summary:
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes never treated with insulin followed by the extension trial investigating the long-term safety and tolerability in terms of comparing NN1250 with insulin glargine in subjects with type 2 diabetes.

All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor treatment is approved for combination treatment together with insulin, otherwise DPP-IV inhibitor treatment is also discontinued). Subjects who consent to participate in the extension trial will continue the treatment (NN1250 or insulin glargine + oral antidiabetic drugs (OADs)) to which they were randomly allocated in the 52 week main trial.

The main period is registered internally at Novo Nordisk as NN1250-3579 while the extension period is registered as NN1250-3643.

ReferenceCitation: Ratner RE, Gough SC, Mathieu C, Del Prato S, Bode B, Mersebach H, Endahl L, Zinman B. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013 Feb;15(2):175-84. doi: 10.1111/dom.12032. Epub 2012 Dec 3.

ReferenceCitation: Sorli C, Warren M, Oyer D, Mersebach H, Johansen T, Gough SC. Elderly patients with diabetes experience a lower rate of nocturnal hypoglycaemia with insulin degludec than with insulin glargine: a meta-analysis of phase IIIa trials. Drugs Aging. 2013 Dec;30(12):1009-18. doi: 10.1007/s40266-013-0128-2.

ReferenceCitation: Einhorn D, Handelsman Y, Bode BW, Endahl LA, Mersebach H, King AB. PATIENTS ACHIEVING GOOD GLYCEMIC CONTROL (HBA1c <7%) EXPERIENCE A LOWER RATE OF HYPOGLYCEMIA WITH INSULIN DEGLUDEC THAN WITH INSULIN GLARGINE: A META-ANALYSIS OF PHASE 3A TRIALS. Endocr Pract. 2015 Aug;21(8):917-26. doi: 10.4158/EP14523.OR. Epub 2015 Jun 29.

ReferenceCitation: Russell-Jones D, Gall MA, Niemeyer M, Diamant M, Del Prato S. Insulin degludec results in lower rates of nocturnal hypoglycaemia and fasting plasma glucose vs. insulin glargine: A meta-analysis of seven clinical trials. Nutr Metab Cardiovasc Dis. 2015 Oct;25(10):898-905. doi: 10.1016/j.numecd.2015.06.005. Epub 2015 Jun 18.

repository_institution: INFN Catania - INFM-OAR

ReferenceCitation: Vora J, Seufert J, Solberg H, Kinduryte O, Johansen T, Hollander P. Insulin degludec does not increase antibody formation versus insulin glargine: an evaluation of phase IIIa trials. Diabetes Obes Metab. 2016 Jul;18(7):716-20. doi: 10.1111/dom.12621. Epub 2016 Feb 8.

ReferenceCitation: Rodbard HW, Cariou B, Zinman B, Handelsman Y, Philis-Tsimikas A, Skjoth TV, Rana A, Mathieu C; BEGIN Once Long trial investigators. Comparison of insulin degludec with insulin glargine in insulin-naive subjects with Type 2 diabetes: a 2-year randomized, treat-to-target trial. Diabet Med. 2013 Nov;30(11):1298-304. doi: 10.1111/dme.12303. Epub 2013 Sep 30.

title: NN1250-3579: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA and Insulin Glargine, Both Injected Once Daily in Combination With Oral Anti-diabetic Drugs (OAD), in Subjects With Type 2 Diabetes Mellitus Currently Treated With OAD(s) and Qualifying for More Intensified Treatment / NN1250-3643: An Extension Trial to NN1250-3579 Comparing Safety and Efficacy of NN1250 Plus OAD(s) With Insulin Glargine Plus OAD(s) in Type 2 Diabetes (BEGIN™: Once Long)

location_country:
Finland
Former Serbia and Montenegro
France
Germany
Slovenia
Norway
Denmark
Austria
Belgium
United States
Spain
Canada
Serbia
Puerto Rico
Czech Republic


title: Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who Are Experiencing Clinical Benefit on Current START or CA180-039 Protocols: Long Term Safety and Efficacy Analysis

acronym: START rollover

summary: This study assesses the long-term safety and tolerability of dasatinib administered to patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or imatinib in previous protocols.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Bristol-Myers Squibb

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Thailand
Canada
France
Hungary
Switzerland
United States
Belgium
Peru
Italy
Norway
United Kingdom
Sweden
Korea, Republic of
Spain
South Africa
Russian Federation
Israel

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Ut Southwestern Medical Center At Dallas

location_facility: The University Of Texas Md Anderson Cancer Center

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


study_start_date_type: Actual

acronym: BEGIN™

lead_sponsor: Novo Nordisk A/S

summary:
This trial is conducted in Africa, Europe and the United States of America (USA).

The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes.

The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension period is registered as NN1250-3644.

ReferenceType: result

ReferenceCitation: Heller S, Mathieu C, Kapur R, Wolden ML, Zinman B. A meta-analysis of rate ratios for nocturnal confirmed hypoglycaemia with insulin degludec vs. insulin glargine using different definitions for hypoglycaemia. Diabet Med. 2016 Apr;33(4):478-87. doi: 10.1111/dme.13002. Epub 2015 Dec 13.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

license_normalized: no license

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

evidence: oa repository (via pmcid lookup)

version: acceptedVersion

repositories:
LIRIAS (KU Leuven)
PubMed Central
eprints.whiterose.ac.uk

repositories_concat: LIRIAS (KU Leuven);PubMed Central;eprints.whiterose.ac.uk

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

unpaywall_oa_status: hybrid

publisher_dissemination: Wiley

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central

publisher_dissemination: Springer

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

repository_normalized: Zenodo

repositories_concat: Zenodo

ReferenceCitation: Vora J, Christensen T, Rana A, Bain SC. Insulin degludec versus insulin glargine in type 1 and type 2 diabetes mellitus: a meta-analysis of endpoints in phase 3a trials. Diabetes Ther. 2014 Dec;5(2):435-46. doi: 10.1007/s13300-014-0076-9. Epub 2014 Aug 1.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

ReferenceCitation: Aye MM, Atkin SL. Patient safety and minimizing risk with insulin administration - role of insulin degludec. Drug Healthc Patient Saf. 2014 Apr 30;6:55-67. doi: 10.2147/DHPS.S59566. eCollection 2014.

ReferenceCitation: Heller S, Buse J, Fisher M, Garg S, Marre M, Merker L, Renard E, Russell-Jones D, Philotheou A, Francisco AM, Pei H, Bode B; BEGIN Basal-Bolus Type 1 Trial Investigators. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet. 2012 Apr 21;379(9825):1489-97. doi: 10.1016/S0140-6736(12)60204-9.

ReferenceCitation: Evans M, Chubb B, Gundgaard J. Cost-effectiveness of Insulin Degludec Versus Insulin Glargine in Adults with Type 1 and Type 2 Diabetes Mellitus. Diabetes Ther. 2017 Apr;8(2):275-291. doi: 10.1007/s13300-017-0236-9. Epub 2017 Feb 16.

title: NN1250-3583: A 52 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Parallel, Treat-to-target Trial Comparing Efficacy and Safety of SIBA and Insulin Glargine Both Administered Once Daily in a Basal-bolus Regimen With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes (BEGIN™: BB T1 LONG) / NN1250-3644: An Extension Trial to Trial NN1250-3583 Comparing Safety and Efficacy of NN1250 With Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin, in Type 1 Diabetes (BEGIN™: T1)

location_country:
Germany
United Kingdom
United States
South Africa
Russian Federation
France


acronym: ASPIRE

lead_sponsor: Tibotec Pharmaceuticals, Ireland

summary: The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).

ReferenceType: derived

ReferenceCitation: Lenz O, Verbinnen T, Fevery B, Tambuyzer L, Vijgen L, Peeters M, Buelens A, Ceulemans H, Beumont M, Picchio G, De Meyer S. Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies. J Hepatol. 2015 May;62(5):1008-14. doi: 10.1016/j.jhep.2014.11.032. Epub 2014 Nov 28.

oa_host_type: publisher

ReferenceCitation: Scott J, Rosa K, Fu M, Cerri K, Peeters M, Beumont M, Zeuzem S, Evon DM, Gilles L. Fatigue during treatment for hepatitis C virus: results of self-reported fatigue severity in two Phase IIb studies of simeprevir treatment in patients with hepatitis C virus genotype 1 infection. BMC Infect Dis. 2014 Aug 26;14:465. doi: 10.1186/1471-2334-14-465.

