Österreichische Agentur für Gesundheit - BASG

Transcription

BASG / AGES
Institut Überwachung
Traisengasse 5, 1200 Wien
Inspektionsverfahren klinischer Prüfungen nach AMG und MPG
Die Daten werden quartalsweise aktualisiert (Stand Q2 2014)
Studientitel
EudraCT
Nummer/
Eudamed
Nummer
Bardoxolone Methyl Evaluation in Patients with
Chronic Kidney Disease and Type 2 Diabetes:
The Occurrence of Renal Events (BEACON)
Rapid Endovascular Catheter Core Cooling
combined with cold saline as an Adjunct to
Percutaneous Coronary Intervention For the
Treatment of Acute Myocardial Infarction,
CHILL-MI Version 2
2010-022297-14
A Randomised, Double-Blind, Double-Dummy,
Active-Drug-Controlled,
Parallel-Group,
Multicentre Acceptability and Safety Study of
the Transfer from Subutex®/Suboxone® to
RBP-6300 in Opioid-Dependent Subjects
Klinische Studie zur Beurteilung der TECNIS®
1-Piece Multifokal Torischen Intraokularlinse,
Modell Serie ZMT
A Phase 3 Evaluation of BMS-790052
(Daclatasvir) Compared with Telaprevir in
Combination with Peg-Interferon Alfa-2a and
Sponsor
Prüfzentrum
(sofern inspiziert)
Status der Inspektion*
Reata Pharmaceuticals, Inc;
2801 Gateway Drive, Suite
150, Irving, TX 75063, USA
Philips Healthcare,
Innercool Business Unit
6740 Top Gun Street, San
Diego, CA 92121, USA
LKH St. Pölten, Probst FührerStraße 4, 3100 St. Pölten
abgeschlossen
Medizinische Universität
Innsbruck,
Universitätsklinik für Innere
Medizin,
Anichstraße 35
6020 Innsbruck
abgeschlossen
2011-003047-22
Reckitt Benckiser
Pharmaceuticals Inc.,
Dansom Lane, HU8 7DS
Hull, UK
abgeschlossen
Nicht verfügbar
Abbott Medical Optics,
1700 E. St. Andrew Place,
Santa Ana, CA, 92705, USA
2011-004237-14
Bristol-Myers Squibb
International Corporation,
Chaussée de la Hulpe 185,
Innsbruck, Univ. Klinik für
Biologische Psychiatrie,
Anichstraße 35, 6020
Innsbruck
Landeskrankenhaus Salzburg –
Universitätsklinikum der PMU,
Universitätsklinik für
Augenheilkunde und
Optometrie, Müllner
Hauptstraße 48, 5020 Salzburg
Krankenhaus der Elisabethinen
Linz, Interne Abteilung,
Fadingerstraße 1, 4020 Linz,
Nicht verfügbar
abgeschlossen
abgeschlossen
Bundesamt für Sicherheit im Gesundheitswesen
Traisengasse 5 l 1200 Wien l www.basg.at l www.ages.at
DVR: 2112611 l Konto Nr.: 50670 871 619 l BLZ: 12000 l IBAN: AT97 1200 0506 7087 1619 l BIC/SWIFT: BKAUATWW
F_INS_VIE_CLTR_I125_01
Gültig ab: 15.06.2011
1 von 15
BASG / AGES
Ribavirin in Treatment-Naive Patients with
Chronic Hepatitis-C
A Clinical Outcomes Study to compare the effect
of Fluticasone Furoate/Vilanterol Inhalation
Powder 100/25mcg with placebo on Survival in
Subjects with moderate Chronic Obstructive
Pulmonary Disease (COPD) and a history of or
at increased risk for cardiovascular disease.
