Q2 2016 Bearbeitungsstand INS klin Prüfungen

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BASG / AGES
Institut Überwachung
Traisengasse 5, 1200 Wien
Inspektionsverfahren klinischer Prüfungen nach AMG/ICH-GCP und MPG
Die Daten werden quartalsweise aktualisiert (Stand Q2 2016)
Studientitel
A Randomized, Double-Blind, Phase III Study of
the Efficacy and Safety of Gemcitabine in
Combination With TH-302 Compared With
Gemcitabine in Combination With Placebo in
Previously Untreated Subjects With Metastatic
or Locally Advanced Unresectable Pancreatic
Adenocarcinoma
An Open Label, Multicenter, randomized, phase
III study to investigate the efficacy and safety
of Bendamustine compared with Bendamustine
+ RO5072759 (GA101) in patients with
Rituximab-refractory, indolent Non-Hodgkin’s
Lymphoma
TWO PERIOD TWO SEQUENCE, CROSS-OVER,
CONTROLLED, BLOCK RANDOMIZED, SINGLE
DOSE
RIOEQUIVALENCE
STUDY
OF
GABAPENTINA KERN 400 mg CAPSULES (TEST
FORMULATION-ALFRED
E.
TIEFENBACHER
GmbH & Co, GERMANY) vs. NEURONTJN® 400
mg CAPSULES (REFERENCE FORMULATIONPFIZER INC.) IN HEALTHY MALE AND FEMALE
VOLUNTEERS
EudraCT
Nummer/
Eudamed
Nummer
Sponsor
Prüfzentrum
(sofern inspiziert)
Status der Inspektion*
2012‐002957‐42
Merck KGaA,
Frankfurterstrasse 250,
64293 Darmstadt,
Deutschland
Kaiser‐Franz‐Josef‐Spital,
Kundratstraße 3, 1100 Wien
abgeschlossen
2009-015504-25
Genentech, Inc.
1 DNA Way
South San Francisco, CA
94080-4990, USA
Universitätsklinik für Innere
Medizin, Medizinische
Universität Graz,
Auenbruggerplatz 38, 8036
Graz
abgeschlossen
Alfred E. Tiefenbacher
GmbH & Co, Van-derSmissen-Strasse 1, 22767
Hamburg, Deutschland
Analytical Site: 3S
Pharmacological Consultation
& Research GmbH/Pharma
Serv International Srl, Calea
13 Septembrie 90,
050726 Bukarest, Romania
Clinical site: Clinical Hospital
oft the Ministry of Health of
the Republic of
Moldova, Chisinau
abgeschlossen
Nicht zutreffend
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 7
BASG / AGES
Single dose oral bioequivalence study of
Darunavir film-coated Tablets 600 mg and
‘PREZISTA®’ (Darunavir) Film tabletten (filmcoated Tablets) 600 mg with co-administration
of ‘NORVIR®’ (Ritonavir) Film tabletten (filmcoated Tablets) 100 mg in healthy adult human
subjects under fed conditions.
Nicht zutreffend
Mylan Laboratories Limited,
Clinical Research Centre,
Saradhi Chambers, Plot No.
4-A, Beside Poulomi
Hospital, Rukminipuri, Dr.
A. S. Rao Nagar,
Hyderabad 500062, India.
A randomised, double-blind, placebo- and
active-controlled parallel group study to assess
the efficacy of 12 weeks of once daily treatment
of two doses of orally inhaled tiotropium+
olodaterol fixed dose combination (delivered by
the Respimat inhaler) in patients with moderate
to severe Chronic Obstructive Pulmonary
Disease (COPD)
A 52-week treatment, multi-center, randomized,
double-blind, double-dummy, parallel-group,
active controlled study to compare the effect of
QVA149 (indacaterol maleate / glycopyrronium
bromide) with salmeterol/fluticasone on the rate
of exacerbations in subjects with moderate to
very severe COPD.
