title: A 102-Week, Open Label, Multicenter Trial To Investigate The Efficacy Of Macugen For The Preservation Of Visual Function In Subjects With Neovascular Age-Related Macular Degeneration (AMD) And To Assess The Benefit Of Treating Early Choroidal Neovascularization (CNV).

acronym: PERSPECTIVES

summary: The purpose of this study is to determine the benefits of treating subjects with neovascular age-related macular degeneration (AMD) at an earlier stage of choroidal neovascularization (CNV) as compared to those with established CNV. Additionally, the study would like to determine the efficacy of Macugen in preserving visual function in those subjects having CNV secondary to neovascular AMD.

ReferenceCitation: Chakravarthy U, Staurenghi G, Kwok K, Tressler CS, Buggage R; PERSPECTIVES Study Group. Treating early choroidal neovascularisation with pegaptanib sodium in patients with neovascular age-related macular degeneration: findings of the PERSPECTIVES study. Br J Ophthalmol. 2012 Oct;96(10):1351-4. doi: 10.1136/bjophthalmol-2011-301444. Epub 2012 Aug 7. No abstract available.

location_country:
Finland
France
Germany
Italy
Poland
Portugal
United Kingdom
Denmark
Austria
Belgium
Spain
Greece
Turkey
Canada
Czech Republic


title: Phase III,Open-label,Prospective,Two-armed,Multicenter Study Comparing Zevalin Regimen With no Further Treatment in Patients With Diffuse Large B-cell Lymphoma.

summary: This study treats patients with diffuse large B-cell lymphoma whose disease is in complete remission due to previous treatment with Cyclophosphamide Doxorubicin hydrochloride Vincristine Prednisolone- Rituximab (CHOP-R). Half of the patients received Zevalin and the other half receive no further anti-cancer treatment. The two patient groups compared to determine if Zevalin given after CHOP-R therapy provides greater benefits than receiving no additional anti-cancer therapy after CHOP-R.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Spectrum Pharmaceuticals, Inc

sponsor_collaborators:
Spectrum Pharmaceuticals, Inc
Bayer

location_country:
Finland
Germany
Ireland
Poland
Thailand
Canada
France
Portugal
Hungary
Switzerland
United States
Belgium
Italy
United Kingdom
Singapore
Austria
Korea, Republic of
Spain
Sweden

location_facility:
Research site
Research Site, Cedax
Research Site
Research Site, Yonsei

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Randomized, Open-Label, Multicenter Study of VELCADE With Rituximab or Rituximab Alone in Subjects With Relapsed or Refractory, Rituximab Naive or Sensitive Follicular B-cell Non-Hodgkin's Lymphoma

summary: The purpose of this study is to determine if the combination of VELCADE and rituximab improves progression free survival relative to rituximab alone in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (B-NHL) who never received rituximab or who have previously responded to rituximab. This is an international study being conducted in the United States and in many countries around the world. A complete list of study locations is listed below.

status: Completed

ReferenceType: derived

ReferenceCitation: Zinzani PL, Khuageva NK, Wang H, Garicochea B, Walewski J, Van Hoof A, Soubeyran P, Caballero D, Buckstein R, Esseltine DL, Theocharous P, Enny C, Zhu E, Elsayed YA, Coiffier B. Bortezomib plus rituximab versus rituximab in patients with high-risk, relapsed, rituximab-naive or rituximab-sensitive follicular lymphoma: subgroup analysis of a randomized phase 3 trial. J Hematol Oncol. 2012 Oct 22;5:67. doi: 10.1186/1756-8722-5-67.

ReferenceCitation: Coiffier B, Osmanov EA, Hong X, Scheliga A, Mayer J, Offner F, Rule S, Teixeira A, Walewski J, de Vos S, Crump M, Shpilberg O, Esseltine DL, Zhu E, Enny C, Theocharous P, van de Velde H, Elsayed YA, Zinzani PL; LYM-3001 study investigators. Bortezomib plus rituximab versus rituximab alone in patients with relapsed, rituximab-naive or rituximab-sensitive, follicular lymphoma: a randomised phase 3 trial. Lancet Oncol. 2011 Aug;12(8):773-84. doi: 10.1016/S1470-2045(11)70150-4. Epub 2011 Jul 1.

lead_sponsor: Millennium Pharmaceuticals, Inc.

collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Thailand
Canada
France
Czech Republic
Portugal
Slovakia
Hungary
United States
Ukraine
India
Romania
Belgium
China
Puerto Rico
Italy
Cyprus
United Kingdom
Sweden
Mexico
Korea, Republic of
Spain
Greece
South Africa
Russian Federation
Israel

location_facility: Moscow Region Clinical Research Institute

location_facility: University General Hospital Attikon - 2nd Department of Internal Medicine - Propedeutic & Research Institute

location_facility: University Hospital of Patras - Department of Internal Medicine - Hematology Division

location_facility: Toronto Sunnybrook Regional Cancer Centre

location_facility: Spitalul Clinic judetean de urgenta Mures

location_facility: Hospital Durans I Reynals - Institut Catala d'Oncologia

location_facility: Institute of Blood Pathology and Transfusional Medicine of AMS of Ukraine, Lviv Clinical Hospital #5

location_facility: Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University

location_facility: FN F.D. Roosevelt - Oddelenie hematologie

location_facility: Katedra i Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku

location_facility: Northwest Georgia Oncology Centers, P.C.

location_facility: Investigative Clinical Research of Indiana

location_facility: Department of Medical Oncology - Regional Cancer Centre

location_facility: Affiliated Hospital of the Academy of Military Medical Sciences

location_facility: The Center for Cancer and Blood Disorders

location_facility: Wojskowy Instytut Medyczny - Klinika Hematologii

location_facility: Aberdeen Royal Infirmary - Department of Haematology

location_facility: Klinika Hematologii i Transplantologii Szpiku AM

location_facility: Hospital de Dia de Hematologia - Hospital de Santa Maria E.P.E.

location_facility: Klinika Hematologii - Uniwersytetu Medycznego

location_facility: Cheliabinsk Regional Oncology Dispensary

location_facility: University of California, Irvine Medical Center

location_facility: St. Petersburg Clinical Research Institute of Hematology and Transfusiology

location_facility: Hematology-Oncology Clinic, Center for Specific Organs Cancer - National Cancer Center

location_facility: Dnepropetrovsk Regional Clinical Oncology Dispensary

location_facility: Spitalul Universitar de Urgenta Hematologie

location_facility: Derriford Hospital - Department of Haematology

location_facility: Ramathibodi Hospital, Mahidol University

location_facility: Emory Univeersity ,Winship Cancer Institute

location_facility: Azienda Ospedaliero Universitaria di Bologna

location_facility: Martinska FN, Klinika hematologie a transfuziologie

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: East Cape Oncology Centre - St. Georges Hospital

location_facility: Cancer Care Associates Medical Group, Inc.

location_facility: Samsung Medical Center - Department of Internal Medicine

location_facility: Spitalul Clinic judetean de urgenta "Sf. Spiridon, Clinica Hematologie

