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.

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

family: Fitoussi

full_name: Olivier Fitoussi

given: Olivier

family: Haioun

full_name: Corinne Haioun

given: Corinne

family: Thieblemont

full_name: Catherine Thieblemont

given: Catherine

family: Quach

full_name: Hang Quach

given: Hang

family: Delarue

full_name: Richard Delarue

given: Richard

family: Glaisner

full_name: Sylvie Glaisner

given: Sylvie

family: Gabarre

full_name: Jean Gabarre

given: Jean

family: Bosly

full_name: André Bosly

given: André

family: Lister

full_name: John Lister

family: Li

full_name: Ju Li

given: Ju

family: Coiffier

full_name: Bertrand Coiffier

given: Bertrand

journal_name: European Journal of Cancer

title: 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

status: Terminated

lead_sponsor: Celgene

location_country:
Belgium
United States
Australia
France

acronym: EXPECT

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

location_facility: Cliniques universitaires UCL de Mont-Godinne

location_facility: Clinical Research Unit Cairns Base Hospital

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

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.

status_simplified: Unknown


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.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: LivaNova

location_country:
Italy
France
Belgium
Germany
United Kingdom

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

intervention_type: Device

lead_sponsor_type: industriel

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)

ReferenceType: derived

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.

family: Cohen

full_name: Alexander T. Cohen

given: Alexander T.

sequence: first

family: Pan

full_name: Sharon Pan

given: Sharon

sequence: additional

family: Byon

full_name: Wonkyung Byon

given: Wonkyung

family: Ilyas

full_name: Bushra S. Ilyas

given: Bushra S.

family: Taylor

full_name: Thomas Taylor

given: Thomas

family: Lee

full_name: Theodore C. Lee

given: Theodore C.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Advances in Therapy

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

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.

name: Department of Haematology, Guy’s and St Thomas' Hospitals, King's College London, London, United Kingdom

full_name: Alexander Cohen

given: Alexander

name: Internal, Vascular and Emergency Medicine, University of Perugia, Perugia, Italy

family: Agnelli

full_name: Giancarlo Agnelli

given: Giancarlo

name: Department of Vascular Medicine, Academic Medical Center, Universiteit van Amsterdam, Amsterdam, The Netherlands

family: Buller

full_name: Harry Buller

given: Harry

name: Department of Haematology, Flinders Medical Centre, Flinders University, Adelaide, Australia

family: Gallus

full_name: Alexander Gallus

name: Hudson College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, University of Oklahoma, Oklahoma, United States

family: Raskob

full_name: Gary Raskob

given: Gary

name: Pfizer Ltd, Walton Oaks, Walton on the Hill, Tadworth, Surrey, United Kingdom

family: Sanders

full_name: Paul Sanders

given: Paul

name: Pfizer Inc, Groton, Connecticut, United States

family: Thompson

full_name: John Thompson

given: John

name: McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada

family: Weitz

full_name: Jeffrey Weitz

given: Jeffrey

journal_name: Thrombosis and Haemostasis

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

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). pii: e002340. doi: 10.1161/JAHA.115.002340.

name: University of Tennessee College of Pharmacy, Memphis, TN

name: Guy's and St Thomas' Hospitals, London, UK

journal_name: Journal of the American Heart Association

publisher: Ovid Technologies (Wolters Kluwer Health)

title: 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

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.

title: Oral Apixaban for the Treatment of Acute Venous Thromboembolism

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

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: University Of Arkansas For Medical Sciences

location_facility: George Washington University Medical Faculty Associates

location_facility: University Of California San Francisco-Fresno

location_facility: Atlanta Institute For Medical Research, Inc

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

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

location_facility: University Of California, Davis Medical Center

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

location_facility: Washington University School Of Medicine


intervention_type: Drug

study_start_date_type: Actual

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.

