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EU Clinical Trial 2004-000238-36 – EMA – Oct 5, 1999

Third International Stroke Trial (IST-3) of thrombolysis for acute ischaemic stroke

Main objective of the trial: To investigate the safety and efficacy of treatment with intravenous recombinant tissue plasminogen activator (rt-PA) within 6 hours of onset of acute ischaemic stroke.
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EU Clinical Trial 2005-002385-11 – EMA – May 16, 2002

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EU Clinical Trial 2006-004084-66 – EMA – Jul 9, 2002

A phase II study on the efficacy and safety of topotecan in the treatment of patients with brain metastases

Main objective of the trial: To assess the clinical efficacy in terms of objective response and time of response
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EU Clinical Trial 2006-002053-69 – EMA – Aug 13, 2002

FRACTURE INCIDENCE REDUCTION AND SAFETY OF TSE-424 (BAZEDOXIFENE ACETATE) COMPARED TO PLACEBO AND RALOXIFENE IN OSTEOPOROTIC POSTMENOPAUSAL WOMEN

Main objective of the trial: To evaluate the efficacy of bazedoxifene acetate 20 mg and bazedoxifene acetate 40 mg in comparison to placebo in reduction of new vertebral fractures in osteoporotic postmenopausal women after 36 months and after 60 mont...
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EU Clinical Trial 2006-002737-21 – EMA – Sep 10, 2002

A randomized phase II study in the advanced or metastatic transitional cell urotelium carcinoma between Gemcitabine + Cisplatin e Gemcitabine + Cisplatino + Taxolo

Main objective of the trial: 1. To estimate the percentage of response in patients with advanced and/or metastatic urotelium carcinoma treated with Gemcitabine + Cisplatin (GC) e Gemcitabine + Cisplatin + Taxol (GCT) 2. To estimate the tolerance of t...
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EU Clinical Trial 2006-003746-42 – EMA – Feb 11, 2003

Immunotherapy vs immuno-chemotherapy in patients with metastatic kidney carcinoma

Main objective of the trial: To estimate if the addition of Gemcitabine and Navelbine leads to increase of activity and therapeutic efficacy with respect to immunotherapy alone
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EU Clinical Trial 2005-001055-38 – EMA – Nov 28, 2003

RANDOMIZED PHASE II TRIAL ON PRIMARY CHEMOTHERAPY WITH HIGH-DOSE METHOTREXATE, ALONE OR ASSOCIATED WITH HIGHDOSE CYTARABINE, FOLLOWED BY RESPONSE- AND AGE-TAILORED RADIOTHERAPY FOR IMMUNOCOMPETENT PATIENTS WITH NEWLY DIAGNOSED PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA

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EU Clinical Trial 2006-003752-38 – EMA – Dec 9, 2003

A phase II study of Capecitabine in combination with oral vinorelbine in advanced Breast Cancer

Main objective of the trial: To assess the Response Rate (RR) of the combination of capecitabine with oral vinorelbina in the treatment of patients with advanced breast cancer previously submitted tochemotherapy with taxanes plus/minus anthracyclines
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EU Clinical Trial 2004-000642-21 – EMA – Jan 1, 2004

A Multicenter, Multinational, Open-Label Extension Study of Recombinant Human N-acetylgalactosamine 4-sulfatase (rhASB) in Patients with Mucopolysaccharidosis VI

Main objective of the trial: The objective of this study is to evaluate the long-term efficacy and safety of rhASB treatment in patients with MPS VI.
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EU Clinical Trial 2004-001223-37 – EMA – Jan 1, 2004

Ensayo clínico abierto en fase IV, para evaluar la inmunogenicidad y reactogenicidad de la vacuna combinada DTPa (Infanrix) de GlaxoSmithKline Biologicals administrada como dosis de recuerdo a los 4 años de edad en niños prematuros (<37 semanas) en comparación con niños nacidos a término, que previamente recibieron 4 dosis de la vacuna DTPa-HBV-IPV/Hib (Infanrix hexa) a los 2, 4, 6 y 18 meses de edad.