2013-002264-24
Boehringer Ingelheim RCV
GmbH & Co. KG, Dr.
Boehringer-Gasse 5-11,
1121 Wien
2012-004966-16
Novartis Pharma Services
AG, Novartis Campus,
Forum 1, 4056 Basel,
Schweiz
Sponsor site: Mylan
Laboratories Limited, Clinical
Research Centre, Saradhi
Chambers, Plot No. 4-A,
Beside Poulomi Hospital,
Rukminipuri, Dr. A. S. Rao
Nagar, Hyderabad 500062,
India.
Clinical Site: Cliantha Research
Limited, 1st floor, Silver
Arcade, Near Ashwamegh III,
Samrajya, Mujmahuda Road,
Akota, Vadodara- 390020,
Gujarat, India
Ordination 4020 Linz
abgeschlossen
Ordination 4020 Linz
durchgeführt
durchgeführt
Gültig ab: 15.06.2011
2 von 7
BASG / AGES
Randomised Phase II Pilot Study: Induction
Chemotherapy with Docetaxel, Cisplatin und
Cetuximab versus Docetaxel, Cisplatin und 5 FU
followed by Radiotherapy with Cetuximab for
locally advanced or not resectable Carcinoma of
the Head and Neck
An open-label, prospective, multicentre, phase
I/II dose escalation study to determine the
maximum tolerated dose and to assess the
safety and efficacy of P1101, PEG-ProlineInterferon
alpha-2b
for
patients
with
Polycythaemia vera (PV)
An open Label, randomized, balanced, twotreatment, two-period, two-sequence,
singledose, crossover, oral bioequivalence study
of AMLODIPINA LPH 10 mg tablets from
Labormed Pharma, Romania compared with
that of NORVASC 10 mg tablets from Pfizer
Manufacturing Deutschland GmbH - Germania,
in healthy, adult, human subjects under fasting
conditions.
2011-005540-99
Arbeitsgemeinschaft
medikamentöse
Tumortherapie
gemeinnützige GmbH
(AGTM), Plenergasse 5/31,
1180 Wien
AOP Orphan
Pharmaceuticals AG
Wilhelminenstrasse 91/II f
1160 Wien
Universitätsklinik für
Strahlentherapie, Medizinische
Universität Wien, Währinger
Gürtel 18-20, 1190 Wien
durchgeführt
Donauspital/SMZ-Ost,
Langobardenstrasse 122,
1220 Wien
durchgeführt
Nicht zutreffend
SC Labormed Pharma SA,
Theodor Pallady 44B,
032266, Rumänien
durchgeführt
2013-000685-11
TESARO Inc.
1000 Winter Street, Suite
3300, 02451 Waltham
USA
Analytical site: Norwich Clinical
Services Pvt. Ltd., 147/F, 8th
Main, 3rd Block, Koramangala,
Bangalore - 560 034,
Karnataka, INDIA.
Clinical Site: Norwich Clinical
Services Pvt. Ltd., Aster CMI
Hospital, 3rd floor, 43/2, NH-7,
Bellary road, Sahakara Nagar,
Bangalore - 560 092,
Karnataka, INDIA
Sponsor site: SC Labormed
Pharma SA, Theodor Pallady
44B, 032266, ROMANIA
Univ. Klinik für
Frauenheilkunde, Medizinische
Gürtel 18, 1090 Wien
A Phase 3 Randomized Double-Blind Trial of
Maintenance with Niraparib Versus Placebo in
Patients with Platinum Sensitive Ovarian Cancer
2010-018768-18
abgeschlossen
Gültig ab: 15.06.2011
3 von 7
BASG / AGES
Efficacy and tolerability of nicotinamide as addon therapy compared to placebo in dialysisdependent patients with hyperphosphatemia
2013-000488-95
MEDICE Arzneimittel Pütter
GmbH & Co. KG, Kuhloweg
37, 58638 Iserlohn,
Deutschland
Krka, d.d., Novo mesto,
Šmarješka 6, 8501 Novo
mesto, Slovenia
SINGLE DOSE CROSSOVER COMPARATIVE
BIOAVAILABILITY STUDY OF LINEZOLID 600
mg FILM-COATED TABLETS IN HEALTHY MALE
AND FEMALE VOLUNTEERS
Nicht zutreffend
A randomized, controlled, double-blind Phase III
trial to compare the efficacy, safety and
pharmacokinetics
of
GP2013
plus
Cyclophosphamide, Vincristine, Prednisone vs.
