title: A Prospective, Single-arm, Multicenter, Uncontrolled, Open-label Phase II Trial of Refametinib (BAY86-9766) in Combination With Sorafenib as First Line Treatment in Patients With RAS Mutant Hepatocellular Carcinoma (HCC)

summary:
This is a study to investigate the potential clinical benefit of refametinib when given in combination with sorafenib as first line treatment in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15 patients at Stage 1 show at least partial response according to an objective criteria to evaluate tumor size based on contrast enhancement [modified response evaluation criteria in solid tumors (mRECIST)] assessed by external independent radiologists.

Refametenib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib in combination with sorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning.

The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib in combination with sorafenib improves the response rate in this patient population compared to historical results observed with the sorafenib only.

location_country:
Germany
New Zealand
Japan
Thailand
Turkey
Czechia
France
Hungary
Hong Kong
Switzerland
United States
Belgium
China
Italy
United Kingdom
Singapore
Austria
Korea, Republic of
Spain
Taiwan
Israel


intervention_type: Drug

lead_sponsor: Pfizer

summary: This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.

ReferenceType: derived

ReferenceCitation: Vandenberghe R, Rinne JO, Boada M, Katayama S, Scheltens P, Vellas B, Tuchman M, Gass A, Fiebach JB, Hill D, Lobello K, Li D, McRae T, Lucas P, Evans I, Booth K, Luscan G, Wyman BT, Hua L, Yang L, Brashear HR, Black RS; Bapineuzumab 3000 and 3001 Clinical Study Investigators. Bapineuzumab for mild to moderate Alzheimer's disease in two global, randomized, phase 3 trials. Alzheimers Res Ther. 2016 May 12;8(1):18. doi: 10.1186/s13195-016-0189-7.

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

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
LIRIAS (KU Leuven)
PubMed Central
UCL Discovery
refubium.fu-berlin.de

repositories_concat: LIRIAS (KU Leuven);PubMed Central;UCL Discovery;refubium.fu-berlin.de

repositories_institution: University College London - UCL Discovery

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Lacey L, Bobula J, Rudell K, Alvir J, Leibman C. Quality of Life and Utility Measurement in a Large Clinical Trial Sample of Patients with Mild to Moderate Alzheimer's Disease: Determinants and Level of Changes Observed. Value Health. 2015 Jul;18(5):638-45. doi: 10.1016/j.jval.2015.03.1787. Epub 2015 Apr 10.

oa_host_type: publisher

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

location_facility: Centro Internacional de Medicina Avanzda (CIMA)

location_facility: Oddzial Neurologiczny i Udarowy Szpital Wolski im. dr Anny Gostynskiej,

location_facility: National Hospital Organization Tokyo National Hospital

location_facility: UAB Clinical Research Pharmacy-Russell Clinic

location_facility: MAC UK Neuroscience, Research Assessment Centre

location_facility: Fundacio ACE Institut Catala de Neurociences Aplicades

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: UPENN Clinical and Transitional Research Center

location_facility: Centre d'Imagerie medicale de Basse Normandie

location_facility: National Hospital Organization Minami-Okayama Medical Center

location_facility: Associated Neurologists of Southern Connecticut, P.C.

location_facility: National Hospital Organization Niigata National Hospital

location_facility: The Center for Pharmaceutical Research P.C.

location_facility: CHU Nord - Hôpital Guillaume et René Laënnec

location_facility: Ohio State University Imaging@Martha Moorehouse

location_facility: Clinical Investigation and Research Unit (CIRU)

location_facility: Participant and Clinical Interactions Resources

location_facility: Rhode Island Mood and Memory Research Institute

location_facility: Juntendo Tokyo Koto Geriatric Medical Center

location_facility: Institute for Cardiovascular Diseases of Vojvodina

location_facility: Kansai Medical University Takii Hospital

location_facility: Memory Enhancement Center of America, Inc.

location_facility: Szpital Uniwersytecki, Oddzial Kliniczny Klinik Chorob Wewnetrznych i

location_facility: Kobe City Hospital Org Kobe City Medical Cente West Hp

location_facility: Carolina Neuropsychological Services, Inc

location_facility: Nippon Medical School Chiba Hokusoh Hospital

location_facility: Nippon Medical School Musashi Kosugi Hospital

location_facility: National Hospital Organization Minami-Kyoto Hospital

location_facility: Research Center for Clinical Studies, Inc.

location_facility: University of Wisconsin Hospitals and Clinics

location_facility: National Hospital Organization Hiroshima-nishi Medical Ctr.

location_facility: Instituto Biomedico de Investigacion A.C

location_facility: University of Michigan Hospital and Health System

location_facility: Groupe Hospitalier Broca-La Rochefoucauld

location_facility: Tokyo Metropolitan Health and Med. Treatment Co. Ebara Hosp

location_facility: McCusker Alzheimer's Research Foundation, Inc.

location_facility: Dekalb Neurology Associates, LLC/NeuroStudies.net, LLC

location_facility: General Clincial Research Center (Infusion Location)

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: National HP.Org.Shizuoka Inst.Epilepsy,Neurological Disorder

location_facility: Dept. of Neurosciences Charing Cross Hospital

location_facility: University of Wisconsin School of Medicine and Public Health

location_facility: IDS Pharmacy (Drug Receipt). Attn:Hyesson Hong

location_facility: National Hospital Organization Chiba-East Hospital

location_facility: Alzheimer's Research Corp./Merician Institute for Aging

location_facility: Southern Illinois University School of Medicine Department

location_facility: University of Pennsylvania-Penn Memory Center

location_facility: National Hospital Organization Maizuru Medical Center

location_facility: Unita' Operativa C - Riabilitazione Neurologica

location_facility: Klinikum der Albert-Ludwigs-Universitaet Freiburg

location_facility: Unita' Operativa Complessa di Neurologia

location_facility: Wm S. Middleton Memorial Veterans Hospital

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika

location_facility: NZOZ "NEURO-KARD" "ILKOWSKI I PARTNERZY" Spolka Partnerska Lekarzy

location_facility: Fondazione IRCCS- Istituto Neurologico Carlo Besta

location_facility: National Hospital Organization Kokura Medical Center

location_facility: Clinical Centre Kragujevac, Clinic of Psichiatry

location_facility: Medical University of South Carolina Hospitals and Clinics

location_facility: Hospital of the University of Pennsylvania

location_facility: CeSI (Centro di Scienze dell'invecchiamento) -

location_facility: Psychiatricka nemocnica Michalovce, n.o.