lead_sponsor: UNICANCER

location_country:
United States
Belgium
France

acronym: TavIx

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

location_facility: CHR - Clinique Saint Joseph - Hopital de Warqueguies

location_facility: Siouxland Hematology-Oncology Associates, LLP

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

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

location_facility: Centre Hospitalier Intercommunal Le Raincy - Montfermeil

location_facility: Centre Hospitalier General de Mont de Marsan

location_facility: CCOP - Geisinger Clinic and Medical Center

location_facility: Roger Maris Cancer Center at MeritCare Hospital

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Centre de Radiotherapie et Oncologie Saint-Faron

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

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

location_facility: CCOP - Missouri Valley Cancer Consortium

location_facility: Oncology Associates at Rapid City Regional Hospital

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

ipd_sharing: Yes

type: Other Identifier

type: EudraCT Number

source: euctr

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.

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.


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


lead_sponsor: NSABP Foundation Inc

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

acronym: BETH

location_facility: Krankenhaus Barmherzige Schwestern Linz, Kooperative Studiengruppe, Chirurgie

location_facility: Florida Cancer Specialists-Bonita Springs

location_facility: Florida Cancer Specialists-Port Charlotte

location_facility: Thompson Cancer Survival Center-Dowell Springs

location_facility: Northwestern Carolina Oncology & Hematology, PA

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

location_facility: University Hospital and Medical Center-SUNY

location_facility: UPMC Cancer Centers - McKeesport Hospital

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Mecklenburg Medical Group - Morehead Medical Dr

location_facility: Ephrata Cancer Center at Ephrata Community Hospital

location_facility: Comprehensive Cancer Centers of Nevada (Siena)

location_facility: Cancer Care and Hematology Specialists of Chicagoland

location_facility: Northern Indiana Cancer Research Consortium

location_facility: Berdat Family Comprehensive Cancer Centre

location_facility: University Hospital and Medical Center - SUNY

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

location_facility: Oncology Associates of Bridgeport-Fairfield

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

location_facility: Northwest Cancer Specialists-Adventist Office

location_facility: Northern Arizona Hematology & Oncology Associates

location_facility: Hubert H. Humphrey Cancer Center-Robbinsdale

location_facility: Hematology Oncology Assaociates of CNY, CCOP

location_facility: Washington Oncology-Hematology Center, PC-Washington

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: Hubert H. Humphrey Cancer Center - Coon Rapids

location_facility: Community Cancer Care Specialists-Mt. Clemens

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

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

location_facility: UPMC Cancer Centers Arnold Palmer-Mt. Pleasant

location_facility: Florida Cancer Specialists-Venice Island

location_facility: Mecklenburg Medical Group - Cameron Valley Pkwy

location_facility: Kaposi Mor oktato korhaz Onkologiai tanszek

location_facility: Krankenhaus Hietzing, Gynaekologische Abteilung

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

location_facility: Instituto de Oncologia Clinica de Piracicaba

location_facility: Rockwood Cancer Treatment Center - Sinto Ave

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

location_facility: Oncology Associates of Bridgeport-Trumbull

location_facility: North County Oncology Medical Clinic, Inc.

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

location_facility: Tartu University Hospital Clinic of Hematology and Oncology

location_facility: University Medical Center of Southern Nevada

location_facility: Central Hematology/Oncology Medical Group, Inc.

location_facility: University of Tennessee Cancer Institute

location_facility: Carolinas Hematology-Oncology - John J. Delaney

location_facility: Santa Barbara Hematology Oncology Medical Group

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

location_facility: Hematology Oncology Centers of the Northern Rockies

location_facility: CCOP, Christiana Care Health Services Inc.