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. - Departmento de Hematologia

location_facility: Innovative Clinical Research of South Florida

location_facility: Ukrainian Medical Stomatological Academy, Poltava Regional Dispensary

location_facility: Nizhniy Novgorod Region Clinical Hospital

location_facility: Postgraduate Institute of Medical Education and Research

location_facility: Mary Potter Oncology Centre - Little Company of Mary Hospital

location_facility: Universitatsklinikum Munster - Klinik fur Innere Medizin

location_facility: Samsung Medical Center - Division of Hematology-Oncology, Department of Medicine

location_facility: Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran

location_facility: Serviço de Onco-hematologia, Instituto Português de Oncologia do Porto Franscisco Gentil, EPE

location_facility: Hematologiska kliniken M54 Karolinska University Hospital

location_facility: Vychodoslovensky Onkologicky Ustave, a.s.

location_facility: Institute for Emergency and Urgent Medical Assistance named after V.K. Gusak of AMS of Ukraine

location_facility: Crimean Republic Clinical Oncology Dispensary

location_facility: Zhitomir Gerbachevsky Regional Clinical Hospital

location_facility: Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista

location_facility: Saint Petersburg Pavlov State Medical University

location_facility: Republikan Hospital named after V.A. Baranov

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: Fakultna nemocnica L. Pasteura - Klinika hematologie a onkohematologie

location_facility: Virga Jesse Ziekenhuis, Dienst Hematologie

location_facility: Servico de Oncologia do Hospital Sao Lucas da PUC do rio Grande do Sul

location_facility: Apollo Hospitals, Hyderabad Apollo Hospital Complex

location_facility: Klinika Hematologii Instytut Chorob Wewnetrznych

location_facility: University Health Network - Princess Margaret Hospital

location_facility: Laiko General Hospital of Athens - 1st Internist Clinic - Hematology Department

location_facility: 1st Republican Clinical Hospital of Udmurtia

location_facility: Novosibirsk State Regional Clinical Hospital

location_facility: SZEgedi Tudomanyegyetem, II Belgyaszati Klinika

location_facility: Addenbrooke's Hospital - Department of Haematology

location_facility: Republican Clinical Hospital of Bashkorkostan

location_facility: Hospital Germans Trias i Pujol Institut Catala d'Oncologia

location_facility: Central Coast Medical Oncology Corporation

location_facility: Severance Hospital, Yonsei University College of Medicine

location_facility: Debreceni Egyetem, Orvos- es Egeszsegtudomanyl Centrum, iii. Belgyogyaszati Klinika

location_facility: Instituto Nacional De Cancerologia Incan

location_facility: Institutul Clinic Fundeni Clinica de Hematologie

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez UANL

location_facility: Lung Cancer Center - National Cancer Center

location_facility: Servico de Hematologia - Hospital de Dia - Hospital Da Universidade de Coimbra

location_facility: Service des Maladies due sang - Hopital haut Leveque

location_facility: Centrum for Hematologi Karolinska University Hospital

location_facility: Central Hematology Oncology Medical Group, Inc

location_facility: Azienda Ospedallera Universitaria Policlinico Tor Vergata

location_facility: UZ Antwerpen - Universitair Ziekenhuis Antwerpen

status_simplified: Completed


title: A Phase 2, Randomized, Double-Blind Study Exploring the Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine Plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects Currently Being Treated With Adefovir Dipivoxil for Chronic Hepatitis B and Having Persistent Viral Replication

summary:
This study explores the efficacy, safety and tolerability of tenofovir DF (TDF) 300 mg once daily monotherapy versus the combination of emtricitabine 200 mg plus tenofovir DF 300 mg (FTC/TDF) once daily in subjects currently being treated with adefovir dipivoxil (Hepsera) for chronic hepatitis B who have persistent viral replication (detectable hepatitis B virus deoxyribonucleic acid [HBV DNA]).

Subjects with confirmed (within 4 weeks) plasma HBV DNA ≥ 400 copies/mL during double blind treatment at Week 24 or any time thereafter have the option of receiving 12 weeks of open-label FTC/TDF which may be continued through the end of the 168-week treatment period if there is a virologic response (HBV DNA < 400 copies/mL). Alternatively, subjects with confirmed HBV DNA < 400 copies/mL at or any time after Week 24 of double-blind treatment may continue blinded therapy up to Week 168 at the discretion of the investigator. If, in the investigator's opinion, it is felt that continued blinded treatment beyond 24 weeks in subjects with confirmed HBV DNA ≥ 400 copies/mL is not beneficial, the subject may discontinue the study and begin commercially available HBV therapy rather than initiate open-label FTC/TDF.

ReferenceType: result

ReferenceCitation: van Bommel F, Zollner B, Sarrazin C, Spengler U, Huppe D, Moller B, Feucht HH, Wiedenmann B, Berg T. Tenofovir for patients with lamivudine-resistant hepatitis B virus (HBV) infection and high HBV DNA level during adefovir therapy. Hepatology. 2006 Aug;44(2):318-25. doi: 10.1002/hep.21253.

ReferenceCitation: Marcellin P, Heathcote EJ, Buti M, Gane E, de Man RA, Krastev Z, Germanidis G, Lee SS, Flisiak R, Kaita K, Manns M, Kotzev I, Tchernev K, Buggisch P, Weilert F, Kurdas OO, Shiffman ML, Trinh H, Washington MK, Sorbel J, Anderson J, Snow-Lampart A, Mondou E, Quinn J, Rousseau F. Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. N Engl J Med. 2008 Dec 4;359(23):2442-55. doi: 10.1056/NEJMoa0802878.

ReferenceCitation: Reijnders JG, Janssen HL. Potency of tenofovir in chronic hepatitis B: mono or combination therapy? J Hepatol. 2008 Mar;48(3):383-6. doi: 10.1016/j.jhep.2007.12.006. Epub 2007 Dec 31. No abstract available.

ReferenceCitation: Tan J, Degertekin B, Wong SN, Husain M, Oberhelman K, Lok AS. Tenofovir monotherapy is effective in hepatitis B patients with antiviral treatment failure to adefovir in the absence of adefovir-resistant mutations. J Hepatol. 2008 Mar;48(3):391-8. doi: 10.1016/j.jhep.2007.09.020. Epub 2008 Jan 3.

ReferenceCitation: van Bommel F, de Man RA, Wedemeyer H, Deterding K, Petersen J, Buggisch P, Erhardt A, Huppe D, Stein K, Trojan J, Sarrazin C, Bocher WO, Spengler U, Wasmuth HE, Reinders JG, Moller B, Rhode P, Feucht HH, Wiedenmann B, Berg T. Long-term efficacy of tenofovir monotherapy for hepatitis B virus-monoinfected patients after failure of nucleoside/nucleotide analogues. Hepatology. 2010 Jan;51(1):73-80. doi: 10.1002/hep.23246.