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Sezione di Neurologia - Dipartimento di Neuroscienze

status: Terminated

title: A Phase Iii, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Efficacy And Safety Trial Of Bapineuzumab (Aab 001, Eln115727) In Subjects With Mild To Moderate Alzheimer Disease Who Are Apolipoprotein E 4 Carriers

primary_purpose: Treatment

type: Other Identifier

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Japan
Croatia
Chile
Serbia
France
Portugal
Slovakia
Switzerland
United States
Belgium
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
South Africa
Sweden

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Unknown


repositories_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

location_facility: National Hospital Organization Minami-Okayama Medical Center

location_facility: Rhode Island Mood and Memory Research Institute

location_facility: AD-CARE, University of Rochester Medical Center

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: National Hospital Organization Chiba-East Hospital

location_facility: Tokyo Metoropolitan Health and Med. Treatment Co. Ebara Hosp

location_facility: Investigational New Drug Services, IDS Pharmacy

location_facility: The clinic: Minnes- och geriatrikmottagningen

location_facility: Institutional Review Board / Ethics Committee

location_facility: University of Rochester/Strong Memorial Hospital

location_facility: Oddzial Neurologiczny i Udarowy Szpital Wolski im. dr Anny Gostynskiej,

location_facility: Southern Illinois University School of Medicine

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Hospital of the University of Pennsylvania (PET)

location_facility: Clinical Investigation and Research Unit (CIRU)

location_facility: Juntendo Tokyo Koto Geriatric Medical Center

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Kansai Medical University Takii Hospital

location_facility: Kobe City Hospital Org Kobe City Medical Cente West Hp

location_facility: National Hospital Organization Minami-Kyoto Hospital

location_facility: Fundació ACE Institut Catala de Neurociences Aplicades

location_facility: The Ohio State University Medical Center

location_facility: Saint Petersburg Psychoneurological Research Institute n.a. V.M.Bekhterev

location_facility: Dekalb Neurology Associates, LLC/NeuroStudies.net, LLC

location_facility: Saint-Petersburg State institution of healthcare, City geriatric medico-social center

location_facility: KonKuk University Hospital, Department of NeuroPsychiatry

location_facility: Medical Research and Health Education Foundation, Incorporated

location_facility: Seoul National University Bundang Hospital, Department of Psychiatry

location_facility: Medical University of South Carolina Investigational Drug Service

location_facility: National Hospital Organization Tokyo National Hospital

location_facility: Four Rivers Clinical Research, Incorporated

location_facility: University of Virginia General Clinical Research Center

location_facility: Carolina Neuropsychological Services, Inc.

location_facility: Heidelberg Repatriation Hospital/ Medical and Cognitive Research Unit

location_facility: National Hospital Organization Niigata National Hospital

location_facility: National Hospital Organization Hiroshima-nishi Medical Ctr.

location_facility: UPENN Clinical and Translational Research Center (CTRC)

location_facility: Nizhny Novgorod regional clinical hospital n.a. N.A.Semashko

location_facility: Methodist Medical Center Research Department

location_facility: McCusker Alzheimer's Research Foundation Inc.

location_facility: University of Viriginia Investigational Pharmacy

location_facility: Nippon Medical School Musashikosugi Hospital

location_facility: Hospital of the University of Pennslyvania

location_facility: Associated Neurologists of Southern Connecticut, P.C.

location_facility: CHU Nord - Hôpital Guillaume et René Laënnec

location_facility: Faculty Physicians and Surgeons of Loma Linda University School of Medicine

location_facility: Memory Enhancement Center of America, Inc.

location_facility: Nippon Medical School Chiba Hokusoh Hospital

location_facility: Instituto Biomedico de Investigacion A.C

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Azienda Ospedaliera S. Gerardo di Monza Università di Milano Bicocca

location_facility: Groupe Hospitalier Broca-La Rochefoucauld

location_facility: Klinik fur Psychiatrie und Psychotherapie

location_facility: The Ohio State University Hospitals Clinic

location_facility: University of North Texas Health Science Center

location_facility: National HP.Org.Shizuoka Inst.Epilepsy,Neurological Disorder

location_facility: Dept. of Neurosciences Charing Cross Hospital

location_facility: Institute for Neurodegenerative Disorders

location_facility: Alexian Brothers Neurosciences Institute

location_facility: Szpital Uniwersytecki w Krakowie,Oddzial Kliniczny Klinik Chorób Wewnetrznych

location_facility: Memory Enhancement Center of New Jersey, Inc.

location_facility: Collaborative Neuroscience Network, Inc.

location_facility: Saint-Petersburg Psychoneurological Research Institute n.a. V.M.Bekhterev

location_facility: Ohio State University Imaging at Martha Morehouse

location_facility: Clinical Trials of America, Incorporated

title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy And Safety Trial Of Bapineuzumab (Aab-001, Eln115727) In Subjects With Mild to Moderate Alzheimer Disease Who Are Apolipoprotein E 4 Non-carriers

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Japan
Croatia
Chile
Canada
Serbia
France
Portugal
Slovakia
Switzerland
United States
Belgium
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Russian Federation
Sweden


title: A Randomized, Double-blind, Placebo-controlled Study Assessing the Effect of RO4607381 on Cardiovascular Mortality and Morbidity in Clinically Stable Patients With a Recent Acute Coronary Syndrome

summary: This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.

status: Completed

ReferenceCitation: Schwartz GG, Leiter LA, Ballantyne CM, Barter PJ, Black DM, Kallend D, Laghrissi-Thode F, Leitersdorf E, McMurray JJV, Nicholls SJ, Olsson AG, Preiss D, Shah PK, Tardif JC, Kittelson J. Dalcetrapib Reduces Risk of New-Onset Diabetes in Patients With Coronary Heart Disease. Diabetes Care. 2020 May;43(5):1077-1084. doi: 10.2337/dc19-2204. Epub 2020 Mar 6.

oa_colors: green other

evidence: open (via free pdf)

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

version: submittedVersion

repositories_concat: PubMed Central;ora.ox.ac.uk

unpaywall_oa_status: bronze

publisher_dissemination: American Diabetes Association

ReferenceCitation: Salahuddin T, Kittelson J, Tardif JC, Shah PK, Olsson AG, Nicholls SJ, Leitersdorf E, Leiter LA, Kallend D, Black DM, Barter PJ, Ballantyne CM, Schwartz GG. Association of high-density lipoprotein particle concentration with cardiovascular risk following acute coronary syndrome: A case-cohort analysis of the dal-Outcomes trial. Am Heart J. 2020 Mar;221:60-66. doi: 10.1016/j.ahj.2019.12.003. Epub 2019 Dec 16.

oa_host_type: closed

ReferenceCitation: Schwartz GG, Ballantyne CM, Barter PJ, Kallend D, Leiter LA, Leitersdorf E, McMurray JJV, Nicholls SJ, Olsson AG, Shah PK, Tardif JC, Kittelson J. Association of Lipoprotein(a) With Risk of Recurrent Ischemic Events Following Acute Coronary Syndrome: Analysis of the dal-Outcomes Randomized Clinical Trial. JAMA Cardiol. 2018 Feb 1;3(2):164-168. doi: 10.1001/jamacardio.2017.3833.