Main objective of the trial: Demostrar que la inmunogenicidad inducida por la vacuna DTPa (Infanrix) un mes después de la dosis de recuerdo a los 4 años en el grupo de niños prematuros (< 37 semanas) no es inferior a la inducida en le grupo de niños...
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EU Clinical Trial 2004-002420-18 – EMA – Jan 1, 2004

A prospective, non-randomised, non-controlled, open label, multicentre phase II study: PTK 787/ZK222584 in patients with advanced neuroendocrine tumours

Main objective of the trial: Examine time to progression in patients with advanced neuroendocrine tumours receiving PTKZK 787
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EU Clinical Trial 2004-004488-31 – EMA – Jan 1, 2004

Does cyclosporine A reduce the insulin secretion from the pancreas?

Main objective of the trial: Test the effect of cyclosporine A on insulin release
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EU Clinical Trial 2004-002071-16 – EMA – Jan 1, 2004

A Phase 2, Multicenter, Open-Label Study to Evaluate the Response to and Safety of an 8-Day Course of Phenoptin Treatment in Subjects with Phenylketonuria Who Have Elevated Phenylalanine Levels

Main objective of the trial: The primary objective of this study is to evaluate the degree and frequency of response to Phenoptin treatment, as demonstrated by a reduction in blood phenylalanine (Phe) level, among subjects with phenylketonuria (PKU)...
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EU Clinical Trial 2004-004248-37 – EMA – Jan 1, 2004

A phase II open (partially double-blind), randomized, controlled, primary vaccination study to assess the immunogenicity, safety and reactogenicity of one intramuscular dose of four different formulations of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine versus one subcutaneous dose of MENCEVAX™ ACWY in healthy adolescents/young adults aged 15-19 years

Main objective of the trial: To evaluate the immune response induced by four different formulations of GSK Biologicals’ MenACWY-TT candidate conjugate vaccine versus MENCEVAX™ ACWY in healthy adolescents/young adults aged 15-19 years.
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EU Clinical Trial 2004-004386-15 – EMA – Jan 1, 2004

An Open-Label, Multicentre, Phase 3 Scintigraphy Study Assessing 123I mIBG Uptake in Subjects Being Evaluated for Phaeochromocytoma or Neuroblastoma

Main objective of the trial: To demonstrate that 123I-mIBG planar scintigraphy is sensitive and specific in confirming or excluding the diagnoses of neuroblastoma and phaeochromocytoma
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EU Clinical Trial 2004-002711-83 – EMA – Jan 1, 2004

Evaluation of anthroposophic supportive medicine on treatment-related toxicity in children receiving cancer therapy

Main objective of the trial: The aim is to investigate the efficiency and safety of anthroposophic supportive medicine including mistletoe plant extracts on any side effects in children with malignancies during the conventional chemotherapy protocols...
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EU Clinical Trial 2004-004482-15 – EMA – Jan 1, 2004

Hirnaktivierung während Gedächtnisaufgaben bei Patienten mit Schizophrenie unter Behandlung von Ziprasidon oder Risperidon. Eine FMRT-Untersuchung.

Main objective of the trial: Untersuchung der differenziellen Wirkung der beiden Neuroleptika auf die mittels funktioneller Kernspintomographie erfasste Hirnaktivierung im medialen Frontallappen unter Bearbeitung des Continuous performance test (CPT;...
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EU Clinical Trial 2004-001174-25 – EMA – Jan 1, 2004

A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO DETERMINE THE EFFICACY, SAFETY AND TOLERABILITY OF A COMBINATION OF GALANTAMINE (AN ACETYLCHOLINESTERASE INHIBITOR) PLUS TRIMIPRAMINE IN SMOKING CESSATION

Main objective of the trial: To assess the efficacy, tolerability and safety of a combination of galantamine plus trimipramine in cigarette smokers who have a desire to stop smoking. The study is designed as a placebo-controlled double-blind study.
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EU Clinical Trial 2004-004743-22 – EMA – Jan 1, 2004

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Vasomotor/Idiopathic Rhinitis

Main objective of the trial: The primary objective of this study is to compare the efficacy and safety of GW685698X 100 mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (≥ 12 years of age) with...
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EU Clinical Trial 2004-001404-12 – EMA – Jan 1, 2004

Estudio prospectivo, aleatorizado, doble ciego, para la evaluación de la eficacia y seguridad del metilfenidato de liberación prolongada con respecto al metilfenidato de liberación inmediata y placebo en niños con trastorno por déficit de atención e hiperactividad.