location_facility: MBCCOP, Virginia Commonwealth University

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

location_facility: Carolinas Hematology-Oncology Associates - Tyron St

location_facility: Hematology and Medical Oncology Consultants-Bettendorf

location_facility: Cancer Care & Hematology Specialists of Chicagoland

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

location_facility: Florida Cancer Specialists-Fort Myers Broadway

location_facility: P. Stradina Clinical University Hospital

location_facility: Fairview Southdale Medical Oncology Clinic

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

location_facility: CCOP, St. John Hospital and Medical Center

location_facility: Cancer and Blood Specialists- Shadow Lane

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

location_facility: Riverview Cancer Care Medical Association

location_facility: Zentrum fur Frauenheilkunde und Geburtshilfe

location_facility: AI Universitätsklinikum der PMU Landeskliniken

location_facility: Department of Oncotherapy National Hospital

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

location_facility: Connecticut Multi Specialty Group-Hartford

location_facility: Hospital Clinico Universitario Lozano Blesa

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

location_facility: Cancer Care Specialists-Central Illinois

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

location_facility: Landeskrankenhaus Voecklabruck, 2. Medizinische Abteilung

location_facility: UPMC Cancer Centers Arnold Palmer Pavilion-Mountainview

location_facility: Suburban Hematology Oncology Associates PC

location_facility: Oncology/Hematology Care Clinical Trials LLC

location_facility: Fachärzte fürlnnere Medizin, Hämatologie

location_facility: Hematology and Medical Oncology Consultants-Davenport

location_facility: Florida Cancer Specialists-Cape Coral Del Prado

location_facility: Henry Ford Medical Center-West Bloomfield

location_facility: Dayton Clinical Oncology Program-Kettering

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: Florida Cancer Specialists-Cape Coral Parkway

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

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

location_facility: Adelaide and Meath National Childrens Hospital

location_facility: Medizinische Universitaet Wien-Allgemeines Krankenhaus, Onkologie

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

location_facility: Minnesota Oncology Hematology PA - Maplewood

location_facility: Allegheny General Hospital/Allegheny-Singer Research Institute

location_facility: Peninsula Regional Oncology & Hematology

location_facility: Michiana Hematology-Oncology, PC Lakeland

location_facility: Bezirkskrankenhaus Kufstein, Innere Medizin

location_facility: UP Hematology/Oncology Associates-Gogebic Range

location_facility: Seoul National University Bundang Hospital

location_facility: Cancer Institute of New Jersey at Hamilton

location_facility: Northern Arizona Hematology & Onclogy Associates

location_facility: Cross Cancer Institute, Dept of Medicine

location_facility: 1st Affiliated Hospital of Zhejiang University

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

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

location_facility: NY Oncology Hematology PC at Albany Medical Center

location_facility: The Center for Cancer and Blood Disorders

location_facility: Carolinas Medical Center - Blumenthal Cancer Center

location_facility: Centro Integral de Oncologia "Clara Campal"

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

location_facility: Upper Peninsula Hematology/Oncology Associates

location_facility: Carolinas Hematology Oncology Associates - Harris Blvd.

location_facility: Michigan State University - Breslin Cancer Center

location_facility: Florida Cancer Specialists-Naples Goodlette

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

location_facility: Providence Oncology and Hematology Care Clinic

location_facility: Harry & Jeannette Weinberg Cancer Institute

location_facility: Hubert H. Humphrey Cancer Center - Fridley

location_facility: Olsztynski Osrodek Onkologiczny "Kopernik"

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

location_facility: Praxis und Tagesklinik fuer Onkologie und

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

location_facility: San Diego Pacific Oncology & Hematology-Vista

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

location_facility: University of Medicine and Dentistry of New Jersey

location_facility: Medizinische Universitat Graz - Onkologie

location_facility: Eastern Connecticut Hematology & Oncology Associates

location_facility: Hospital Das Clinicas de Porto Alegre-HCPA

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

location_facility: Landeskrankenhaus Leoben, Abteilung fur Haemato-Onkologie

location_facility: North Treatment Center - Blue Ash Medical Center

location_facility: Krankenhaus Barmherzige Brueder Graz, Medizinische Abteilung

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Connecticut Multi Specialty Group-Wethersfield

location_facility: Complejo Hospitalario Universitario A Coruna

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

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

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Florida Cancer Specialists-Fort Myers Summerlin

location_facility: Hematology Oncology Associates of CNY, CCOP

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

location_facility: Cancer Care Associates Medical Group, Inc.

location_facility: Fuzhou General Hospital of Nanjing Military Area

location_facility: Klinikverbund Suedwest - Sindelfingen-Böeblingen Clinical Centre

location_facility: Central Coast Medical Oncology Corporation

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

location_facility: The Lady Davis Carmel Medical Center/Lynn

location_facility: UPMC Cancer Centers Arnold Palmer-Oakbrook

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

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.


