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No. RADICADO FECHA DE RADICACION CODIGO AGENCIA NACIONAL DE REFERENCIA REGIONAL DIRECCIÓN DE MEDICAMENTOS Y PRODUCTOS BIOLÓGICOS FUNCIÓN REGULADORA PUBLICACIÓN FECHA DE PUBLICACIÓN/ ACTUALIZACIÓN GRUPO DE INVESTIGACIÓN CLÍNICA (GIC) PROTOCOLOS DE INVESTIGACIÓN CLÍNICA 2014-2020 AGOSTO DEL 2020 NUMERO DE FECHA DE CODIGO ENLACE DE REGISTRO FECHA DE ACTO NÚMERO ACTO No. RADICADO IDENTIFICACION TÍTULO DEL ESTUDIO PATROCINADOR / CRO ACTA CONCEPTO ESTADO RADICACION PATROCINADOR PRIMARIO ADMINISTRATIVO ADMINISTRATIVO (DD/MM/AAAA) PRIMARIO “Estudio de fase III, multicéntrico, aleatorizado, de LDK378 administrado por vía oral en comparación con la quimioterapia estándar en pacientes Acta No. 01 del 30 y https://clinicaltrials.gov/ct2/sh 1 2013107281 20/09/2013 CLDK378A2301 NCT01685138 adultos con cáncer de pulmón de células no Novartis de Colombia S.A. 31 de enero del 2014 APROBADO 22/07/2014 600-6392-14 CERRADO ow/NCT01685138 pequeñas, no escamosas en etapa IIIB o IV, con Numeral 3.15.1 re-arreglo de ALK (ALK positiva) sin tratamiento previo.” “Estudio aleatorizado, doble ciego, controlado con Acta No. 01 del 30 y https://clinicaltrials.gov/ct2/sh placebo, multicéntrico para evaluar la seguridad y Alexion Pharmaceuticals, Inc. / 2 2013120429 22/10/2013 ECU-NMO-301 NCT01892345 31 de enero del 2014 APROBADO 22/12/2014 600-10481-14 CERRADO ow/NCT01892345 eficacia del eculizumab en pacientes con Quintiles Colombia Ltda Numeral 3.15.2 neuromielitis óptica (nmo) recidivante”. “Estudio multicéntrico aleatorizado, doble ciego, de grupos paralelos, control activo y con placebo, para la evaluación de la eficacia, seguridad y Acta No. 01 del 30 y https://clinicaltrials.gov/ct2/sh tolerabilidad de combinaciones de Succinato de Astellas Pharma Europe Ltd / 3 2013136488 21/11/2013 178-CL-101 NCT01972841 31 de enero del 2014 APROBADO 06/01/2015 600-12186-14 CERRADO ow/NCT01972841 Solifenacina y Mirabegron en comparación con INC Research Colombia Ltda Numeral 3.15.3 monoterapias de Succinato de Solifenacina y de Mirabegron en el tratamiento de Vejiga Hiperactiva” https://www.clinicaltrialsregiste “Estudio multicéntrico, abierto, de seguimiento a Acta No. 01 del 30 y r.eu/ctr- largo plazo de la seguridad y eficacia de Galapagos NV / INC Research 4 2013136695 22/11/2013 GLPG0634-CL-205 2012-003655-11 31 de enero del 2014 APROBADO 21/01/2014 600-11355-14 ACTIVO search/search?query=2012- GLPG0634 en pacientes con artritis reumatoidea colombia Ltda Numeral 3.15.4 003655-11 activa de moderada a severa” Un estudio abierto de seguridad y eficacia, de 24 meses, multicéntrico, aleatorizado, de https://www.clinicaltrialsregiste concentración-controlada de everolimus con Acta No. 01, del 30 y r.eu/ctr- inhibidor de calcineurina reducida vs micofenolato 5 2013137051 22/11/2013 CRAD001A2433 2013-000322-66 Novartis de Colombia S.A. 31 de enero del 2014 APROBADO 07/11/2014 600-9088-14 CERRADO search/search?query=eudract_ con inhibidor de calcineurina estándar en Numeral 3.15.5 number:2013-000322-66 trasplante renal de novo – Avance de la eficacia en trasplante renal y resultados de seguridad con un régimen con base en everolimus (Transform).” “Un estudio fase III, Aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia, Acta No. 04 del 3 y 4 https://clinicaltrials.gov/ct2/sh seguridad y tolerabilidad de lebrikizumab en F. Hoffmann- La Roche Ltd / 6 2013141623 03/12/2013 WB28183 NCT01875003 de marzo del 2014 APROBADO 19/02/2015 600-0864-15 CERRADO ow/NCT01875003 pacientes adolescentes con Asma no controlada PPD Colombia S.A.S. Numeral 3.15.1 bajo tratamiento con corticosteroides inhalados y un segundo medicamento de control.” AGENCIA NACIONAL DE REFERENCIA REGIONAL DIRECCIÓN DE MEDICAMENTOS Y PRODUCTOS BIOLÓGICOS FUNCIÓN REGULADORA PUBLICACIÓN FECHA DE PUBLICACIÓN/ ACTUALIZACIÓN GRUPO DE INVESTIGACIÓN CLÍNICA (GIC) PROTOCOLOS DE INVESTIGACIÓN CLÍNICA 2014-2020 AGOSTO DEL 2020 NUMERO DE FECHA DE CODIGO ENLACE DE REGISTRO FECHA DE ACTO NÚMERO ACTO No. RADICADO IDENTIFICACION TÍTULO DEL ESTUDIO PATROCINADOR / CRO ACTA CONCEPTO ESTADO RADICACION PATROCINADOR PRIMARIO ADMINISTRATIVO ADMINISTRATIVO (DD/MM/AAAA) PRIMARIO “Ensayo Fase 3 Aleatorizado, Doblemente Enmascarado Y Controlado Para Establecer La Seguridad Y Eficacia De La Administración https://clinicaltrials.gov/ct2/sh Intravítrea De Fovistatm (Aptámero Pegilado Anti- OPHTHOTECH CORP./ Acta No. 04 del 3 y 4 2013143188 7 05/12/2013 OPH1003 NCT01940900 ow/NCT01940900?term=NCT01 Pdgf-B) En Politerapia Con Lucentis® En Parexel Internacional Colombia de marzo del 2014 APROBADO 19/02/2015 600-0959-15 CERRADO 13093893 940900&rank=1 Comparación Con Lucentis® En Monoterapia En S.A.S Numeral 3.15.2 Sujetos Afectados Por Degeneración Macular Asociada A La Edad Con Neovascularización Subfoveal” “Estudio clínico de no inferioridad entre Daflon1000 mg, suspensión oral en un sobre al https://www.clinicaltrialsregiste I.R.I.S (institut de recherches día y Daflon® 500 mg, 2 tabletas al día después Acta No. 04 del 3 y 4 r.eu/ctr- internationales servier) / Acta 04 del 03 y 04 de 8 2013147898 13/12/2013 CL3-05682-105 2012-003559-13 de ocho semanas de tratamiento en pacientes que de marzo del 2014 APROBADO 04/03/2014 ACTIVO search/search?query=2012- Laboratorios Servier de Marzo sufren de Enfermedad Venosa Crónica (CVD) Numeral 3.15.3 Colombia S.A.S 003559-13 sintomática. Estudio internacional, multicéntrico, doble ciego, aleatorizado, de grupos paralelos.” “Estudio multicéntrico, aleatorizado, paralelo, a doble ciego, controlado con placebo, con dosis fija Acta No. 04 del 3 y 4 https://clinicaltrials.gov/ct2/sh Sunovion Pharmaceuticals Inc. 9 2013150809 18/12/2013 D1050301 NCT01911429 durante 6 semanas para evaluar la eficacia y la de marzo del 2014 APROBADO 19/02/2015 600-0794-15 CERRADO ow/NCT01911429 / Quintiles Colombia Ltda seguridad de la lurasidona en sujetos Numeral 3.15.4 adolescentes con esquizofrenia” “Estudio de extensión con dosis flexible, abierto, multicéntrico, de 104 semanas de duración, para Acta No. 04 del 3 y 4 https://clinicaltrials.gov/ct2/sh evaluar la efectividad y la seguridad a largo plazo Sunovion Pharmaceuticals Inc. 10 2013151330 18/12/2013 D1050302 NCT01914393 de marzo del 2014 APROBADO 09/03/2015 600-1526-15 CERRADO ow/NCT01914393 de la Lurasidona en sujetos pediátricos con / Quintiles Colombia Ltda Numeral 3.15.5 esquizofrenia y sujetos con irritabilidad asociada con el trastorno autista” “Ensayo