repositories_concat: PubMed Central

publisher_dissemination: American Medical Association

ReferenceCitation: Pitts R, Gunzburger E, Ballantyne CM, Barter PJ, Kallend D, Leiter LA, Leitersdorf E, Nicholls SJ, Shah PK, Tardif JC, Olsson AG, McMurray JJ, Kittelson J, Schwartz GG. Aldosterone Does Not Predict Cardiovascular Events Following Acute Coronary Syndrome in Patients Initially Without Heart Failure. J Am Heart Assoc. 2017 Jan 10;6(1):e004119. doi: 10.1161/JAHA.116.004119.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Adelaide - Adelaide Research & Scholarship (AR&S)

repository_institution: Australian Catholic University - Research Bank

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

ReferenceCitation: Tardif JC, Rhainds D, Brodeur M, Feroz Zada Y, Fouodjio R, Provost S, Boule M, Alem S, Gregoire JC, L'Allier PL, Ibrahim R, Guertin MC, Mongrain I, Olsson AG, Schwartz GG, Rheaume E, Dube MP. Genotype-Dependent Effects of Dalcetrapib on Cholesterol Efflux and Inflammation: Concordance With Clinical Outcomes. Circ Cardiovasc Genet. 2016 Aug;9(4):340-8. doi: 10.1161/CIRCGENETICS.116.001405. Epub 2016 Jul 14.

ReferenceCitation: Schwartz GG, Abt M, Bao W, DeMicco D, Kallend D, Miller M, Mundl H, Olsson AG. Fasting triglycerides predict recurrent ischemic events in patients with acute coronary syndrome treated with statins. J Am Coll Cardiol. 2015 Jun 2;65(21):2267-75. doi: 10.1016/j.jacc.2015.03.544. Erratum In: J Am Coll Cardiol. 2015 Jul 21;66(3):334.

ReferenceCitation: Tardif JC, Rheaume E, Lemieux Perreault LP, Gregoire JC, Feroz Zada Y, Asselin G, Provost S, Barhdadi A, Rhainds D, L'Allier PL, Ibrahim R, Upmanyu R, Niesor EJ, Benghozi R, Suchankova G, Laghrissi-Thode F, Guertin MC, Olsson AG, Mongrain I, Schwartz GG, Dube MP. Pharmacogenomic determinants of the cardiovascular effects of dalcetrapib. Circ Cardiovasc Genet. 2015 Apr;8(2):372-82. doi: 10.1161/CIRCGENETICS.114.000663. Epub 2015 Jan 11.

ReferenceCitation: Schwartz GG, Olsson AG, Abt M, Ballantyne CM, Barter PJ, Brumm J, Chaitman BR, Holme IM, Kallend D, Leiter LA, Leitersdorf E, McMurray JJ, Mundl H, Nicholls SJ, Shah PK, Tardif JC, Wright RS; dal-OUTCOMES Investigators. Effects of dalcetrapib in patients with a recent acute coronary syndrome. N Engl J Med. 2012 Nov 29;367(22):2089-99. doi: 10.1056/NEJMoa1206797. Epub 2012 Nov 5.

ReferenceCitation: Luscher TF, Taddei S, Kaski JC, Jukema JW, Kallend D, Munzel T, Kastelein JJ, Deanfield JE; dal-VESSEL Investigators. Vascular effects and safety of dalcetrapib in patients with or at risk of coronary heart disease: the dal-VESSEL randomized clinical trial. Eur Heart J. 2012 Apr;33(7):857-65. doi: 10.1093/eurheartj/ehs019. Epub 2012 Feb 16.

ReferenceCitation: Derks M, Abt M, Parr G, Meneses-Lorente G, Young AM, Phelan M. No clinically relevant drug-drug interactions when dalcetrapib is co-administered with atorvastatin. Expert Opin Investig Drugs. 2010 Oct;19(10):1135-45. doi: 10.1517/13543784.2010.509342.

ReferenceCitation: Schwartz GG, Olsson AG, Ballantyne CM, Barter PJ, Holme IM, Kallend D, Leiter LA, Leitersdorf E, McMurray JJ, Shah PK, Tardif JC, Chaitman BR, Duttlinger-Maddux R, Mathieson J; dal-OUTCOMES Committees and Investigators. Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome. Am Heart J. 2009 Dec;158(6):896-901.e3. doi: 10.1016/j.ahj.2009.09.017.

ReferenceCitation: Stein EA, Stroes ES, Steiner G, Buckley BM, Capponi AM, Burgess T, Niesor EJ, Kallend D, Kastelein JJ. Safety and tolerability of dalcetrapib. Am J Cardiol. 2009 Jul 1;104(1):82-91. doi: 10.1016/j.amjcard.2009.02.061.

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Grenada
Czechia
Canada
France
Slovakia
Hungary
Denmark
Switzerland
United States
Belgium
China
Puerto Rico
Italy
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Israel


study_start_date_type: Actual

acronym: EXPECT

lead_sponsor: Celgene

summary:
This is a Phase II, multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to subjects with relapsed or refractory T-cell lymphoma. This study will be conducted in two phases: a Treatment Phase and a Follow-up Phase.

Subjects who qualify for enrollment into the study will enter the Treatment Phase and receive single-agent lenalidomide 25 mg once daily on Days 1-21 every 28 days (28-day cycles). Subjects may continue participation in the Treatment Phase of the study for a maximum duration of 24 months, or until disease progression or unacceptable adverse events develop.

All subjects who discontinue the Treatment Phase for any reason will continue to be followed until progression of disease or until next lymphoma treatment is given, whichever comes first, during the Follow-up Phase.

Objectives:

Primary:

• To determine the efficacy of lenalidomide monotherapy in relapsed or refractory T-cell Non-Hodgkin's Lymphoma (NHL). Efficacy will be assessed by measuring the response rate, tumor control rate, duration of response, time to progression and progression free survival.

Secondary:

• To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory T-cell NHL.

ReferenceType: result

ReferenceCitation: Morschhauser F, Fitoussi O, Haioun C, Thieblemont C, Quach H, Delarue R, Glaisner S, Gabarre J, Bosly A, Lister J, Li J, Coiffier B. A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: the EXPECT trial. Eur J Cancer. 2013 Sep;49(13):2869-76. doi: 10.1016/j.ejca.2013.04.029. Epub 2013 May 31.

location_facility: Clinical Research Unit Cairns Base Hospital

location_facility: Box Hill Hospital, 4th Floor, Clive Ward Centre

location_facility: Cliniques universitaires UCL de Mont-Godinne

title: A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid®) in Subjects With Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma

location_country:
United States
Australia
Belgium
France


title: Spontaneous Atrio Ventricular Conduction Preservation

acronym: SAVER

summary:
In case of sinus node dysfunction, it is often necessary to choose the safer option provided by a DDD pacemaker even though the most appropriate mode of pacing is AAI mode.

