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EU Clinical Trial 2007-003780-50 – EMA – Jul 30, 2008

Estudio de fase 3, abierto y aleatorizado, de bosutinib comparado con imatinib en sujetos con leucemia mieloide crónica cromosoma Filadelfia positiva en fase crónica, de diagnóstico reciente A Phase 3 Randomized, Open-Label Study of Bosutinib Versus Imatinib in Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia

Main objective of the trial: Compare the rate of complete cytogenetic response (CCyR) at one year in chronic phase subjects receiving bosutinib alone versus chronic phase subjects receiving imatinib alone.
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EU Clinical Trial 2010-021870-12 – EMA – Feb 15, 2011

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men with Metastatic Castrate Resistant Prostate Cancer

Main objective of the trial: The primary objective of this study is to confirm the effect of tasquinimod on delaying disease progression or death compared with placebo.
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EU Clinical Trial 2009-015507-52 – EMA – Nov 13, 2009

A multicenter, randomized, double-blind, placebo controlled phase III study of panobinostat in combination with bortezomib and dexamethasone in patients with relapsed multiple myeloma.

Main objective of the trial: To compare progression-free survival (PFS), in patients treated with PAN in combination with BTZ/Dex vs. patients treated with placebo in combination with BTZ/Dex.
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EU Clinical Trial 2009-014563-39 – EMA – Mar 2, 2010

Phase III randomized trial of BIBW 2992 plus weekly paclitaxel versus Investigator`s choice of chemotherapy following BIBW 2992 monotherapy in non-small cell lung cancer patients failing previous erlotinib or gefitinib treatment

Main objective of the trial: To investigate the efficacy of BIBW 2992 plus weekly paclitaxel versus Investigator`s choice chemotherapy in patients with Stage IIIb or IV non-small cell lung cancer (NSCLC) experiencing a benefit from BIBW 2992 monother...
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EU Clinical Trial 2010-021128-92 – EMA – Nov 11, 2010

MULTICENTRE, SINGLE-ARM, OPEN LABEL CLINICAL TRIAL INTENDED TO PROVIDE EARLY ACCESS TO CABAZITAXEL IN PATIENTS WITH METASTATIC HORMONE REFRACTORY PROSTATE CANCER PREVIOUSLY TREATED WITH A DOCETAXEL-CONTAINING REGIMEN AND TO DOCUMENT SAFETY OF CABAZITAXEL IN THESE PATIENTS

Main objective of the trial: to allow patients similar to those evaluated in the TROPIC trial, and Investigators access to cabazitaxel for the management of metastatic Hormone Refractory Prostate Cancer (mHRPC) in patients who have progressed during...
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EU Clinical Trial 2009-012504-13 – EMA – Jan 20, 2010

PHASE 2, OPEN-LABEL SINGLE ARM STUDY OF THE EFFICACY AND SAFETY OF PF 02341066 IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING A TRANSLOCATION OR INVERSION INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) GENE LOCUS

Main objective of the trial: • To assess the anti-tumor efficacy of oral single agent PF-02341066 administered to patients with advanced NSCLC after failure of at least one line of chemotherapy and harbor a translocation or inversion event involving...
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EU Clinical Trial 2008-004104-31 – EMA – Mar 13, 2009

A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV)

Main objective of the trial: The primary objectives of this study are to test if aliskiren monotherapy is superior or at least non-inferior to enalapril monotherapy ((in the entire study population) and to test if aliskiren/enalapril combination is s...
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EU Clinical Trial 2012-001770-29 – EMA – Jul 6, 2015

AN OPEN-LABEL, MULTICENTER EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF LACOSAMIDE AS ADJUNCTIVE THERAPY FOR UNCONTROLLED PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN SUBJECTS WITH IDIOPATHIC GENERALIZED EPILEPSY

Main objective of the trial: The primary objective is to assess the safety and tolerability of LCM as an adjunctive therapy for uncontrolled PGTC seizures in subjects with IGE during long-term exposure.
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EU Clinical Trial 2015-001507-31 – EMA – Jun 9, 2015

A phase IIIb, open-label, multicentre study to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ combined diphtheria-tetanus-acellular pertussis (DTPa)- Haemophilus influenzae type b (Hib) vaccine (DTPa/Hib) compared with GSK Biologicals’ DTPa and Hib vaccines co-administered at different injection sites, when administered as booster vaccination to healthy Chinese subjects aged 18 to 24 months previously primed with the same vaccines in study DTPa-131 (104567)