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 HbA₁c < 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.

name: Department Medicine IV; Universitätsklinikum Tübingen; Tübingen Germany

family: Gallwitz

full_name: B. Gallwitz

given: B.

name: Dallas Diabetes and Endocrine Center at Medical City; Dallas TX USA

family: Rosenstock

full_name: J. Rosenstock

given: J.

family: Emser

full_name: A. Emser

given: A.

family: von Eynatten

full_name: M. von Eynatten

given: M.

family: Woerle

full_name: H.-J. Woerle

journal_name: International Journal of Clinical Practice

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Linagliptin is more effective than glimepiride at achieving a composite outcome of target HbA1c< 7% with no hypoglycaemia and no weight gain over 2 years

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.

full_name: Baptist Gallwitz

given: Baptist

full_name: Julio Rosenstock

given: Julio

family: Rauch

full_name: Thomas Rauch

family: Bhattacharya

full_name: Sudipta Bhattacharya

given: Sudipta

family: Patel

full_name: Sanjay Patel

given: Sanjay

full_name: Maximilian von Eynatten

given: Maximilian

family: Dugi

full_name: Klaus A Dugi

given: Klaus A

full_name: Hans-Juergen Woerle

given: Hans-Juergen

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

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.

family: Johansen

full_name: Odd Johansen

given: Odd

family: Neubacher

full_name: Dietmar Neubacher

given: Dietmar

currency_apc_doaj: GBP

journal_name: Cardiovascular Diabetology

oa_colors: green gold

evidence: oa journal (via doaj)

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

location_facility: 1218.20.39033 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.45013 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.45006 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.45001 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3309C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.46002 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3305B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35207 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3307E Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3307F Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49019 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10029 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49002 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3306D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10006 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3304C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.85202 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35202 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.45003 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49014 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3308A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.46003 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.27002 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.85201 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.47001 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3311A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49007 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10013 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10024 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49011 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.31023 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.36204 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10034 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.31014 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44111 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3310D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10037 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.27003 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10026 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3307D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3306B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49008 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3307B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3307C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10032 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.47004 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3303I Boehringer Ingelheim Investigational Site

location_facility: 1218.20.45002 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3313C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3308D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10035 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.85204 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3309D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3310E Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49013 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10033 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.39020 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3306F Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3314C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.91027 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10020 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.48202 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10007 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44104 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.46001 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49004 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44103 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35203 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.36202 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3313B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.39034 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3302H Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3302C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49020 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.31011 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10028 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3310A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3302G Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3314B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49028 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.36207 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3307I Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10003 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3311D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.45007 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.91020 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49025 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3314F Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49010 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49016 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.31016 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3307A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49026 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3303A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49006 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3302E Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44113 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3308F Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3312C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3313D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3304B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.39029 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10002 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49017 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3303H Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3307H Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3311B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35308 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35303 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.27007 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35306 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3301A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.45011 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.27004 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49009 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3314D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35201 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49003 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.36205 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49022 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.31019 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49021 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3314E Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35304 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.48205 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.36201 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.31013 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44112 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.39032 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3310B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3304F Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44116 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3306G Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3303B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3314A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49030 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49015 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.39028 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3306A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10009 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.47005 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3302D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.48207 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.48203 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49012 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10031 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.91026 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.27005 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3312D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49018 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.48209 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44109 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3304A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.31012 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3303C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49024 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.91024 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.39027 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.91021 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.36203 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44110 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.36206 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3313A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49027 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10042 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.47003 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10045 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3308E Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3306I Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44105 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3309A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10023 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.48206 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44106 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3312A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3303E Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44102 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.91022 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3304H Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3310C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44108 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49005 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.39030 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3302I Boehringer Ingelheim Investigational Site

