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Medicament De Medicament De International Nr Medicament de Medicament de International Nr. estimat de Nr. de pacienti Data autorizarii Nr. Numar investigatie Aria Denumirea Data aprobarii Data Inceperii Inchidere Cod Protocol investigatie clinica Placebo Solicitant Sponsor / Faza pacienti pt. inrolati in studiului clinic de Inchidere studiu crt. EudraCT clinica terapeutică studiului Comisiei de Etica Studiului Temporara testat national Romania Romania catre ANMDM comparator A Phase III Randomised, Double-Blind, Parallel Group, Quintiles Romania SRL Multicentre Study to Compare the Efficacy, Safety, SB3-G31-BC, version 1.0, dated Bujor Eugen Almasan Pharmacokinetics and Immunogenicity between SB3 1 2013-004172-35 SB3 (trastuzumab biosimilar) Herceptin® (trastuzumab) Nu Afecţiuni oncologice Samsung Bioepis Co., Ltd. internaţional III 45 05.06.2014 28.05.2014 25.06.2014 14.02.2017 08.11.2013 E-mail: bujor- (proposed trastuzumab biosimilar) and Herceptin® in Women [email protected] with Newly Diagnosed HER2 Positive Early or Locally Advanced Breast Cancer in Neoadjuvant Setting PAREXEL International Romania SRL A multicenter, prospective, randomized, open label study to CRLX030A3301, version 00, dated Novartis Pharma Services 2 2013-002513-35 serelaxin (RLX030) standard-of-care Nu Afecţiuni cardiovasculare Mirela Bogdan internaţional assess the effect of serelaxin versus standard of care in III 56 25.06.2014 04.08.2014 25.04.2017 22.03.2017 13.09.2013 Romania SRL E-mail: acute heart failure (AHF) patients [email protected] The Study of the Immunogenity and Reactogenity of Institutul Național de Cercetare- Institutul Național de Cercetare- IC/VG/P01-2013, version vaccin gripal trivalent purificat şi Trivalent, Purified, Inactivated Influenza Vaccine for 3 2013-005292-40 Nu Nu Afecţiuni virale Dezvoltare pentru Microbiologie si Dezvoltare pentru Microbiologie si naţional IV 100 16.01.2014 ed.1/rev.0, dated 15.12.2013 inactivat Parenteral Administration in Adults, for the 2013-2014 Imunologie "Cantacuzino" Imunologie "Cantacuzino" Season, Produced by INCDMI Cantacuzino Argint International Clinical Research & Development Services Kft. Long term, single-arm, open-label extension study of protocol AC-055-308, version 3, dated 4 2012-004411-31 macitentan (ACT-064992) Nu Nu Afecţiuni cardiovasculare Teodora Dinu Actelion Pharmaceuticals Ltd. internaţional AC-055-305 to assess the safety, tolerability and efficacy of III 8 18.07.2014 26.05.2014 12.11.2014 19.09.2013 E-mail: macitentan in subjects with Eisenmenger Syndrome [email protected] om Pharmaceutical Research A Multicenter, Double blind, Randomized, Placebo controlled, Afecţiuni ale sistemului Associates Romania SRL Parallel group Study to Investigate the Efficacy and Safety of 5 SP0969, dated 22.05.2013 2012-004996-38 Vimpat® (lacosamide) Nu Da UCB BIOSCIENCES, Inc. internaţional III 6 18.07.2014 05.06.2014 05.12.2014 25.10.2016 nervos Ioana Comes Lacosamide as Adjunctive Therapy in Subjects with epilepsy E-mail:[email protected] ≥4 Years to <17 Years of Age with Partial Onset Seizures Pharmaceutical Research A Multicenter, Open-label, Long-term extension Study to Associates Romania SRL Afecţiuni ale sistemului Investigate the Efficacy and Safety of Lacosamide as 6 EP0034, dated 24.05.2013 2012-005012-26 Vimpat® (lacosamide) Nu Nu Ioana Comes UCB BIOSCIENCES, Inc. internaţional