Main objective of the trial: To evaluate the immune response to all vaccine antigens, i.e. diphtheria and tetanus toxoids, pertussis toxoid (PT), filamentous haemagglutinin (FHA), pertactin (PRN), and polyribosyl-ribitol-phosphate (PRP), one month af...
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EU Clinical Trial 2015-001407-31 – EMA – Oct 28, 2015

Open Label, Multinational, Multicenter, Real World Treatment Study of Single Agent AZD9291 for Patients with Advanced/Metastatic Epidermal Growth Factor Receptor (EGFR) T790M Mutation-Positive Non-Small Cell Lung Cancer (NSCLC) Who Have Received Prior Therapy with an EGFR Tyrosine Kinase Inhibitor (EGFR-TKI)

Main objective of the trial: The primary objective of this study is to assess the efficacy and safety of single agent AZD9291 in a real world setting in adult patients with advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutatio...
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EU Clinical Trial 2012-003554-83 – EMA – Jan 29, 2013

A double-blind, placebo-controlled, randomized, multicenter phase III study evaluating the efficacy and safety of pertuzumab in combination with trastuzumab and chemotherapy in patients with HER2-positive metastatic gastro-esophageal junction and gastric cancer

Main objective of the trial: To compare overall survival (OS) in patients treated with pertuzumab in addition to Herceptin® (trastuzumab) plus fluoropyrimidine plus cisplatin (TFP) versus patients treated with placebo in addition to TFP
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EU Clinical Trial 2014-002630-31 – EMA – Mar 25, 2015

A phase IIIb multicenter, open-label, single arm study to evaluate the efficacy and safety of pasireotide in patients with acromegaly inadequately controlled with first generation somatostatin analogues

Main objective of the trial: Primary objective: - To evaluate the efficacy of pasireotide LAR in patients with acromegaly who are inadequately controlled with maximal approved doses of currently available somatostatin analogues Supporting Analysis fo...
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EU Clinical Trial 2017-004261-26 – EMA – Oct 29, 2018

RESILIENT: A Randomized, Open Label Phase 3 Study of Irinotecan Liposome Injection (ONIVYDE®) versus Topotecan in Patients with Small Cell Lung Cancer Who Have Progressed on or after Platinum-based First-Line Therapy

Main objective of the trial: Primary Objective Part I -Describe the safety and tolerability of irinotecan liposome injection monotherapy administered every 2 weeks - To determine the irinotecan liposome injection monotherapy dose (85 mg/m2 or 70 mg/m...
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EU Clinical Trial 2009-015834-31 – EMA – Jan 1, 2010

A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction

Main objective of the trial: To test if LCZ696 is superior to enalapril in delaying time to first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization, in patients with CHF (NYHA class II – IV) and reduced e...
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EU Clinical Trial 2018-002484-25 – EMA – Jan 1, 2018

A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TAK-935 AS AN ADJUNCTIVE THERAPY IN PEDIATRIC PATIENTS WITH DEVELOPMENTAL AND/OR EPILEPTIC ENCEPHALOPATHIES

Main objective of the trial: To investigate the effect on the frequency of all seizures (convulsive and drop) in patients treated with TAK-935 as an adjunctive therapy compared to placebo at the end of the Treatment Period (Titration plus Maintenance...
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EU Clinical Trial 2010-020426-18 – EMA – Oct 27, 2010

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine

Main objective of the trial: The primary objective is to demonstrate efficacy in terms of prolonged overall survival time (OS) in patients treated with paclitaxel plus ramucirumab (IMC 1121B) drug product (thereafter referred to as ramucirumab DP) co...
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EU Clinical Trial 2017-001987-39 – EMA – Dec 18, 2017

An open label, multi-center roll-over study to assess long-term safety in patients who are ongoing or have completed a prior global Novartis or GSK sponsored Tafinlar (dabrafenib) and/or Mekinist (trametinib) study and are judged by the investigator to benefit from continued treatment

Main objective of the trial: The primary objective is to evaluate long term safety as assessed by the occurrence of AEs/SAEs.
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EU Clinical Trial 2018-001508-12 – EMA – Nov 2, 2018

A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)

Main objective of the trial: The primary objective of this study is to determine the effect of VAY736 and of CFZ533 versus their respective placebo on disease activity in SLE patients using the SRI-4 index.
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EU Clinical Trial 2018-002087-12 – EMA – Dec 7, 2018

AN OPEN-LABEL STUDY OF RISDIPLAM IN INFANTS WITH GENETICALLY DIAGNOSED AND PRESYMPTOMATIC SPINAL MUSCULAR ATROPHY

Main objective of the trial: •To evaluate the efficacy of risdiplam in patients with two copies of the survival motor neuron (SMN)2 gene (excluding the known SMN2 gene modifier mutation c.859G> C) and baseline compound muscle action potential (CMAP)...
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EU Clinical Trial 2013-003457-25 – EMA – Jun 13, 2014

Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Main objective of the trial: - To evaluate the long-term safety and tolerability of macitentan 10 mg in subjects with inoperable CTEPH - To evaluate the long term effects of macitentan 10 mg on exercise capacity and functional class (FC).
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EU Clinical Trial 2014-002694-11 – EMA – Dec 17, 2014

A phase III, double-blind, randomised study to assess the efficacy and safety of AZD9291 versus a standard of care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as first-line treatment in patients with Epidermal Growth Factor Receptor Mutation Positive, locally advanced or Metastatic Non-Small Cell Lung Cancer

Main objective of the trial: To assess the efficacy of single agent AZD9291 compared with standard of care (SoC) Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) therapy as measured by progression free survival (PFS)
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EU Clinical Trial 2012-004966-16 – EMA – Feb 27, 2013

A 52-week treatment, multi-center, randomized, double-blind, double-dummy, parallel-group, active controlled study to compare the effect of QVA149 (indacaterol maleate / glycopyrronium bromide) with salmeterol/fluticasone on the rate of exacerbations in subjects with moderate to very severe COPD.

Main objective of the trial: To demonstrate that QVA149 (110/50 μg o.d.) is at least noninferior to salmeterol/fluticasone (50/500 μg b.i.d.) in terms of rate of COPD exacerbations (mild/moderate/severe) during 52 weeks of treatment.
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EU Clinical Trial 2015-001590-41 – EMA – Jan 11, 2016

A multi-part, randomized, double-blind, placebo-controlled study to assess the safety, tolerability and efficacy of tropifexor (LJN452) in patients with primary biliary cholangitis

Main objective of the trial: • To determine the safety and tolerability of daily dosing of LJN452 in patients with Primary Biliary Cholangitis • To determine the effect of LJN452 on cholestatic markers in patients with Primary Biliary Cholangitis. Mo...
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EU Clinical Trial 2017-001833-15 – EMA – Sep 29, 2017

A Two-Part Phase 2/3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Of Varlitinib Plus mFOLFOX6 Versus Placebo Plus mFOLFOX6 in Subjects with HER1/ HER2 Co-Expressing Advanced or Metastatic Gastric Cancer Without Prior Exposure to Systemic Therapy

Main objective of the trial: Phase 2 Part: To compare the efficacy between Varlitinib in combination with mFOLFOX6 to placebo in combination with mFOLFOX6, as measured by the percentage change from baseline in TS at 12 weeks. Phase 3 Part: To compare...
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EU Clinical Trial 2011-006056-37 – EMA – Sep 5, 2013

A large, international, randomized, placebo-controlled trial to assess the impact of dabigatran (a direct thrombin inhibitor) and omeprazole (a proton-pump inhibitor) in patients suffering myocardial injury after noncardiac surgery

Main objective of the trial: To determine the effect of dabigatran versus placebo on the risk of a major vascular complication (i.e., a composite of vascular mortality, nonfatal myocardial infarction, nonfatal non-hemorrhagic stroke, nonfatal periphe...
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EU Clinical Trial 2017-004339-35 – EMA – Jan 16, 2019

A Randomized double-blind placebo-controlled multicenter Phase 3 study of efficacy and safety of AR-301 as adjunct therapy to antibiotics in the treatment of Ventilator-Associated Pneumonia (VAP) caused by S. aureus

Main objective of the trial: Efficacy: To assess the efficacy of AR-301, administered as a single dose in addition to standard of care (SOC) antibiotic regimen on Clinical Cure rates between SOC alone and SOC with AR-301 at Day 21. Stringent Clinical...
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EU Clinical Trial 2010-021590-37 – EMA – Jan 3, 2011

A MULTICENTER, GLOBAL, RANDOMIZED, DOUBLE-BLIND STUDY OF AXITINIB PLUS BEST SUPPORTIVE CARE VERSUS PLACEBO PLUS BEST SUPPORTIVE CARE IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA FOLLOWING FAILURE OF ONE PRIOR ANTIANGIOGENIC THERAPY

Main objective of the trial: Primary Objective: • To compare the OS of patients with advanced HCC receiving axtitinib + best supportive care (BSC) versus (vs) placebo + BSC following failure of one prior antiangiogenic therapy.
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EU Clinical Trial 2013-000087-29 – EMA – Aug 26, 2013

A multicenter, open-label, single-arm, phase IIIb, international study evaluating the safety of Obinutuzumab alone or in combination with chemotherapy in patients with previously untreated or relapsed/refractory Chronic Lymphocytic Leukemia.