In addition to saving energy, the latter mode allows spontaneous ventricular activation, the haemodynamic consequences of which are, in most cases, better than those obtained with dual chamber pacing.

Recent studies as the MOST study suggest also that ventricular desynchronization imposed by right ventricular apical pacing even when AV synchrony is preserved increases the risk of atrial fibrillation in patients with SND. Similar results were already given by anterior studies (PIPAF) which, taking into account the percentage of ventricular pacing, suggested that AF prevention algorithm in combination with a preserved native conduction are efficient in reducing AF burden.

However, current practice is to implant a dual chamber pacemaker to prevent the risk of atrioventricular block (AVB) even if DDDR pacing with a fixed long AV delay was found inefficient in reducing ventricular pacing and was associated with a high risk of arrhythmias.

The Symphony 2550 cardiac pacemaker offers pacing modes that automatically switch from AAI(R) mode to DDD(R) or DDI(R) in event of severe atrioventricular conduction disorder, irrespective of whether or not these are accompanied by an atrial arrhythmia, returning spontaneously to AAI(R) mode as soon as the spontaneous AV conduction has resumed. These 2 particular modes are called the AAI SafeR and DDD/AMC (R) mode.

The main differences between both modes are that (i) AAI SafeR does not trigger any AV Delay after a sensed or paced atrial event which allows long PR intervals or even limited ventricular pauses with no switch to DDD(R), while (ii) DDD/AMC (R) is able to optimize AV Delay after switching to DDD(R) according to measured spontaneous conduction times and to provide an acceleration in case of vaso-vagal syndrome. This pacing mode has previously been assessed in clinical studies.

This study intends to demonstrate that the automatic modes switching significantly reduce the percentage of ventricular pacing in patients implanted with a spontaneous AV conduction and reduce the occurrence of atrial arrhythmias, on a mid-term follow-up period, in comparison to standard DDD pacing with long AVDelay.

lead_sponsor: LivaNova

location_country:
Germany
Italy
United Kingdom
Belgium
France

location_facility:
CH Albi
Klinikum Lüdenscheid
Universitätskliniken Bonn
Istituto Policlinico
InParys Cardiology
CHU - Hopital Michallon
Castle Hill Hospital
Klinikum Wolgast
Bristol Royal Infirmary
Ospedale Civili Reuniti
Prof. Frey Praxis Starnberg
CHU Hopital C. Nicolle
Ospedale S. G. Battista
CHU Jean Minjoz
Uni Regensburg
Hôpital Vésale (univ.)
CHU - Tivoli
KH Holweide
Klinikum Bogenhausen
Barts and The London NHS Trust
CHU de Nancy
Holzminden Praxis Bub
Centre Hospitalier
Hôpital universitaire Brugmann
CHU d'Angers
CHRU de Lille - Hôpital Cardiologique
Queens Hospital
Univ. Mainz
Europa ziekenhuis
CHU de Nantes
Clinique Louis Caty
Praxis Bitar
Leeds General Infirmary
Augustinum
Universitätsklinikum Schleswig-Holstein
Queen Elizabeth Hospital
Ospedale Mellini
CH Montpellier
St. Salvator Krankenhaus Halberstadt
Hospice St-Jacques-Hôspital G.Montpied
CHU de Nice
Onze lieve Vrouw ziekenhuis
CH Emile Muller
Clinique Bizet
CHU Pontchaillou
Ospedale Moscati
Städt. Kh. Lüneburg
Rot-Kreuz Krankenhaus
Waren-Müritzklinikum
Heiling Hart van Jezus
Nouvelles Cliniques Nantaises
Hürth Sana
Ospedale Civile
Univ. Marburg
St.Josef-Stift Bremen
Herzzentrum Kassel
CHU de Limoges
Uni Ulm
Marien Hospital
St Thomas' Hospital,
Ospedale Umberto I
Klinkum Memmingen
CH de CASTRES

intervention_type: Device

status_simplified: Completed


title: A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism

summary: The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)

ReferenceCitation: Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.

oa_colors: green hybrid

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: Cohen AT, Pan S, Byon W, Ilyas BS, Taylor T, Lee TC. Efficacy, Safety, and Exposure of Apixaban in Patients with High Body Weight or Obesity and Venous Thromboembolism: Insights from AMPLIFY. Adv Ther. 2021 Jun;38(6):3003-3018. doi: 10.1007/s12325-021-01716-8. Epub 2021 Apr 22. Erratum In: Adv Ther. 2021 Aug;38(8):4596-4597.

ReferenceCitation: Cohen AT, Agnelli G, Buller HR, Gallus A, Raskob GE, Sanders P, Thompson J, Weitz JI. Characteristics and Outcomes in Patients with Venous Thromboembolism Taking Concomitant Anti-Platelet Agents and Anticoagulants in the AMPLIFY Trial. Thromb Haemost. 2019 Mar;119(3):461-466. doi: 10.1055/s-0038-1676983. Epub 2019 Jan 16.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

publisher_dissemination: Georg Thieme

ReferenceCitation: Liu X, Johnson M, Mardekian J, Phatak H, Thompson J, Cohen AT. Apixaban Reduces Hospitalizations in Patients With Venous Thromboembolism: An Analysis of the Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy (AMPLIFY) Trial. J Am Heart Assoc. 2015 Dec 1;4(12):e002340. doi: 10.1161/JAHA.115.002340.

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Masiukiewicz U, Pak R, Thompson J, Raskob GE, Weitz JI; AMPLIFY Investigators. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013 Aug 29;369(9):799-808. doi: 10.1056/NEJMoa1302507. Epub 2013 Jul 1.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: Bristol-Myers Squibb

sponsor_collaborators:
Bristol-Myers Squibb
Pfizer

location_country:
Germany
Poland
Argentina
Australia
Brazil
Chile
Canada
France
Czech Republic
Portugal
Hungary
Hong Kong
Denmark
United States
Ukraine
India
Romania
China
Malaysia
Puerto Rico
Italy
Norway
Singapore
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
South Africa
Russian Federation
Israel

location_facility: George Washington University Medical Faculty Associates

location_facility: University Of California, Davis Medical Center

location_facility: Dept Of Internal Med, Sect Of Pulmonary & Critical Care Med

location_facility: Chest Medicine & Critical Care Medical Gr. Inc.

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: University Of California San Francisco-Fresno

location_facility: Internal Medical Associates Of Grand Island, P.C

location_facility: University Of Arkansas For Medical Sciences

location_facility: Washington University School Of Medicine

location_facility: Atlanta Institute For Medical Research, Inc


acronym: TavIx

lead_sponsor: UNICANCER

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them after surgery may kill any tumor cells remaining after surgery. It is not yet known whether docetaxel is more effective than ixabepilone when given after surgery and combination chemotherapy in treating breast cancer.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy followed by docetaxel or ixabepilone to compare how well they work in treating patients who have undergone surgery for nonmetastatic breast cancer.

