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EU Clinical Trial 2009-009256-20 – EMA – Dec 23, 2009

Ofatumumab versus Rituximab Salvage Chemoimmunotherapy followed by ASCT in Relapsed or Refractory DLBCL

Main objective of the trial: To evaluate the progression-free survival (PFS) in subjects receiving ofatumumab in addition to salvage chemotherapy (O-chemo) compared to subjects receiving rituximab in addition to salvage chemotherapy (R-chemo).
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EU Clinical Trial 2009-013648-35 – EMA – Jun 23, 2010

A Kaletra ONCE daily Randomised Trial of the pharmacokinetics, safety and efficacy of twice-dailyversus once-daily Iopinavir/ritonavir tablets dosed by weight as part of combination antiretroviral therapy in HIV-1 infected chiidren (PENTA 18)

Main objective of the trial: Evaluate the pharmacokinetics, safety, efficacy and acceptability of twice- and once-daily dosing of lopinavir/ritonavir tablets (Kaletra) dosed by weight in HIV- 1 infected children who are currently taking lopinavir/nto...
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EU Clinical Trial 2011-000443-24 – EMA – Jun 29, 2011

Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa

Main objective of the trial: To evaluate the longer term safety, tolerability and efficacy of Arikace™ 590 mg administered once daily for up to twelve cycles with each cycle consisting of 28 days on-treatment followed by 28 days off treatment.
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EU Clinical Trial 2012-002742-20 – EMA – Mar 20, 2013

Effect of ivabradine versus placebo on cardiac function, exercise capacity, and neuroendocrine activation in patients with Chronic Heart Failure with Preserved left ventricular Ejection Fraction An 8-month, randomised double-blind, placebo controlled, international, multicentre study.

Main objective of the trial: To assess the effect of ivabradine compared to placebo on the diastolic function, the exercise capacity and the neuroendocrine activation over an 8-month treatment period.
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EU Clinical Trial 2012-005418-20 – EMA – Jul 3, 2013

A 12-month, randomized, double-masked, sham-controlled, multicenter study to evaluate the efficacy and safety of 0.5 mg ranibizumab intravitreal injections in patients with visual impairment due to vascular endothelial growth factor (VEGF) driven macular edema (ME)

Main objective of the trial: To demonstrate that an individualized regimen of intravitreal injection of 0.5 mg ranibizumab has superior efficacy compared to sham treatment in adult patients with visual impairment due to VEGF-driven ME. The primary ob...
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EU Clinical Trial 2010-024513-31 – EMA – Jun 15, 2011

Efficacy and Safety of Brinzolamide 10 mg/ml / Brimonidine 2 mg/ml Eye Drops, Suspension Compared to Brinzolamide 10 mg/ml Eye Drops, Suspension plus Brimonidine 2 mg/ml Eye Drops, Solution in Patients with Open-Angle Glaucoma or Ocular Hypertension

Main objective of the trial: The primary objective of this study is to demonstrate that the fixed combination (BID) brinzolamide 10 mg/mL / brimonidine 2 mg/mL eyes drops, suspension is non-inferior to the unfixed combination (BID) brinzolamide 10 mg...
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EU Clinical Trial 2016-004764-18 – EMA – Jul 24, 2017

Ketamine as an adjunctive therapy for Major Depression - a randomised controlled pilot trial: The KARMA-Dep Trial

Main objective of the trial: The aim of this trial is to assess ketamine as an adjunctive therapy in major depression. We hypothesise that ketamine will accelerate the recovery time in those patients who have been admitted to hospital with a depressi...
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EU Clinical Trial 2010-019867-13 – EMA – Aug 12, 2010

"Ensayo aleatorizado, de adaptación y con dos partes de ridaforolimus combinado con dalotuzumab en comparación con exemestano o en comparación con ridaforolimus o dalotuzumab en monoterapia en pacientes con cáncer de mama con receptores estrogénicos positivos";"A Two-Part, Adaptive, Randomized Trial of Ridaforolimus in Combination with Dalotuzumab Compared to Exemestane or Compared to Ridaforolimus or Dalotuzumab Monotherapy in Estrogen Receptor Positive Breast Cancer Patients"