location_facility: 1218.20.49029 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35307 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3303G Boehringer Ingelheim Investigational Site

location_facility: 1218.20.48210 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.48201 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44101 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.39022 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.47002 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3308C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3304D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.48208 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3309B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44107 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10036 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.46004 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3302A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44114 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35310 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3309E Boehringer Ingelheim Investigational Site

location_facility: 1218.20.91023 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.31022 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.91025 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10022 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.39021 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3305H Boehringer Ingelheim Investigational Site

location_facility: 1218.20.31018 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3305A Boehringer Ingelheim Investigational Site

location_facility: 1218.20.44115 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.27006 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3307G Boehringer Ingelheim Investigational Site

location_facility: 1218.20.35204 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3311C Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3303D Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3312B Boehringer Ingelheim Investigational Site

location_facility: 1218.20.10030 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.36208 Boehringer Ingelheim Investigational Site

location_facility: 1218.20.3306H 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

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


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.

apc_source: doaj

family: Neldam

full_name: Steen Neldam

given: Steen

family: Edwards

full_name: Colin Edwards

given: Colin

family: Lang

full_name: Margreet Lang

given: Margreet

family: Jones

full_name: Russell Jones

given: Russell

currency_apc_doaj: USD

journal_name: Current Therapeutic Research

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

repository_institution: PubMed Central - Europe PMC

title: 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

lead_sponsor: Boehringer Ingelheim

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

location_facility: 1235.7.3307F Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3310A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20009 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3309E Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31010 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20006 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3306A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27004 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.88608 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.32005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27010 Boehringer Ingelheim Investigational Site

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location_facility: 1235.7.82001 Boehringer Ingelheim Investigational Site

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location_facility: 1235.7.88601 Boehringer Ingelheim Investigational Site

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location_facility: 1235.7.3309C Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.47004 Boehringer Ingelheim Investigational Site

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location_facility: 1235.7.35004 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3304A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301J Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3305B Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3306D Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3308A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3308F Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3302A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63006 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3303C Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20013 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3304C Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20007 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20012 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45007 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20010 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20011 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3307A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3306F Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31006 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.47002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3309A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.35003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301F Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20014 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301C Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301L Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3302C Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3306B Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31004 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.46005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45009 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82007 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3305A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.35002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45006 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3306C Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.46001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.47003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.47001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.35001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.32007 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.32010 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3309D Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3302F Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301H Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3307D Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3306E Boehringer Ingelheim Investigational Site

location_facility: 1235.7.46003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3309F Boehringer Ingelheim Investigational Site

location_facility: 1235.7.32003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63009 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3307E Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.32008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3308E Boehringer Ingelheim Investigational Site

location_facility: 1235.7.46004 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.32004 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3309B Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27006 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.88605 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301E Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301N Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.46002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3308B Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82006 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.88603 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301B Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3302D Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27009 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3304B Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31007 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63007 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82004 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301M Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301G Boehringer Ingelheim Investigational Site


title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of Drotrecogin Alfa (Activated) Administered as a Continuous 96-hr Infusion to Adult Patients With Septic Shock

summary: The purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated) treatment provides significant mortality reduction improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock. This study will also assess the effectiveness of drotrecogin alfa (activated) in reducing 28-day mortality in patients with septic shock and concomitant severe protein C deficiency.

