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EU Clinical Trial 2004-003495-11 – EMA – Mar 16, 2005

PHASE III STUDY OF CHEMOHORMONAL THERAPY WITH TO DIFFERENT MODALITIES CONCOMITANT OR ALTERNATE VERSUS HORMONAL THERAPY ALONE IN ADVANCED PROSTATE CANCER PATIENTS.

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EU Clinical Trial 2007-000483-25 – EMA – Jan 15, 2007

Buprenorfina TDS in old patients with chronic pain not give moderated cancer of intensita serious. Study in open, of Phase IV, not controlled, multicentric, spontaneous

Main objective of the trial: To estimate analgesic effectiveness and tollerabilita of Buprenorfina TDS in old patients with particular attention to the cognitivo/comportamentale state.
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EU Clinical Trial 2007-005047-21 – EMA – Dec 24, 2007

Effects of Sirolimus on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and severe renal insufficiency

Main objective of the trial: To compare the change over baseline of renal function (estimated by Delta GFR, measured by plasma iohexol clearance) in SRL and conventional treatment ADPKD patients with severe renal insufficiency (<40ml/min/1.73m2) afte...
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EU Clinical Trial 2009-010665-23 – EMA – Jul 1, 2009

A 12-week treatment, multi-center, randomized, parallel group, blinded, double dummy study to compare the efficacy and safety of Indacaterol (150 μg o.d.) delivered via a SDDPI with Tiotropium (18 μg o.d.) delivered via a HandiHaler®, in patients with moderate-to-severe COPD.

Main objective of the trial: To demonstrate non-inferiority of indacaterol (150 μg o.d.) versus tiotropium (18 μg o.d.) with respect to trough Forced Expiratory Volume in one second (trough FEV1) 24h post dose after 12 weeks (84 days) of treatment in...
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EU Clinical Trial 2009-013256-69 – EMA – Apr 13, 2010

A 64-week treatment, multi-center, randomized, double-blind, parallel-group, active controlled study to evaluate the effect of QVA149 (110/50 μg o.d.) vs NVA237 (50 μg o.d.) and open-label tiotropium (18 μg o.d.) on COPD exacerbations in patients with severe to very severe chronic obstructive pulmonary disease (COPD)

Main objective of the trial: To demonstrate that QVA149 (110/50 μg o.d.) is superior to NVA237 (50 μg o.d.) with regard to the rate of moderate to severe COPD exacerbations during the treatment period.
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EU Clinical Trial 2004-000866-11 – EMA – Aug 6, 2004

A multicenter, randomized, parallel group, controlled, double-blind study to evaluate efficacy and safety of pholcodine as antitussive agent vs dextrometorphan in non-productive cough

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EU Clinical Trial 2011-002411-29 – EMA – Apr 26, 2012

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting.

Main objective of the trial: Assess the effect of adalimumab on QOL as measured by the Short Inflammatory Bowel Disease (SIBDQ), the utilization of health care resources and the costs of care for the UC subjects treated with adalimumab.
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EU Clinical Trial 2010-019507-28 – EMA – Oct 15, 2010

Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% for Prevention and Treatment of Ocular Inflammation and Pain after Cataract Surgery

Main objective of the trial: To demonstrate that: 1) Nepafenac Ophthalmic Suspension, 0.3% dosed once daily is not inferior to NEVANAC dosed three times daily for the prevention and treatment of ocular inflammation 14 days after cataract extraction....
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EU Clinical Trial 2009-016759-22 – EMA – Jun 28, 2010

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered with Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

Main objective of the trial: To evaluate the efficacy of a regimen containing GS-9350-boosted atazanavir versus ritonavir-boosted atazanavir, each administered with emtricitabine/tenofovir disoproxil fumarate, in HIV-1 infected, antiretroviral treatm...
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EU Clinical Trial 2008-001462-81 – EMA – Oct 27, 2008

Effects of Losartan versus Nebivolol versus the association of both on the progression of aortic root dilation in Marfan Syndrome (MFS) with FBN1 gene mutations