Main objective of the trial: En la parte A de este estudio, el objetivo principal es evaluar la eficacia de la combinación de ridaforolimus y dalotuzumab en comparación con exemestano mediante el análisis de la supervivencia sin progresión en pacient...
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EU Clinical Trial 2015-002192-23 – EMA – Jun 3, 2016

A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects with Cystic Fibrosis

Main objective of the trial: To evaluate the effect of GS-5745 on pre-bronchodilator forced expiratory volume in 1 second (FEV1) in subjects with cystic fibrosis (CF) after 8 weeks of treatment
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EU Clinical Trial 2012-000042-35 – EMA – Jul 8, 2013

BOTOX® Treatment in Pediatric Lower Limb Spasticity: Double-blind Study

Main objective of the trial: To evaluate the safety and efficacy of a single treatment of 2 doses (4 U/kg and 8 U/kg) of BOTOX with standardized PT in pediatric patients with lower limb spasticity. Valutare la sicurezza e l'efficacia di un singolo tr...
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EU Clinical Trial 2016-004618-93 – EMA – Dec 12, 2017

Evaluation of the safety of CEdiranib in the prevention of Bowel perforation in platinum-resistant Ovarian Cancer

Main objective of the trial: The trial is trying to find out if it is safe to treat women who have advanced ovarian cancer and are at risk of developing malignant bowel obstruction (bowel blockage due to advanced cancer) with a weekly dose of standar...
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EU Clinical Trial 2010-021587-15 – EMA – Sep 8, 2010

A Phase III Clinical Trial Comparing TC to TAC for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

Main objective of the trial: To determine whether the addition of Bevacizumab to the TC regimen (TCB) improves invasive disease-free survival (IDFS) relative to TC alone.
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EU Clinical Trial 2011-001253-82 – EMA – Dec 2, 2011

Protocol I2R-MC-BIAO The Impact of LY2605541 versus Insulin Glargine for Patients with Type 1 Diabetes Mellitus Treated with Preprandial Insulin Lispro: a Double-Blind, Randomized, 52 Week Study The IMAGINE 3 Study

Main objective of the trial: To demonstrate that glycemic control as measured by HbA1c at 52 weeks for LY2605541 is non-inferior compared with insulin glargine when each is combined with pre-prandial insulin lispro in patients with T1DM. El objetivo...
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EU Clinical Trial 2009-018077-31 – EMA – Nov 25, 2010

A PHASE I/II DOSE SCHEDULE FINDING STUDY OF CH14.18/CHO CONTINUOUS INFUSION COMBINED WITH SUBCUTANEOUS ALDESLEUKIN (IL-2) IN PATIENTS WITH PRIMARY REFRACTORY OR RELAPSED NEUROBLASTOMA A SIOPEN Study

Main objective of the trial: Primary :____ find a treatment plan that reduces the pain as tolerable profile tossicita'dell'anticorpo ch.14 18/CHO maintaining efficiency immunomodulation in patients (1 to 21 years) with refractory neuroblastoma (≥ 1 l...
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EU Clinical Trial 2004-002103-32 – EMA – Mar 2, 2005

Phase III multicentre open-label randomised study of ICE plus Rituximab (R-ICE) versus DHAP plus Rituximab (R-DHAP) in previously treated patients with CD 20 positive diffuse large B-cell lymphoma, eligible for transplantation followed by randomised maintenance treatment with Rituximab

Main objective of the trial: The main objective of the induction therapy is to evaluate the efficacy and safety of ICE plus Rituximab (R-ICE) in comparison with DHAP plus Rituximab (R-DHAP) in previously treated patients with CD20 positive diffuse la...
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EU Clinical Trial 2018-000141-39 – EMA – Mar 8, 2018

Tolerabililty of laser-assisted cisplatin+5-fluorouracil― an exploratory proof of concept study of topical combination chemotherapy for basal cell carcinoma

Main objective of the trial: To investigate tolerability (i.e. local skin reactions and side effects) of ablative fractional laser-assisted cisplatin+5-FU therapy for basal cell carcinoma
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EU Clinical Trial 2013-000604-41 – EMA – Jan 21, 2014