III 6 18.07.2014 11.11.2014 24.04.2015 nervos Adjunctive Therapy in Pediatric Subjects with epilepsy with E-mail: Partial-Onset Seizures [email protected] A phase 3, multicenter, randomized, single-blind, dose- Afecţiuni şi anomalii ranging, crossover study to evaluate the safety and efficacy 0624-301, version: Am#2 dated Comac Medical SRL 7 2013-002453-29 Cinryze® (C1-INH) Nu Nu congenitale, ereditare şi internaţional of intravenous administration of Cinryze® (C1 esterase III 1 11.07.2014 22.05.2014 17.07.2014 28.12.2016 11.12.2013 Diana Munteanu Shire ViroPharma Incorporated neonatale inhibitor [human]) for the prevention of angioedema attacks in children 6 to 11 years of age with hereditary angioedema INC Research Romania SRL Doina Dobjanschi A Phase 3, Multicenter, Extension of Study ALK9072- ALK9072-003EXT2, version Final, Afecţiuni ale sistemului 8 2013-001423-39 aripiprazole lauroxil (ALKS 9072) Nu Nu E-mail: Alkermes, Inc. internaţional 003EXT to Assess the Long-term Safety and Durability of III 25 13.08.2014 17.10.2014 22.06.2016 dated 04.04.2013 nervos SM_INC_Regulatory_Romania@I Effect of ALKS 9072 in Subjects with Stable Schizophrenia NCResearch.com PAREXEL International Romania A Phase 3, Randomized, Double-Blind, Placebo-Controlled, s.r.l. MK-8835-007 (Protocol B1521017 Merck Sharp & Dohme Corp., a 26-Week Multicenter Study With a 78-Week Extension to Afecţiuni nutriţionale şi Andreea Raluca Ghinea 9 Pfizer) (Protocol 210226 Parexel), 2013-003290-95 ertugliflozin (MK-8835) glimepiride Da subsidiary of Merck & Co., Inc., internaţional Evaluate The Efficacy and Safety of Ertugliflozin in Subjects III 62 22.08.2014 05.06.2014 20.10.2014 metabolice E-mail: version 00, dated 20.09.2013 USA With Type 2 Diabetes Mellitus and Inadequate Glycemic andreea- Control on Metformin Monotherapy [email protected] A multicenter, randomized, double-blind phase 3 study to Quintiles Romania SRL evaluate tolerability and pharmacokinetics of 500μg RO-2455-302-RD, version Final, Afecţiuni ale tractului Bujor Eugen Almasan Takeda Development Centre roflumilast once daily with an up-titration regimen in COPD, 10 2013-001788-21 roflumilast Nu Da internaţional III 96 30.05.2014 10.07.2014 19.08.2014 30.11.2015 dated 01.11.2013 respirator E-mail: bujor- Europe LTD including an open-label down-titration period evaluating [email protected] tolerability and pharmacokinetics of 250μg roflumilast once daily in subjects not tolerating 500μg roflumilast once-daily Efficacy and Safety of a Single TRUS-guided Intraprostatic Afecţiuni ale sistemulului NX1207-IT-CL0414, version Final, Omexel® L.p. (tamsulosin Recordati S.p.A. Injection of NX-1207 in Patients with Lower Urinary Tract 11 2012-002451-41 NX-1207 Da urinar şi reproducător Recordati S.p.A. internaţional III 30 25.06.2014 10.07.2014 26.11.2014 12.11.2014 dated 28.06.2013 hydrochloride) Federica Miotto Symptoms Associated with Benign Prostatic Hyperplasia: A masculin Phase III European Clinical Study Octavian Florin Magazin A double-blind, randomised, placebo-controlled, parallel group GWAP1241, version 1, dated Afecţiuni ale sistemului Octavian Florin Magazin 12 2013-000212-22 cannabidiol (GWP42003) Nu Da GW Research Ltd internaţional study of GWP42003 as adjunctive therapy in the first line II 40 11.07.2014 06.05.2014 08.01.2015 13.09.2013 nervos E-mail: treatment of schizophrenia or related psychotic disorder [email protected] A