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

unpaywall_oa_status: gold

ReferenceCitation: Zeuzem S, Berg T, Gane E, Ferenci P, Foster GR, Fried MW, Hezode C, Hirschfield GM, Jacobson I, Nikitin I, Pockros PJ, Poordad F, Scott J, Lenz O, Peeters M, Sekar V, De Smedt G, Sinha R, Beumont-Mauviel M. Simeprevir increases rate of sustained virologic response among treatment-experienced patients with HCV genotype-1 infection: a phase IIb trial. Gastroenterology. 2014 Feb;146(2):430-41.e6. doi: 10.1053/j.gastro.2013.10.058. Epub 2013 Nov 1.

evidence: open (via free pdf)

unpaywall_oa_status: bronze

title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including PegIFNa-2a and Ribavirin in HCV Genotype 1 Infected Subjects Who Failed Previous Standard Therapy

type: Other Identifier

type: EudraCT Number

source: euctr

design_allocation: Randomized

location_country:
Germany
Poland
Portugal
New Zealand
Israel
Norway
United Kingdom
Australia
Austria
Belgium
United States
Canada
Russian Federation
France


title: A Pilot Study to Assess the Antiviral Activity of GSK1349572 Containing Regimen in Antiretroviral Therapy (ART)-Experienced, HIV-1-infected Adult Subjects With Raltegravir Resistance

summary:
Integrase is an enzyme produced by HIV so that the virus can multiply in the human body. GSK1349572 is a new drug in the integrase inhibitor class that prevents the enzyme from working properly and therefore prevents the virus from multiplying.

GSK1349572 has shown to be effective against viruses in a short-term monotherapy study in adults with no previous exposure to integrase inhibitors. The purpose of this study is to determine whether GSK1349572 is effective in the treatment of HIV-infected patients who no longer respond to treatment with the approved integrase inhibitor raltegravir and carry viruses with resistance to this drug. The safety and efficacy of GSK1349572 50mg once daily in combination with the background HIV drugs previously administered (unless discontinuation of a particular drug is required) will be assessed over 10 days (functional monotherapy phase), followed by the evaluation of the safety and efficacy of GSK1349572 given with a new optimised background regimen from Day 11 through at least Week 24.

ReferenceType: background

ReferenceCitation: Eron JJ, Clotet B, Durant J, Katlama C, Kumar P, Lazzarin A, Poizot-Martin I, Richmond G, Soriano V, Ait-Khaled M, Fujiwara T, Huang J, Min S, Vavro C, Yeo J; VIKING Study Group. Safety and efficacy of dolutegravir in treatment-experienced subjects with raltegravir-resistant HIV type 1 infection: 24-week results of the VIKING Study. J Infect Dis. 2013 Mar 1;207(5):740-8. doi: 10.1093/infdis/jis750. Epub 2012 Dec 7.

lead_sponsor: ViiV Healthcare

sponsor_collaborators:
ViiV Healthcare
GlaxoSmithKline

location_country:
Italy
United States
Spain
Canada
France


lead_sponsor: Hoffmann-La Roche

summary: In this open-label multicenter trial, participants with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil, epirubicin, and cyclophosphamide) concurrent with either SC Herceptin or IV Herceptin. After surgery, participants will receive a further 10 cycles of SC or IV Herceptin as per randomization to complete 1 year of treatment. All cycles will be 21 days in length. After the end of study treatment, participants will be followed for safety and efficacy for up to 5 years or until disease recurrence, whichever is earlier.

ReferenceCitation: Jackisch C, Stroyakovskiy D, Pivot X, Ahn JS, Melichar B, Chen SC, Meyenberg C, Al-Sakaff N, Heinzmann D, Hegg R. Subcutaneous vs Intravenous Trastuzumab for Patients With ERBB2-Positive Early Breast Cancer: Final Analysis of the HannaH Phase 3 Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):e190339. doi: 10.1001/jamaoncol.2019.0339. Epub 2019 May 9.

oa_colors: green other

publisher_dissemination: American Medical Association

ReferenceCitation: Ismael G, Hegg R, Muehlbauer S, Heinzmann D, Lum B, Kim SB, Pienkowski T, Lichinitser M, Semiglazov V, Melichar B, Jackisch C. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol. 2012 Sep;13(9):869-78. doi: 10.1016/S1470-2045(12)70329-7. Epub 2012 Aug 9.

location_facility: Phramongkutklao Hospital;Dept Surgery/Surgical Oncology Unit

location_facility: Groote Schuur Hospital ( Uni of Capetown ); Oncology Dept

location_facility: Tartu University Hospital; Clinic of Hematology and Oncology

location_facility: Gachon Medical School Gil Medical Center; Medical Oncology

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Hospital Nacional Edgardo Rebagliati Martins; Oncologia

location_facility: Saratov Regional Clinical Hospital & Pathology Centre

location_facility: ASST DI CREMONA; Dip. Medicina - S.C. Oncologia

location_facility: Wojewodzki Szpital Zespolony; Oddział Onkologii

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Changhua Christian Hospital; Dept of Surgery

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF

location_facility: Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

location_facility: CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Hospital of Aladar Petz; Dept of Oncoradiology

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Hospital das Clinicas - UFPR; Quimioterapia

location_facility: Hospital Universitari Sant Joan de Reus; Servicio de Oncologia

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

location_facility: Istanbul Uni of Medicine Faculty; Oncology Dept

location_facility: Fondazione Salvatore Maugeri; Servizio Di Prevenzione Oncologica

location_facility: Sankt Elisabeth Krankenhaus; Gynaekology

location_facility: Krajska Nemocnice Pardubice Neurologicka Klinika

location_facility: Moscow city oncology hospital #62 of Moscow Healthcare Department

location_facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: Centro Oncológico Estatal; ISSSEMYM Oncología

location_facility: Johanniter GmbH; Johanniter-Krankenhaus; Internistische Onkologie

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Institut Daniel Hollard; Chimiotherapie Ambulatoire

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

location_facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

location_facility: Unidad de Investigacion Oncologia Clinica - Piura; Unidad de Oncología Clínica

location_facility: CAMPUS CHARITÉ MITTE; Tagesklinik für Onkologie u.Hämatologie

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Olsztyński Ośrodek Onkologiczny Kopernik sp. z o.o.

location_facility: FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF

location_facility: GUZ Vladimir Regional Clinical Oncological Dispensary

location_facility: Saint-Petersburg City Clinical Oncology Dispensary

location_facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

location_facility: Wits Donald Gordon Clinical Trial Centre; Medical Oncology

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Instituto de Oncologia de Sorocaba - CEPOS

location_facility: North Estonia Medical Centre Foundation; Oncology Centre

location_facility: Dokuz Eylul Uni Medical Faculty; Oncology Dept

location_facility: Lekarske Fakulty Univerzity Karlovy Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary

location_facility: State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Korea University Anam Hospital; Oncology Haemotology

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Prince of Songkla Uni ; Unit of Medical Oncology

location_facility: Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni

location_facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

title: A Phase III, Randomized Open-Label Study to Compare the Pharmacokinetics, Efficacy, and Safety of Subcutaneous (SC) Trastuzumab With Intravenous (IV) Trastuzumab Administered in Women With HER2-Positive Early Breast Cancer (EBC)

location_country:
Germany
Poland
Argentina
Brazil
Thailand
Turkey
Czechia
Canada
France
Colombia
Slovakia
Hungary
Hong Kong
Peru
Estonia
Italy
Guatemala
Sweden
Mexico
Korea, Republic of
Spain
Panama
South Africa
Taiwan
Russian Federation
Israel


acronym: EU/LA/AUS Pearl Index study – transdermal contraceptive patch

lead_sponsor: Bayer

summary: The aim of the present study is to prove efficacy and safety of a new contraceptive patch.

title: Multicenter, Open-label, Uncontrolled Study to Investigate the Efficacy and Safety of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene (Material no. 80876395) in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects

primary_purpose: Prevention

location_country: Germany Italy Argentina Australia Mexico Spain Chile France


title: A Multicenter, Randomized, Double Blind (Double Dummy), Active Controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Pioglitazone in Type 2 Diabetes Patients Inadequately Controlled on Therapy With Sulfonylurea or Metformin Plus Sulfonylurea

summary: This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. After an initial screening period, patients will be randomized to one of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target sample size is 500+ individuals.