ReferenceCitation: Póvoa P, Salluh JI, Martinez ML, Guillamat-Prats R, Gallup D, Al-Khalidi HR, Thompson BT, Ranieri VM, Artigas A. Clinical impact of stress dose steroids in patients with septic shock: insights from the PROWESS-Shock trial. Crit Care. 2015 Apr 28;19:193. doi: 10.1186/s13054-015-0921-x.

family: Póvoa

full_name: Pedro Póvoa

given: Pedro

family: Salluh

full_name: Jorge I F Salluh

given: Jorge I F

family: Martinez

full_name: Maria L Martinez

given: Maria L

family: Guillamat-Prats

full_name: Raquel Guillamat-Prats

given: Raquel

family: Gallup

full_name: Dianne Gallup

given: Dianne

family: Al-Khalidi

full_name: Hussein R Al-Khalidi

given: Hussein R

family: Thompson

full_name: B Taylor Thompson

given: B Taylor

family: Ranieri

full_name: V Marco Ranieri

given: V Marco

family: Artigas

full_name: Antonio Artigas

given: Antonio

journal_name: Critical Care

license: cc-by

license_normalized: cc-by

ReferenceCitation: Ranieri VM, Thompson BT, Barie PS, Dhainaut JF, Douglas IS, Finfer S, Gårdlund B, Marshall JC, Rhodes A, Artigas A, Payen D, Tenhunen J, Al-Khalidi HR, Thompson V, Janes J, Macias WL, Vangerow B, Williams MD; PROWESS-SHOCK Study Group. Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med. 2012 May 31;366(22):2055-64. doi: 10.1056/NEJMoa1202290. Epub 2012 May 22.

full_name: V. Marco Ranieri

given: V. Marco

full_name: B. Taylor Thompson

given: B. Taylor

family: Barie

full_name: Philip S. Barie

given: Philip S.

family: Dhainaut

full_name: Jean-François Dhainaut

given: Jean-François

family: Douglas

full_name: Ivor S. Douglas

given: Ivor S.

family: Finfer

full_name: Simon Finfer

given: Simon

family: Gårdlund

full_name: Bengt Gårdlund

repository_institution: The University of Queensland - Queensland's institutional digital repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Audencia Business School

title: Drotrecogin Alfa (Activated) in Adults with Septic Shock

location_country:
Italy
United States
Brazil
India
Switzerland
Mexico
Netherlands
Germany
Spain
Finland
United Kingdom
France
Belgium
Australia
New Zealand
Portugal
Canada
Czech Republic

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


design_allocation: Non-Randomized

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

location_facility: 248.633.91009 Boehringer Ingelheim Investigational Site

location_facility: 248.633.43004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3313A Boehringer Ingelheim Investigational Site

location_facility: 248.633.88602 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3302B Boehringer Ingelheim Investigational Site

location_facility: 248.633.81015 Boehringer Ingelheim Investigational Site

location_facility: 248.633.01008 Boehringer Ingelheim Investigational Site

location_facility: 248.633.36006 Boehringer Ingelheim Investigational Site

location_facility: 248.633.07006 Boehringer Ingelheim Investigational Site

location_facility: 248.633.31003 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3311B Boehringer Ingelheim Investigational Site

location_facility: 248.633.3303B Boehringer Ingelheim Investigational Site

location_facility: 248.633.38003 Boehringer Ingelheim Investigational Site

location_facility: 248.633.01009 Boehringer Ingelheim Investigational Site

location_facility: 248.633.88605 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3303C Boehringer Ingelheim Investigational Site

location_facility: 248.633.31006 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49003 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3306B Boehringer Ingelheim Investigational Site

location_facility: 248.633.81006 Boehringer Ingelheim Investigational Site

location_facility: 248.633.81004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.81001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.81005 Boehringer Ingelheim Investigational Site

location_facility: 248.633.01005 Boehringer Ingelheim Investigational Site

location_facility: 248.633.35802 Boehringer Ingelheim Investigational Site

location_facility: 248.633.36003 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3304A Boehringer Ingelheim Investigational Site

location_facility: 248.633.49015 Boehringer Ingelheim Investigational Site

location_facility: 248.633.81008 Boehringer Ingelheim Investigational Site

location_facility: 248.633.43001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49017 Boehringer Ingelheim Investigational Site