A phase III, randomized, comparative, openlabel study of intravenous iron oligosaccharide
(Monofer®) administered by infusions or
repeated bolus injections in comparison with
oral iron sulphate in inflammatory bowel disease
subjects with iron deficiency anaemia
Klinische Pilotstudie zur intranasalen
Anwendbarkeit von Dopamin bei Patienten mit
Morbus Parkinson
1170 Brüssel, Belgien
Österreich
GlaxoSmithKline Research
& Development Ltd, 1-3
Iron Bridge Road, Stockley
Park West, Uxbridge
Middlesex, UB11 1BU,
United Kingdom
Pharmacosmos A/S,
Roervangsvej 30, 4300
Holbaek, DK
Ordination,
8330 Feldbach
abgeschlossen
Medizinische Universität Wien,
Univ. Klinik für Innere Medizin
IV, Währinger Gürtel 18-20,
1090 Wien
abgeschlossen
2011-006150-93
M et P Pharma AG,
Schynweg 7, 6376
Emmetten, Schweiz
Confraternität- Privatklinik
Josefstadt, Skodagasse 32,
1080 Wien
abgeschlossen
An open, multi-centre pilot study to investigate
the functional performance, system accuracy
and precision of the GLUCOPEARL blood glucose
monitoring system in 600 type 1 and type 2
diabetic patients
A prospective, randomized, multicenter study to
demonstrate the superiority of the Barricaid® to
discectomy for primary lumbar disc herniation
Nicht verfügbar
4a medicom GmbH
Industriepark 1
A-8772 Traboch
Nicht zutreffend
abgeschlossen
Nicht verfügbar
Intrinsic Therapeutics
Inc.,30 Commerce Way
Woburn, MA 01801, USA
abgeschlossen
Nalmefene Efficacy Study I: Randomised,
double-blind, placebo-controlled, parallel-group,
efficacy study of 20 mg nalmefene, as needed
2007-002334-11
H. Lundbeck A/S, Ottiliavej
9, 2500 Copenhagen –
Valby, DK
Neurochirurgie, Medizinische
Universität Innsbruck,
Anichstraße 35, 6020
Innsbruck
Univ.-Klinik f. Innere Medizin
III, Währinger Gürtel 18-20,
2010-021638-72
2009-012544-16
abgeschlossen
Gültig ab: 15.06.2011
2 von 15
BASG / AGES
use, in patients with alcohol dependence
EXenatide Study of Cardiovascular Event
Lowering Trial (EXSCEL) – A randomized,
placebo controlled clinical trial to evaluate
cardiovascular outcomes after treatment with
exenatide once weekly in patients with type 2
diabetes mellitus
2010-021069-63
Amylin Pharmaceuticals
Inc., 9360 Towne Centre
Drive, San Diego, California
92121 USA und Eli Lilly and
Company, Lilly Corporate
Center, Indianapolis,
Indiana 46285 USA
F. Hoffmann-La Roche Ltd.,
Grenzacherstrasse 124,
4070 Basel, Schweiz
A Multi-Center, Randomized, Double-Blind,
Placebo Controlled, Parallel- Group Study to
Investigate the Efficacy and Safety of
RO4995819 Versus Placebo, as Adjunctive
Therapy in Patients with Major Depressive
Disorder Having Inadequate Response to
Ongoing Antidepressant Treatment (ARTDeCo)
A Phase 1/2a, Open Label, Dose Escalation,
Safety Study of Intra-thrombus Plasmin
(Human) Administration in Acute, Middle
Cerebral Artery, Ischemic Stroke.
2011-002160-24
2009-012086-66
Grifols, Inc., 79 TW
Alexander Drive, Research
Triangle Park, North
Carolina 27709, US
A Pivotal, Multicentre, Double-Blind, DoubleDummy, Randomised Trial on the Contraceptive
Efficacy, Tolerability and Safety of LF111
(Drospirenone) Over 9 Cycles in Comparison
With Desogestrel 0.075 mg
Randomized, Double-Blind, Phase 3 Study of
TAS-102 Plus Best Supportive Care (BSC)
Versuc Placebo Plus BSC In Patients With
2011-002396-42
"Laboratorios León Farma
S.A., La Vallina s/n,
Polígono Industrial de
Navatejera, 24008
Navatejera (León), Spanien
Taiho Pharma USA, 202
Carnegie Center, Suite 100,
08540, Princeton, New
2012-000109-66
1090 Wien
Krankenanstalt Rudolfstiftung
inklusive Standort Semmelweis
Frauenklinik,
Medizinische
Abteilung, Juchgasse 25, 1030
Wien
abgeschlossen
Ordination, 1090 Wien
abgeschlossen
Landes-Nervenklinik WagnerJauregg, Neurologische
Abteilung, Wagner-JaureggWeg 15, 4020 Linz;
Christian-Doppler-Klinik
Salzburg, Universitätsklinik für
Neurologie, Ignaz Harrer Str.
79, 5020 Salzburg
Medizinische Universität Wien AKH Wien, Universitätsklinik
für Frauenheilkunde,
Währinger Gürtel 18-20, 1090
Wien
für Innere Medizin I,
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Gültig ab: 15.06.2011
3 von 15
BASG / AGES
Metastatic Clorectal Cancer Refractory To
Standard Chemotherapies
A Phase III, randomized, double-blind trial to
evaluate the efficacy, safety and tolerability of
TMC435 vs. telaprevir, both in combination with
PegIFNα-2a and ribavirin, in chronic hepatitis C
genotype-1 infected subjects who were null or
partial responders to prior PegIFNα and ribavirin
therapy.