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

Main objective of the trial: To evaluate the long term safety and tolerability of lumacaftor in combination with ivacaftor in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the for the F508del-CFTR mutation
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EU Clinical Trial 2013-004619-31 – EMA – Sep 1, 2014

A phase IIIb/IV randomized, controlled, open label, parallel group study to compare the efficacy of vancomycin therapy to extended duration fidaxomicin therapy in the sustained clinical cure of Clostridium difficile Infection in an older population

Main objective of the trial: The primary objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 4...
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EU Clinical Trial 2013-000093-29 – EMA – Jun 2, 2014

A Phase 2, Multicenter, Open-label Study to Assess the Efficacy and Safety of Enzalutamide with Trastuzumab in Subjects with HER2+ AR+ Metastatic or Locally Advanced Breast Cancer

Main objective of the trial: To evaluate the efficacy of enzalutamide with trastuzumab in evaluable subjects with human epidermal growth factor receptor 2 positive (HER2+), androgen receptor positive (AR+) and estrogen receptor negative (ER-)/progest...
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EU Clinical Trial 2008-005354-20 – EMA – Mar 15, 2016

Interventional, randomised, double-blind, placebo-controlled, active reference (fluoxetine), fixed-dose study of vortioxetine in paediatric patients aged 12 to 17 years, with Major depressive disorder (MDD)

Main objective of the trial: Evaluation of the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive symptoms in adolescents with a DSM-5™ diagnosis of MDD. Évaluer l'efficacité de la vortioxétine 10 mg/jour et 20 mg/jour cont...
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EU Clinical Trial 2016-002347-41 – EMA – Jan 1, 2016

Risk-based, response-adapted, Phase II open-label trial of nivolumab + brentuximab vedotin (N + Bv) for children, adolescents, and young adults with relapsed/refractory (R/R) CD30 + classic Hodgkin lymphoma (cHL) after failure of first-line therapy, followed by brentuximab + bendamustine (Bv + B) for participants with a suboptimal response. CheckMate 744: CHECKpoint pathway and nivolumab clinical Trial Evaluation

Main objective of the trial: - R1 (Low Risk) Cohort: To describe event-free survival (EFS) rate at 3 years, as assessed by blinded independent central review (BICR). - R2 (Standard Risk) Cohort: to describe the complete metabolic response (CMR) rate...
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EU Clinical Trial 2015-001834-15 – EMA – Sep 24, 2015

An open label, single group, long term safety extension trial of BI 655066, in patients with moderately to severely active Crohn's disease

Main objective of the trial: To investigate long-term safety of BI 655066, in patients with moderately to severely active Crohn`s disease, who showed a clinical response or remission on previous treatment with BI 655066 and are now receiving long ter...
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EU Clinical Trial 2012-002107-17 – EMA – Feb 1, 2013

International Randomised Controlled Trial for the Treatment of Newly Diagnosed Ewing's Sarcoma Family of Tumours

Main objective of the trial: The objective of the induction/consolidation chemotherapy randomisation (R1) is to compare the VIDE strategy (VIDE induction and VAI/VAC/BuMel consolidation) with the VDC/IE/BuMel strategy (compressed VDC/IE induction and...
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EU Clinical Trial 2010-023066-52 – EMA – Feb 9, 2011

An open label, multicenter study investigating the safety and efficacy of ofatumumab therapy versus physicians' choice in patients with bulky fludarabine refractory chronic lymphocytic leukaemia (CLL)

Main objective of the trial: To evaluate the improvement in progression free survival (PFS), defined as the time from randomization to the date of disease progression or death due to any cause, in subjects with bulky fludarabine-refractory CLL receiv...
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EU Clinical Trial 2008-002783-33 – EMA – Mar 2, 2009

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease

Main objective of the trial: Co-Primary Objective for the Induction Phase • To determine the effect of MLN0002 induction treatment on clinical remission at 6 weeks (primary) • To determine the effect of MLN0002 induction treatment on enhanced clinica...
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EU Clinical Trial 2009-014290-40 – EMA – Feb 10, 2010