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Costa Rica
Thailand
Canada
France
Slovakia
United States
Ukraine
Peru
Puerto Rico
United Kingdom
Mexico
Spain
South Africa
Russian Federation


title: Study PMA112509, a Phase I/II Study of Eltrombopag in Thrombocytopenic Subjects With Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia After MDS (sAML/MDS)

summary: This study will evaluate the safety and tolerability of eltrombopag in the treatment of low platelet counts in adult subjects with advanced myelodysplastic syndrome (MDS), secondary acute myeloid leukemia after MDS (sAML/MDS), or de novo AML that are relapsed, refractory or ineligible to receive azacitidine, decitabine, intensive chemotherapy or autologous/allogeneic stem cell transplantation. This is a placebo-controlled study in which patients will receive study medication daily for 6 months, during which time the dose of study medication may be adjusted based upon individual platelet counts and bone marrow blast counts. All subjects will receive best standard of care (platelet transfusions, mild chemotherapy, cytokines, valproic acid, all-trans retinoic acid, ESAs or G-CSF) in addition to study medication. Subjects taking placebo may be allowed to crossover to eltrombopag treatment if a clinically and statistically significant improvement in bone marrow blast counts is seen in subjects treated with eltrombopag.

ReferenceCitation: Mavroudi I, Pyrovolaki K, Pavlaki K, Kozana A, Psyllaki M, Kalpadakis C, Pontikoglou C, Papadaki HA. Effect of the nonpeptide thrombopoietin receptor agonist eltrombopag on megakaryopoiesis of patients with lower risk myelodysplastic syndrome. Leuk Res. 2011 Mar;35(3):323-8. doi: 10.1016/j.leukres.2010.06.029. Epub 2010 Aug 4.

ReferenceCitation: Platzbecker U, Wong RS, Verma A, Abboud C, Araujo S, Chiou TJ, Feigert J, Yeh SP, Gotze K, Gorin NC, Greenberg P, Kambhampati S, Kim YJ, Lee JH, Lyons R, Ruggeri M, Santini V, Cheng G, Jang JH, Chen CY, Johnson B, Bennett J, Mannino F, Kamel YM, Stone N, Dougherty S, Chan G, Giagounidis A. Safety and tolerability of eltrombopag versus placebo for treatment of thrombocytopenia in patients with advanced myelodysplastic syndromes or acute myeloid leukaemia: a multicentre, randomised, placebo-controlled, double-blind, phase 1/2 trial. Lancet Haematol. 2015 Oct;2(10):e417-26. doi: 10.1016/S2352-3026(15)00149-0. Epub 2015 Oct 1.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
United Kingdom
Hong Kong
Denmark
Brazil
United States
Korea, Republic of
Taiwan
Puerto Rico
France


acronym: PILLAR

summary: The purpose of this study is to evaluate the efficacy of 4 different regimens of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the proportion of patients with sustained virologic response at Week 72 (patients with undetectable plasma HCV RNA [less than 25 IU per mL undetectable] at the end of treatment and at Week 72), compared to the control group receiving PegIFN and RBV in combination with TMC435-matched placebo.

repositories_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

repositories_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

ReferenceCitation: Fried MW, Buti M, Dore GJ, Flisiak R, Ferenci P, Jacobson I, Marcellin P, Manns M, Nikitin I, Poordad F, Sherman M, Zeuzem S, Scott J, Gilles L, Lenz O, Peeters M, Sekar V, De Smedt G, Beumont-Mauviel M. Once-daily simeprevir (TMC435) with pegylated interferon and ribavirin in treatment-naive genotype 1 hepatitis C: the randomized PILLAR study. Hepatology. 2013 Dec;58(6):1918-29. doi: 10.1002/hep.26641. Epub 2013 Oct 11.

oa_host_type: repository

repositories_concat: 4t64gv67x;PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin In Treatment-Naive Genotype 1 Hepatitis C-Infected Subjects

location_country:
Germany
Poland
New Zealand
Norway
Denmark
Australia
Austria
Belgium
United States
Spain
Canada
Russian Federation
France


lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this Phase III study was to confirm the value of adding everolimus to weekly paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.

ReferenceCitation: Toi M, Shao Z, Hurvitz S, Tseng LM, Zhang Q, Shen K, Liu D, Feng J, Xu B, Wang X, Lee KS, Ng TY, Ridolfi A, Noel-Baron F, Ringeisen F, Jiang Z. Efficacy and safety of everolimus in combination with trastuzumab and paclitaxel in Asian patients with HER2+ advanced breast cancer in BOLERO-1. Breast Cancer Res. 2017 Apr 11;19(1):47. doi: 10.1186/s13058-017-0839-0.

repository_institution: Kyoto University - Kyoto University Research Information Repository

repository_institution: University of California - eScholarship University of California

publisher_dissemination: Springer-Nature

ReferenceCitation: Buyse M, Hurvitz SA, Andre F, Jiang Z, Burris HA, Toi M, Eiermann W, Lindsay MA, Slamon D. Statistical controversies in clinical research: statistical significance-too much of a good thing .... Ann Oncol. 2016 May;27(5):760-2. doi: 10.1093/annonc/mdw047. Epub 2016 Feb 9.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Hurvitz SA, Andre F, Jiang Z, Shao Z, Mano MS, Neciosup SP, Tseng LM, Zhang Q, Shen K, Liu D, Dreosti LM, Burris HA, Toi M, Buyse ME, Cabaribere D, Lindsay MA, Rao S, Pacaud LB, Taran T, Slamon D. Combination of everolimus with trastuzumab plus paclitaxel as first-line treatment for patients with HER2-positive advanced breast cancer (BOLERO-1): a phase 3, randomised, double-blind, multicentre trial. Lancet Oncol. 2015 Jul;16(7):816-29. doi: 10.1016/S1470-2045(15)00051-0. Epub 2015 Jun 16.

repository_institution: University of Pretoria - UpSpace Institutional Repository

version: submittedVersion

location_facility: Cancer Care Associates Medical Group Dept. of CCA

location_facility: Central Indiana Cancer Centers CICC - East (3)

location_facility: Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(5)

location_facility: University of California at Los Angeles Dept. of UCLA

location_facility: University of Nebraska Medical Center Unv Nebraska Med Ctr (2)

location_facility: University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.

location_facility: Beth Israel Medical Center Dept.ofBeth Israel Med. Ctr(2)

location_facility: Santa Barbara Hematolgy Oncology Medical Group Dept.ofSantaBarbaraHem/Onc

location_facility: Northwest Cancer Specialists Vancouver Cancer Center (3)

location_facility: Comprehensive Blood and Cancer Center Dept. of CBCC (2)

location_facility: St. Jude Heritage Medical Group Virginia Crosson Cancer Center

location_facility: Central Coast Medical Oncology Corporation Onc Dept

location_facility: Rocky Mountain Cancer Centers RMCC - Denver-Midtown (3)

location_facility: Florida Cancer Specialists Dept.of FloridaCancerSpec. (2)

location_facility: Tyler Cancer Center Dept.ofTylerCancerCtr. (2)

location_facility: Texas Oncology Charles A. Sammons Cancer Ctr

location_facility: New York Oncology Hematology NYOH Amsterdam

title: A Randomized Phase III, Double-Blind, Placebo-Controlled Multicenter Trial of Everolimus in Combination With Trastuzumab and Paclitaxel, as First Line Therapy in Women With HER2 Positive Locally Advanced or Metastatic Breast Cancer

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Germany
Ireland
Argentina
Australia
Brazil
Japan
Turkey
Canada
France
Colombia
Hong Kong
Switzerland
United States
Lebanon
Belgium
China
Peru
Puerto Rico
Egypt
Italy
United Kingdom
Venezuela
Mexico
Korea, Republic of
Greece
South Africa
Taiwan
Russian Federation

ipd_sharing: Undecided


title: An Open-label Randomized Phase II Trial of Belinostat (PXD101) in Combination With Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Previously Untreated Carcinoma of Unknown Primary

summary: The purpose of this study is to assess efficacy and safety of belinostat in combination with carboplatin and paclitaxel in patients with previously untreated carcinoma of unknown primary.

lead_sponsor: Valerio Therapeutics

sponsor_collaborators:
Valerio Therapeutics
Spectrum Pharmaceuticals, Inc

location_country:
United States
Denmark
Germany
France

location_facility: Centre Henri Becquerel, Oncologie Médicale

location_facility: Chattanooga Oncology & Hematology Associates, PC

location_facility: Carl-Gustav-Carus Medicinische Klinik und Poliklinik I

location_facility: Tennessee Oncology Sarah Cannon Research

location_facility: CRLCC Francois Baclesse, Oncologie medicale


summary: Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934) will be asked to participate in this long term extension study with BAY63-2521.