MabThera® plus Cyclophosphamide, Vincristine,
Prednisone, followed by GP2013 or MabThera®
maintenance therapy in patients with previously
untreated, advanced stage follicular lymphoma.
A multicenter, open, randomized, Phase II/III
study, evaluating efficacy and safety of
erythrocytes encapsulating L-asparaginase
(GRASPA) versus reference L-asparaginase
treatment in combination with standard polychemotherapy in patients with first recurrence
of Philadelphia chromosome negative acute
lymphoblastic leukemia (ALL Ph-)
2010-019522-13
HEXAL AG, Industriestrasse
25, D-83607 Holzkirchen,
Germany
2009-012584-34
ERYTECH Pharma,
Bâtiment Adénine - 60
Avenue Rockefeller, 69008
Lyon, Frankreich
2 Dialysezentren in Salzburg
durchgeführt
Analytical site: Algorithme
Pharma Inc., 575 ArmandFrappier Blvd., Laval, Quebec,
H7V 4B3, Canada
Clinical site: Algorithme
Pharma Inc., 1200 Beaumont
Ave., Mount-Royal, Quebec,
H3P 3P1, Canada
Hanusch Krankenhaus der
Wiener Gebietskrankenkasse,
Heinrich-Collin-Str. 30, 1040
Wien
durchgeführt
Clinical site: Hopital Mere
Enfant, 38 Bd Jean Monnet,
44093 Nantes – Cewdex 1,
Frankreich
UND
Clinical site: Hopital des
Enfants Groupe Hospitalier
Pellegrin, Place Amélie Raba
Léon, 33076 Bordeaux,
Frankreich
abgeschlossen
durchgeführt
Gültig ab: 15.06.2011
4 von 7
BASG / AGES
A Phase 3, Multicenter, Open-label, Randomized
Study of nab-Paclitaxel Plus Gemcitabine versus
Gemcitabine Alone as Adjuvant Therapy in
Subjects with Surgically Resected Pancreatic
Adenocarcinoma
Multiple, fixed-dose, comparative efficacy and
safety evaluation of RGB-02 and Neulasta®
in patients undergoing chemotherapy treatment
known to induce neutropenia
2013-003398-91
Celgene Corporation, 86
Morris Avenue, 07901
Summit, NJ, USA
Landesklinikum Wr. Neustadt,
Corvinusring 3, 2700 Wiener
Neustadt
durchgeführt
2013-003166-14
Gedeon Richter Plc,
Gyömrői út 19-21, 1103
Budapest, Ungarn
durchgeführt
Correlation Research Trial between the NonInvasive Cerebral Pressure Monitor (CPM)
System and invasive Intracranial Pressure (ICP)
Values and Waveforms in Subjects with Brain
Pathology or Injury that Requires ICP
Monitoring
A 52-week, Double Blind, Double dummy,
Randomized, Multinational, Multicentre, 2-arm
Parallel Group, active Controlled Clinical Trial of
fixed
combination
of
beclometasone
dipropionate plus formoterol fumarate plus
Glycopyrronium bromide administered via pMDI
(CHF 5993) versus indacaterol/glycopyrronium
(Ultibro®) via DPI in patients with Chronic
Obstructive Pulmonary Disease
Nicht zutreffend
Orsan Medical Technologies
Ltd., 4 Arie Regev St., POB
8079 Sappir Industrial Park
Netanya, Zip 42504, Israel
Clinical site: Klinikai Központ ,
Onkoterápiás Klinika, 6720
Szeged, UNGARN
Sponsor site: Gedeon Richter