A Double-Blind, Randomized, Parallel Group,
Multi-Centre Study to
Evaluate the Efficacy and Safety of Mirabegron
Compared to Solifenacin in Subjects with
Overactive Bladder (OAB) Treated with
Antimuscarinics and Dissatisfied due to Lack of
Efficacy
Phase III, Parallel-group, Placebo Controlled,
Double-blind, Randomized, Multicenter
International Study to Investigate the Safety
and Efficacy of Propionyl-L-Carnitine (ST261)
Modified Release Tablets in Patients Affected by
Mild Ulcerative Colitis under Oral Stable
Treatment.
A Phase 2b, Randomized, Double-Blind,
Placebo-Controlled Trial Evaluating 16 and 24
Weeks of a Four-Drug Regimen and 24 Weeks
of a Three-Drug Regimen of GS-9451,
Peginterferon Alfa 2a (PEG, Pegasys®) and
Ribavirin (RBV, Copegus®) With and Without
Tegobuvir (GS-9190) Followed by Response
Guided PEG and RBV in Treatment Naïve
Jersey, USA
Wien
Kaiser-Franz-Josef-Spital der
Stadt Wien, Kundratstraße 3,
1100 Wien
2011-001180-53
Janssen R&D Ireland,
Turnhoutseweg 30, 2340
Beerse, Belgien
abgeschlossen
2011-005713-37
Astellas Pharma Europe
Ltd, Lovett House, Lovett
Road, Staines, Middlesex,
TW18 3AZ, UK
Krankenhaus Rudolfstiftung,
Gynäkologie, Juchgasse 25,
1030 Wien.
abgeschlossen
2011-004770-28
Sigma-Tau Industrie
Farmaceutiche Riunite
S.p.A.,Viale Shakespeare,
47, Rome 00144, Italy
abgeschlossen
2010-023952-10
Gilead Science
Incorporated,
333 Lakeside Drive, Foster
City
CA 94404, US
Allgemeines Krankenhaus
Wien
Klinische Abteilung für
Gastroenterologie und
Hepatologie
Währinger Gürtel 18 - 20
1090 Wien, Austria
Med. Univ. Innsbruck, Innere
Med. II, Anichstraße 35, 6020
Innsbruck
abgeschlossen
Gültig ab: 15.06.2011
4 von 15
BASG / AGES
Subjects with Chronic Genotype 1 Hepatitis C
Virus Infection (Protocol GS-US-196-0140)
The influence on the reward properties of food:
an fMRI study on healthy volunteers
A Multicenter, Randomized, Double-Blind,
Placebo-Controlled Study to Evaluate
Cardiovascular Outcomes Following Treatment
with Alogliptin in Addition to Standard of Care in
Subjects with Type 2 Diabetes and Acute
Coronary Syndrome
Comparative bioavailability study of
escitalopram after single dose administration
(fasting conditions) of Escitalopram 20 mg Filmcoated tablets (Nobel Ilac, Turkey) and Cipralex
20 mg Filmtabletten (Lundbeck GmbH,
Germany) in 24 healthy subjects
Open label, balanced, randomized, twotreatment, two-sequence, two-period, singledose, crossover oral bioequivalence study of
Entacapone tablets 200 mg (film-coated
tablets), manufactured by AET Laboratories
Private Limited, Hyderabad, India and
Comtess® 200 mg film-coated tablets
containing 200 mg Entacapone manufactured
by Orion Corporation, Finnland, in normal,
healthy, adult, male, human subjects under
fasting conditions.
2008-008658-22
Wien -AKH Wien,
Medizin III, Währinger
Gürtel 18-20, 1090 Wien
Takeda Global Research &
Development Centre
(Europe) Ltd., 61 Aldwych,
WC2B 4AE London, UK
für Innere Medizin III,
Wien
Wien
abgeschlossen
nicht verfügbar
Nobel Ilac Paz. Ve San. Ltd.
Sti. Inkilap Mah.