ReferenceCitation: Benza RL, Boucly A, Farber HW, Frost AE, Ghofrani HA, Hoeper MM, Lambelet M, Rahner C, Bansilal S, Nikkho S, Meier C, Sitbon O. Change in REVEAL Lite 2 risk score predicts outcomes in patients with pulmonary arterial hypertension in the PATENT study. J Heart Lung Transplant. 2022 Mar;41(3):411-420. doi: 10.1016/j.healun.2021.10.013. Epub 2021 Oct 28.

ReferenceCitation: Benza RL, Farber HW, Frost AE, Ghofrani HA, Corris PA, Lambelet M, Nikkho S, Meier C, Hoeper MM. Application of the REVEAL risk score calculator 2.0 in the CHEST study. Respir Med. 2022 Apr-May;195:106783. doi: 10.1016/j.rmed.2022.106783. Epub 2022 Mar 1.

ReferenceCitation: Ghofrani HA, Grimminger F, Grunig E, Huang Y, Jansa P, Jing ZC, Kilpatrick D, Langleben D, Rosenkranz S, Menezes F, Fritsch A, Nikkho S, Humbert M. Predictors of long-term outcomes in patients treated with riociguat for pulmonary arterial hypertension: data from the PATENT-2 open-label, randomised, long-term extension trial. Lancet Respir Med. 2016 May;4(5):361-71. doi: 10.1016/S2213-2600(16)30019-4. Epub 2016 Apr 8.

ReferenceCitation: Ghofrani HA, Humbert M, Langleben D, Schermuly R, Stasch JP, Wilkins MR, Klinger JR. Riociguat: Mode of Action and Clinical Development in Pulmonary Hypertension. Chest. 2017 Feb;151(2):468-480. doi: 10.1016/j.chest.2016.05.024. Epub 2016 Jun 2.

repository_institution: Imperial College London - Spiral

ReferenceCitation: Benza RL, Ghofrani HA, Grunig E, Hoeper MM, Jansa P, Jing ZC, Kim NH, Langleben D, Simonneau G, Wang C, Busse D, Meier C, Ghio S. Effect of riociguat on right ventricular function in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. J Heart Lung Transplant. 2021 Oct;40(10):1172-1180. doi: 10.1016/j.healun.2021.06.020. Epub 2021 Jul 10.

ReferenceCitation: Humbert M, Coghlan JG, Ghofrani HA, Grimminger F, He JG, Riemekasten G, Vizza CD, Boeckenhoff A, Meier C, de Oliveira Pena J, Denton CP. Riociguat for the treatment of pulmonary arterial hypertension associated with connective tissue disease: results from PATENT-1 and PATENT-2. Ann Rheum Dis. 2017 Feb;76(2):422-426. doi: 10.1136/annrheumdis-2015-209087. Epub 2016 Jul 25.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

ReferenceCitation: Saleh S, Becker C, Frey R, Muck W. Population pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of riociguat in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulm Circ. 2016 Mar;6(Suppl 1):S86-96. doi: 10.1086/685404.

ReferenceCitation: Rosenkranz S, Ghofrani HA, Beghetti M, Ivy D, Frey R, Fritsch A, Weimann G, Saleh S, Apitz C. Riociguat for pulmonary arterial hypertension associated with congenital heart disease. Heart. 2015 Nov;101(22):1792-9. doi: 10.1136/heartjnl-2015-307832. Epub 2015 Jul 1.

ReferenceCitation: Rubin LJ, Galie N, Grimminger F, Grunig E, Humbert M, Jing ZC, Keogh A, Langleben D, Fritsch A, Menezes F, Davie N, Ghofrani HA. Riociguat for the treatment of pulmonary arterial hypertension: a long-term extension study (PATENT-2). Eur Respir J. 2015 May;45(5):1303-13. doi: 10.1183/09031936.00090614. Epub 2015 Jan 22.

ReferenceCitation: Ghofrani HA, Galie N, Grimminger F, Grunig E, Humbert M, Jing ZC, Keogh AM, Langleben D, Kilama MO, Fritsch A, Neuser D, Rubin LJ; PATENT-1 Study Group. Riociguat for the treatment of pulmonary arterial hypertension. N Engl J Med. 2013 Jul 25;369(4):330-40. doi: 10.1056/NEJMoa1209655.

location_facility: Centro Hospitalar de Lisboa Norte - Hospital Santa Maria

location_facility: Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

title: Long-term Extension, Multicentre, Multi-national Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg,1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH)

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Czechia
Canada
France
Portugal
Denmark
Switzerland
United States
Belgium
China
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Greece
Taiwan
Russian Federation
Sweden


title: An Open-Label, Multi-Center Controlled Clinical Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Resistant Atypical Hemolytic Uremic Syndrome (aHUS)

acronym: aHUS

summary: The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adolescent patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS).

ReferenceCitation: Pugh D, O'Sullivan ED, Duthie FA, Masson P, Kavanagh D. Interventions for atypical haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2021 Mar 23;3(3):CD012862. doi: 10.1002/14651858.CD012862.pub2.

ReferenceCitation: Legendre CM, Licht C, Muus P, Greenbaum LA, Babu S, Bedrosian C, Bingham C, Cohen DJ, Delmas Y, Douglas K, Eitner F, Feldkamp T, Fouque D, Furman RR, Gaber O, Herthelius M, Hourmant M, Karpman D, Lebranchu Y, Mariat C, Menne J, Moulin B, Nurnberger J, Ogawa M, Remuzzi G, Richard T, Sberro-Soussan R, Severino B, Sheerin NS, Trivelli A, Zimmerhackl LB, Goodship T, Loirat C. Terminal complement inhibitor eculizumab in atypical hemolytic-uremic syndrome. N Engl J Med. 2013 Jun 6;368(23):2169-81. doi: 10.1056/NEJMoa1208981.

evidence: open (via free article)

repository_institution: Lund University - Lund University Publications

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: Alexion Pharmaceuticals, Inc.

location_country:
Germany
United Kingdom
Austria
United States
France


summary: The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adult patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS).

repositories_institution: Lund University - Lund University Publications

title: An Open-Label, Multi-Center Controlled Clinical Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant Atypical Hemolytic Uremic Syndrome (aHUS)


title: A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose Study to Evaluate the Efficacy and Safety of Intravenous GSK679586 in Patients With Severe Asthma

summary: Treatment, Randomised, Double Blind, Parallel Assignment, Safety/efficacy Study

ReferenceCitation: Anderson WH, Koshy BT, Huang L, Mosteller M, Stinnett SW, Condreay LD, Ortega H. Genetic analysis of asthma exacerbations. Ann Allergy Asthma Immunol. 2013 Jun;110(6):416-422.e2. doi: 10.1016/j.anai.2013.04.002.

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.

location_country:
Germany
Poland
Norway
United Kingdom
Netherlands
United States
South Africa
France


title: An International, Observational Study to Define Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia

summary: A post marketing, international, multicenter, observational, prospective, longitudinal study. The purpose of the study is to describe cervical dystonia sub-types with their injection protocols and response to BoNT-A.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Trosch RM, Misra VP, Maisonobe P, Om S. Impact of abobotulinumtoxinA on the clinical features of cervical dystonia in routine practice. Clin Park Relat Disord. 2020 Jun 15;3:100063. doi: 10.1016/j.prdoa.2020.100063. eCollection 2020.

repositories_concat: PubMed Central;spiral.imperial.ac.uk

ReferenceCitation: Misra VP, Ehler E, Zakine B, Maisonobe P, Simonetta-Moreau M; INTEREST IN CD group. Factors influencing response to Botulinum toxin type A in patients with idiopathic cervical dystonia: results from an international observational study. BMJ Open. 2012 Jun 14;2(3):e000881. doi: 10.1136/bmjopen-2012-000881. Print 2012. Erratum In: BMJ Open. 2013 May 31;3(5):null.

lead_sponsor: Ipsen

location_country:
Germany
Portugal
United Kingdom
Australia
Netherlands
Belgium
Czechia
Russian Federation
France

location_facility: Centre Hospitalier de Liège, Domaine Universitaire Sart Tilmen

location_facility: Hospital General San Antonio - Centro Hospitalar do Porto

location_facility: National Hospital for Neurology & Neurosurgery

location_facility: Hôpital Neurologique et Neurochirurgical Pierre Wertheimer

location_facility: Praxis für Neurologie, International Neuroscience Institute

location_facility: Walton Centre for Neurology & Neurosurgery, Hope Hospital

location_facility: Serviço de Neurologia - Hospital de São João


title: An Open-Label Study of AMG 386 in Combination With Either Paclitaxel and Trastuzumab or Capecitabine and Lapatinib in Subjects With HER2-positive Locally Recurrent or Metastatic Breast Cancer

summary:
The purpose of this study is to determine if AMG 386 in combination with either paclitaxel and trastuzumab or capecitabine and lapatinib is safe and well tolerated in subjects with HER2-positive locally recurrent or metastatic breast cancer.