ReferenceCitation: Berg T, Marcellin P, Zoulim F, Moller B, Trinh H, Chan S, Suarez E, Lavocat F, Snow-Lampart A, Frederick D, Sorbel J, Borroto-Esoda K, Oldach D, Rousseau F. Tenofovir is effective alone or with emtricitabine in adefovir-treated patients with chronic-hepatitis B virus infection. Gastroenterology. 2010 Oct;139(4):1207-17. doi: 10.1053/j.gastro.2010.06.053. Epub 2010 Jun 20.

lead_sponsor: Gilead Sciences

location_country:
United States
Spain
Germany
France


type: EudraCT Number

title: A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY 43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)

summary: A randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel plus or minus sorafenib in chemonaive patients with stage III-IV non-small cell lung cancer.

ReferenceCitation: Scagliotti G, Novello S, von Pawel J, Reck M, Pereira JR, Thomas M, Abrao Miziara JE, Balint B, De Marinis F, Keller A, Aren O, Csollak M, Albert I, Barrios CH, Grossi F, Krzakowski M, Cupit L, Cihon F, Dimatteo S, Hanna N. Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced non-small-cell lung cancer. J Clin Oncol. 2010 Apr 10;28(11):1835-42. doi: 10.1200/JCO.2009.26.1321. Epub 2010 Mar 8.

lead_sponsor: Bayer

location_country:
Germany
Poland
Argentina
Australia
Brazil
Chile
Canada
France
Hungary
Hong Kong
United States
Belgium
Puerto Rico
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Taiwan
Russian Federation
Sweden


title: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes

summary: This is a 12-week randomized, double-blind, multi-center, active-controlled (open-label pioglitazone) and placebo-controlled study of tesaglitazar (0.1, 0.5, 1, 2, and 3 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 2-week enrollment period, 4 week placebo single blind run in period followed by a 12-week double blind treatment period and a 3-week follow-up period

ReferenceCitation: Goldstein BJ, Rosenstock J, Anzalone D, Tou C, Ohman KP. Effect of tesaglitazar, a dual PPAR alpha/gamma agonist, on glucose and lipid abnormalities in patients with type 2 diabetes: a 12-week dose-ranging trial. Curr Med Res Opin. 2006 Dec;22(12):2575-90. doi: 10.1185/030079906x154169.

lead_sponsor: AstraZeneca

location_country:
United States
Canada
Mexico
France


title: A Pilot, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Preliminary Clinical Activity and Immunogenicity of Multiple Doses of LEA29Y and CTLA4Ig Administered Intravenously to Subjects With Rheumatoid Arthritis

summary: This randomized, double-blind, placebo controlled, parallel and multiple dose study provided safety, preliminary efficacy, and immunogenicity information about the use of BMS-188667 and BMS-224818 in subjects with RA

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Ireland
United Kingdom
Netherlands
Switzerland
Belgium
United States
Canada
France

location_facility:
Local Instiution
Local Institution


title: A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

summary: The purpose of this study is to compare the efficacy of visilizumab to placebo in subjects with intravenous steroid-refractory ulcerative colitis.

ReferenceCitation: Sandborn WJ, Colombel JF, Frankel M, Hommes D, Lowder JN, Mayer L, Plevy S, Stokkers P, Travis S, Van Assche G, Baumgart DC, Targan SR. Anti-CD3 antibody visilizumab is not effective in patients with intravenous corticosteroid-refractory ulcerative colitis. Gut. 2010 Nov;59(11):1485-92. doi: 10.1136/gut.2009.205443.

lead_sponsor: Facet Biotech

sponsor_collaborators:
Facet Biotech
PDL BioPharma, Inc.

location_country:
France
Germany
Slovakia
Hungary
Israel
Norway
Australia
Netherlands
Austria
Belgium
United States
Canada
Ukraine
Czech Republic


title: A Prospective Randomised Open- Label Blinded-Endpoint (PROBE) Trial Comparing Telmisartan (MICARDIS®) (40-80-80mg QD) and Ramipril (2.5-5--10mg QD) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring. PRISMA = Prospective Randomised Investigation of the Safety and Efficacy of Micardis® vs Ramipril Using ABPM

acronym: PRISMA

summary: The primary objective of this study is to demonstrate that telmisartan 80 mg (MICARDIS®) is at least as effective and possibly superior to ramipril 5mg and 10mg in lowering mean ambulatory diastolic blood pressure (DBP) and systolic blood pressure (SBP) during the last 6 hours of the 24-hour dosing interval in mild-to-moderate hypertensive patients at the end of an 8 and 14-week treatment period, respectively.

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
United Kingdom
Netherlands
Austria
Switzerland
Spain
South Africa
France

location_facility: Rehabilitationszentrum für Herz- und Kreislauferkrankungen

location_facility: Boehringer Ingelheim Investigational Site


title: Randomized Phase 3 Trial of Decitabine Versus Patient's Choice With Physician's Advice of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia

summary: The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of either cytarabine or supportive care medication.

ReferenceCitation: Mayer J, Arthur C, Delaunay J, Mazur G, Thomas XG, Wierzbowska A, Ravandi F, Berrak E, Jones M, Li Y, Kantarjian HM. Multivariate and subgroup analyses of a randomized, multinational, phase 3 trial of decitabine vs treatment choice of supportive care or cytarabine in older patients with newly diagnosed acute myeloid leukemia and poor- or intermediate-risk cytogenetics. BMC Cancer. 2014 Feb 6;14:69. doi: 10.1186/1471-2407-14-69.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer

lead_sponsor: Eisai Inc.

location_country:
Poland
Hungary
United Kingdom
Romania
Australia
Mexico
United States
Spain
Croatia
Taiwan
Czechia
Canada
Serbia
Russian Federation
France


title: Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT)

acronym: BENEFIT

summary: The purpose of this study is to learn if Belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immunosuppressive medications such as kidney damage. Effects on kidney function and patient survival as well as drug safety will also be studied.

ReferenceCitation: Vincenti F, Rostaing L, Grinyo J, Rice K, Steinberg S, Gaite L, Moal MC, Mondragon-Ramirez GA, Kothari J, Polinsky MS, Meier-Kriesche HU, Munier S, Larsen CP. Belatacept and Long-Term Outcomes in Kidney Transplantation. N Engl J Med. 2016 Jan 28;374(4):333-43. doi: 10.1056/NEJMoa1506027. Erratum In: N Engl J Med. 2016 Feb 18;374(7):698.

oa_colors: green other

evidence: open (via free article)

license: public-domain

license_normalized: public-domain

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Dobbels F, Wong S, Min Y, Sam J, Kalsekar A. Beneficial effect of belatacept on health-related quality of life and perceived side effects: results from the BENEFIT and BENEFIT-EXT trials. Transplantation. 2014 Nov 15;98(9):960-8. doi: 10.1097/TP.0000000000000159.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

version: acceptedVersion

repositories_concat: LIRIAS (KU Leuven)