Main objective of the trial: the comparative evaluation of the effects of Losartan, Nebivolol and the association of both on the progression of aortic root growth rate (measured at the level of the sinuses of valsalva).
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EU Clinical Trial 2007-000535-26 – EMA – Jun 4, 2007

swiTching from etAnercept to iNfliximab in the treatment of moderate to severe psoriasis; a multi-center, open label trial evaluating the efficacy, tOlerance and safety (TANGO)

Main objective of the trial: To assess the efficacy of infliximab therapy (infusion of 5 mg/kg at weeks 0, 2, 6, 14, 22), evaluated through PASI 75 (defined as the proportion of subjects achieving at least a 75% PASI – Psoriasis Area and Severity Ind...
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EU Clinical Trial 2007-000819-29 – EMA – Sep 26, 2007

A Multinational, Randomized, Double-Blind Study Comparing Aflibercept Versus Placebo in Patients Treated with Second-Line Docetaxel after Failure of One Platinum Based Therapy for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)

Main objective of the trial: To demonstrate overall survival (OS) improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
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EU Clinical Trial 2004-001317-34 – EMA – Nov 1, 2004

A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsules [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] compared to subcutaneous enoxaparin 40 mg once daily for 8+/-2 days, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery.

Main objective of the trial: To determine the comparative efficacy of two oral regimens of dabigatran etexilate compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total...
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EU Clinical Trial 2006-000946-38 – EMA – Jan 24, 2007

International randomized double blind clinical study evaluating the efficacy and safety of clopidogrel 0.2mg/kg once daily versus placebo in neonates and infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt (e.g. modified Blalock Taussig shunt)

Main objective of the trial: To evaluate the efficacy of 0.2 mg/kg/day of clopidogrel versus placebo for the reduction of all-cause mortality and shunt-related morbidity in neonates or infants with cyanotic congenital heart disease palliated with a s...
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EU Clinical Trial 2011-004578-27 – EMA – Apr 26, 2012

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Main objective of the trial: To demonstrate the efficacy of tofacitinib in inducing remission in subjects with moderately to severely active UC.
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EU Clinical Trial 2007-001545-17 – EMA – Aug 22, 2007

An Open-Label Extension Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects ages 1 to <11 years: A long Term Study.

Main objective of the trial: to describe the clinical experience in ipertensive pediatric subjects ages 1 to <11 years who have participated in the study Protocol 328 (D2451C00002), who did not discontinue due to a study drug related adverse event, a...
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EU Clinical Trial 2010-023909-35 – EMA – Jun 24, 2011

A Prospective, Randomized, Double-Blind, Phase 3 Study Comparing rhBSSL and Placebo Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants Born Before Week 32 of Gestational Age

Main objective of the trial: The primary objective of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo when administered in infant formula or PBM.
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EU Clinical Trial 2004-002016-28 – EMA – Jan 4, 2005

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Adjuvant Radiotherapy and Chemotherapy (RT/CT)

Main objective of the trial: To evaluate the efficacy of palifermin administered at the dose of 120 mcg/kg IV in weekly doses (minimum of 7 weekly doses, until RT is complete) in reducing the incidence of severe [World Health Organization Grade 3 or...
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EU Clinical Trial 2006-003709-15 – EMA – Nov 8, 2006

A Double-Blind, Randomized, Placebo-controlled Study of Two Different Schedules of Palifermin (Pre- and Post Chemotherapy and Pre-Chemotherapy only) for Reduction in Severity of Oral Mucositis in Subjects with Multiple Myeloma (MM) Receiving High Dose Melphalan followed by Autologous Peripheral Blood Stem Cell Transplantation (PBSCT)

Main objective of the trial: To compare the efficacy of palifermin relative to placebo when given either pre- and post-high dose chemotherapy or pre- high dose chemotherapy only with regard to the severity of oral mucositis (WHO grades 0/ 1, 2, 3 or...
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EU Clinical Trial 2006-003771-12 – EMA – Jan 3, 2007

A multicenter, double-blind, randomized parallel-group study to demonstrate the effect of 24 weeks treatment with vildagliptin 100 mg qd as add-on to metformin 500 mg bid compared to metformin up to 1000 mg bid in patients with type 2 diabetes inadequately controlled on metformin 500 mg bid monotherapy.