Plc, Gyömrői út 19-21, 1103
Budapest, UNGARN
Universitätsklinik f. Neurologie,
Medizinische Universität
Innsbruck, Anichstraße 35,
6020 Innsbruck
2014-001704-22
Chiesi Farmaceutici S.p.A.;
Laura Fabbri; Via Palermo
26A ; 43100 Parma; Italien
Ordination, Bundesland
Salzburg
durchgeführt
durchgeführt
Gültig ab: 15.06.2011
5 von 7
BASG / AGES
A Single-Arm, Open-Label, Multicenter Clinical
Trial with Nivolumab (BMS-936558) for Subjects
with Histologically Confirmed Stage III
(unresectable)
or
Stage
IV
Melanoma
Progressing After Prior Treatment Containing an
Anti-CTLA-4 Monoclonal Antibody
Bewertung der Leistungsfähigkeit von Atos-P,
einem
System
zur
kontinuierlichen
Glukosemessung
An
open-label,
balanced,
randomized,
twotreatment,
two-period,
two-sequence,
multipledose, crossover, oral bioequivalence
study of Bupropion Hydrochloride Modified
Release
Tablets
300
mg
of Alembic
Pharmaceuticals Ltd, India and Elontril®
(Bupropionhydrochlorid) 300 mg Tabletten mit
Veränderter Wirkstofffreisetzung, Manufactured
by GlaxoSmithKline GmbH & Co.; Germany, in
healthy, adult, human male subjects.
A Phase 3, Open-Label, Single-Arm Study to
Evaluate the Safety and Efficacy of TMC435 plus
Pegylated Interferon alfa-2a and Ribavirin
Administered for 12 Weeks in Treatment-Naïve
Subjects with Chronic Genotype 1 or Genotype
4 HCV Infection.
Randomised, double-blind, 56 week placebocontrolled, parallel group, multicentre, phase 3
study to evaluate the efficacy and safety of 2
doses of benralizumab in patients with
moderate to very severe COPD with a history of
exacerbations (GALATHEA)
2014-001286-28
Bristol-Myers Squibb
International Corporation
Chaussée de la Hulpe 185
Brussels, 1170 Belgien
Universitätsklinik
für Dermatologie, Medizinische
Gürtel 18-20, 1090 Wien
durchgeführt
Nicht zutreffend
Roche Diagnostics GmbH,
Sandhoferstr. 116, 68305
Mannheim, Deutschland
Alembic Pharmaceuticals
Limited, Alembic Road,
Vadodara, Gujarat, Indien
390 003
Privatklinik Salzburg
durchgeführt
Micro Therapeutic Research
Labs Private Limited, No.6,
Kamarajar Salai, Selaiyur, East
Tambaram, Chennai – 600
059, Tamil Nadu, India.
durchgeführt
2012-004905-29
Janssen-Cilag International
NV, Turnhoutseweg 30,
Beerse 2340, Belgien
Wilhelminenspital
Montleartstrasse 37
1160 Wien
durchgeführt
2013-004590-27
Astra Zeneca, Vastra
Malarehamnen, 151 85
Sodertalje, Schweden
Ordination, Bundesland
Oberösterreich
angekündigt
Nicht zutreffend
Gültig ab: 15.06.2011
6 von 7
BASG / AGES
* angekündigt, durchgeführt, abgeschlossen. Das Inspektionsergebnis wird aus datenschutzrechtlichen Erwägungen nicht im Detail veröffentlicht.
Gültig ab: 15.06.2011
7 von 7

Q2 2016 Bearbeitungsstand INS klin Prüfungen

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