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Vincenti F, Larsen CP, Alberu J, Bresnahan B, Garcia VD, Kothari J, Lang P, Urrea EM, Massari P, Mondragon-Ramirez G, Reyes-Acevedo R, Rice K, Rostaing L, Steinberg S, Xing J, Agarwal M, Harler MB, Charpentier B. Three-year outcomes from BENEFIT, a randomized, active-controlled, parallel-group study in adult kidney transplant recipients. Am J Transplant. 2012 Jan;12(1):210-7. doi: 10.1111/j.1600-6143.2011.03785.x. Epub 2011 Oct 12.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
Canada
France
Czech Republic
Hungary
Switzerland
United States
India
Belgium
Italy
Sweden
Austria
Mexico
Spain
South Africa
Israel

location_facility: Henry Ford Hospital, Transplant Institute

location_facility: University Of California San Francisco Medical Center

location_facility: Western New England Renal & Transplant Associates, Pc

location_facility: Columbia University College Of Physicians & Surgeons

location_facility: Yale University School Of Medicine-Yale New Haven Hospital

location_facility: Loma Linda University Medical Center-Transplantation Institu

location_facility: University Of North Carolina At Chapel Hill

location_facility: Washington University School Of Medicine

location_facility: Div Of Multi-Organ Trans, Hepato-Biliary-Pancreatic Surgery

location_facility: Sacred Heart Medical Ctr Providence Medical Research Ctr

location_facility: University Of Colorado Health Sciences Center

location_facility: University Of Iowa Hospitals And Clinics


title: A 24-Week Randomized, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Administered as Monotherapy to Drug-Naïve Patients With Type 2 Diabetes

summary:
This is a 24-week randomized, double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6-week single-blind placebo run-in period, followed by 24-week treatment period and a 3-week follow-up period.

The study design of GALLANT 2 is identical to GALLANT 22; the blinded study data from GALLANT 2 will be transferred to the GALLANT 22 database and will be analyzed together with the data from GALLANT 22 clinical study.

location_country:
Lithuania
Poland
Slovakia
Hungary
Norway
Australia
Sweden
Latvia
Greece
Former Serbia and Montenegro
Estonia
Czech Republic
Philippines
France


title: An Open, Randomized, Multicenter, Phase IIIB Study During 5 Years to Assess Long-term Efficacy and Tolerability of Esomeprazole Compared to Laparoscopic Anti-reflux Surgery in Adult Subjects With Gastroesophageal Reflux Disease - LOTUS.

acronym: LOTUS

summary: The study investigates the efficacy of long-term treatment of esomeprazole compared to anti-reflux surgery in the control of gastroesophageal reflux disease by assessing time to treatment failure.

ReferenceCitation: Hatlebakk JG, Zerbib F, Bruley des Varannes S, Attwood SE, Ell C, Fiocca R, Galmiche JP, Eklund S, Langstrom G, Lind T, Lundell LR; LOTUS Study Group. Gastroesophageal Acid Reflux Control 5 Years After Antireflux Surgery, Compared With Long-term Esomeprazole Therapy. Clin Gastroenterol Hepatol. 2016 May;14(5):678-85.e3. doi: 10.1016/j.cgh.2015.07.025. Epub 2015 Jul 27.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Attwood SE, Ell C, Galmiche JP, Fiocca R, Hatlebakk JG, Hasselgren B, Langstrom G, Jahreskog M, Eklund S, Lind T, Lundell L. Long-term safety of proton pump inhibitor therapy assessed under controlled, randomised clinical trial conditions: data from the SOPRAN and LOTUS studies. Aliment Pharmacol Ther. 2015 Jun;41(11):1162-74. doi: 10.1111/apt.13194. Epub 2015 Apr 10.

oa_host_type: closed

publisher_dissemination: Wiley

ReferenceCitation: Lundell L, Hatlebakk J, Galmiche JP, Attwood SE, Ell C, Fiocca R, Persson T, Nagy P, Eklund S, Lind T. Long-term effect on symptoms and quality of life of maintenance therapy with esomeprazole 20 mg daily: a post hoc analysis of the LOTUS trial. Curr Med Res Opin. 2015 Jan;31(1):65-73. doi: 10.1185/03007995.2014.980500. Epub 2014 Oct 31.

publisher_dissemination: Informa

ReferenceCitation: Fiocca R, Mastracci L, Attwood SE, Ell C, Galmiche JP, Hatlebakk J, Barthel A, Langstrom G, Lind T, Lundell L; LOTUS trial collaborators. Gastric exocrine and endocrine cell morphology under prolonged acid inhibition therapy: results of a 5-year follow-up in the LOTUS trial. Aliment Pharmacol Ther. 2012 Nov;36(10):959-71. doi: 10.1111/apt.12052. Epub 2012 Sep 23.

ReferenceCitation: Galmiche JP, Hatlebakk J, Attwood S, Ell C, Fiocca R, Eklund S, Langstrom G, Lind T, Lundell L; LOTUS Trial Collaborators. Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial. JAMA. 2011 May 18;305(19):1969-77. doi: 10.1001/jama.2011.626.

location_country:
Finland
Germany
Italy
Norway
United Kingdom
Denmark
Sweden
Netherlands
Austria
Belgium
Iceland
France


title: Phase IIB, Randomized, Multicenter, Parallel Group, Study to Evaluate the Safety, Pharmacokinetics and Antiviral Effect of Four Blinded Dosing Regimens of GW640385X/Ritonavir Compared to Open-label Current PI Therapy in HIV-1 Infected, Protease Inhibitor Experienced Adults for 2 Weeks With Long-term Assessment (>48 Weeks) of Safety, Pharmacokinetic and Antiviral Activity of Selected 385/RTV Dosing Regimen(s) vs. a Ritonavir-boosted, Protease Inhibitor Containing Regimen

summary: This is a two phase study (randomised and non-randomised phase). The randomised phase will initially examine 4 blinded doses of GW640385 boosted with rtv (with continuation of current background therapy) in comparison to an ongoing, open-labeled rtv-boosted protease inhibitor (PI) regimen for 15 days. At the Day 15 visit, all subjects will optimize background therapy. Additionally, subjects receiving the lowest dose of GW640385 will be re-randomised to one of the higher doses and subjects in the control arm will receive a new rtv-boosted PI based on resistance testing at screening. Subjects will remain in the randomized phase on one of these 4 continuing treatment arms for at least 48 weeks. An interim analysis will occur during the randomised phase to select for a dose of GW640385 to evaluate further in Phase III studies. After dose selection subjects will move to the non-randomised phase of the study. In the non-randomised phase subjects who are receiving GW640385 will be assigned to final selected dose for assessment of long term safety, tolerability, pharmacokinetics, and antiviral activity.

lead_sponsor: ViiV Healthcare

location_country:
Germany
Italy
Portugal
United Kingdom
Romania
Australia
Belgium
United States
Canada
Puerto Rico
France


title: A Multicentre Prospective Controlled Observer Blinded Cohort Study in Patients With Acromegaly to Evaluate the Risk of Cardiac Valvular Regurgitation in Patients Treated With Lanreotide Relative to Patients Treated With Octreotide

summary: The aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Colao A, Marek J, Goth MI, Caron P, Kuhn JM, Minuto FM, Weissman NJ. No greater incidence or worsening of cardiac valve regurgitation with somatostatin analog treatment of acromegaly. J Clin Endocrinol Metab. 2008 Jun;93(6):2243-8. doi: 10.1210/jc.2007-2199. Epub 2008 Apr 1.

lead_sponsor: Ipsen

location_country:
Italy
Poland
Hungary
United Kingdom
Denmark
Sweden
Belgium
Spain
Czechia
France

location_facility: 1st School of Medicine, Charles University

location_facility: Dipartimento di Scienze, Endocrinologiche e Metaboliche

location_facility: Research Centre for Endocrinology and Metabolism


type: Other Identifier

title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial to Investigate the Efficacy and Tolerability of Topiramate in Prolonged Migraine Prevention

acronym: PROMPT

summary: The purpose of this study is to evaluate the safety and effectiveness (beyond 6 months) of individualized doses (100 to 200 milligrams) of topiramate for the prevention of migraine headaches over a period of 26 weeks.