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Centre de Radiotherapie et Oncologie Saint-Faron

location_facility: Oncology Associates at Rapid City Regional Hospital

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: CHR - Clinique Saint Joseph - Hopital de Warqueguies

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: CCOP - Missouri Valley Cancer Consortium

location_facility: Roger Maris Cancer Center at MeritCare Hospital

location_facility: Centre Hospitalier Intercommunal Le Raincy - Montfermeil

location_facility: CCOP - Geisinger Clinic and Medical Center

location_facility: Centre Hospitalier General de Mont de Marsan

location_facility: Southeast Nebraska Hematology Oncology Consultants at Southeast Nebraska Cancer Center

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Green Bay Oncology, Limited at St. Mary's Hospital

location_facility: Siouxland Hematology-Oncology Associates, LLP

title: Randomized, Open Label, Multicentric Phase III Evaluating the Benefit of a Sequential Regimen Associating FEC 100 and Ixabepilone in Adjuvant Treatment of Non Metastatic, Poor Prognosis Breast Cancer Defined as Triple-negative Tumor [HER2 Negative - ER Negative - PR Negative] or [HER2 Negative and PR Negative] Tumor; in Node Positive or Node Negative Patients.

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

location_country:
United States
Belgium
France

ipd_sharing: Yes


title: A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 (Zibotentan) 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients

acronym: ENTHUSE M0

summary:
Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC).

This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve progression-free survival and overall survival against a background of existing prostate cancer treatments.

ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising PSA after surgical or medical castration but have no evidence of metastases.

All patients participating in this clinical trial will receive existing prostate cancer treatments in addition to trial therapy.

Half the patients will receive ZD4054 (Zibotentan) , and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour.

No patients will be deprived of standard prostate cancer therapy.

lead_sponsor: AstraZeneca

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Canada
Serbia
France
Czech Republic
Colombia
Portugal
Hungary
Denmark
Switzerland
United States
Latvia
India
Romania
Belgium
China
Peru
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel


title: An Open Label, Multi-center Pasireotide Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Pasireotide Study and Are Judged by the Investigator to Benefit From Continued Pasireotide Treatment

summary: The purpose of this study is to allow continued use of pasireotide in patients who are on pasireotide treatment in a Novartis-sponsored study and are benefiting from the treatment as judged by the investigator.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

lead_sponsor: RECORDATI GROUP

location_country:
Germany
Poland
Argentina
Japan
Brazil
Thailand
Turkey
Canada
France
Portugal
Hungary
Switzerland
United States
India
Romania
Belgium
Malaysia
Peru
Italy
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: University of Michigan Comprehensive Cancer Center SC-2

location_facility: Stanford Universtiy Medical Center Stanford Hospital & Clinics

location_facility: Swedish Cancer Institute Swedish Cancer Institute (SC)

location_facility: Cedars Sinai Medical Center Cedars Sinai 4

location_facility: Memorial Sloan-Kettering Cancer Center SC

status_simplified: Ongoing


acronym: BETH

lead_sponsor: NSABP Foundation Inc

summary: The trial will determine the value of adding bevacizumab to chemotherapy plus trastuzumab in patients with resected node-positive or high risk node-negative, HER2-positive breast cancer.

sponsor_collaborators: Cancer International Research Group (CIRG)

location_facility: Northwestern Carolina Oncology & Hematology, PA

location_facility: Hubert H. Humphrey Cancer Center - Coon Rapids

location_facility: University Medical Center of Southern Nevada

location_facility: North Treatment Center - Blue Ash Medical Center

location_facility: 1st Affiliated Hospital of Zhejiang University

location_facility: Medizinische Universitat Graz - Onkologie

location_facility: Michiana Hematology-Oncology, P.C. Cedar St.

location_facility: Cancer and Blood Specialists- Shadow Lane

location_facility: University Hospital and Medical Center-SUNY

location_facility: Cancer Institute of New Jersey at Hamilton

location_facility: Centro Integral de Oncologia "Clara Campal"

location_facility: UPMC Cancer Centers - McKeesport Hospital

location_facility: Central Hematology/Oncology Medical Group, Inc.

location_facility: Cancer Care & Hematology Specialists of Chicagoland

location_facility: Henry Ford Medical Center-West Bloomfield

location_facility: CCOP-Colorado Cancer Research Prog. Inc.(Administrative Only)

location_facility: P. Stradina Clinical University Hospital

location_facility: Berdat Family Comprehensive Cancer Centre

location_facility: UPMC Cancer Centers Arnold Palmer Pavilion-Mountainview

location_facility: Florida Cancer Specialists-Fort Myers Broadway

location_facility: University of Medicine and Dentistry of New Jersey

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Oncology/Hematology Care Clinical Trials LLC, Cincinnati, OH Blue Ash Med. Cntr. (Administrative Only)

location_facility: Hospital Das Clinicas de Porto Alegre-HCPA

location_facility: Carolinas Hematology-Oncology Associates - Tyron St

location_facility: Centro de Oncologia e Hematologia da Faculdade de Medicina do ABC

location_facility: Hematology Oncology Associates of CNY, CCOP

location_facility: Covenant Health System dba Joe Arrington Cancer Research & Treatment Center

location_facility: Fuzhou General Hospital of Nanjing Military Area

location_facility: Mecklenburg Medical Group - Morehead Medical Dr

location_facility: Hematology and Medical Oncology Consultants-Bettendorf

location_facility: Cancer Care Specialists-Central Illinois

location_facility: Michiana Hematology-Oncology, P.C. (LaPorte)

location_facility: Michiana Hematology-Oncology, P.C. (Elkhart)

location_facility: Case Western Reserve/University Hospitals-Ireland Cancer Cntr.

location_facility: Providence Oncology and Hematology Care Clinic

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: MBCCOP, Virginia Commonwealth University

location_facility: Michiana Hematology-Oncology, PC Lakeland

location_facility: Florida Cancer Specialists-Cape Coral Parkway

location_facility: (Azienda u.s.I. chieti) - Policinico Ospedaliero

location_facility: University Hospital and Medical Center - SUNY

location_facility: Fachärzte fürlnnere Medizin, Hämatologie

location_facility: Hematology Oncology Assaociates of CNY, CCOP

location_facility: Drs. Forte, Schleider, Attas and Condemi, PA

location_facility: Northern Indiana Cancer Research Consortium

location_facility: Centre Regional de Lutte contre le Cancer (CRLC) Val d'Aurelle

location_facility: Florida Cancer Specialists-Naples Goodlette

location_facility: Hematology/Oncology Associates of OH and MI, PC

location_facility: Thompson Cancer Survival Center-Dowell Springs

location_facility: Michiana Hematology-Oncology, P.C. (Main Office)

location_facility: Allegheny General Hospital/Allegheny-Singer Research Institute

location_facility: Cross Cancer Institute, Dept of Medicine

location_facility: Minnesota Oncology Hematology PA - Maplewood

location_facility: The Center for Cancer and Blood Disorders

location_facility: Connecticut Multi Specialty Group-Hartford

location_facility: Landeskrankenhaus Leoben, Abteilung fur Haemato-Onkologie

location_facility: AI Universitätsklinikum der PMU Landeskliniken

location_facility: Santa Barbara Hematology Oncology Medical Group

location_facility: Adelaide and Meath National Childrens Hospital

location_facility: Carolinas Hematology Oncology Associates - Harris Blvd.