This is an open-label phase 1b trial and has 2 study parts. Study part 1 is a dose escalation study to determine a tolerable dose of AMG 386 in combination with paclitaxel and trastuzumab (cohort A) or with capecitabine and lapatinib (cohort B). Study part 2 is cohort expansion of the tolerable doses determined in part 1.

ReferenceCitation: Kaufman PA, Wildiers H, Freyer G, Kemeny M, Goncalves A, Jerusalem G, Stopeck A, Vrindavanam N, Dalenc F, Nanayakkara N, Wu B, Pickett CA. Phase 1b Study of Trebananib Plus Paclitaxel and Trastuzumab in Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer. Clin Breast Cancer. 2019 Feb;19(1):47-57. doi: 10.1016/j.clbc.2018.09.012. Epub 2018 Oct 9.

lead_sponsor: Amgen

location_country:
United States
Belgium
France


title: An Open Phase I/IIa Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Intravenous BI 6727 as Monotherapy or in Combination With Subcutaneous Cytarabine in Patients With Acute Myeloid Leukaemia

summary: The trial will be performed in two parts, a phase I part and a phase IIa part. In the phase I part of the trial, BI 6727 will be investigated as monotherapy and in combination with low dose cytarabine (LD-Ara-C) in patients with relapsed/refractory AML that are not eligible for intensive treatment. The dose of BI 6727 will be escalated to determine the maximum tolerated dose (MTD) of BI 6727 monotherapy and BI 6727 in combination with LD-Ara-C in AML patients. In the phase IIa part, the combination of BI 6727 at MTD with LD-Ara-C and LD-Ara-C monotherapy will be investigated to explore the efficacy of the combination schedule in comparison to LD-Ara-C monotherapy in previously untreated AML patients that are not eligible for intensive treatment.

ReferenceCitation: Dohner H, Lubbert M, Fiedler W, Fouillard L, Haaland A, Brandwein JM, Lepretre S, Reman O, Turlure P, Ottmann OG, Muller-Tidow C, Kramer A, Raffoux E, Dohner K, Schlenk RF, Voss F, Taube T, Fritsch H, Maertens J. Randomized, phase 2 trial of low-dose cytarabine with or without volasertib in AML patients not suitable for induction therapy. Blood. 2014 Aug 28;124(9):1426-33. doi: 10.1182/blood-2014-03-560557. Epub 2014 Jul 8.

publisher_dissemination: American Society of Hematology

lead_sponsor: Boehringer Ingelheim

location_country: Germany Italy Norway Austria Belgium Canada France

location_facility: Oslo Universitetssykehus HF, Ullevål sykehus

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: HOP, Centre Hospitalier René Dubos, Hémato, Paris

location_facility: Azienda Ospedaliera Policlinico di Modena

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Montreal General Hospital - McGill University Health Centre


title: A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) in Combination With Lumiliximab Versus FCR Alone in Subjects With Previously Untreated Chronic Lymphocytic Leukemia

summary: This is a Phase 2, randomized, open-label, multicenter study in subjects with previously untreated CLL. It is designed to evaluate safety and efficacy of fludarabine, cyclophosphamide, rituximab (FCR) and lumiliximab versus FCR alone.

status: Terminated

lead_sponsor: Biogen

location_country:
Poland
United Kingdom
Australia
Austria
Belgium
United States
Canada
France

location_facility: Vanderbilt University Medical Center-IPF Program

location_facility: University of Florida/Pulmonary, Critical Care & Sleep Medicine

location_facility: University of Miami Miller School of Medicine

status_simplified: Unknown


summary: This trial is conducted in Asia, Europe and North America. This trial aims for comparison of the effect on the glycemic control in subjects with type 2 diabetes of basal insulin analogue with one oral anti-diabetic drug (OAD) versus oral anti-diabetic drug alone.

ReferenceCitation: Hollander P, Raslova K, Skjoth TV, Rastam J, Liutkus JF. Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial. Diabetes Obes Metab. 2011 Mar;13(3):268-75. doi: 10.1111/j.1463-1326.2010.01351.x.

title: Effect of Detemir and Sitagliptin on Blood Glucose Control in Subjects With Type 2 Diabetes Mellitus

location_country:
Finland
Slovakia
Hungary
United States
Korea, Republic of
Turkey
Canada
France


title: A 28 Week Extension to a 24 Week Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of Vildagliptin (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

summary: This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency

lead_sponsor: Novartis

location_country:
Finland
Germany
India
Norway
Argentina
Australia
Costa Rica
Sweden
Spain
Canada
Russian Federation
France

location_facility: Kardiol. Gemeinschaftspraxis PD Dr. Winkelmann

location_facility: Site Management Organisation of Clinical Trials Centers

location_facility: Hospital Clinico Universitario Santiago de Compostela

location_facility: Meenakshi Mission Hospital & Research Centre

location_facility: Health Sciences Centre - Diabetes Research Group

location_facility: Saint- Petersburg State Mtchnikov's Medical Academy

location_facility: MSU of Medicine and Dentistry on the base of CityHospital 23

location_facility: Instituto de Investigaciones Clinicas de Mar del Plata

location_facility: St. Olavs Hospital, Endokrinologisk seksjon

location_facility: Univ.-Klinikum München, Campus Innenstadt

location_facility: S.R. Kalla Memorial Gastro & General Hospital

location_facility: Forschungszentrum Ruhr, KliFoCenter GmbH

location_facility: Hospital General de Jerez de La Frontera

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Saint-Petersburg State Pavlov's Medical University

location_facility: M V Hospital for Diabetes and Diabetic Research Center

location_facility: MSUMD on the base of City Clinical Hospital #67

location_facility: City polyclinic # 17, City Diabetic Centre #3

location_facility: Ciutat Sanitaria I Universitaria de Bellvitge

location_facility: Tampereen lääkärikeskus Oy, Koskiklinikka


acronym: TOWER

lead_sponsor: Sanofi

summary:
The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS.

Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression.

Other secondary objectives were:

To assess the effect of the two doses of teriflunomide in comparison to placebo on:

Fatigue;
Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being.
To evaluate the safety and tolerability of teriflunomide.

ReferenceCitation: Confavreux C, O'Connor P, Comi G, Freedman MS, Miller AE, Olsson TP, Wolinsky JS, Bagulho T, Delhay JL, Dukovic D, Truffinet P, Kappos L; TOWER Trial Group. Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014 Mar;13(3):247-56. doi: 10.1016/S1474-4422(13)70308-9. Epub 2014 Jan 23.

ReferenceCitation: Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.

repository_institution: University of Ottawa - uO Research

repositories_concat: PubMed Central;ruor.uottawa.ca

ReferenceCitation: Miller AE, Olsson TP, Wolinsky JS, Comi G, Kappos L, Hu X, Xu X, Lublin AL, Truffinet P, Chavin J, Delhay JL, Benamor M, Purvis A, Freedman MS; TOWER investigators. Long-term safety and efficacy of teriflunomide in patients with relapsing multiple sclerosis: Results from the TOWER extension study. Mult Scler Relat Disord. 2020 Nov;46:102438. doi: 10.1016/j.msard.2020.102438. Epub 2020 Aug 1.

ReferenceCitation: Qiu W, Huang DH, Hou SF, Zhang MN, Jin T, Dong HQ, Peng H, Zhang CD, Zhao G, Huang YN, Zhou D, Wu WP, Wang BJ, Li JM, Zhang XH, Cheng Y, Li HF, Li L, Lu CZ, Zhang X, Bu BT, Dong WL, Fan DS, Hu XQ, Xu XH; TOWER Trial Chinese Group. Efficacy and Safety of Teriflunomide in Chinese Patients with Relapsing Forms of Multiple Sclerosis: A Subgroup Analysis of the Phase 3 TOWER Study. Chin Med J (Engl). 2018 Dec 5;131(23):2776-2784. doi: 10.4103/0366-6999.246067.