ReferenceCitation: Diener HC, Agosti R, Allais G, Bergmans P, Bussone G, Davies B, Ertas M, Lanteri-Minet M, Reuter U, Sanchez Del Rio M, Schoenen J, Schwalen S, van Oene J; TOPMAT-MIG-303 Investigators Group. Cessation versus continuation of 6-month migraine preventive therapy with topiramate (PROMPT): a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2007 Dec;6(12):1054-62. doi: 10.1016/S1474-4422(07)70272-7. Epub 2007 Nov 7. Erratum In: Lancet Neurol. 2008 Jan;7(1):25.

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Germany
Ireland
Poland
Turkey
France
Slovenia
Czech Republic
Portugal
Hungary
Denmark
Switzerland
Belgium
Norway
United Kingdom
Austria
Saudi Arabia
Spain
Greece
Bulgaria
Russian Federation


title: A Ten-Week, Randomized, Double-Blind Study Evaluating the Efficacy of Duloxetine 60mg Once Daily Versus Placebo in Outpatients With Major Depressive Disorder and Pain

summary: To determine the efficacy of Duloxetine vs. placebo on pain as determined by change in the Brief Pain Inventory (BPI) from baseline over 8 weeks of treatment

ReferenceCitation: Demyttenaere K, Desaiah D, Petit C, Croenlein J, Brecht S. Time course of improvement of different symptom clusters in patients with major depression and pain treated with duloxetine or placebo. Curr Med Res Opin. 2012 Jan;28(1):41-8. doi: 10.1185/03007995.2011.645561. Epub 2011 Dec 22.

ReferenceCitation: Demyttenaere K, Desaiah D, Petit C, Croenlein J, Brecht S. Patient-assessed versus physician-assessed disease severity and outcome in patients with nonspecific pain associated with major depressive disorder. Prim Care Companion J Clin Psychiatry. 2009;11(1):8-15. doi: 10.4088/pcc.08m00670.

ReferenceCitation: Brecht S, Courtecuisse C, Debieuvre C, Croenlein J, Desaiah D, Raskin J, Petit C, Demyttenaere K. Efficacy and safety of duloxetine 60 mg once daily in the treatment of pain in patients with major depressive disorder and at least moderate pain of unknown etiology: a randomized controlled trial. J Clin Psychiatry. 2007 Nov;68(11):1707-16. doi: 10.4088/jcp.v68n1110.

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Boehringer Ingelheim

location_country:
Finland
Germany
Slovakia
Belgium
Czech Republic
France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes: A Double-blind, Active and Placebo Controlled Study of Aggrenox vs. Clopidogrel, With and Without Micardis

summary: The purpose of the trial is to determine if extended-release dipyridamole + aspirin [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one.

primary_purpose: Prevention

ReferenceCitation: Ovbiagele B, Bath PM, Cotton D, Sha N, Diener HC; PRoFESS Investigators. Low glomerular filtration rate, recurrent stroke risk, and effect of renin-angiotensin system modulation. Stroke. 2013 Nov;44(11):3223-5. doi: 10.1161/STROKEAHA.113.002463. Epub 2013 Aug 29.

ReferenceCitation: Bohm M, Cotton D, Foster L, Custodis F, Laufs U, Sacco R, Bath PM, Yusuf S, Diener HC. Impact of resting heart rate on mortality, disability and cognitive decline in patients after ischaemic stroke. Eur Heart J. 2012 Nov;33(22):2804-12. doi: 10.1093/eurheartj/ehs250. Epub 2012 Aug 26.

ReferenceCitation: Weber R, Weimar C, Blatchford J, Hermansson K, Wanke I, Moller-Hartmann C, Gizewski ER, Forsting M, Demchuk AM, Sacco RL, Saver JL, Warach S, Diener HC, Diehl A; PRoFESS Imaging Substudy Group. Telmisartan on top of antihypertensive treatment does not prevent progression of cerebral white matter lesions in the prevention regimen for effectively avoiding second strokes (PRoFESS) MRI substudy. Stroke. 2012 Sep;43(9):2336-42. doi: 10.1161/STROKEAHA.111.648576. Epub 2012 Jun 26.

ReferenceCitation: Weber R, Weimar C, Wanke I, Moller-Hartmann C, Gizewski ER, Blatchford J, Hermansson K, Demchuk AM, Forsting M, Sacco RL, Saver JL, Warach S, Diener HC, Diehl A; PRoFESS Imaging Substudy Group. Risk of recurrent stroke in patients with silent brain infarction in the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) imaging substudy. Stroke. 2012 Feb;43(2):350-5. doi: 10.1161/STROKEAHA.111.631739. Epub 2012 Jan 19.

ReferenceCitation: Ovbiagele B, Diener HC, Yusuf S, Martin RH, Cotton D, Vinisko R, Donnan GA, Bath PM; PROFESS Investigators. Level of systolic blood pressure within the normal range and risk of recurrent stroke. JAMA. 2011 Nov 16;306(19):2137-44. doi: 10.1001/jama.2011.1650.

ReferenceCitation: Diener HC, Sacco RL, Yusuf S, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlof B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, VanderMaelen C, Voigt T, Weber M, Yoon BW; Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) study group. Effects of aspirin plus extended-release dipyridamole versus clopidogrel and telmisartan on disability and cognitive function after recurrent stroke in patients with ischaemic stroke in the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) trial: a double-blind, active and placebo-controlled study. Lancet Neurol. 2008 Oct;7(10):875-84. doi: 10.1016/S1474-4422(08)70198-4. Epub 2008 Aug 29. Erratum In: Lancet Neurol. 2008 Nov;7(11):985.

ReferenceCitation: Yusuf S, Diener HC, Sacco RL, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlof B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, VanderMaelen C, Voigt T, Weber M, Yoon BW; PRoFESS Study Group. Telmisartan to prevent recurrent stroke and cardiovascular events. N Engl J Med. 2008 Sep 18;359(12):1225-37. doi: 10.1056/NEJMoa0804593. Epub 2008 Aug 27.