location_facility: Zentrum fur Frauenheilkunde und Geburtshilfe

location_facility: Saint-Petersburg State Medical Institution "City Clinical Oncology Dispensary"

location_facility: Cancer Care and Hematology Specialists of Chicagoland

location_facility: Northern Arizona Hematology & Onclogy Associates

location_facility: Praxis und Tagesklinik fuer Onkologie und

location_facility: Oncology Associates of Bridgeport-Fairfield

location_facility: State Medical Institution "Republican Clinical Oncology Dispensary Ministry of Health of Republic Tatarstan"

location_facility: Federal State Institution "Research Institute of Oncology n.a. N.N. Petrov Rosmedtechnologiy"

location_facility: UPMC Cancer Centers-John P. Murtha Cancer Center

location_facility: Comprehensive Cancer Centers of Nevada (Siena)

location_facility: Northwest Cancer Specialists-Adventist Office

location_facility: Washington Oncology-Hematology Center, PC-Washington

location_facility: Centre Hospitalier Affilie Universitaire De Quebec, Hospital du St-Sacrement

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Florida Cancer Specialists-Port Charlotte

location_facility: Krankenhaus Hietzing, Gynaekologische Abteilung

location_facility: Florida Cancer Specialists-Fort Myers Summerlin

location_facility: Upper Peninsula Hematology/Oncology Associates

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: Ephrata Cancer Center at Ephrata Community Hospital

location_facility: Eastern Connecticut Hematology & Oncology Associates

location_facility: Krankenhaus Barmherzige Schwestern Linz, Kooperative Studiengruppe, Chirurgie

location_facility: UPMC Cancer Centers Arnold Palmer-Mt. Pleasant

location_facility: Riverview Cancer Care Medical Association

location_facility: Hematology Oncology Assoc. of CNY, CCOP (Comm. General Hospital Satellite Office)

location_facility: North County Oncology Medical Clinic, Inc.

location_facility: CCOP, St. John Hospital and Medical Center

location_facility: Medizinische Universitaet Wien-Allgemeines Krankenhaus, Onkologie

location_facility: MBCCOP, John H. Stroger, JR., Hospital of Cook County-Chicago

location_facility: Instituto de Oncologia Clinica de Piracicaba

location_facility: Hematology and Medical Oncology Consultants-Davenport

location_facility: Community Cancer Care Specialists-Mt. Clemens

location_facility: Connecticut Multi Specialty Group-Wethersfield

location_facility: University of Tennessee Cancer Institute

location_facility: Berkshire Hematology Oncology, P.C.-North Adams

location_facility: Hubert H. Humphrey Cancer Center-Robbinsdale

location_facility: CCOP, Christiana Care Health Services Inc.

location_facility: Cancer Care Associates Medical Group, Inc.

location_facility: Bezirkskrankenhaus Kufstein, Innere Medizin

location_facility: Tartu University Hospital Clinic of Hematology and Oncology

location_facility: Northern Arizona Hematology & Oncology Associates

location_facility: NY Oncology Hematology PC at Albany Medical Center

location_facility: NY Oncology Hematology PC- Latham- Capital District Oncology Hematology

location_facility: State Institution "Russian Oncological Research Center n.a. N.N. Blokhin of RAMS"

location_facility: Dayton Clinical Oncology Program-Kettering

location_facility: Landeskrankenhaus Voecklabruck, 2. Medizinische Abteilung

location_facility: Klinikverbund Suedwest - Sindelfingen-Böeblingen Clinical Centre

location_facility: Florida Cancer Specialists-Bonita Springs

location_facility: Fairview Southdale Medical Oncology Clinic

location_facility: P.G. Hospital of Thessaloniki "Papageorgiou"

location_facility: Department of Oncotherapy National Hospital

location_facility: Central Coast Medical Oncology Corporation

location_facility: St. John's Regional Health Center-Joplin

location_facility: Dayton Physicians-LLC-Hematology & Medical Oncology Division

location_facility: Hubert H. Humphrey Cancer Center - Fridley

location_facility: Carolinas Medical Center - Blumenthal Cancer Center

location_facility: Kaposi Mor oktato korhaz Onkologiai tanszek

location_facility: Olsztynski Osrodek Onkologiczny "Kopernik"

location_facility: Krankenhaus Barmherzige Brueder Graz, Medizinische Abteilung

location_facility: Rockwood Cancer Treatment Center - Sinto Ave

location_facility: Florida Cancer Specialists-Cape Coral Del Prado

location_facility: Irmandade da Santa Casa de Misericoria de Porto Alegre Nucleo de Novos Tratamentos

location_facility: Peninsula Regional Oncology & Hematology

location_facility: Klinikum Wels-Grieskirchen, Kooperative Gruppe Wels/4. Medizinische Abteilung

location_facility: IRCCS - Instituto Nazionale per lo Studio e la Cura

location_facility: UPMC Cancer Centers Arnold Palmer-Oakbrook

location_facility: Suburban Hematology Oncology Associates PC

location_facility: UP Hematology/Oncology Associates-Gogebic Range

location_facility: Oncology Associates of Bridgeport-Trumbull

location_facility: UP Hematology/Oncology Assoc.-Doctor's Park Family Physicians

location_facility: Hematology Oncology Centers of the Northern Rockies

location_facility: The Lady Davis Carmel Medical Center/Lynn

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Florida Cancer Specialists-Venice Island

location_facility: Mecklenburg Medical Group - Cameron Valley Pkwy

location_facility: Carolinas Hematology-Oncology - John J. Delaney

location_facility: NY Oncology Hematology PC-Hudson Carvell Cancer Tx Prog.

location_facility: San Diego Pacific Oncology & Hematology-Vista

location_facility: Seoul National University Bundang Hospital

location_facility: Michigan State University - Breslin Cancer Center

location_facility: Washington Oncology-Hematology Center, PC-Chevy Chase

location_facility: Oncology/Hematology Care Clinical Trials LLC

location_facility: Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca

location_facility: Harry & Jeannette Weinberg Cancer Institute

location_facility: Hospital Nacional Edgardo Rebagliati Martins

title: A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients With HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab With Chemotherapy Plus Trastuzumab Plus Bevacizumab