ReferenceCitation: Freedman MS, Morawski J, Thangavelu K. Clinical efficacy of teriflunomide over a fixed 2-year duration in the TOWER study. Mult Scler J Exp Transl Clin. 2018 May 16;4(2):2055217318775236. doi: 10.1177/2055217318775236. eCollection 2018 Apr-Jun.

publisher_dissemination: SAGE Publications

ReferenceCitation: Freedman MS, Wolinsky JS, Comi G, Kappos L, Olsson TP, Miller AE, Thangavelu K, Benamor M, Truffinet P, O'Connor PW; TEMSO and TOWER Study Groups. The efficacy of teriflunomide in patients who received prior disease-modifying treatments: Subgroup analyses of the teriflunomide phase 3 TEMSO and TOWER studies. Mult Scler. 2018 Apr;24(4):535-539. doi: 10.1177/1352458517695468. Epub 2017 Mar 17.

location_facility: Sanofi-Aventis Investigational Site Number 056004

location_facility: Sanofi-Aventis Investigational Site Number 250005

location_facility: Sanofi-Aventis Investigational Site Number 804116

location_facility: Sanofi-Aventis Investigational Site Number 203001

location_facility: Sanofi-Aventis Investigational Site Number 840011

location_facility: Sanofi-Aventis Investigational Site Number 840078

location_facility: Sanofi-Aventis Investigational Site Number 608001

location_facility: Sanofi-Aventis Investigational Site Number 792002

location_facility: Sanofi-Aventis Investigational Site Number 788004

location_facility: Sanofi-Aventis Investigational Site Number 840083

location_facility: Sanofi-Aventis Investigational Site Number 840033

location_facility: Sanofi-Aventis Investigational Site Number 840013

location_facility: Sanofi-Aventis Investigational Site Number 840086

location_facility: Sanofi-Aventis Investigational Site Number 703003

location_facility: Sanofi-Aventis Investigational Site Number 642001

location_facility: Sanofi-Aventis Investigational Site Number 840015

location_facility: Sanofi-Aventis Investigational Site Number 608003

location_facility: Sanofi-Aventis Investigational Site Number 112104

location_facility: Sanofi-Aventis Investigational Site Number 250008

location_facility: Sanofi-Aventis Investigational Site Number 156022

location_facility: Sanofi-Aventis Investigational Site Number 250002

location_facility: Sanofi-Aventis Investigational Site Number 792005

location_facility: Sanofi-Aventis Investigational Site Number 840063

location_facility: Sanofi-Aventis Investigational Site Number 276010

location_facility: Sanofi-Aventis Investigational Site Number 792009

location_facility: Sanofi-Aventis Investigational Site Number 156011

location_facility: Sanofi-Aventis Investigational Site Number 156005

location_facility: Sanofi-Aventis Investigational Site Number 056002

location_facility: Sanofi-Aventis Investigational Site Number 616001

location_facility: Sanofi-Aventis Investigational Site Number 703006

location_facility: Sanofi-Aventis Investigational Site Number 840079

location_facility: Sanofi-Aventis Investigational Site Number 804102

location_facility: Sanofi-Aventis Investigational Site Number 840084

location_facility: Sanofi-Aventis Investigational Site Number 156021

location_facility: Sanofi-Aventis Investigational Site Number 804109

location_facility: Sanofi-Aventis Investigational Site Number 233002

location_facility: Sanofi-Aventis Investigational Site Number 276001

location_facility: Sanofi-Aventis Investigational Site Number 152002

location_facility: Sanofi-Aventis Investigational Site Number 804107

location_facility: Sanofi-Aventis Investigational Site Number 724001

location_facility: Sanofi-Aventis Investigational Site Number 840061

location_facility: Sanofi-Aventis Investigational Site Number 764001

location_facility: Sanofi-Aventis Investigational Site Number 203002

location_facility: Sanofi-Aventis Investigational Site Number 156018

location_facility: Sanofi-Aventis Investigational Site Number 840041

location_facility: Sanofi-Aventis Investigational Site Number 608004

location_facility: Sanofi-Aventis Investigational Site Number 156019

location_facility: Sanofi-Aventis Investigational Site Number 156012

location_facility: Sanofi-Aventis Investigational Site Number 788002

location_facility: Sanofi-Aventis Investigational Site Number 840029

location_facility: Sanofi-Aventis Investigational Site Number 840020

location_facility: Sanofi-Aventis Investigational Site Number 250001

location_facility: Sanofi-Aventis Investigational Site Number 840008

location_facility: Sanofi-Aventis Investigational Site Number 112102

location_facility: Sanofi-Aventis Investigational Site Number 156004

location_facility: Sanofi-Aventis Investigational Site Number 036002

location_facility: Sanofi-Aventis Investigational Site Number 124004

location_facility: Sanofi-Aventis Investigational Site Number 276009

location_facility: Sanofi-Aventis Investigational Site Number 528002

location_facility: Sanofi-Aventis Investigational Site Number 840006

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location_facility: Sanofi-Aventis Investigational Site Number 616003

location_facility: Sanofi-Aventis Investigational Site Number 840076

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location_facility: Sanofi-Aventis Investigational Site Number 156003

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location_facility: Sanofi-Aventis Investigational Site Number 484003

location_facility: Sanofi-Aventis Investigational Site Number 124003

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location_facility: Sanofi-Aventis Investigational Site Number 792003

location_facility: Sanofi-Aventis Investigational Site Number 642005

location_facility: Sanofi-Aventis Investigational Site Number 528001

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location_facility: Sanofi-Aventis Investigational Site Number 156001

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location_facility: Sanofi-Aventis Investigational Site Number 792001

location_facility: Sanofi-Aventis Investigational Site Number 826005

location_facility: Sanofi-Aventis Investigational Site Number 840034

title: A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis

location_country:
Germany
Poland
Australia
Thailand
Turkey
Chile
Canada
France
Czech Republic
Belarus
Slovakia
United States
Ukraine
Romania
Tunisia
Belgium
China
Estonia
Philippines
United Kingdom
Netherlands
Austria
Mexico
Spain
Greece
Sweden


acronym: READY

summary: The purpose of this study is to determine whether survival can be prolonged in patients with castration-resistant prostate cancer who receive dasatinib with docetaxel and prednisone.

ReferenceCitation: de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

ReferenceCitation: Araujo JC, Trudel GC, Saad F, Armstrong AJ, Yu EY, Bellmunt J, Wilding G, McCaffrey J, Serrano SV, Matveev VB, Efstathiou E, Oudard S, Morris MJ, Sizer B, Goebell PJ, Heidenreich A, de Bono JS, Begbie S, Hong JH, Richardet E, Gallardo E, Paliwal P, Durham S, Cheng S, Logothetis CJ. Docetaxel and dasatinib or placebo in men with metastatic castration-resistant prostate cancer (READY): a randomised, double-blind phase 3 trial. Lancet Oncol. 2013 Dec;14(13):1307-16. doi: 10.1016/S1470-2045(13)70479-0. Epub 2013 Nov 8.

location_facility: Desert Hematology Oncology Medical Group

location_facility: Associates In Hematology & Oncology, P.C.

location_facility: The University Of Texas Md Anderson Cancer Center

location_facility: Piedmont Hematology Oncology Associates, Pllc

location_facility: Fort Wayne Medical Oncology And Hematology Inc

location_facility: Compassionate Cancer Care Medical Group, Inc.

location_facility: North Mississippi Hematology And Oncology Associates, Ltd

location_facility: University Of South Alabama / Mitchell Cancer Institute

location_facility: Compassionate Cancer Care Medical Group Inc

title: A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Canada
France
Czech Republic
Hungary
United States
India
Romania
Peru
Italy
Norway
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
South Africa
Russian Federation
Sweden


acronym: ADVANTAGE

lead_sponsor: Merck KGaA, Darmstadt, Germany

summary:
The purpose of this open-label, randomized, controlled, Phase 1/2 study of the integrin inhibitor cilengitide is to evaluate the safety and efficacy of the combination of different regimens of cilengitide added to cisplatin, 5-fluorouracil (5-FU), and cetuximab in participants with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN).

The Phase 1 part was conducted in dedicated study centers. In the Phase 2 part of this trial, cilengitide is administered at two different doses to two experimental groups. The third group will only receive cisplatin, 5-FU and cetuximab. In the Phase 1 part of this trial, the dose of cilengitide in combination with cisplatin, 5-FU and cetuximab was determined.