ReferenceCitation: Sacco RL, Diener HC, Yusuf S, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlof B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, Vandermaelen C, Voigt T, Weber M, Yoon BW; PRoFESS Study Group. Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke. N Engl J Med. 2008 Sep 18;359(12):1238-51. doi: 10.1056/NEJMoa0805002. Epub 2008 Aug 27.

collaborators: GlaxoSmithKline Bayer

sponsor_collaborators:
Boehringer Ingelheim
GlaxoSmithKline
Bayer

location_country:
Finland
Germany
Ireland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Canada
France
Portugal
Hong Kong
Denmark
United States
Ukraine
India
Belgium
China
El Salvador
Malaysia
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel

location_facility: 9.159.1065 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1039 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1657 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1723 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2302 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1730 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2616 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1111 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1154 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1373 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2935 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2957 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1335 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1521 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2800 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2516 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1112 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2079 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1140 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1194 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2627 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1188 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2209 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1383 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1517 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1216 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1033 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1032 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1091 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1359 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1712 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2503 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2950 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1824 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1372 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2631 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1364 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1006 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2056 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1376 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2247 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1165 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2114 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1218 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2483 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2606 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2501 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1548 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1380 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1635 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2607 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1003 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2287 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1591 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2515 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2612 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1171 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2801 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1391 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1116 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1820 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1851 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2250 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2629 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1214 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2491 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1021 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1721 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2973 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1082 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1035 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1204 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1016 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2505 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1195 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1070 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2521 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2621 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1094 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2295 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2289 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2938 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2449 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1727 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2451 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2961 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1852 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1113 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2029 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2971 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2248 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2452 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2496 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2379 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2826 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1368 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2298 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2082 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2443 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2943 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2951 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1545 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1041 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1155 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2092 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1095 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1731 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2799 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1182 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2102 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2828 Dkuz Eylul Universitesi Tip Fakultesi Noroloji A.B.D.

location_facility: 9.159.2061 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2223 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1377 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1145 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2303 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1036 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1596 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1004 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1331 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1179 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2445 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1118 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1009 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2212 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1186 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1198 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1956 TweeSteden Ziekenhuis Tilburg

location_facility: 9.159.2939 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1046 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1189 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1156 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1018 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1632 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2294 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2111 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1710 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2970 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1077 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1595 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1556 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1684 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1683 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1724 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1038 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1030 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2104 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1551 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2615 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1394 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1711 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2965 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1104 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1053 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1020 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2085 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1631 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1709 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1597 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1594 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1052 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1385 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1074 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1363 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2206 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2520 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1169 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2954 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2972 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2603 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2253 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1106 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2605 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1213 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2388 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2106 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2292 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1515 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1640 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2392 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1121 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1388 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1209 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2181 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2714 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1128 St. Luke's Hospital MABSI Research

location_facility: 9.159.1876 Azienda Ospedaliera di Padova -Policlinico Universitario

location_facility: 9.159.2937 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2498 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1148 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1139 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2830 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2243 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2511 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1729 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2098 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2611 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1061 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1873 Istituto Scientifico "S. Luca"

location_facility: 9.159.1177 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2306 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2949 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2624 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2060 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2288 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1395 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1064 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1151 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1519 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1107 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2113 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1136 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1215 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2110 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1058 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2608 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1367 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1334 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2447 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1210 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1638 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2704 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1060 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2291 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1119 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1865 Ospedale Regionale "S. Salvatore"

location_facility: 9.159.1371 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2825 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1639 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1146 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1130 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2084 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1125 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.2507 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.1101 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.2963 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2500 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1200 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2620 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2215 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1025 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1369 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.2512 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1014 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1201 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2251 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1819 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2705 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1593 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2297 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.2120 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.1679 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.1057 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1170 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2487 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2058 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1153 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1713 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1134 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1022 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1180 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2296 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2284 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1173 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.2869 Complexo Hospitalar Universitario Prof Edgard Santos

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location_facility: 9.159.1141 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1162 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1389 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2604 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.2488 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2216 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2299 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1085 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2245 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1066 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.1378 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1738 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.1737 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.2055 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2112 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1374 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2204 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1079 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1001 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2510 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1361 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1152 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1147 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1007 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1516 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2626 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2089 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2936 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2107 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2798 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2613 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1219 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1132 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1722 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1164 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2619 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1875 Università degli Studi di Ancona

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location_facility: 9.159.1212 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1102 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2495 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.2115 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1012 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1108 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1202 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2614 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.1656 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2706 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1100 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2948 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1681 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1203 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1392 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1633 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2290 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2499 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2222 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1366 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1123 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2509 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1659 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2387 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1196 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1365 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.2080 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2224 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1163 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1547 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1081 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.1592 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1206 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2116 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.1078 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.2203 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1089 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.2964 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2090 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1126 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1069 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.2962 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1735 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1159 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2765 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2246 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.1120 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1160 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1023 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1864 Azienda Ospedaliera "S. Giovanni Battista"

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location_facility: 9.159.1637 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1680 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1175 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1734 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.1357 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.1092 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2283 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1002 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2105 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1178 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2100 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1717 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2723 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1166 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1048 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1550 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1176 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2450 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2041 Centro Hospitalar de Lisboa Norte

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location_facility: 9.159.1520 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2853 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1191 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2178 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1143 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2492 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1192 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1047 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1008 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1739 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2081 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1205 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2091 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2947 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2713 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1362 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.2304 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.2502 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2632 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2707 Boehringer Ingelheim Investigational Site

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location_facility: 9.159.2609 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2094 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2214 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2180 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2244 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1019 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2623 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1382 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2308 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2205 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2945 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1083 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1110 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2103 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1685 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1076 North Shore University Hospital

location_facility: 9.159.2506 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2933 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1042 Neurology Consultants of Burlington County

location_facility: 9.159.1011 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1199 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2493 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2213 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2946 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2285 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1090 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1355 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1013 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1024 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1029 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1544 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2208 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2382 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1096 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1137 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2504 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2956 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2444 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1379 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1051 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1636 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2944 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1826 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1071 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1211 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2039 Centro Hospitalar e Universitário de Coimbra, EPE

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location_facility: 9.159.2083 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2831 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2305 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1370 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1360 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1068 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2969 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1075 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1732 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2109 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2095 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1333 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2625 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2966 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1190 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1183 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2300 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1384 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1877 Azienda Ospedaliera Umberto I

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location_facility: 9.159.2484 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1150 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1122 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1005 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1726 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1135 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1716 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1634 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1217 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1084 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1080 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1187 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1356 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2519 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1336 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1733 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2389 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2286 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1099 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1720 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2179 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1332 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2117 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2176 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1049 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2497 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2175 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1821 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1144 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2610 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1869 Università degli Studi di Genova

location_facility: 9.159.2797 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2617 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2086 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2249 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1708 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1184 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1017 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2513 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1543 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2514 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2724 Rambam Medical Center, Tel-Aviv Medical

location_facility: 9.159.2093 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1658 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2211 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2384 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2953 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2485 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1133 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1207 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1387 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1114 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2028 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2293 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2307 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1825 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2703 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2827 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2489 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2952 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2380 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1045 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2027 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1342 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2967 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2088 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1554 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1553 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2934 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1208 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1055 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1087 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1871 Azienda Ospedaliera "Careggi"

location_facility: 9.159.1037 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1062 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1728 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2097 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2829 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2622 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1027 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2959 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2252 Boehringer Ingelheim Investigational Site

location_facility: 9.159.2059 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1220 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1393 Boehringer Ingelheim Investigational Site

location_facility: 9.159.1158 Boehringer Ingelheim Investigational Site


title: A Randomised, Open Label, Active Controlled Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir Plus 100 mg or 200 mg Ritonavir p.o. BID in Combination With Standard Background Regimen in Comparison to 400 mg Lopinavir Plus 100 mg Ritonavir p.o. BID in Combination With Standard Background Regimen in Antiretroviral Therapy Naive Patients for 48 With Extension up to 156 Weeks