Akcakoca Sok. No 10
TR-34768 UmraniyeIstanbul, Türkei
abgeschlossen
nicht verfügbar
AET Laboratories Private
Limited, Survey No.42 ,
Gaddapotharam, Kazipally
Industrial Area, Medak Dist,
502 319, Hyderabad,
Andhra Pradesh, Indien
DEKAM-IKU - Center for Good
Clinical Practice
Erciyes University Medical
Factory
Hakan Cetinsaya GCP Unit
TR-38039 Kayseri, Türkei
GVK Biosciences Pvt. Ltd.,
Clinical Pharmacology Unit, 7th
Floor, Swarna Jayanthi
Commercial Complex,
Ameerpet, Hyderabad –
500038, Indien
2009-011222-34
abgeschlossen
abgeschlossen
Gültig ab: 15.06.2011
5 von 15
BASG / AGES
A single-dose, comparative bioavailability study
of two formulations of Ezetimibe 10mg tablets
under fasting
Nicht verfügbar
Lek Pharmaceuticals d.d.,
Verovskova 57, SI-1526
Ljubljana, Slovenia
Pharma Medical Research Inc.
6100 Belgrave Road,
Mississauga, Ontario, Canada,
L5R 0B7
abgeschlossen
Klinische Pilotstudie zur Evaluierung von
Sicherheit und Wirksamkeit der neuartigen
Methode der subkutanen implantatgestützten
Verankerung von Exoprothesen (Subcutaneous
Implant Supported Attachment / SISA) an
transhumeral amputierten Personen
Study on the relative bioavailability of
dronabinol administered as single dose 10 mg
"Ölige Tropfen Dronabinol 2% Lösung" and
Marinol Capsules in 16 healthy subjects
Nicht verfügbar
Otto Bock Healthcare
Products GmbH
Kaiserstraße 39
1070 Wien, Österreich
Univ.-Klink für Chirurgie,
Währinger Gürtel 18-20
1090 Wien
abgeschlossen
2005-004112-79
Sanatorium Hansa,
Körblergasse 42, 8010 Graz
abgeschlossen
Multi-centre, randomized, double-blind, placebocontrolled study to investigate the efficacy and
safety of the pain relieving effect of Dronabinol
in patients with multiple sclerosis associated
with central neuropathic pain
2006-004255-38
Bionorica Research Gmbh,
Mitterweg 24
6020 Innsbruck
Mitterweg 24
6020 Innsbruck
Mitterweg 24
6020 Innsbruck
abgeschlossen
Treatment
of
Patients
Suffering
from
Nausea/Vomiting with Dronabinol
(tetrahydrocannabinol) Comparsion of three
dosages versus standard therapy in a cross-over
design
Study on the bioavailability of dronabinol
administered as single and multiple doses of
4.17 mg 'Ölige Tropfen Dronabinol 2% Lösung'
in 18 healthy subjects.
2007-000444-27
Mitterweg 24
6020 Innsbruck
Ordination, 1010 Wien;
LKH Villach, Nikolaigasse 43,
9500 Villach;
Barmherzige Brüder GrazEggenberg, Bergstraße 27,
8020 Graz
LKH Klagenfurt, St.
Veiterstraße 47, 9020
Klagenfurt
2007-001297-90
Mitterweg 24
6020 Innsbruck
Zentrum für medizinische
Grundlagenforschung Graz
abgeschlossen
abgesagt
Gültig ab: 15.06.2011
6 von 15
BASG / AGES
Treatment of Patients Suffering from Tumour
Cachexia with Dronabinol
(tetrahydrocannabinol) or Placebo Comparison
of individually optimised dosages in a double
blind, randomised parallel design
Verbesserung des Cardiac Output durch
automatische Optimierung der kardialen
Resynchronisationstherapie mittels Signalen der
endokardialen Beschleunigung
A randomized, placebo-controlled, dose-ranging,
multi-centre trial of
QAW039 (1-450 mg p.o.), to investigate the
effect on FEV1 and ACQ in patients with
moderate-to-severe, persistent, allergic asthma,
inadequately controlled with ICS therapy
Bioequivalence study of Ethinylestradiol 0.03 mg
I Drospirenone 3 mg mibe film-coated tablets
(mibe
GmbH Arzneimittel, test formulation) vs.
Yasmin® film-coated tablets (Bayer Vital GmbH,
Germany,
reference formulation) after single dose
administration to healthy female volunteers
under fasting
conditions
A one-year trial evaluating the efficacy and
safety of the ALK house dust mite allergy
immunotherapy tablet in adult subjects with
house dust mite allergic rhinitis.