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Bosnia and Herzegovina
Thailand
Croatia
Chile
Czechia
Canada
Serbia
France
Slovenia
Portugal
Hungary
Hong Kong
United States
Latvia
Romania
Belgium
China
Peru
Estonia
Egypt
Philippines
Italy
United Kingdom
Sweden
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel

collaborators: Cancer International Research Group (CIRG)


lead_sponsor: Boehringer Ingelheim

summary: The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably > 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control

ReferenceCitation: Gallwitz B, Rosenstock J, Emser A, von Eynatten M, Woerle HJ. Linagliptin is more effective than glimepiride at achieving a composite outcome of target HbA(1)c < 7% with no hypoglycaemia and no weight gain over 2 years. Int J Clin Pract. 2013 Apr;67(4):317-21. doi: 10.1111/ijcp.12101.

evidence: oa journal (via publisher name)

publisher_dissemination: Hindawi

ReferenceCitation: Gallwitz B, Rosenstock J, Rauch T, Bhattacharya S, Patel S, von Eynatten M, Dugi KA, Woerle HJ. 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, non-inferiority trial. Lancet. 2012 Aug 4;380(9840):475-83. doi: 10.1016/S0140-6736(12)60691-6. Epub 2012 Jun 28.

ReferenceCitation: Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.

location_facility: 1218.20.10031 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3311A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3308C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49004 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49030 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.39028 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.27005 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3309E Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3312A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35303 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10013 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49017 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.85202 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49024 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.31023 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3303C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3304B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.36204 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.91023 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49003 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44101 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49009 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.31012 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.47005 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44104 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35204 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.36201 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.91020 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35306 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49008 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3304H Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3303E Boehringer Ingelheim Investigational Site

location_facility: 1218.20.48208 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.91027 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3304C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3314D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3308F Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3309A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3307I Boehringer Ingelheim Investigational Site

location_facility: 1218.20.91022 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10035 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3304F Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44111 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3302H Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44106 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3307G Boehringer Ingelheim Investigational Site

location_facility: 1218.20.85204 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3307H Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3305H Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49010 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.45003 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49011 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.39029 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3312C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3314A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49018 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3307B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44107 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3310B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10037 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3310C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3314E Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49016 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3312D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3314B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.47004 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49012 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10042 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.48209 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.48210 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44115 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44110 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.31018 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3302G Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44112 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10020 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10033 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10002 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35202 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.36206 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35203 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.48205 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10024 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3308D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49014 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.48202 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49028 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44108 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3310D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10026 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3312B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49006 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.39020 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10036 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.47001 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.31016 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44102 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10006 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10022 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.48207 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.31019 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10034 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3314F Boehringer Ingelheim Investigational Site

location_facility: 1218.20.45006 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35304 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3308A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3307E Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3314C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3306G Boehringer Ingelheim Investigational Site

location_facility: 1218.20.46001 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49013 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.31022 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49029 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10045 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3309D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3303H Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3305B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.91021 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35308 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.39022 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44109 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49019 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49027 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.36202 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3301A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35307 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.45002 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49025 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.27004 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49022 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3302E Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10028 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3307C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3311B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3303G Boehringer Ingelheim Investigational Site

location_facility: 1218.20.39021 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.47003 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3304A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44105 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3308E Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3313D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3303D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3306D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.39030 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3306I Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3311D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.39033 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3307D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49021 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3313C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.36205 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3302D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3313A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10009 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.91024 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3310A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49026 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3307A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3306F Boehringer Ingelheim Investigational Site

location_facility: 1218.20.45013 Boehringer Ingelheim Investigational Site

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location_facility: 1218.20.3304D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.45007 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3302I Boehringer Ingelheim Investigational Site

location_facility: 1218.20.91025 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49020 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.27003 Boehringer Ingelheim Investigational Site

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location_facility: 1218.20.3306H Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10003 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.46002 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10029 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49015 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.46003 Boehringer Ingelheim Investigational Site

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location_facility: 1218.20.3306A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.31013 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49002 Boehringer Ingelheim Investigational Site

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location_facility: 1218.20.36203 Boehringer Ingelheim Investigational Site

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location_facility: 1218.20.3303A Boehringer Ingelheim Investigational Site

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location_facility: 1218.20.35207 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49005 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49007 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.39032 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.31014 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3311C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.27006 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44103 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.46004 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35201 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.48201 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10030 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3302A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3303I Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3305A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44114 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.48206 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.27002 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.47002 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3306B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10007 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3313B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.31011 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3303B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3309C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3309B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3307F Boehringer Ingelheim Investigational Site

location_facility: 1218.20.91026 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.45011 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10023 Boehringer Ingelheim Investigational Site

title: A Randomised Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 1356 ( 5.0 mg, Administered Orally Once Daily) Compared to Glimepiride Over Two Years in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy

location_country:
Germany
Ireland
Italy
Poland
India
Hungary
Hong Kong
Denmark
Norway
Sweden
Netherlands
United Kingdom
United States
South Africa
Bulgaria
France


title: An Open Label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Combination of Telmisartan 40mg + Amlodipine 5mg or the Combination of Telmisartan 80mg + Amlodipine 5mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension.

summary: The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label treatment.

ReferenceCitation: Neldam S, Edwards C, Lang M, Jones R; TEAMSTA-5 and TEAMSTA-10 Investigators. Long-Term Tolerability and Efficacy of Single-Pill Combinations of Telmisartan 40-80 mg Plus Amlodipine 5 or 10 mg in Patients Whose Blood Pressure Was Not Initially Controlled by Amlodipine 5-10 mg: Open-Label, Long-Term Follow-Ups of the TEAMSTA-5 and TEAMSTA-10 Studies. Curr Ther Res Clin Exp. 2012 Feb;73(1-2):65-84. doi: 10.1016/j.curtheres.2012.02.004.

location_country:
Finland
Norway
Denmark
Sweden
Netherlands
Belgium
Korea, Republic of
South Africa
Taiwan
Canada
Philippines
France

location_facility: 1235.7.20007 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3308B Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3307E Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.47003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.46005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20011 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3309E Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3307A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27009 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3307F Boehringer Ingelheim Investigational Site

location_facility: 1235.7.47004 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3308E Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20014 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3309D Boehringer Ingelheim Investigational Site

location_facility: 1235.7.32002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3302D Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63007 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.35004 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3309A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.32004 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3310A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3304B Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3306D Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27010 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301J Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.88603 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27006 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.35002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.46002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301E Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31007 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.46003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3307D Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31004 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.32008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31010 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301B Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82007 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.35001 Boehringer Ingelheim Investigational Site

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location_facility: 1235.7.3301M Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3308F Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27004 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3306A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3303C Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45006 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301H Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.88601 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3302C Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20009 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3305B Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301I Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45007 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.88608 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3302A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45009 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20010 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301N Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31006 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3306F Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82004 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3305A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301G Boehringer Ingelheim Investigational Site

location_facility: 1235.7.32003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301D Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27007 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20006 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.32010 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82006 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301L Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63006 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3309F Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20012 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3302F Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.46001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.35003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3304C Boehringer Ingelheim Investigational Site

location_facility: 1235.7.46004 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63009 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.88605 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3308A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.32005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3309B Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3306C Boehringer Ingelheim Investigational Site

location_facility: 1235.7.47001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.32007 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3306B Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301F Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.47002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20013 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3309C Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3306E Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301C Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3304A Boehringer Ingelheim Investigational Site


title: An International Observational Prospective Study On Long-Term Response To Botulinum Toxin Type A (BoNT-A) Injections In Subjects Suffering From Idiopathic Cervical Dystonia (CD) - Pharmaco-Economic Impact

summary: The purpose of the study is to document long-term response in real-life practice after injection cycles with BoNT-A in subjects suffering from idiopathic cervical dystonia (Long-term clinical and pharmaco-economic data).