Main objective of the trial: Determinar si el tratamiento con metilfenidato de liberación prolongada (dosis única) es eficaz y seguro para controlar y mejorar la sintomatología típica de niños con tastorno por déficit de atención e hiperactividad: pr...
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EU Clinical Trial 2004-001130-16 – EMA – Jan 1, 2004

12 months long term safety and tolerability of Rupatadine 10 mg in the treatment of moderate-severe persistent allergic rhinitis.

Main objective of the trial:  To assess long term safety of rupatadine 10 mg fumarate in the treatment of moderate-severe persistent allergic rhinitis in 12 months follow-up.
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EU Clinical Trial 2004-005207-15 – EMA – Jan 1, 2004

Low dose muscle relaxant in intubation in children

Main objective of the trial: Intravenous induction of an anaesthesia to a child is an established method in our department. Certain procedures requires tracheal intubation after administration of a muscle relaxant. If you want to avoid succinylcholin...
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EU Clinical Trial 2004-000356-17 – EMA – Jan 1, 2004

PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQ USING A NOVEL CAPILLARY BLOOD COLLECTION METHOD

Main objective of the trial: To establish an optimal monitoring regimen for IGF-I in NutropinAq treated children, using a newly developed capillary blood spot IGF-I measurements technology.
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EU Clinical Trial 2004-004988-30 – EMA – Jan 1, 2004

PHARMACOKINETICS AND ANALGESIC EFFICACY OF LAEVOBUPIVACAINE, FENTANYL AND CLONIDINE FOR POSTOPERATIVE PARAVERTEBRAL ANAESTHESIA.

Main objective of the trial: The objectives of the proposed study are to evaluate the pharmacokinetics of laevobupivacaine, fentanyl and clonidine by measuring their plasma concentrations at defined time intervals after paravertebral analgesia, and t...
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EU Clinical Trial 2004-004691-37 – EMA – Jan 1, 2004

Etanercept in Psoriasis and Psoriatic Arthritis: a single center, open-label study in 15 patients.

Main objective of the trial: The proposed study is a single center, open label study of 15 patients with PsA and cutaneous Ps treated with a 3-month course of Etanercept (Enbrel). The aims of this study are to assess the effect of TNF inhibition with...
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EU Clinical Trial 2004-002050-66 – EMA – Jan 1, 2004

Treatment Interruption in Children with Chronic HIV-Infection: the TICCH Trial

Main objective of the trial: To evaluate the role of planned treatment interruptions (PTIs) in the management of HIV infected children who have responded well to antiretroviral therapy and to determine whether children undergoing a PTI are disadvanta...
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EU Clinical Trial 2004-001653-28 – EMA – Jan 1, 2004

A comparison of the effects on prostaglandin synthesis and cytokine production of an olive-oil based lipid emulsion (Clinoloeic) with a soya based emulsion (Intralipid) in newborn infnats receiving parenteral nutrition.

Main objective of the trial: To compare the effect of an olive oil based lipid emulsions used in parenteral nutrition on prostaglandin synthesis and cytokine production in preterm infants, compared with standard lipid emulsion.
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EU Clinical Trial 2004-004443-22 – EMA – Jan 1, 2004

Untersuchung der Wirksamkeit einer glycerinhaltigen Creme bei der Behandlung von Atopischer Dermatitis. Kontrolliert, randomisierte Doppel-Blind-Studie.