Main objective of the trial: To demonstrate the efficacy of vildagliptin 100 mg qd used in combination with metformin 500 mg bid in patients with type 2 diabetes inadequately controlled on metformin 500 mg bid monotherapy by testing the hypothesis th...
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EU Clinical Trial 2009-012149-43 – EMA – Sep 6, 2010

Ensayo aleatorizado, cruzado, abierto, en dos partes, para evaluar la farmacocinética, la eficacia y el perfil de seguridad de FVIII recombinante libre de proteínas plasmáticas formulado con sacarosa (BAY 81-8973), en sujetos con hemofilia - A severa, previamente tratados con terapia profiláctica.

Main objective of the trial: - Demostrar la no inferioridad del tratamiento profiláctico con BAY 81 8973 (como en Enm1) (dosis determinada por SC/FE frente a la dosis determinada por SC/ADJ determinado mediante la tasa de hemorragia (después de combi...
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EU Clinical Trial 2010-021793-12 – EMA – Apr 4, 2011

A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension

Main objective of the trial: To evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension (PAH).
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EU Clinical Trial 2005-006083-57 – EMA – Oct 26, 2006

A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010) Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols Revised Protocol 05, incorporating Administrative Letter 01, 02, Amendments 01, 04, 05, 06 and 07 (version 7.0, dated 09-Sep-08)

Main objective of the trial: To monitor the safety of ipilimumab (MDX-010) administered either as Re-Induction (10 mg/kg or 3 mg/kg) or as Maintenance therapy (0.3, 3 or 10 mg/kg) in this ipilimumab (MDX-010) clinical study.
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EU Clinical Trial 2013-001211-75 – EMA – Nov 15, 2013

A Phase III Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients who are in Complete or Partial Response Following Platinum based Chemotherapy

Main objective of the trial: Determine the efficacy by progression free survival of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based...
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EU Clinical Trial 2009-015868-34 – EMA – Feb 15, 2011

A PHASE III, MULTICENTRE, DOUBLE BLIND, PROSPECTIVE, RANDOMISED, PLACEBO CONTROLLED STUDY, ASSESSING THE EFFICACY AND SAFETY OF DYSPORT USED FOR THE TREATMENT OF LOWER LIMB SPASTICITY IN ADULT SUBJECTS WITH HEMIPARESIS DUE TO STROKE OR TRAUMATIC BRAIN INJURY.

Main objective of the trial: The primary study objective is to assess the efficacy of Dysport compared to placebo at Week 4 on the change from baseline in the gastrocnemius-soleus complex (GSC) muscle tone (knee extended) in hemiparetic subjects with...
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EU Clinical Trial 2014-004902-13 – EMA – Apr 9, 2015

A 12-Week, Multicenter, Randomized, Parallel-Group Study to Assess the Safety, Tolerability, Pharmacokinetics, Biomarker Effects, Efficacy, and Effect on Microglia Activation, as Measured by Positron Emission Tomography, of AZD3241 in Subjects with Multiple System Atrophy

Main objective of the trial: • To assess the safety and tolerability of AZD3241. • To determine the effect of AZD3241 on microglia activation, as measured by [11C]PBR28 binding.
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EU Clinical Trial 2016-001706-42 – EMA – Nov 16, 2016

A Phase 2, Open-Label, Multiple Cohort, Single-Arm, Multi-Center Trial To Determine The Safety, Feasibility, And Efficacy Of JCAR015 In Adult Subjects With B-Cell Acute Lymphoblastic Leukemia

Main objective of the trial: Cohorts 1 – 4: To evaluate the efficacy of JCAR015 as measured by overall remission rate (ORR) after the final JCAR015 infusion in subjects with morphologic evidence of disease, based on independent review committee (IRC)...
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EU Clinical Trial 2012-005736-29 – EMA – Jul 8, 2014

A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate with Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subjects with Overactive Bladder

Main objective of the trial: To evaluate the safety and tolerability of long-term combination treatment of solifenacin (5 mg) with mirabegron (50 mg) compared to solifenacin and mirabegron monotherapy in subjects with overactive bladder (OAB)
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EU Clinical Trial 2015-001910-88 – EMA – Dec 17, 2015