A phase 3, randomized, double-blind, double-dummy, parallel-group, multi-center, multi-national study for the evaluation of efficacy and safety of (LMW) heparin/edoxaban versus (LMW) heparin/warfarin in subjects with symptomatic deep-vein thrombosis and/or pulmonary embolism

Main objective of the trial: To evaluate whether initial (Low Molecular Weight) heparin followed by edoxaban only ([LMW] heparin/edoxaban) is non-inferior to initial (LMW) heparin overlapping with warfarin, followed by warfarin only ([LMW] heparin/wa...
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EU Clinical Trial 2013-003127-11 – EMA – Feb 26, 2014

A prospective, multicenter, 12-week, randomized open-label study to evaluate the efficacy and safety of glycopyrronium (50 micrograms o.d.) or indacaterol maleate and glycopyrronium bromide fixed-dose combination (110/50 micrograms o.d.) regarding symptoms and health status in patients with moderate chronic obstructive pulmonary disease (COPD) switching from treatment with any standard COPD regimen

Main objective of the trial: • To show the superiority of glycopyrronium (50 μg o.d.) vs. short-acting bronchodilators (SABA and/or SAMA as monotherapy or in free or FDC) on FEV1 at week 12. • To show the non-inferiority of glycopyrronium (50 μg o.d....
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EU Clinical Trial 2014-004314-29 – EMA – Feb 27, 2015

MULTICENTRE, OPEN LABEL, RANDOMIZED, TWO-ARM, PARALLEL-GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF ENVARSUS® COMPARED WITH TACROLIMUS USED AS PER CURRENT CLINICAL PRACTICE IN THE INITIAL MAINTENANCE SETTING IN DE NOVO KIDNEY TRANSPLANT PATIENTS.

Main objective of the trial: To compare tacrolimus dosing of the new Envarsus®-based immunosuppressive regimen with current clinical practice over 6 months following de novo renal transplantation in a real-life setting in different European Countries...
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EU Clinical Trial 2013-001634-17 – EMA – Oct 30, 2013

LONG-TERM 24-HOUR INTRAOCULAR PRESSURE CONTROL AND PROGRESSION RATE OBTAINED WITH THE ASSOCIATION OF COMBIGAN IN THE MORNING AND GANFORT IN THE EVENING COMPARED WITH LATANOPROST IN HIGH RISK OPEN-ANGLE GLAUCOMA.

Main objective of the trial: To compare for the first time the quality of 24-hour IOP control obtained after 3 and 24 months of therapy with the combined administration of Combigan in the morning and Ganfort in the evening versus latanoprost administ...
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EU Clinical Trial 2012-004008-37 – EMA – Jul 5, 2013

A phase II multicentre open-label study on allogeneic stem cell transplantation from unrelated, cord-blood and family haploidentical donors in patients with active acute leukemia

Main objective of the trial: The experimental treatment consists in the application of a therapeutic strategy of allogeneic transplantation as a potential curative procedure in a population of patients with chemoresistant acute leukemias. Therapeutic...
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EU Clinical Trial 2014-001815-38 – EMA – Dec 16, 2014

Evaluation of the Safety and Efficacy of Treatment With BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for Subjects With Facial Rhytides (Forehead Lines, Glabellar Lines, Lateral Canthal Lines)

Main objective of the trial: - to evaluate the safety and efficacy of BOTOX treatment for forehead lines (FHL), defined as treatment of the frontalis muscle (eyebrow elevator) with simultaneous treatment of the glabellar complex (procerus and corruga...
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EU Clinical Trial 2014-000275-14 – EMA – Aug 7, 2014

A Phase II, randomized, double-blind, placebo-controlled bronchoscopy study to evaluate the effects of Lebrikizumab on airway eosinophilic inflammation in patients with uncontrolled asthma on inhaled corticosteroids and a second controller medication

Main objective of the trial: To evaluate the effect of lebrikizumab in reducing airway eosinophilic inflammation, as measured by a relative change in the number of airway submucosal eosinophils per surface area of basal lamina (cells/mm2) obtained vi...
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EU Clinical Trial 2009-013788-21 – EMA – Apr 28, 2010

A phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis

Main objective of the trial: to establish the long term tolerability and safety profile of BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis in a roll-over study stanovit profil dlouhodobé tolerance a bezpečnosti BIBF 1120 u pacientů s idiopat...
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EU Clinical Trial 2015-002142-31 – EMA – Nov 16, 2016

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SAGE-547 INJECTION IN THE TREATMENT OF SUBJECTS WITH SUPER-REFRACTORY STATUS EPILEPTICUS

Main objective of the trial: To determine the response to a 144-hour (6 day) continuous intravenous infusion of SAGE-547 compared to placebo administered to support the weaning of all third-line agents in adult and pediatric subjects with SRSE, and f...
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EU Clinical Trial 2012-001630-33 – EMA – Nov 14, 2012

An Open-Label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients with Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

Main objective of the trial: To evaluate the long-term safety and tolerability of memantine in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). L’obiettivo di...
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EU Clinical Trial 2012-002944-25 – EMA – Aug 20, 2014

EuroHYP-1: European multicentre, randomised, phase III clinical trial of therapeutic hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke.

Main objective of the trial: To determine whether systemic cooling to a target body temperature between 34.0 and 35.0°C, started within 6 hours of symptom onset and maintained for 12 hours, improves functional outcome at 3 months in patients with acu...
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EU Clinical Trial 2012-004544-30 – EMA – Apr 3, 2013

A phase III, randomised, open label, active-controlled study of an interferon-free regimen of BI 207127 in combination with Faldaprevir and Ribavirin compared to Telaprevir in combination with pegylated interferon-a and ribavirin in treatment-naive patients with chronic genotype 1b Hepatitis C Virus infection.

Main objective of the trial: The main objective of the trial is to determine if BI207127 + Faldaprevir + Ribavirin for 24 weeks is non-inferior to treatment with telaprevir for 12 weeks + Ribavirin and Pegylated interferon for 24 or 48 weeks. El obje...
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EU Clinical Trial 2013-000744-26 – EMA – Aug 28, 2013

Phase II multicenter randomized, double blind, placebo controlled study assessing the efficacy of buparlisib (BKM120) plus paclitaxel vs. placebo plus paclitaxel in patients with platinum pre-treated recurrent or metastatic head and neck squamous cell carcinoma.

Main objective of the trial: to estimate the efficacy of buparlisib in combination with paclitaxel
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EU Clinical Trial 2012-002057-38 – EMA – Aug 16, 2012

A placebo and active controlled study to assess the long-term safety of once daily QVA149 for 52 weeks in Chronic Obstructive Pulmonary Disease (COPD) patients with moderate to severe airflow limitation

Main objective of the trial: To demonstrate the non-inferiority of QVA149 110/50 μg qd compared to placebo in terms of overall SAE rate from initiation of study treatment through 30 days post last treatment.
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EU Clinical Trial 2017-002473-19 – EMA – Nov 13, 2018

PREDICTIVE FACTORS AND MAGNITUDE OF RESPONSE TO OMALIZUMAB AND MEPOLIZUMAB IN ALLERGIC AND EOSINOPHILIC SEVERE ASTHMA: A MULTICENTER PRAGMATIC TRIAL IN BELGIUM

Main objective of the trial: To determine theranostic features, i.e. clinical features and blood (or sputum) biomarkers able to predict a better response to omalizumab or mepolizumab in severe asthma patients eligible to both therapies. The candidate...
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EU Clinical Trial 2014-002206-20 – EMA – Dec 22, 2014

A Phase II Clinical Trial of Pembrolizumab (MK-3475) in Subjects with Advanced/Unresectable or Metastatic Urothelial Cancer

Main objective of the trial: 1.Objective: To evaluate anti-tumor activity of pembrolizumab (MK-3475) as 1L therapy in subjects with advanced/unresectable (inoperable) or metastatic urothelial cancer who are ineligible for cisplatin-based therapy and...
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EU Clinical Trial 2007-001626-27 – EMA – Apr 14, 2009