Main objective of the trial: barrier recovery in subjects with atopic dermatitis
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EU Clinical Trial 2004-001397-92 – EMA – Jan 1, 2004

An extension to a phase II study to determine the efficacy and safety of STI571 in patients with chronic myeloid leukemia who are refractory to or intolerant of interferon-alpha

Main objective of the trial: •To enable patients to have access to study drug and continue study treatment •To decrease data collection to include overall survival and serious adverse events
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EU Clinical Trial 2004-001396-19 – EMA – Jan 1, 2004

An extension to a phase II study to determine the safety and anti-leukemic effects of STI571 in patients with Philadelphia chromosome-positive leukemia including acute lymphoblastic leukaemia, acute myeloid leukaemia, and accelerated phase chronic myeloid leukemia

Main objective of the trial: •To enable patients to have access to study drug and continue study treatment •To decrease data collection to include overall survival and serious adverse events
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EU Clinical Trial 2004-001928-20 – EMA – Jan 1, 2004

Open-label, multi-centre study to compare the effectiveness of QvarTM Autohaler therapy with conventional therapy (similar doses) in children with stable asthma

Main objective of the trial: Compare the effectiveness of QvarTM AH therapy with conventional (fixed combination) asthma therapy (similar doses)
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EU Clinical Trial 2004-003816-47 – EMA – Jan 1, 2004

Clinical pilot study on the effect of Metformin in adipose children and adolescents with insulin-resistance Klinische Pilotstudie zur Untersuchung der Wirkung von Metformin bei adipösen Kindern und Jugendlichen mit Insulin-Resistenz (IR)

Main objective of the trial: Improvement of the insuline resistance (assessed on the basis of HOMA (homeostasis model assessment)
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EU Clinical Trial 2004-001346-33 – EMA – Jan 1, 2004

A Phase 3 Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents (Age 2 to <18) with Chronic Hepatitis B

Main objective of the trial: To investigate the efficacy of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to < 18) compared to placebo following 48 weeks of treatment.
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EU Clinical Trial 2006-004751-38 – EMA – Feb 11, 2004

Vaccine with dendritic cells pulsed tumoral cell line or with autologue tumor in patients with kidney carcinoma

Main objective of the trial: 1. CHEMICAL: administration of the vaccine, clinical monitoring, clinical safety and efficacy, 2. BIOLOGICAL: methods of colture, evaluation of the biological efficacy,
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EU Clinical Trial 2004-000784-97 – EMA – Feb 16, 2004

A Randomized, Double-blind, Double-Dummy, Multicenter, Non-inferiority Phase III Study to Assess the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily, versus Oral Cephalexin, 500mg in Adults, or 12.5mg/kg (250mg/5mL) in Children, Twice Daily, in the Treatment of Secondarily-Infected Dermatoses

Main objective of the trial: The primary objective of this study is to demonstrate that topical 1% SB-275833 ointment, applied twice daily for 5 days, is at least as effective clinically as oral cephalexin, 500mg in adults, or 12.5mg/kg in children,...
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EU Clinical Trial 2004-001855-12 – EMA – Feb 16, 2004

Randomized, two arm, placebo controlled study to compare the efficacy of IV loading doses followed by maintenance treatment with IV ibandronic acid versus zoledronic acid in patients with skeletal metastases experiencing moderate to severe pain.

Main objective of the trial: The primary objective is to compare the difference in pain responses between treatment with ibandronic acid vs. zoledronic acid in patients with malignancy and painful metastatic bone disease. In this study, pain response...
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EU Clinical Trial 2005-005155-18 – EMA – Feb 24, 2004

Study on the effectiveness of a treatment with statine in reducing the morbility and cardiovascular mortality in patients with moderate-strict renal insufficiency.

Main objective of the trial: To verify in a population of patients with moderate-strict IR that an aggressive treatment of cholesterolemia target the levels of cholesterol LDL 100 mg/dL meaningfully reduces the entity of a end point composite, consti...
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EU Clinical Trial 2004-000966-10 – EMA – Mar 23, 2004

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EU Clinical Trial 2005-005384-28 – EMA – Mar 24, 2004

Randomized study of high-dose chemotherapy plus rituximab (R-HDS) vs conventional chemotherapy with rituximab (R-FC) in chronic lymphocytic leukemia at high risk.