location_facility: 248.633.81014 Boehringer Ingelheim Investigational Site

location_facility: 248.633.31001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3301C Boehringer Ingelheim Investigational Site

location_facility: 248.633.42004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.91007 Boehringer Ingelheim Investigational Site

location_facility: 248.633.38004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.31002 Boehringer Ingelheim Investigational Site

location_facility: 248.633.81012 Boehringer Ingelheim Investigational Site

location_facility: 248.633.36004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3306F Boehringer Ingelheim Investigational Site

location_facility: 248.633.38005 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49012 Boehringer Ingelheim Investigational Site

location_facility: 248.633.36002 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49009 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3305B Boehringer Ingelheim Investigational Site

location_facility: 248.633.01004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.38001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49016 Boehringer Ingelheim Investigational Site

location_facility: 248.633.42101 Boehringer Ingelheim Investigational Site

location_facility: 248.633.36007 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49002 Boehringer Ingelheim Investigational Site

location_facility: 248.633.38002 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3308A Boehringer Ingelheim Investigational Site

location_facility: 248.633.81002 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3301B Boehringer Ingelheim Investigational Site

location_facility: 248.633.36001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.88601 Boehringer Ingelheim Investigational Site

location_facility: 248.633.01012 Boehringer Ingelheim Investigational Site

location_facility: 248.633.36005 Boehringer Ingelheim Investigational Site

location_facility: 248.633.01016 Boehringer Ingelheim Investigational Site

location_facility: 248.633.35803 Boehringer Ingelheim Investigational Site

location_facility: 248.633.91001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3306D Boehringer Ingelheim Investigational Site

location_facility: 248.633.81003 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3309A Boehringer Ingelheim Investigational Site

location_facility: 248.633.3302A Boehringer Ingelheim Investigational Site

location_facility: 248.633.3302C Boehringer Ingelheim Investigational Site

location_facility: 248.633.38006 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49018 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3311A Boehringer Ingelheim Investigational Site

location_facility: 248.633.07003 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.81013 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49011 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3306A Boehringer Ingelheim Investigational Site

location_facility: 248.633.81009 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3305A Boehringer Ingelheim Investigational Site

location_facility: 248.633.35801 Boehringer Ingelheim Investigational Site

location_facility: 248.633.81007 Boehringer Ingelheim Investigational Site

location_facility: 248.633.42003 Boehringer Ingelheim Investigational Site

location_facility: 248.633.07001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3301F Boehringer Ingelheim Investigational Site

location_facility: 248.633.3301G Boehringer Ingelheim Investigational Site

location_facility: 248.633.36008 Boehringer Ingelheim Investigational Site

location_facility: 248.633.01001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.60004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.42001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49013 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3301D Boehringer Ingelheim Investigational Site

location_facility: 248.633.07004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.91005 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3306C Boehringer Ingelheim Investigational Site

location_facility: 248.633.3308B Boehringer Ingelheim Investigational Site

location_facility: 248.633.88603 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3308E Boehringer Ingelheim Investigational Site

location_facility: 248.633.81010 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3301A Boehringer Ingelheim Investigational Site

location_facility: 248.633.42103 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3308C Boehringer Ingelheim Investigational Site

location_facility: 248.633.01013 Boehringer Ingelheim Investigational Site

location_facility: 248.633.81011 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3303A Boehringer Ingelheim Investigational Site

location_facility: 248.633.3308D Boehringer Ingelheim Investigational Site

location_facility: 248.633.91011 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49007 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3312A Boehringer Ingelheim Investigational Site

location_facility: 248.633.42002 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49005 Boehringer Ingelheim Investigational Site

location_facility: 248.633.31004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.01018 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49019 Boehringer Ingelheim Investigational Site

location_facility: 248.633.91004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.01010 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3312B Boehringer Ingelheim Investigational Site

location_facility: 248.633.07002 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3309B Boehringer Ingelheim Investigational Site

location_facility: 248.633.91002 Boehringer Ingelheim Investigational Site

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

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).