A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF LENALIDOMIDE (REVLIMID®) AS MAINTENANCE THERAPY FOR PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA FOLLOWING SECOND-LINE THERAPY (THE CONTINUUM TRIAL)

Main objective of the trial: To compare the efficacy of lenalidomide versus placebo maintenance therapy
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EU Clinical Trial 2014-002448-42 – EMA – Mar 12, 2015

A Phase I/II, open-label multicenter study to determine safety, pharmacokinetics and efficacy of GMI-1271 in combination with chemotherapy in patients with acute myeloid leukemia

Main objective of the trial: To evaluate the safety of GMI-1271 in combination with chemotherapy
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EU Clinical Trial 2011-001278-24 – EMA – Sep 2, 2011

EFFICACY OF RANOLAZINE IN PATIENTS WITH CORONARY ARTERY DISEASE (CAD)

Main objective of the trial: The primary study objective will be to verify whether ranolazine 750 mg b.i.d. is effective in increasing exercise capacity (exercise treadmill time at peak). първичната цел на проучването е да провери дали ранолазин в до...
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EU Clinical Trial 2014-001097-34 – EMA – Sep 8, 2014

A Phase 2 Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-ranging Study of the Efficacy and Safety of MEDI4893, a Human Monoclonal Antibody Against Staphylococcus aureus Alpha Toxin in Mechanically Ventilated Adult Subjects

Main objective of the trial: • To evaluate the effect of MEDI4893 in reducing the incidence of S aureus pneumonia • To evaluate the safety of a single IV dose of MEDI4893
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EU Clinical Trial 2015-002024-89 – EMA – Dec 23, 2015

A Phase III Study of Pembrolizumab (MK-3475) vs. Chemotherapy in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (KEYNOTE-177)

Main objective of the trial: 1) To compare Progression Free Survival (PFS) per RECIST 1.1 by central imaging vendor in subjects with stage IV MSI-H or dMMR CRC treated with first line (1L) pembrolizumab versus SOC chemotherapies. 2)To compare Overall...
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EU Clinical Trial 2013-000768-27 – EMA – Jan 29, 2015

Multicenter, randomized, double-blind, double-dummy, active-comparator, event-driven, superiority phase III study of secondary prevention of stroke and prevention of systemic embolism in patients with a recent Embolic Stroke of Undetermined Source (ESUS), comparing rivaroxaban 15 mg once daily with aspirin 100 mg (NAVIGATE ESUS)

Main objective of the trial: The primary efficacy objective is to evaluate whether rivaroxaban is superior to aspirin in reducing the risk of recurrent stroke and systemic embolism in patients with a recent ESUS.
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EU Clinical Trial 2015-001997-16 – EMA – Jan 1, 2015

A Phase 3, 2-Part, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have a CFTR Gating Mutation

Main objective of the trial: Part A : - To evaluate the safety of ivacaftor treatment in subjects with cystic fibrosis (CF) who are <24 months of age at treatment initiation and have a CF transmembrane conductance regulator (CFTR) gene gating mutatio...
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EU Clinical Trial 2014-001749-26 – EMA – Nov 21, 2014

A Phase III Randomized Trial of MK-3475 (Pembrolizumab) versus Standard Treatment in Subjects with Recurrent or Metastatic Head and Neck Cancer

Main objective of the trial: - To compare the overall survival (OS) in subjects with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) treated with pembrolizumab compared to standard treatment. - To compare progression-free...
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EU Clinical Trial 2017-004896-30 – EMA – Jul 6, 2018

A Randomized, Active-Controlled, Blinded, Phase III Clinical Trial of BMS- 986213 (Fixed Dose Combination of Relatlimab [anti-LAG-3] and Nivolumab) in Combination with Chemotherapy versus Placebo in Combination with Chemotherapy as First-Line Treatment in Participants with Unresectable, Locally Advanced or Metastatic LAG-3 Positive Gastric or Gastroesophageal Junction Adenocarcinoma

Main objective of the trial: - To compare OS of BMS-986213 in combination with chemotherapy with OS of chemotherapy alone in participants with unresectable, untreated, locally advanced or metastatic LAG-3 positive gastric or GEJ adenocarcinoma - To c...
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