

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Rennes, , France

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Vesoul, , France

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Göttingen, , Germany

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Großhansdorf, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Karlsruhe, , Germany

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Löwenstein, , Germany

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Mainz, , Germany

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Mönchengladbach, , Germany

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Ulm, , Germany

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Hong Kong, , Hong Kong

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Bangalore, , India

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Karnataka, , India

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New Delhi, , India

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Pune, , India

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Trivandrum, , India

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Bandung, , Indonesia

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Jakarta, , Indonesia

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Solo, , Indonesia

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Ancona, , Italy

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Avellino, , Italy

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Catania, , Italy

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Genova, , Italy

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Mantova, , Italy

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Milan, , Italy

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Orbassano, , Italy

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Parma, , Italy

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Perugia, , Italy

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Roma, , Italy

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Rozzano, , Italy

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Juchitán, , Mexico

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Monterrey, , Mexico

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Morelia, , Mexico

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Puebla City, , Mexico

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Saltillo, , Mexico

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Zacatecas City, , Mexico

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Harderwijk, , Netherlands

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Nieuwegein, , Netherlands

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Rotterdam, , Netherlands

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Zwolle, , Netherlands

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Bergen, , Norway

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Haugesund, , Norway

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Kristiansand, , Norway

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Oslo, , Norway

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Stavanger, , Norway

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Tromsø, , Norway

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Trondheim, , Norway

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Cebu City, , Philippines

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Davao City, , Philippines

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Manila, , Philippines

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Pasay, , Philippines

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Quezon City, , Philippines

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Seoul, , South Korea

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Elche(Alicante), , Spain

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Jaén, , Spain

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Madrid, , Spain

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Mataró(Barcelona), , Spain

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Málaga, , Spain

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Pamplona, , Spain

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Taichung, , Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Bangkok, , Thailand

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Chiang Mai, , Thailand

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Lampang, , Thailand

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Songkhla, , Thailand

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Birmingham, , United Kingdom

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Cambridge, , United Kingdom

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Leicester, , United Kingdom

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Liverpool, , United Kingdom

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Nottingham, , United Kingdom

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Sheffield, , United Kingdom

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Wolverhampton, , United Kingdom

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Countries

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United States Argentina Australia Brazil Canada China Denmark France Germany Hong Kong India Indonesia Italy Mexico Netherlands Norway Philippines South Korea Spain Taiwan Thailand United Kingdom

References

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Natale RB, Thongprasert S, Greco FA, Thomas M, Tsai CM, Sunpaweravong P, Ferry D, Mulatero C, Whorf R, Thompson J, Barlesi F, Langmuir P, Gogov S, Rowbottom JA, Goss GD. Phase III trial of vandetanib compared with erlotinib in patients with previously treated advanced non-small-cell lung cancer. J Clin Oncol. 2011 Mar 10;29(8):1059-66. doi: 10.1200/JCO.2010.28.5981. Epub 2011 Jan 31.

Reference Type RESULT
PMID: 21282542 (View on PubMed)

Mishina A, Zhudenkov K, Helmlinger G, Peskov K. A Systematic Comparative Analysis of Tumor Size Models Based on Erlotinib Clinical Data in Advanced NSCLC. CPT Pharmacometrics Syst Pharmacol. 2025 Aug 11. doi: 10.1002/psp4.70095. Online ahead of print.

Reference Type DERIVED
PMID: 40785488 (View on PubMed)

Platt A, Morten J, Ji Q, Elvin P, Womack C, Su X, Donald E, Gray N, Read J, Bigley G, Blockley L, Cresswell C, Dale A, Davies A, Zhang T, Fan S, Fu H, Gladwin A, Harrod G, Stevens J, Williams V, Ye Q, Zheng L, de Boer R, Herbst RS, Lee JS, Vasselli J. A retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies. BMC Cancer. 2015 Mar 23;15:171. doi: 10.1186/s12885-015-1146-8.

Reference Type DERIVED
PMID: 25881079 (View on PubMed)

Related Links

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Other Identifiers

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EUDRACT No. 2006-000259-16

Identifier Type: -

Identifier Source: secondary_id

D4200C00057

Identifier Type: -

Identifier Source: org_study_id

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