An Open-Label, Intrapatient Dose Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, and Biological Activity of ATYR1940 in Patients with Limb Girdle and Facioscapulohumeral Muscular Dystrophies

Main objective of the trial: To evaluate the safety, tolerability, and immunogenicity of the weekly and twice weekly intravenous (IV) administration of ATYR1940, at doses of 0.3, 1.0, and 3.0 mg/kg, to patiens with Dysferlinopathy (Limb Girdle Muscul...
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EU Clinical Trial 2010-021572-29 – EMA – Nov 23, 2010

An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired

Main objective of the trial: The primary objective is the long-term safety and tolerability of ambrisentan in the paediatric PAH population.
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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 2006-004423-11 – EMA – Jan 22, 2007

An uncontrolled, open-label, titration, long-term safety (up to 12 months) and efficacy study of tamsulosin hydrochloride in children with neuropathic bladder, with a randomized pharmacokinetic sub-study investigating low, medium and high dose ranges

Main objective of the trial: This study also serves as a long-time open-label extension for a 3-Month double-blind study (Study 527.51).
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EU Clinical Trial 2011-001777-43 – EMA – May 15, 2012

A randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution (2.5 µg and 5 µg) delivered via Respimat® inhaler once daily in the evening over 12 weeks as add-on controller therapy on top of usual care in children (6 to 11 years old) with severe persistent asthma

Main objective of the trial: To demonstrate superiority of tiotropium (5 mcg and possibly 2.5 mcg once daily in the evening) over placebo with regard to the primary pulmonary function endpoint after 12 weeks of treatment.
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EU Clinical Trial 2010-021638-72 – EMA – Jun 9, 2011

A Clinical Outcomes Study to compare the effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg with placebo on Survival in Subjects with moderate Chronic Obstructive Pulmonary Disease (COPD) and a history of or at increased risk for cardiovascular disease.

Main objective of the trial: The primary objective of this study is to prospectively evaluate the effect of Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25mcg QD compared with placebo on survival in subjects with moderate COPD (≥50...
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EU Clinical Trial 2014-000227-24 – EMA – Jan 1, 2014

A Study of Thiotepa, Ifosphamide, Etoposide and Rituximab for the treatment of relapsed or refractory primary central nervous system lymphoma

Main objective of the trial: The first phase (Phase 1) of the study is to find the maximum safe dose (maximum Tolerated Dose) of thiotepa which is safe to give in combination with ifosphamide, etoposide and rituximab in patients with Primary Central...
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EU Clinical Trial 2014-001436-10 – EMA – Feb 26, 2015

A Randomized, Double-Blind Phase 2 Study of Ruxolitinib or Placebo in Combination With Pemetrexed/Cisplatin and Pemetrexed Maintenance for Initial Treatment of Subjects With Nonsquamous Non–Small Cell Lung Cancer That Is Stage IIIB, Stage IV, or Recurrent

Main objective of the trial: •Part 1: To evaluate the safety and tolerability of ruxolitinib in combination with pemetrexed/cisplatin and select a dose for further evaluation •Part 2: To evaluate and compare the OS of subjects with nonsquamous NSCLC...
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EU Clinical Trial 2014-001489-85 – EMA – Feb 23, 2015

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects with Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation

Main objective of the trial: •Evaluate the safety and tolerability of 2 fixed doses of FRM-0334 (300 and 500 mg daily in 2 sequential periods) over 28 days in subjects with prodromal to moderate frontotemporal dementia with granulin mutation (FTD-GRN...
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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 2004-001730-17 – EMA – Sep 16, 2004

A Phase 3, Randomized Double-Blind Study of Ceftobiprole Medocaril Versus Linezolid Plus Ceftazidime in the Treatment of Nosocomial Pneumonia

Main objective of the trial: To demonstrate the noninferiority of ceftobiprole plus placebo compared with linezolid plus ceftazidime with respect to the clinical cure rate in subjects with nosocomial pneumonia (NP) at the test-of-cure (TOC) visit.
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EU Clinical Trial 2006-000914-19 – EMA – Oct 23, 2006

A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatment of anemia.