2007-002968-10
Nicht verfügbar
Wien -AKH Wien,
Medizin III, Währinger
Dr. Süssenbacher
Wien
Innsbruck, Univ.-Klinik für
Innere Medizin III, Anichstraße
35, 6020 Innsbruck
Ordination Linz
abgeschlossen
abgeschlossen
2011-001062-18
Novartis Pharma Services
AG, Forum 1, Novartis
Campus, Basel CH-4056,
Schweiz
abgeschlossen
Nicht verfügbar
Dermapharm AG, LilDagover-Ring 7, 82031
Gruenwald, Deutschland
hameln rds a.s., Homa 36, 900
01 Modra, Slovak Republic
abgeschlossen
2011-002277-38
ALK-Abelló A/S
Bøge Aile 6-8
Hørsholm
DK-2970 Denmark
Allgemeines Krankenhaus der
Stadt Wien
Dermatologie
Währinger Gürtel 18 – 20
1090 Wien
abgeschlossen
Gültig ab: 15.06.2011
7 von 15
BASG / AGES
Multicenter, randomized, double-masked, 2
parallel arm, vehicle controlled, 6-month phase
III trial with a 6 month open label treatment
safety follow up period to evaluate the efficacy
and safety of CYCLOKAT® 1mg/ml
(Ciclosporin/Cyclosporine) eye drops, emulsion
administered once daily in adult patients with
severe Dry Eye Disease (DED)
A Phase 3 Study to Evaluate the Efficacy and
Safety of Induction and Maintenance Regimens
of Brodalumab Compared With Placebo and
Ustekinumab in Subjects With Moderate to
Severe Plaque Psoriasis: AMAGINE-2
A Phase 1b/2 Open Label Study to Evaluate the
Safety and Efficacy of TRU-016 in Combination
with Bendamustine vs. Bendamustine Alone in
Patients with Relapsed Chronic Lymphocytic
Leukemia
A Phase III, randomized, double-blind, placebocontrolled study to investigate the efficacy,
safety and tolerability of TMC435 vs. placebo as
part of a treatment regimen including
peginterferon α-2a and ribavirin in hepatitis C,
genotype 1 infected subjects who relapsed after
previous interferon-based therapy”
TMC435HPC3007 (PROMISE)
2011-000160-97
NOVAGALI Pharma S.A., 1
rue Pierre Fontaine Bâtiment Genavenir IV, F91058 Evry; contact : Iris
Pharma
Medizinische Universität Graz,
Universitäts-Augenklinik,
Auenbruggerplatz 4, 8036 Graz
abgeschlossen
2012-000656-34
Amgen Inc., One Amgen
Center Drive, Thousand
Oaks, CA 91320, USA
Allgemeines Krankenhaus der
Stadt Wien, Universitätsklinik
für Dermatologie, Währinger
Gürtel 18 - 20, 1090 Wien
abgeschlossen
2010-019554-41
Emergent
Product
Development Seattle, LLC,
2401 4th Avenue, Suite
1050
Univ.klinik für Innere Medizin
I, Währinger Gürtel 18-20,
1090 Wien
abgeschlossen
nz
Janssen
R&D
(formerly
Pharmaceuticals)
Auckland City Hospital, Park
Road, Grafton, Auckland 1010,
New Zealand
abgeschlossen
Ireland
Tibotec
UND
Waikato Hospital, 214
Pembroke Street, Hamilton,
New Zealand
UND
UND
A Phase III, randomized, double-blind, placebocontrolled study to investigate the efficacy,
Toronto Western Hospital,
Gültig ab: 15.06.2011
8 von 15
BASG / AGES
safety and tolerability of TMC435 vs. placebo as
part of a treatment regimen including
peginterferon α-2a and ribavirin in treatmentnaïve, genotype 1 hepatitis C-infected subjects”
TMC435-TiDP16-C208 (QUEST-1)
Clinical Study to investigate the
pharmacokinetics, efficacy, safety, and
immunogenicity of human-cl rhFVIII, a newly
developed human cell-line derived recombinant
FVIII concentrate in previously treated patients
with severe haemophilia A
UND
Health Network University
Toronto, Toronto M5T 2S8,
Canada
2008-001563-11
Octapharma
Seidenstrasse
2,
Lachen, Schweiz
AG,
8853
UND
2010-018644-14
Prospective,
non-controlled,
open
label,
multinational, multicentre phase III study
A Randomized, Double-Blinded, ActiveControlled Study of CB-183,315 in Patients with
Clostridium Difficile Associated Diarrhea
2012-000252-34
CLINICAL EFFICACY AND SAFETY OF
TAZAROTENE CREAM 0.05% IN THE INITIAL
AND MAINTENANCE THERAPIES OF LAMELLAR
ICHTHYOSIS (LI)
2010-022284-35
Multicenter, Randomized, Active-Controlled
2012-000255-13
Cubist
Pharmaceuticals,
Inc., 65 Hayden Avenue,