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EU Clinical Trial 2004-001605-10 – EMA – Apr 27, 2004

A Phase II, open-label study of PTK787/ZK222584 in the treatment of metastatic gastrointestinal stromal tumors GISTs resistant to imatinib mesylate

Main objective of the trial: To determine safety and tolerability and efficacy of chronic oral administration of PTK787/ZK222584 in the treatment of imatinib-resistent GISTs
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EU Clinical Trial 2004-005014-36 – EMA – Apr 27, 2004

TOLLERANZA ED EFFICACIA DELL?a-TOCOFEROLO SUCCINATO NEL TRATTAMENTO DI PAZIENTI IN ETA? PEDIATRICA AFFETTI DA EPATITE CRONICA HBsAg POSITIVA

Main objective of the trial: efficacia e tollerabilita' del trattamento con vitamina E in bambini affetti da epatite cronica HBsAg./HBeAg positivi
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EU Clinical Trial 2004-001647-30 – EMA – Apr 28, 2004

An open-label study to evaluate the safety and efficacy of IMATINIB with chemotherapy in pediatric patients with Ph+/BCR-ABL+ acute lymphoblastic leukemia (Ph+ALL)

Main objective of the trial: To evaluate in patients with Ph+ALL the efficacy and safety of IMATINIB continuous exposure on top of intensive, BFM-type chemotherapy. The endpoint for response will be the evaluation on the long-term clinical outcome. V...
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EU Clinical Trial 2004-002973-22 – EMA – Apr 28, 2004

Epidemiological open-label study to evaluate the frequency of helicobacter Pylori infections prior to and after equimolar switch from therapy with MMF to enteric-coated Mycophenolic Acid (MYFORTIC-ERL080) in stable renal transplant patients

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EU Clinical Trial 2004-001035-32 – EMA – May 13, 2004

NON-MYELOABLATIVE ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION FROM HLA IDENTICAL SIBLING FOR METASTATIC SOFT TISSUE SARCOMAS

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EU Clinical Trial 2004-000349-40 – EMA – May 19, 2004

Efficacy of Exenatide Compared with Insulin Glargine in Patients with Type 2 Diabetes Using Metformin or Sulfonylurea for Whom Insulin is the Next Appropriate Therapy

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EU Clinical Trial 2004-001321-25 – EMA – May 19, 2004

A prospective, open label, monocenter trial to evaluate the interaction between the Platelia Aspergillus ELISA test and the administration of piperacillin/tazobactam.

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EU Clinical Trial 2004-000376-14 – EMA – May 28, 2004

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE CONTROLLED STUDY TO COMPARE THE EFFECT OF 52 WEEKS TREATMENT WITH LAF237 50 MG BID TO METFORMIN UP TO 1000 MG BID IN DRUG NAIVE PATIENTS WITH TYPE 2 DIABETES

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EU Clinical Trial 2009-017840-15 – EMA – May 31, 2004

Srovnání účinnosti kapecitabinu (Xeloda) s kontinuálním podáním 5-fluorouracilu v předoperační konkomitantní léčbě s radioterapií u karcinomu rekta

Main objective of the trial: Primary end point: to set and to compare the portion of complete histopathological remissions between two arms A and B defined by histopathological examination of the surgical sample.
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EU Clinical Trial 2004-000374-31 – EMA – Jun 9, 2004

A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-Ranging Study to Investigate the Efficacy and Safety of Three Months administration of SB 683699 (150 - 1200mg twice daily) in Subjects with Relapsing Multiple Sclerosis

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EU Clinical Trial 2004-000782-35 – EMA – Jun 10, 2004

EVALUATION OF THE QUALITY OF LIFE AND GASTROINTESTINAL SYMPTOMS AFTER CONVERSION TO MYFORTIC (ERL080) and CELLCEPT WITHDRAWAL IN MAINTENANCE RENAL TRANSPLANT RECIPIENTS TREATED WITH TACROLIMUS.

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