Cilengitide is an experimental anti-cancer substance interacting with so-called integrins. Integrins are protein molecules that are known to be present on the surface of certain cancer cells. Integrins are also found on certain cells that belong to growing blood vessels (endothelial cells). Integrins potentially facilitate the blood vessels' support of the tumor (angiogenesis) as well as the tumor's growth and further spread throughout the body (metastasis). By inhibiting integrins on the tumor cell surface, cilengitide potentially kills cancer cells, and potentially sensitizes cancer cells to other co-administered therapeutics. By inhibiting integrins on the endothelial cell surface, it potentially inhibits the ingrowth of additional blood vessels towards the tumor.

Cilengitide is given as an intravenous infusion (given by a drip in one vein of your arm). If any unacceptable side effect occurs, treatment with the study drug will be stopped.

ReferenceCitation: Vermorken JB, Peyrade F, Krauss J, Mesia R, Remenar E, Gauler TC, Keilholz U, Delord JP, Schafhausen P, Erfan J, Brummendorf TH, Iglesias L, Bethe U, Hicking C, Clement PM. Cisplatin, 5-fluorouracil, and cetuximab (PFE) with or without cilengitide in recurrent/metastatic squamous cell carcinoma of the head and neck: results of the randomized phase I/II ADVANTAGE trial (phase II part). Ann Oncol. 2014 Mar;25(3):682-688. doi: 10.1093/annonc/mdu003.

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

title: Open-label, Randomized, Controlled Phase I/II Study of Cilengitide to Evaluate the Safety and Efficacy of the Combination of Different Regimens of Cilengitide Added to Cisplatin, 5-FU, and Cetuximab in Subjects With Recurrent/Metastatic Squamous Cell Cancer of the Head and Neck

location_country: Germany Italy Poland Hungary Switzerland Austria Belgium Spain France


lead_sponsor: Eisai Inc.

summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.

ReferenceCitation: Maguire M. Response to "Perampanel and pregnancy: Could experience be a gloomy lantern that does not even illuminate its bearer?". Epilepsy Behav. 2022 Apr;129:108654. doi: 10.1016/j.yebeh.2022.108654. Epub 2022 Mar 16. No abstract available.

ReferenceCitation: French JA, Gil-Nagel A, Malerba S, Kramer L, Kumar D, Bagiella E. Time to prerandomization monthly seizure count in perampanel trials: A novel epilepsy endpoint. Neurology. 2015 May 19;84(20):2014-20. doi: 10.1212/WNL.0000000000001585. Epub 2015 Apr 15.

ReferenceCitation: Rosenfeld W, Conry J, Lagae L, Rozentals G, Yang H, Fain R, Williams B, Kumar D, Zhu J, Laurenza A. Efficacy and safety of perampanel in adolescent patients with drug-resistant partial seizures in three double-blind, placebo-controlled, phase III randomized clinical studies and a combined extension study. Eur J Paediatr Neurol. 2015 Jul;19(4):435-45. doi: 10.1016/j.ejpn.2015.02.008. Epub 2015 Mar 5.

ReferenceCitation: Steinhoff BJ, Ben-Menachem E, Ryvlin P, Shorvon S, Kramer L, Satlin A, Squillacote D, Yang H, Zhu J, Laurenza A. Efficacy and safety of adjunctive perampanel for the treatment of refractory partial seizures: a pooled analysis of three phase III studies. Epilepsia. 2013 Aug;54(8):1481-9. doi: 10.1111/epi.12212. Epub 2013 May 10.

ReferenceCitation: French JA, Krauss GL, Steinhoff BJ, Squillacote D, Yang H, Kumar D, Laurenza A. Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: results of randomized global phase III study 305. Epilepsia. 2013 Jan;54(1):117-25. doi: 10.1111/j.1528-1167.2012.03638.x. Epub 2012 Aug 20.

location_facility: Neurology Associates of Northern Colorado

location_facility: North Alabama Neuroscience Research Associates

location_facility: Neurological Research Center at Hattiesburg Clinic

location_facility: Saint Luke's Comprehensive Epilepsy Center

location_facility: The Comprehensive Care Center for Children And Adults

location_facility: Dean Foundation for Health, Research and Education, Inc.

title: A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

location_country:
Finland
Germany
Italy
India
Israel
United Kingdom
Sweden
Netherlands
Austria
Belgium
United States
South Africa
Russian Federation
France


summary: The purpose of this randomized, multicenter, Phase III study was to compare the efficacy of paseriotide LAR and octreotide LAR in patients whose disease-related symptoms are inadequately controlled by currently available somatostatin analogues.

location_facility: University of Arizona / Arizona Cancer Center

location_facility: Cedars Sinai Medical Center Cedars Sinai 4

location_facility: Loma Linda University Dept. of Loma Linda CancerCent

location_facility: Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service

location_facility: Duke University Medical Center Dept. of Duke Cancer Center(2)

location_facility: H. Lee Moffitt Cancer Center/University of South Florida Dept of H. Lee Moffit

location_facility: Mount Sinai School of Medicine Study Coordinator

location_facility: St. Luke's Hospital and Health Network St. Luke's Cancer Network

location_facility: MD Anderson Cancer Center/University of Texas Dept. of MD Anderson (9)

title: A Multicenter, Randomized, Blinded Efficacy and Safety Study of Pasireotide LAR vs Octreotide LAR in Patients With Metastatic Carcinoid Tumors Whose Disease-related Symptoms Are Inadequately Controlled by Somatostatin Analogues.

location_country:
Germany
Italy
Poland
Israel
Argentina
Norway
Singapore
Brazil
Sweden
Austria
Belgium
United Kingdom
United States
Spain
Canada
France


title: A Randomized, Double Blind, Placebo Controlled, Flexible Dose, Multicentre Study of Levitra in a Broad Population of Men With Erectile Dysfunction and Previously Untreated With PDE5 Inhibitors.

acronym: FINDER

summary: The objective of this study was to evaluate the efficacy and tolerability of the phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of subjects with erectile dysfunction of different aetiologies and severity, who have not been previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.

location_country:
Finland
Germany
United Kingdom
Denmark
Belgium
Spain
France


title: A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.

summary: This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.

ReferenceCitation: Nauck MA, Del Prato S, Meier JJ, Duran-Garcia S, Rohwedder K, Elze M, Parikh SJ. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care. 2011 Sep;34(9):2015-22. doi: 10.2337/dc11-0606. Epub 2011 Aug 4.

ReferenceCitation: Nauck M, del Prato S, Meier JJ, Duran-Garcia S, Rohwedder K, Elze M, Parikh SJ. [Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S6-15. doi: 10.1055/s-0032-1305283. Epub 2013 Mar 25. German.

publisher_dissemination: Georg Thieme

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
Bristol-Myers Squibb

location_country:
Germany
Italy
United Kingdom
Argentina
Sweden
Netherlands
Mexico
Spain
South Africa
France


acronym: Extension trial to Trial 25643: Oral Cladribine in MS

lead_sponsor: EMD Serono Research & Development Institute, Inc.

summary: The purpose of this extension trial was to further evaluate the safety and tolerability of oral cladribine in subjects who have previously completed treatment within Trial 25643 (CLARITY). This trial also explored clinical benefit of prolonged 192-week versus 96-week treatment.

ReferenceCitation: Stefano N, Sormani MP, Giovannoni G, Rammohan K, Leist TP, Coyle PK, Dangond F, Alexandri N, Galazka A. Relapses in people with multiple sclerosis treated with cladribine tablets followed for up to 5 years: a plain language summary. Neurodegener Dis Manag. 2022 Dec;12(6):303-310. doi: 10.2217/nmt-2022-0019. Epub 2022 Aug 26.

publisher_dissemination: Future Science Ltd

ReferenceCitation: Giovannoni G, Comi G, Rammohan K, Rieckmann P, Dangond F, Jack D, Vermersch P. Disease stability over five years in people with multiple sclerosis treated with cladribine tablets: a plain language summary. Neurodegener Dis Manag. 2022 Dec;12(6):295-301. doi: 10.2217/nmt-2022-0018. Epub 2022 Aug 26.

ReferenceCitation: Giovannoni G, Coyle PK, Vermersch P, Walker B, Aldridge J, Nolting A, Galazka A, Lemieux C, Leist TP. Integrated Lymphopenia Analysis in Younger and Older Patients With Multiple Sclerosis Treated With Cladribine Tablets. Front Immunol. 2021 Dec 24;12:763433. doi: 10.3389/fimmu.2021.763433. eCollection 2021.

publisher_dissemination: Frontiers

ReferenceCitation: Giovannoni G, Comi G, Rammohan K, Rieckmann P, Dangond F, Keller B, Jack D, Vermersch P. Long-Term Disease Stability Assessed by the Expanded Disability Status Scale in Patients Treated with Cladribine Tablets 3.5 mg/kg for Relapsing Multiple Sclerosis: An Exploratory Post Hoc Analysis of the CLARITY and CLARITY Extension Studies. Adv Ther. 2021 Sep;38(9):4975-4985. doi: 10.1007/s12325-021-01865-w. Epub 2021 Aug 9.