Lexington MA 02421, USA
Orfagen
CRDPF - Langlade
3 avenue Hubert Curien
BP 13562
Toulouse 31035
France
Portola
Pharmaceuticals,
Medizinische Hochschule
Hannover
Feodor-Lynen-Str. 5
30625 Hannover
UND
Moscow Children’s Hematology
Centre
Izmailovsky Children’s Hospital
Verhniaja Pervomayskaya St,
48/15
105077, Moscow
Russian Federation
Krankenhaus Barmherzige
Schwestern Wien,
Chirurgische Abteilung
Stumpergasse 13
1060 Wien
Innsbruck
Univ.- Klinik für Dermatologie
und Venerologie
Anichstrasse 35
6020 Innsbruck
Wilhelminenspital Wien,
abgeschlossen
abgeschlossen
abgeschlossen
abgeschlossen
Gültig ab: 15.06.2011
9 von 15
BASG / AGES
Efficacy And Safety Study Comparing Extended
Duration Betrixaban With Standard Of Care
Enoxaparin For The Prevention Of Venous
Thromboembolism In Acute Medically Ill
Patients
A randomized, double-blind, double. dummy,
placebo controlled, multicenter study of sc
secukinumab to demonstrate efficacy after
twelve weeks of treatment, compared to
placebo and etanercept, and to assess the
safety, tolerability and long-term efficacy up to
one year in subjects with moderate to severe
chronic plaque-type psoriasis.
Inc., 270 East Grand
Avenue,
South
San
Francisco,
CA
94080,
United States of America
Montleartstraße 37, 1160 Wien
CAIN457A230
Novartis
Pharma
AG,
Lichtstraße 35, CH-4056
Basel
Site 3200, Cutis Kopavogur,
Island, IS-201
UND
WiXi AppTec C., Ltd, 228 Fute
Zhong Road Shanghai China
200131, Waigaoqia Free Trade
Zone
UND
Cognizant Technology
Solutions, Floor Level 6th and
7th, Unit No 5, Mindspace SEZ
Navi Mumbai India 400708,
Thane Belapur Road, Airoli
abgeschlossen
A multi-centre, open label, uncontrolled, Phase
IIa clinical trial evaluating the safety and
efficiacy of NOX-A12 in combination with a
background therapy of bendamustine and
rituximab (BR) in previously treated patients
with chronic lymphocytic leukemia (CLL)
Efficacy and safety of 3 doses of S 38093 (2, 5
and 20 mg/day) versus placebo, in coadministration with donepezil (10 mg/day) in
patients with moderate Alzheimer's Disease.
2011-004672-11
NOXXON Pharma AG, MaxDohrn-Strasse 8-10, 10589
Berlin, Deutschland
Medizin, Medizinische
Universität Innsbruck,
Anichstrasse 35, 6020
Innsbruck
abgeschlossen
2011-005862-40
Krankenhaus der
Barmherzigen Brüder Linz,
Seilerstätte 2,
4021 Linz
abgeschlossen
A multi-centre, randomized, double-blind,
2011-000393-61
Institut
de
Recherches
Internationales Servier
50 rue Carnot
92284 Suresnes
France
HAL Allergy B.V.
Universitätsklinik für Hals-,
abgeschlossen
Gültig ab: 15.06.2011
10 von 15
BASG / AGES
placebo-controlled, dose range finding study to
identify the optimal (i.e. safe and effective)
dose of PURETHAL® Mites SCIT in patients with
house dust mites-induced persistent allergic
rhinitis/rhinoconjunctivitis
A PHASE 3, MULTI SITE, RANDOMIZED,
DOUBLE BLIND, PLACEBO CONTROLLED,
PARALLEL GROUP STUDY OF THE EFFICACY
AND SAFETY OF 2 ORAL DOSES OF CP-690,550
AND 1 SUBCUTANEOUS DOSE OF ETANERCEPT
IN SUBJECTS WITH MODERATE TO SEVERE
CHRONIC PLAQUE PSORIASIS
A Phase 3, Randomized, Double-Blind,
Multicenter Study Comparing Oral MLN9708 Plus
Lenalidomide and Dexamethasone Versus
Placebo Plus Lenalidomide and Dexamethasone
in Adult Patients With Relapsed and/or
Refractory Multiple Myeloma
A multi-centre, double-blind dose-ranging study
to evaluate
the efficacy and safety/tolerability of Birch
Modified Allergen Tyrosine-adsorbed + MPL
(POLLINEX Quattro® Birch) in Subjects with
seasonal allergic rhinoconjunctivitis due to birch
pollen
A 12-Week Efficacy and Safety Evaluation of
Budesonide/Formoterol
SPIROMAX® 160/4.5 mcg Inhalation Powder
Versus SYMBICORT®
TURBOHALER® 200/6 mcg in Adult and
Adolescent Patients with
Oortweg 15-17
2333 CH Leiden
Niederlanden
2010-020004-30
2011-005496-17
Pfizer Inc.