summary: Evaluation of safety and efficacy of Tipranavir (TPV) boosted with Ritonavir (RTV) versus an active control arm (Lopinavir / RTV) in antiretroviral (ARV) therapy naïve HIV-1 infected patients

location_country:
Germany
Poland
Bahamas
Colombia
United Kingdom
Argentina
Romania
Australia
Brazil
Mexico
Spain
Thailand
Canada
Russian Federation
France

location_facility: UNIFESP/ Hospital São Paulo- Univers. Federal de São Paulo

location_facility: Universidade Federal da Bahia-Unidade Docente Assistencial d

location_facility: Unidade de Pesquisa Clínica (UPC) - AIDS

location_facility: Centro de Referência e Treinamento - DST/AIDS

location_facility: Sunnybrook & Woman's College Health Science Centre

location_facility: Montreal Chest Institute, McGill University Health Centre

location_facility: Hospital Geral de Nova Iguaçu - Ministério da Saúde

location_facility: Hospital do Servidor Público Estadual de São Paulo

location_facility: Canadian Immunodeficiency Research Collaborative Inc.

location_facility: I.I. Emilio Ribas - Moléstias Infecciosas

location_facility: Matei Bals Institute of Infectious Diseases

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Boehringer Ingelheim Investigational Site

location_facility: Instituto de Crianca / Hospital das Clínicas-FMUSP

location_facility: Ciutat Sanitaria Universitaria de Bellvitge


title: An Observer-blind, Multicenter, Non-inferiority, Comparative Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, Versus Topical 2% Fusidic Acid Cream Applied Three Times Daily for 7 Days in the Treatment Adult and Paediatric Subjects With Impetigo

summary: The goal of this study is to determine if topical SB-275833 ointment, 1% is as safe and effective as topical sodium fusidate ointment, 2% for the treatment of impetigo in adults and children as young as 9 months of age.

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Poland
India
Costa Rica
Netherlands
Mexico
South Africa
Peru
Canada
France


title: Open, Randomized, Controlled, Multicenter Phase II Study Comparing 5-FU/FA Plus Oxaliplatin (FOLFOX-4) Plus Cetuximab Versus 5-FU/FA Plus Oxaliplatin (FOLFOX-4) as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer

acronym: OPUS

summary: This is an open label, randomized, controlled, multicenter phase II study comparing 5-FU/FA + oxaliplatin (FOLFOX-4) + cetuximab versus 5-FU/FA + oxaliplatin as first-line treatment for epidermal growth factor receptor (EGFR)-expressing mCRC.

ReferenceCitation: Bokemeyer C, Bondarenko I, Makhson A, Hartmann JT, Aparicio J, de Braud F, Donea S, Ludwig H, Schuch G, Stroh C, Loos AH, Zubel A, Koralewski P. Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer. J Clin Oncol. 2009 Feb 10;27(5):663-71. doi: 10.1200/JCO.2008.20.8397. Epub 2008 Dec 29.

ReferenceCitation: Bokemeyer C, Bondarenko I, Hartmann JT, de Braud F, Schuch G, Zubel A, Celik I, Schlichting M, Koralewski P. Efficacy according to biomarker status of cetuximab plus FOLFOX-4 as first-line treatment for metastatic colorectal cancer: the OPUS study. Ann Oncol. 2011 Jul;22(7):1535-1546. doi: 10.1093/annonc/mdq632. Epub 2011 Jan 12.

lead_sponsor: Merck KGaA, Darmstadt, Germany

location_country:
Germany
Italy
Poland
Portugal
Israel
Romania
Austria
Belgium
Spain
Greece
Ukraine
Russian Federation
France


title: A Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF Versus Adefovir Dipivoxil for the Treatment of HBeAg Positive Chronic Hepatitis B

summary: The primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of HBeAg-positive chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks (double-blind). After 48 weeks, eligible participants switched to open-label TDF for up to 480 weeks.

study_start_date_type: Actual

ReferenceCitation: Kitrinos KM, Corsa A, Liu Y, Flaherty J, Snow-Lampart A, Marcellin P, Borroto-Esoda K, Miller MD. No detectable resistance to tenofovir disoproxil fumarate after 6 years of therapy in patients with chronic hepatitis B. Hepatology. 2014 Feb;59(2):434-42. doi: 10.1002/hep.26686.

ReferenceCitation: Marcellin P, Gane E, Buti M, Afdhal N, Sievert W, Jacobson IM, Washington MK, Germanidis G, Flaherty JF, Aguilar Schall R, Bornstein JD, Kitrinos KM, Subramanian GM, McHutchison JG, Heathcote EJ. Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study. Lancet. 2013 Feb 9;381(9865):468-75. doi: 10.1016/S0140-6736(12)61425-1. Epub 2012 Dec 10.

ReferenceCitation: Gordon SC, Krastev Z, Horban A, Petersen J, Sperl J, Dinh P, Martins EB, Yee LJ, Flaherty JF, Kitrinos KM, Rustgi VK, Marcellin P. Efficacy of tenofovir disoproxil fumarate at 240 weeks in patients with chronic hepatitis B with high baseline viral load. Hepatology. 2013 Aug;58(2):505-13. doi: 10.1002/hep.26277. Epub 2013 May 3.

oa_host_type: repository

unpaywall_oa_status: green

ReferenceCitation: Tsai NC, Marcellin P, Buti M, Washington MK, Lee SS, Chan S, Trinh H, Flaherty JF, Kitrinos KM, Dinh P, Charuworn P, Subramanian GM, Gane E. Viral suppression and cirrhosis regression with tenofovir disoproxil fumarate in Asians with chronic hepatitis B. Dig Dis Sci. 2015 Jan;60(1):260-8. doi: 10.1007/s10620-014-3336-7. Epub 2014 Sep 2.

ReferenceCitation: Fung S, Gordon SC, Krastev Z, Horban A, Petersen J, Sperl J, Gane E, Jacobson IM, Yee LJ, Dinh P, Martins EB, Flaherty JF, Kitrinos KM, Dusheiko G, Trinh H, Flisiak R, Rustgi VK, Buti M, Marcellin P. Tenofovir disoproxil fumarate in Asian or Pacific Islander chronic hepatitis B patients with high viral load (>/= 9 log10 copies/ml). Liver Int. 2015 Feb;35(2):422-8. doi: 10.1111/liv.12694. Epub 2014 Oct 28.

ReferenceCitation: Marcellin P, Buti M, Krastev Z, de Man RA, Zeuzem S, Lou L, Gaggar A, Flaherty JF, Massetto B, Lin L, Dinh P, Subramanian GM, McHutchison JG, Flisiak R, Gurel S, Dusheiko GM, Heathcote EJ. Kinetics of hepatitis B surface antigen loss in patients with HBeAg-positive chronic hepatitis B treated with tenofovir disoproxil fumarate. J Hepatol. 2014 Dec;61(6):1228-37. doi: 10.1016/j.jhep.2014.07.019. Epub 2014 Jul 18.