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.

repository_institution: Imperial College London - Spiral

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

lead_sponsor: Ipsen

location_country:
Germany
Poland
Taiwan
Algeria
Australia
Brazil
Thailand
Turkey
Czechia
Serbia
France
Slovenia
Portugal
Hungary
United States
Latvia
Romania
Lebanon
Belgium
China
Malaysia
Estonia
Philippines
Italy
United Kingdom
Singapore
Sweden
Austria
Mexico
United Arab Emirates
Korea, Republic of
Jordan
Russian Federation
Israel

location_facility: CHRU Lyon Est Hôpital Neurologique et Neurochirurgical Pierre Wertheimer

location_facility: Spitalul Universitar de Urgenta Bucuresti, neurologie

location_facility: Hospital General Dr. Santiago Ramón y Cajal

location_facility: Medical University of Vienna Spitalgasse 23

location_facility: Department of Neurology 1st LF UK and VFN

location_facility: State Educational Institution of high professional education "St-Peterbusrg state medical university named after I.P. Pavlov of Roszdrav"

location_facility: Istanbul University Cerrahpaşa Medical Faculty

location_facility: State Educational Institution of high professional education "Krasnoyarsk State Medical University named after Professor V.F. Voyno-Yasenetsky of the Ministry of Health and Social Development of Russia"

location_facility: Centre Hospitalier Universitaire Notre Dame de Secours

location_facility: Parkinson's and Movement Disorders Center of Maryland

location_facility: National Rehabilitation center "Vaivari"

location_facility: Policlinico Umberto I, Università La Sapienza

location_facility: Tartu University Hospital, Neurology Clinic

location_facility: Pusan National University Yangsan Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: P. Stradins Clinical University hospital

location_facility: The Parkinson's and Movement Disorders Center

location_facility: State Institution "Interregional clinical diagnostic centre"

location_facility: Centro Hospitalar de Trás-os-Montes e Alto Douro

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Centro de Rehabilitación Integral de Querétaro

location_facility: Hospital das Clínicas, Universidade Federal de Minas Gerais

location_facility: Spitalul Clinic Judetean de Urgenta Timisoara, neurologie II

location_facility: State Federal Budgetary Institution Scientific Center of Neurology RAMS

location_facility: Instituto Nacional de Neurología y Neurocirugía "Manuel Velasco Suárez"

location_facility: Instituto de Medicina Física e Reabilitaçao

intervention_type: Biological


summary: The general aim of this study is to obtain long-term safety and tolerability data on pramipexole ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or 248.636(NCT00558025) trial).

location_facility: 248.633.3301F Boehringer Ingelheim Investigational Site

location_facility: 248.633.38006 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3306F Boehringer Ingelheim Investigational Site

location_facility: 248.633.31006 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3311B Boehringer Ingelheim Investigational Site

location_facility: 248.633.38003 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3312B Boehringer Ingelheim Investigational Site

location_facility: 248.633.42101 Boehringer Ingelheim Investigational Site

location_facility: 248.633.43001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.36005 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3301D Boehringer Ingelheim Investigational Site

location_facility: 248.633.49007 Boehringer Ingelheim Investigational Site

location_facility: 248.633.01009 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3305A Boehringer Ingelheim Investigational Site

location_facility: 248.633.81005 Boehringer Ingelheim Investigational Site

location_facility: 248.633.88605 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49017 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3302B Boehringer Ingelheim Investigational Site

location_facility: 248.633.49003 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49019 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3306A Boehringer Ingelheim Investigational Site

location_facility: 248.633.3303A Boehringer Ingelheim Investigational Site

location_facility: 248.633.49005 Boehringer Ingelheim Investigational Site

location_facility: 248.633.81007 Boehringer Ingelheim Investigational Site

location_facility: 248.633.01016 Boehringer Ingelheim Investigational Site

location_facility: 248.633.81004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.81009 Boehringer Ingelheim Investigational Site

location_facility: 248.633.01018 Boehringer Ingelheim Investigational Site

location_facility: 248.633.01012 Boehringer Ingelheim Investigational Site

location_facility: 248.633.36007 Boehringer Ingelheim Investigational Site

location_facility: 248.633.91001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.38004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3306C Boehringer Ingelheim Investigational Site

location_facility: 248.633.36004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.01008 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3308E Boehringer Ingelheim Investigational Site

location_facility: 248.633.49016 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3308B Boehringer Ingelheim Investigational Site

location_facility: 248.633.81014 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49002 Boehringer Ingelheim Investigational Site

location_facility: 248.633.31004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.36002 Boehringer Ingelheim Investigational Site

location_facility: 248.633.07003 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3309A Boehringer Ingelheim Investigational Site

location_facility: 248.633.38002 Boehringer Ingelheim Investigational Site

location_facility: 248.633.42003 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49009 Boehringer Ingelheim Investigational Site

location_facility: 248.633.91009 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3301A Boehringer Ingelheim Investigational Site

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location_facility: 248.633.88602 Boehringer Ingelheim Investigational Site

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location_facility: 248.633.3303B Boehringer Ingelheim Investigational Site

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location_facility: 248.633.07002 Boehringer Ingelheim Investigational Site

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location_facility: 248.633.81015 Boehringer Ingelheim Investigational Site

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location_facility: 248.633.81008 Boehringer Ingelheim Investigational Site

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location_facility: 248.633.01013 Boehringer Ingelheim Investigational Site

location_facility: 248.633.81001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3312A Boehringer Ingelheim Investigational Site

location_facility: 248.633.07004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.31003 Boehringer Ingelheim Investigational Site

location_facility: 248.633.35803 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3308A Boehringer Ingelheim Investigational Site

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location_facility: 248.633.3303C Boehringer Ingelheim Investigational Site

title: Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).

location_country:
Finland
Germany
India
Slovakia
Hungary
Japan
Netherlands
Austria
United States
Malaysia
Taiwan
Ukraine
Czech Republic
Russian Federation
France