ReferenceCitation: De Stefano N, Sormani MP, Giovannoni G, Rammohan K, Leist T, Coyle PK, Dangond F, Keller B, Alexandri N, Galazka A. Analysis of frequency and severity of relapses in multiple sclerosis patients treated with cladribine tablets or placebo: The CLARITY and CLARITY Extension studies. Mult Scler. 2022 Jan;28(1):111-120. doi: 10.1177/13524585211010294. Epub 2021 May 10.

ReferenceCitation: Giovannoni G, Galazka A, Schick R, Leist T, Comi G, Montalban X, Damian D, Dangond F, Cook S. Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis: An Integrated Analysis of Safety. Drug Saf. 2020 Jul;43(7):635-643. doi: 10.1007/s40264-020-00948-x.

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repositories_concat: PubMed Central;ddd.uab.cat

ReferenceCitation: Comi G, Cook S, Rammohan K, Soelberg Sorensen P, Vermersch P, Adeniji AK, Dangond F, Giovannoni G. Long-term effects of cladribine tablets on MRI activity outcomes in patients with relapsing-remitting multiple sclerosis: the CLARITY Extension study. Ther Adv Neurol Disord. 2018 Jan 23;11:1756285617753365. doi: 10.1177/1756285617753365. eCollection 2018.

repository_institution: University of Copenhagen - Research at the University of Copenhagen

title: A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects With Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY)

location_country:
Finland
Germany
Poland
Australia
Brazil
Turkey
Croatia
Czechia
Canada
Serbia
France
Lithuania
Portugal
Denmark
Switzerland
United States
Latvia
Morocco
Ukraine
Tunisia
Lebanon
Belgium
Estonia
Italy
United Kingdom
Netherlands
Austria
Saudi Arabia
Greece
Bulgaria
Russian Federation


acronym: POTENT I

summary: This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.

ReferenceCitation: Debruyne FM, Gittelman M, Sperling H, Borner M, Beneke M. Time to onset of action of vardenafil: a retrospective analysis of the pivotal trials for the orodispersible and film-coated tablet formulations. J Sex Med. 2011 Oct;8(10):2912-23. doi: 10.1111/j.1743-6109.2011.02462.x. Epub 2011 Aug 30.

ReferenceCitation: Sperling H, Debruyne F, Boermans A, Beneke M, Ulbrich E, Ewald S. The POTENT I randomized trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. J Sex Med. 2010 Apr;7(4 Pt 1):1497-507. doi: 10.1111/j.1743-6109.2010.01806.x. Epub 2010 Mar 3.

ReferenceCitation: Heinig R, Weimann B, Dietrich H, Bottcher MF. Pharmacokinetics of a new orodispersible tablet formulation of vardenafil: results of three clinical trials. Clin Drug Investig. 2011;31(1):27-41. doi: 10.2165/11584950-000000000-00000.

ReferenceCitation: Sperling H, Gittelman M, Norenberg C, Ulbrich E, Ewald S. Efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction in elderly men and those with underlying conditions: an integrated analysis of two pivotal trials. J Sex Med. 2011 Jan;8(1):261-71. doi: 10.1111/j.1743-6109.2010.02005.x. Epub 2010 Aug 30.

sponsor_collaborators: Bayer GlaxoSmithKline Schering-Plough

title: Pivotal Phase III Trial to Investigate the Efficacy and Safety of an Orodispersible Tablet Vardenafil Versus Placebo in the Treatment of Men With Erectile Dysfunction (ED) - a Fixed-dose, Double-blind, Randomized Multi-center Trial - POTENT I

location_country:
Germany
Netherlands
Belgium
Spain
South Africa
France

collaborators: GlaxoSmithKline Schering-Plough


acronym: RAD

summary: This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate of fibrosis in hepatitis C virus (HCV) positive patients.

ReferenceCitation: Charlton M, Rinella M, Patel D, McCague K, Heimbach J, Watt K. Everolimus Is Associated With Less Weight Gain Than Tacrolimus 2 Years After Liver Transplantation: Results of a Randomized Multicenter Study. Transplantation. 2017 Dec;101(12):2873-2882. doi: 10.1097/TP.0000000000001913.

ReferenceCitation: Fischer L, Saliba F, Kaiser GM, De Carlis L, Metselaar HJ, De Simone P, Duvoux C, Nevens F, Fung JJ, Dong G, Rauer B, Junge G; H2304 Study Group. Three-year Outcomes in De Novo Liver Transplant Patients Receiving Everolimus With Reduced Tacrolimus: Follow-Up Results From a Randomized, Multicenter Study. Transplantation. 2015 Jul;99(7):1455-62. doi: 10.1097/TP.0000000000000555.

ReferenceCitation: Saliba F, De Simone P, Nevens F, De Carlis L, Metselaar HJ, Beckebaum S, Jonas S, Sudan D, Fischer L, Duvoux C, Chavin KD, Koneru B, Huang MA, Chapman WC, Foltys D, Dong G, Lopez PM, Fung J, Junge G; H2304 Study Group. Renal function at two years in liver transplant patients receiving everolimus: results of a randomized, multicenter study. Am J Transplant. 2013 Jul;13(7):1734-45. doi: 10.1111/ajt.12280. Epub 2013 May 28.

endpoint_id: nbfzapbzoypsdcgeiryx

repository_institution: University of Modena and Reggio Emilia - IRIS UNIMORE

repository_institution: University of Liège - Open Repository and Bibliography

title: A 24 Month, Multicenter, Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients

location_country:
Germany
Ireland
Argentina
Australia
Brazil
Canada
France
Czech Republic
Colombia
Hungary
United States
Belgium
Italy
United Kingdom
Sweden
Netherlands
Spain
Russian Federation
Israel


acronym: RE-DEEM

summary: The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4 doses of orally administered dabigatran etexilate, administered twice daily, compared to placebo when given in addition to dual antiplatelet treatment in patients with an index event (MI) at high risk for new ischaemic cardiovascular events.

sponsor_collaborators:
Boehringer Ingelheim
Uppsala University

location_facility: 1160.67.32008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.48001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82009 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.47004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3303B Boehringer Ingelheim Investigational Site

location_facility: 1160.67.45002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3303D Boehringer Ingelheim Investigational Site

location_facility: 1160.67.45004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.39001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.34005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11018 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.42005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3305A Boehringer Ingelheim Investigational Site

location_facility: 1160.67.48005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.95002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.39005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11012 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.39003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.34001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.34003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.42001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.95003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.44002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11017 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.58002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49019 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.39006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.58004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11020 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.42003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.10002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11010 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11014 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82012 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.47005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.39004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.48004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.42007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.53002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59012 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.53001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.39002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.34002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3305B Boehringer Ingelheim Investigational Site

location_facility: 1160.67.47001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.48006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82013 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38006 Boehringer Ingelheim Investigational Site

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location_facility: 1160.67.32001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.95005 Boehringer Ingelheim Investigational Site

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location_facility: 1160.67.59004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40001 Boehringer Ingelheim Investigational Site

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location_facility: 1160.67.49007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.44003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36009 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.42002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.95001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3303A Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70011 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59010 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49017 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31009 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3301A Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82011 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.34006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31011 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.45001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.95004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.58003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.45003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.95006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.48003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.42008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59009 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.48002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70010 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.47002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11009 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.34004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3303C Boehringer Ingelheim Investigational Site

location_facility: 1160.67.58001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32011 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70003 Boehringer Ingelheim Investigational Site

title: RandomizEd Dabigatran Etexilate Dose Finding Study in Patients With Acute Coronary Syndromes Post Index Event With Additional Risk Factors for Cardiovascular Complications Also Receiving Aspirin and Clopidogrel: Multi-centre, Prospective, Placebo Controlled, Cohort Dose Escalation Study (RE-DEEM)

location_country:
Finland
Germany
Ireland
Poland
Canada
France
Czech Republic
Hungary
Denmark
United States
Ukraine
India
Romania
Belgium
Italy
Norway
United Kingdom
Netherlands
Korea, Republic of
Spain
Bulgaria
Georgia
Russian Federation
Sweden