clínico controlado con asignación Acta No. 04 del 3 y 4 https://clinicaltrials.gov/ct2/sh aleatoria de la eficacia del Metil Aminolevulinato Fundacion Dermabase / JSS 11 2013151949 19/12/2013 2013-01INT NCT02139618 de marzo del 2014 APROBADO 30/12/2014 600-11105-14 CERRADO ow/NCT02139618 (MAL) + luz solar vs placebo + luz solar en la Medical Research Latam S.A.S. Numeral 3.15.6 mejoría del daño actínico facial” “Estudio de Fase 3, Doble Ciego, Aleatorizado, Controlado Con Placebo y De Grupos Paralelos Pfizer Colombia S.A.S / ICON Acta No. 04 del 3 y 4 https://clinicaltrials.gov/ct2/sh Para Evaluar La Eficacia, Seguridad a Largo Holdings Clinical Research 12 2013153181 20/12/2013 B1481020 NCT01968967 de marzo del 2014 APROBADO 20/11/2014 600-9736-14 CERRADO ow/NCT01968967 Plazo y Tolerabilidad de PF-04950615 En Sujetos International Limited Sucursal Numeral 3.15.7 Con Hiperlipidemia Primaria o Dislipidemia Mixta Colombia En Riesgo De Sufrir Eventos Cardiovasculares.” AGENCIA NACIONAL DE REFERENCIA REGIONAL DIRECCIÓN DE MEDICAMENTOS Y PRODUCTOS BIOLÓGICOS FUNCIÓN REGULADORA PUBLICACIÓN FECHA DE PUBLICACIÓN/ ACTUALIZACIÓN GRUPO DE INVESTIGACIÓN CLÍNICA (GIC) PROTOCOLOS DE INVESTIGACIÓN CLÍNICA 2014-2020 AGOSTO DEL 2020 NUMERO DE FECHA DE CODIGO ENLACE DE REGISTRO FECHA DE ACTO NÚMERO ACTO No. RADICADO IDENTIFICACION TÍTULO DEL ESTUDIO PATROCINADOR / CRO ACTA CONCEPTO ESTADO RADICACION PATROCINADOR PRIMARIO ADMINISTRATIVO ADMINISTRATIVO (DD/MM/AAAA) PRIMARIO “Estudio De Fase 3, Multicéntrico, Doble Ciego, Aleatorizado, Controlado Con Placebo, Con Pfizer Colombia S.A.S / ICON Grupos Paralelos Para Evaluar La Eficacia, Acta No. 04 del 3 y 4 https://clinicaltrials.gov/ct2/sh Holdings Clinical Research 13 2013153185 20/12/2013 B1481038 NCT01975389 Seguridad Y Tolerabilidad Del PF-04950615,En La de marzo del 2014 APROBADO 20/11/2014 600-9735-14 CERRADO ow/NCT01968967 International Limited Sucursal Reducción De La Aparición De Episodios Numeral 3.15.8 Colombia Cardiovasculares Graves En Sujetos De Alto Riesgo” “Estudio De Fase 3, Multicéntrico, Doble Ciego, Aleatorizado, Controlado Con Placebo, Con Pfizer Colombia S.A.S / ICON Grupos Paralelos Para Evaluar La Eficacia, Acta No. 04 del 3 y 4 https://clinicaltrials.gov/ct2/sh Holdings Clinical Research 14 2013153282 20/12/2013 B1481022 NCT01975376 Seguridad Y Tolerabilidad Del Pf-04950615, En La de marzo del 2014 APROBADO 20/11/2014 600-9734-14 CERRADO ow/NCT01975376 International Limited Sucursal Reducción De La Aparición De Episodios Numeral 3.15.9 Colombia Cardiovasculares Graves En Sujetos De Alto Riesgo” La eficacia y la seguridad de Trimetazidina en https://www.clinicaltrialsregiste pacientes con angina de pecho tratados con I.R.I.S (institut de recherches Acta No. 6 del 1 y 2 r.eu/ctr- intervención con intervención coronaria internationales servier) / 15 2014005593 22/01/2014 CL3-06790-010 2010-022134-89 de abril del 2014 NEGADO 30/12/2014 600-11978-14 NO ACTIVO search/search?query=2010- percutánea. Estudio ATPCI. Estudio internacional Parexel International Colombia Numeral 3.15.1 022134-89+ multicéntrico aleatorizado, doble ciego controlado S.A.S con placebo. "Un estudio randomizado,
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