235 East 42nd Street
New York NY 10017
NYO-219-08-01
219 East 42nd Street
NY 10017 New York
United States
Millennium
Pharmaceuticals, Inc
40 Landsdowne Street
02139 Cambridge, MA
USA
Nasen und
Ohrenerkrankungen,
Innsbruck, Anichstraße 35,
6020 Innsbruck
Dermatologie,
Landeskrankenhaus Salzburg,
5020 Salzburg
abgeschlossen
Wilhelminenspital Wien,
Montleartstraße 37, 1160 Wien
abgeschlossen
2012-004336-28
Allergy Therapeutics (UK)
Ltd.
Dominion Way
Worthing, West Sussex
BN14 8SA
United Kingdom
Universitätsklinik für Hals-,
Nasen und
Ohrenerkrankungen,
Währinger Gürtel 18-20,
1090 Wien
abgeschlossen
2013-000081-11
Teva Branded
Pharmaceutical Products
R&D, Inc.
41 Moores Road
PA 19355 Frazer
United States
Ordination Wels
abgeschlossen
Gültig ab: 15.06.2011
11 von 15
BASG / AGES
Persistent Asthma
Randomized, Multicenter, Open-label, Phase III
Study of Plitidepsin in Combination with
Dexamethasone vs. Dexamethasone Alone in
Patients with Relapsed/Refractory Multiple
Myeloma
A 36-month, multi-centre, randomized doubleblind placebo-controlled study to evaluate the
safety and efficacy of low dose Ladostigil in
patients with Mild Cognitive Impairment (MCI)
Evaluation of the effectiveness, safety, and
tolerability of tapentadol PR versus a
combination of tapentadol PR and pregabalin in
subjects with severe chronic low back pain with
a neuropathic pain component
An Open-Label Multicenter Study to Evaluate
the Impact of Adalimumab on Quality of Life,
Health Care Utilization and Costs of Ulcerative
Colitis Subjects in the Usual Clinical Practice
Setting
A Phase 3, Randomized, Multi-Center, MultiNational, Double-Blind Study to Evaluate the
Efficacy, Safety, and Pharmacokinetics of Once
Daily versus Twice Daily Dosing of Genz-112638
in Patients with Gaucher Disease Type 1 who
have Demonstrated Clinical Stability on a Twice
Daily Dose of Genz-112638
2009-016138-29
Pharma Mar, S.A.
Av. de los Reyes, 1 - Pol.
Ind. "La Mina",
28770 Colmenar Viejo
(Madrid), Spanien
2011-004187-30
Avraham Pharmaceuticals
Ltd.
42 Hayarkon Street,
Northern Industrial Zone
Yavneh 81227, Israel
Grünenthal GmbH
Zieglerstr. 6
52078 Aachen
Deutschland
2010-019998-14
2011-002411-29
2009-015811-42
AbbVie Deutschland GmbH
& Co. KG
Knollstrasse 50, 67061
Ludwigshafen
Deutschland
Genzyme Europe B.V.,
Gooimeer 10, 1411 DD
Naarden, Niederlanden
Medizin III,
Landeskrankenhaus Salzburg –
Universitätsklinikum der
Paracelsus Medizinischen
Privatuniversität, Müllner
Hauptstr. 48, 5020 Salzburg
Ordination 1130 Wien
abgeschlossen
Klinikum Klagenfurt am
Wörthersee
St.-Veiter-Strasse 47
9020 Klagenfurt
durchgeführt
Ordination Hainburg/Donau
durchgeführt
Medizin III, Medizinische
Universität Wien, Währinger
durchgeführt
durchgeführt
Gültig ab: 15.06.2011
12 von 15
BASG / AGES
Double-blind, randomized, placebo-controlled,
phase II dose-finding study comparing different
doses of norursodeoxycholic acid capsules with
placebo in the treatment of primary sclerosing
cholangitis
2011-002754-31
Dr. Falk Pharma GmbH
Leinweberstrasse 5
79108 Freiburg
Deutschland
Medizinische Universität Graz
Klinik für Innere Medizin
Abteilung Gastroenterologie
und Hepatologie
Auenbruggerplatz 15
8036 Graz
abgeschlossen
Efficacy and Safety of AM-101 in the Treatment
of Acute Peripheral
Tinnitus 3 (TACTT3)
2012-004099-20
Auris Medical AG
Falknerstrasse 4
4001 Basel
Switzerland
durchgeführt
Offene, verblindet ausgewertete, prospektive,
kontrollierte, randomisierte, multizentrische
klinische Studie Phase III zum intraindividuellen Vergleich der Wirksamkeit und
Verträglichkeit von Oleogel-S10 im Vergleich zur
Standardtherapie hinsichtlich der
Beschleunigung der Wundheilung an
Spalthautentnahmestellen.