ReferenceCitation: Buti M, Fung S, Gane E, Afdhal NH, Flisiak R, Gurel S, Flaherty JF, Martins EB, Yee LJ, Dinh P, Bornstein JD, Mani Subramanian G, Janssen HL, George J, Marcellin P. Long-term clinical outcomes in cirrhotic chronic hepatitis B patients treated with tenofovir disoproxil fumarate for up to 5 years. Hepatol Int. 2015 Apr;9(2):243-50. doi: 10.1007/s12072-015-9614-4. Epub 2015 Mar 13.

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: Erasmus University Rotterdam - EUR Research Repository

version: submittedVersion

repositories_concat: PubMed Central;pure.eur.nl;repub.eur.nl

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

ReferenceCitation: Buti M, Tsai N, Petersen J, Flisiak R, Gurel S, Krastev Z, Aguilar Schall R, Flaherty JF, Martins EB, Charuworn P, Kitrinos KM, Subramanian GM, Gane E, Marcellin P. Seven-year efficacy and safety of treatment with tenofovir disoproxil fumarate for chronic hepatitis B virus infection. Dig Dis Sci. 2015 May;60(5):1457-64. doi: 10.1007/s10620-014-3486-7. Epub 2014 Dec 23.

ReferenceCitation: Liu Y, Corsa AC, Buti M, Cathcart AL, Flaherty JF, Miller MD, Kitrinos KM, Marcellin P, Gane EJ. No detectable resistance to tenofovir disoproxil fumarate in HBeAg+ and HBeAg- patients with chronic hepatitis B after 8 years of treatment. J Viral Hepat. 2017 Jan;24(1):68-74. doi: 10.1111/jvh.12613. Epub 2016 Sep 23.

ReferenceCitation: Corsa A, Liu Y, Flaherty JF, Marcellin P, Miller M, Kitrinos KM. No Detectable Resistance to Tenofovir Disoproxil Fumarate (TDF) in HBeAg+ and HBeAg- Patients With Chronic Hepatitis B (CHB) After Eight Years of Treatment [Abstract 1707]. The 65th Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting (AASLD); 2014 08-10 November; Boston MA.

ReferenceCitation: Marcellin P, Gane EJ, Flisiak R, Trinh HN, Petersen J, Gurel S, et al. Long Term Treatment with Tenofovir Disoproxil Fumarate for Chronic Hepatitis B Infection is Safe and Well Tolerated and Associated with Durable Virologic Response with no Detectable Resistance: 8 Year Results from Two Phase 3 Trials [Abstract]. 55th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2014 November 7-11; Boston, MA.

ReferenceCitation: Gane EJ, Marcellin P, Sievert W, Trinh HN, Shiffman ML, Washington MK, et al. Five years of Treatment with Tenofovir DF for Chronic Hepatitis B Infection in Asian Patients is Associated with Sustained Viral Suppression and Significant Regression of Histological Fibrosis and Cirrhosis [Poster Number 1429]. 62nd Annual Meeting of the American Association for the Study of Liver Diseases; 2011 November 4-8; San Francisco, California.

ReferenceCitation: Marcellin P, Wong DK, Sievert W, Buggisch P, Petersen J, Flisiak R, Manns M, Kaita K, Krastev Z, Lee SS, Cathcart AL, Crans G, Op den Brouw M, Jump B, Gaggar A, Flaherty J, Buti M. Ten-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B virus infection. Liver Int. 2019 Oct;39(10):1868-1875. doi: 10.1111/liv.14155. Epub 2019 Jul 10.

repository_institution: Helmholtz-Zentrum für Infektionsforschung GmbH - HZI Open Repository

ReferenceCitation: Buti M, Wong DK, Gane E, Flisiak R, Manns M, Kaita K, Janssen HLA, Op den Brouw M, Jump B, Kitrinos K, Crans G, Flaherty J, Gaggar A, Marcellin P. Safety and efficacy of stopping tenofovir disoproxil fumarate in patients with chronic hepatitis B following at least 8 years of therapy: a prespecified follow-up analysis of two randomised trials. Lancet Gastroenterol Hepatol. 2019 Apr;4(4):296-304. doi: 10.1016/S2468-1253(19)30015-9. Epub 2019 Feb 20.

ReferenceCitation: Jacobson IM, Washington MK, Buti M, Thompson A, Afdhal N, Flisiak R, Akarca US, Tchernev KG, Flaherty JF, Aguilar Schall R, Myers RP, Subramanian GM, McHutchison JG, Younossi Z, Marcellin P, Patel K. Factors Associated With Persistent Increase in Level of Alanine Aminotransferase in Patients With Chronic Hepatitis B Receiving Oral Antiviral Therapy. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1087-1094.e2. doi: 10.1016/j.cgh.2017.01.032. Epub 2017 Feb 12.

ReferenceCitation: Bayliss J, Yuen L, Rosenberg G, Wong D, Littlejohn M, Jackson K, Gaggar A, Kitrinos KM, Subramanian GM, Marcellin P, Buti M, Janssen HLA, Gane E, Sozzi V, Colledge D, Hammond R, Edwards R, Locarnini S, Thompson A, Revill PA. Deep sequencing shows that HBV basal core promoter and precore variants reduce the likelihood of HBsAg loss following tenofovir disoproxil fumarate therapy in HBeAg-positive chronic hepatitis B. Gut. 2017 Nov;66(11):2013-2023. doi: 10.1136/gutjnl-2015-309300. Epub 2016 Aug 17.

ReferenceCitation: Pan CQ, Chan S, Trinh H, Yao A, Bae H, Lou L. Similar efficacy and safety of tenofovir in Asians and non-Asians with chronic hepatitis B. World J Gastroenterol. 2015 May 14;21(18):5524-31. doi: 10.3748/wjg.v21.i18.5524.

ReferenceCitation: Heathcote EJ, Marcellin P, Buti M, Gane E, De Man RA, Krastev Z, Germanidis G, Lee SS, Flisiak R, Kaita K, Manns M, Kotzev I, Tchernev K, Buggisch P, Weilert F, Kurdas OO, Shiffman ML, Trinh H, Gurel S, Snow-Lampart A, Borroto-Esoda K, Mondou E, Anderson J, Sorbel J, Rousseau F. Three-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B. Gastroenterology. 2011 Jan;140(1):132-43. doi: 10.1053/j.gastro.2010.10.011. Epub 2010 Oct 16.

ReferenceCitation: Marcellin P, Heathcote EJ, Buti M, Gane E, de Man RA, Krastev Z, Germanidis G, Lee SS, Flisiak R, Kaita K, Manns M, Kotzev I, Tchernev K, Buggisch P, Weilert F, Kurdas OO, Shiffman ML, Trinh H, Washington MK, Sorbel J, Anderson J, Snow-Lampart A, Mondou E, Quinn J, Rousseau F. Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. N Engl J Med. 2008 Dec 4;359(23):2442-55. doi: 10.1056/NEJMoa0802878.

location_country:
France
Germany
Italy
Poland
New Zealand
United Kingdom
Australia
Netherlands
United States
Spain
Greece
Turkey
Bulgaria
Canada
Czech Republic