Phase 1/3, Randomised, Parallel-Group, Active-Controlled, Double-Blind Study to Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 CT-P10-3.3, version 1.0, dated PPD Romania SRL 13 2013-004493-96 CT-P10 (rituximab biosimilar) Rituxan® (rituximab) Nu Afecţiuni oncologice CELLTRION, Inc. internaţional in Comparison With Rituxan, Each Administered in III 12 25.06.2014 19.01.2015 04.11.2013 Ana-Maria Tanase Combination With Cyclophosphamide, Vincristine, and Prednisone (CVP) in Patients With Advanced Follicular Lymphoma A Double-Blind, Placebo-Controlled, Randomized, Parallel leuco-methylthioninium TRx-237-007, version 5.0, dated Afecţiuni ale sistemului Worldwide Clinical Trials Limited Group, 12-Month Safety and Efficacy Trial of Leuco- 14 2011-005529-34 bis(hydromethanesulfonate) Nu Da TauRx Therapeutics Ltd internaţional III 6 04.06.2014 27.10.2014 10.09.2015 20.11.2013 nervos Marcelina Rybianska methylthioninium bis(hydromethanesulfonate) in Subjects with (LMTM/TRx0237) Behavioral Variant Frontotemporal Dementia (bvFTD) ICON Clinical Research srl Phase 3b/4 randomized safety endpoint study of 2 doses of A3921133, version Final tofacitinib citrate (Xeljanz®/CP- Afecţiuni ale sistemului 15 2013-003177-99 Enbrel® (etanercept) Nu Alin Balalau Pfizer Inc., New York internaţional Tofacitinib in comparison to a tumor necrosis factor (TNF) III/IV 92 Amendment 3, dated 20.11.2013 690,550-10) imunitar E-mail: [email protected] inhibitor in subjects with rheumatoid arthritis A Randomized, Controlled, Double-Blind, Parallel-Group, CT-P10 3.2, version 2.0, dated MabThera® (rituximab) Afecţiuni ale sistemului PPD Romania SRL Phase 3 Study to Compare the Pharmacokinetics, Efficacy 16 2013-004555-21 CT-P10 (rituximab biosimilar) Nu CELLTRION, Inc. internaţional III 8 25.06.2014 11.11.2014 15.02.2017 18.11.2013 Rituxan® (rituximab) imunitar Brindusa Stoica and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis Pharmaceutical Research An Open-Label, Single-arm Extension Study to Evaluate the 20130258, version 1.0, dated Afecţiuni ale sistemului 17 2013-004654-13 ABP 501 Nu Nu Associates Romania SRL Amgen Inc. internaţional Long-term Safety and Efficacy of ABP 501 in Subjects with III 40 27.06.2014 12.05.2014 04.03.2015 11.04.2016 30.10.2013 imunitar Roxana Dimitriu Moderate to Severe Rheumatoid Arthritis A 12-week double-blind, randomised, placebo-controlled, ICON Clinical Research srl parallel group phase III study, followed by a 4-week NAK-06, version 3.0, dated Afecţiuni ale sistemului 18 2013-000894-56 ibodutant (MEN15596) Nu Da Alin Balalau Menarini Ricerche S.p.A. internaţional randomised withdrawal period to evaluate the efficacy and III 52 03.04.2014 16.05.2014 04.07.2014 22.06.2015 05.12.2013 digestiv E-mail: [email protected] safety of oral ibodutant 10 mg once daily in female patients with irritable bowel syndrome with diarrhoea (IBS-D) A Phase III, Multicenter, Randomized, Double-Blind, Placebo- Controlled Clinical Trial to Evaluate the Efficacy and Safety Covance Clinical and Periapproval MK-8835-001, version 00, dated Afecţiuni nutriţionale şi Merck Sharp & Dohme Corp., a of Ertugliflozin (MK-8835/PF-04971729) in Subjects with 19 2013-003587-31 ertugliflozin (MK-8835) Nu Da Services Limited internaţional III 22 18.07.2014 10.07.2014 09.09.2014 28.09.2016 03.09.2013 metabolice subsidiary of Merck & Co., Inc.
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