Main objective of the trial: The primary objective is to compare the safety with respect to the incidence of clinically relevant and objectively confirmed TVEs in 2 dosing regimens of epoetin alfa when used following guidelines for baseline Hb (<=11...
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EU Clinical Trial 2013-001265-16 – EMA – Sep 30, 2013

An Open-Label, Single-arm, Phase Ib/II study of AEB071 (a Protein Kinase C Inhibitor) and Everolimus (mTOR inhibitor) in Patients with CD79-mutant or ABC subtype Diffuse Large B-Cell Lymphoma

Main objective of the trial: Phase Ib: Estimate the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of the AEB071 and everolimus combination therapy in patients with DLBCL Phase II: Assess the preliminary evidence for anti-tumor...
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EU Clinical Trial 2016-003632-20 – EMA – May 16, 2017

A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Switching from Tenofovir Disoproxil Fumarate (TDF) 300 mg QD to Tenofovir Alafenamide (TAF) 25mg QD in Subjects with Chronic Hepatitis B who are Virologically Suppressed

Main objective of the trial: The primary objectives of this study are as follows: -To evaluate the efficacy of switching to TAF 25 mg QD versus continued TDF 300 mg QD in virologically suppressed subjects with chronic HBV as determined by the proport...
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EU Clinical Trial 2006-000297-72 – EMA – Apr 24, 2007

Phase III, multicentre, open study to assess the efficacy and safety profiles of the co-administration of lanreotide Autogel 120 mg (administered via deep subcutaneous injections every 28 days) and pegvisomant 40 to 120 mg per week (administered via subcutaneous route once or twice a week) in acromegalic patients failing to respond to lanreotide Autogel 120 mg

Main objective of the trial: To assess the efficacy of the co-administration of lanreotide Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant (administered at 40 to 120 mg per week via sub-cutaneous injectio...
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EU Clinical Trial 2012-004019-29 – EMA – Apr 29, 2013

A Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled, adaptive dose-ranging study to evaluate the efficacy and safety of AIN457 in patients with relapsing multiple sclerosis

Main objective of the trial: To evaluate the efficacy of multiple doses of AIN457 in reducing the number of new Gadolinium-enhancing lesions on MRI compared to placebo
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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 2006-004693-27 – EMA – Nov 9, 2006

A RANDOMISED, PHASE 3 STUDY OF DOCETAXEL IN COMBINATION WITH SUNITINIB VERSUS DOCETAXEL IN THE FIRST-LINE TREATMENT OF ADVANCED BREAST CANCER PATIENTS

Main objective of the trial: To demonstrate that the combination of docetaxel with sunitinib is superior to docetaxel in prolonging PFS in patients with advanced breast cancer who have relapsed after an anthracycline-based chemotherapy in the adjuvan...
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EU Clinical Trial 2011-003814-18 – EMA – May 3, 2012

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE)

Main objective of the trial: • To evaluate the efficacy of belimumab administered SC in adult subjects with SLE. • To evaluate the safety and tolerability of belimumab administered SC in adult subjects with SLE.
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EU Clinical Trial 2011-002066-20 – EMA – Nov 1, 2012

A Phase 3, Double-Blind, Randomized, Multi-center, Placebo-Controlled Sequential Dose Titration Study to Assess Efficacy, Safety and Population Pharmacokinetics of Solifenacin Succinate Suspension in Pediatric Subjects from 5 to less than 18 years of Age with Overactive Bladder (OAB)

Main objective of the trial: To evaluate the efficacy and safety of solifenacin succinate o.d. in children and adolescents with OAB
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EU Clinical Trial 2012-001251-40 – EMA – Oct 16, 2012

MEA115588 A randomised, double-blind, double-dummy, placebo-controlled, parallel-group, multi-centre study of the efficacy and safety of mepolizumab adjunctive therapy in subjects with severe uncontrolled refractory asthma

Main objective of the trial: To evaluate the efficacy of mepolizumab 75 mg intravenous (i.v.) or 100 mg subcutaneous (SC) every 4 weeks versus placebo on the frequency of clinically significant exacerbations in adult and adolescent subjects with seve...
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