A multi-center, randomized, double-blind, threearm, 16 week, adaptive phase III clinical study
to investigate the efficacy and safety of
LAS41008 vs LASW1835 and vs Placebo in
patients with moderate to severe plaque
psoriasis
A Phase 3, Randomized, Double Blind, Placebo
Controlled, Parallel Group Study to Evaluate the
Efficacy and Safety of Lumacaftor in
Combination With Ivacaftor in Subjects Aged 12
Years and Older With Cystic Fibrosis,
2012-000777-23
Birken AG
Streiflingsweg 11
Niefern-Öschelbronn
75223 Deutschland
Krankenhaus der Elisabethinen
Abteilung für Hals-NasenOhrenheilkunde
Elisabethinergasse 14
8020 Graz
Universitätsklinik für Chirurgie,
1090 Wien
2012-000055-13
Almirall S.A., Rda General
Mitre 151, 08022 Barcelona
Ordination 1100 Wien
durchgeführt
2012-003990-24,
2013-000604-41
Vertex Pharm. Inc. 50
Northern Avenue 02210
Boston, MA
Klinikum Wels Grieskirchen
Grieskirchnerstrasse 42
4600 Wels
durchgeführt
durchgeführt
Gültig ab: 15.06.2011
13 von 15
BASG / AGES
Homozygous for the F508del CFTR Mutation
Und
A Phase 3, Rollover Study to Evaluate the Safety
and Efficacy of Long-term Treatment With
Lumacaftor in Combination With Ivacaftor in
Subjects Aged 12 Years and Older With Cystic
Fibrosis, Homozygous or Heterozygous for the
F508del-CFTR Mutation
Phase 3 Randomised, Double-Masked, PlaceboControlled Study of the Effect of OMS302 on
Intraoperative Pupil Diameter in Subjects at
High Risk of Intraoperative Floppy Iris
Syndrome Undergoing Intraocular Lens
Replacement.
A 12-Week Efficacy and Safety Evaluation of
Budesonide/Formoterol
SPIROMAX® 160/4.5 mcg Inhalation Powder
Versus SYMBICORT®
TURBOHALER® 200/6 mcg in Adult and
Adolescent Patients with
Persistent Asthma
Long-term effects of Aldara® 5% cream and
Solaraze® 3% gel in the treatment of actinic
keratosis on the face or scalp with respect to
the risk of progression to in-situ and invasive
squamous cell carcinoma (LEIDA 2).
A Multicenter, Randomized, Double-blind,
Placebo-controlled, Parallel-group Study of the
Safety and Efficacy of a Single Treatment of
2013-003885-15
Omeros Corporation, 201
Elliott Avenue West, WA
98119 Seattle
Hanusch Krankenhaus,
Heinrich – Collin – Str. 30,
1140 Wien
durchgeführt
2013-000081-11
Teva Branded
Pharmaceutical Products
R&D, Inc.
41 Moores Road
PA 19355 Frazer
United States
Ordination Grieskirchen
durchgeführt
2010-022054-16
MEDA Pharma GmbH & Co.
KG
Benzstraße 1
Bad Homburg
61352 Deutschland
Allergan Ltd, Marlow
International, First Floor,
Parkway, SL7 1YL Marlow,
Ordination Maria Enzersdorf
angekündigt
Anästhesie, Allgemeine
Intensivmedizin und
angekündigt
2012-002240-24
Gültig ab: 15.06.2011
14 von 15
BASG / AGES
AGN-214868 in Patients With Postherpetic
Neuralgia
Buckinghamshire, United
Kingdom
Schmerztherapie, Medizinische
Universität Wien,
1090 Wien
* angekündigt, durchgeführt, abgeschlossen. Das Inspektionsergebnis wird aus datenschutzrechtlichen Erwägungen nicht im Detail veröffentlicht.
Gültig ab: 15.06.2011
15 von 15

Österreichische Agentur für Gesundheit - BASG

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