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.