Main objective of the trial: • To evaluate the safety and tolerability of obinutuzumab alone or in combination with chemotherapy
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EU Clinical Trial 2009-015878-35 – EMA – Mar 22, 2010

Randomized, double blind, placebo controlled, parallel group, multi-center study to evaluate the hemodynamic effects of Riociguat (BAY 63-2521) as well as safety and kinetics in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

Main objective of the trial: The primary objective of this study is to assess the hemodynamic profile of Riociguat in patients with symptomatic pulmonary hypertension associated with left ventricular systolic dysfunction (PH-sLVD).
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EU Clinical Trial 2005-000051-15 – EMA – Jan 1, 2005

CONTINUING ACCESS TO THE TYROSINE KINASE INHIBITOR OF VEGFR-2, AG-013736 (A406) FOR PATIENTS PREVIOUSLY RECEIVING AG-013736 IN CLINICAL TRIALS

Main objective of the trial: The objective of the trial is to provide continued access to AG-013736 tablets to patients who were assigned to an AG-013736 containing treatment arm in a previous AG-013736 trial and who had documented stable or respondi...
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EU Clinical Trial 2016-005126-11 – EMA – Feb 23, 2018

A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients with Unresectable Hepatocellular Carcinoma

Main objective of the trial: To assess the efficacy of durvalumab plus tremelimumab compared with sorafenib. Valutare l'efficacia di durvalumab più tremelimumab rispetto a sorafenib
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EU Clinical Trial 2016-000250-35 – EMA – Jun 16, 2016

A Phase III, multicenter, randomized, placebo-controlled study of atezolizumab (anti-PD-L1 antibody) as monotherapy and in combination with platinum-based chemotherapy in patients with untreated locally advanced or metastatic urothelial carcinoma

Main objective of the trial: • To evaluate efficacy of atezolizumab (Atez) plus platinum-based chemotherapy vs. placebo plus platinum-based chemotherapy based on progression-free survival (PFS) and overall survival (OS) • To evaluate efficacy of Atez...
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EU Clinical Trial 2018-001155-13 – EMA – Apr 2, 2019

A Phase III, Randomized, Open-Label Study Investigating the Addition of Durvalumab to an Anthracycline-Taxane based Chemotherapy in Early-Stage Triple-Negative Breast Cancer

Main objective of the trial: 1. Pathologic complete response in the breast and axillary lymph nodes (ypT0/ypN0): To compare pathological complete response (pCR=ypT0/ypN0) rates between TNBC patients treated with durvalumab concurrently given to chemo...
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EU Clinical Trial 2008-005872-29 – EMA – Sep 24, 2009

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination with Carboplatin and Taxane in Subjects with Platinum-sensitive Ovarian Cancer in First Relapse

Main objective of the trial: To assess the effect of two dose levels of MORAb-003 or placebo in combination with carboplatin and taxane on progression-free survival (PFS), as determined by RECIST, in subjects with platinum-sensitive ovarian cancer in...
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EU Clinical Trial 2013-003093-27 – EMA – Dec 18, 2013

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination with Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects with Previously Treated Indolent Non-Hodgkin Lymphoma (iNHL)

Main objective of the trial: The primary objective of this study is to evaluate whether the addition of ibrutinib to bendamustine and rituximab (BR) combination or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) combina...
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EU Clinical Trial 2016-003288-20 – EMA – May 7, 2017

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, EFFICACY AND SAFETY STUDY OF CRENEZUMAB IN PATIENTS WITH PRODROMAL TO MILD ALZHEIMER’S DISEASE

Main objective of the trial: To evaluate the efficacy of crenezumab compared with placebo based on change from baseline to Week (W) 105 in global outcomes as assessed by Clinical Dementia Rating-Sum of Boxes (CDR-SB)
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EU Clinical Trial 2013-004054-21 – EMA – Sep 26, 2014

Phase 3 Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Compare the Efficacy and Safety of Lenalidomide (CC-5013) Plus R-CHOP Chemotherapy (R2-CHOP) Versus Placebo Plus R-CHOP Chemotherapy in Subjects with Previously Untreated Activated B-cell Type Diffuse Large B-cell Lymphoma.

Main objective of the trial: To compare the efficacy of lenalidomide, rituximab, cyclophosphamide, doxorubicin,vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (pl...
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EU Clinical Trial 2015-002553-35 – EMA – Feb 20, 2016

A 52-week, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of QAW039 when added to existing asthma therapy in patients with uncontrolled severe asthma.

Main objective of the trial: In patients with severe asthma and high eosinophil counts (≥250 cells/μl) receiving SoC asthma therapy, to demonstrate the efficacy (as measured by rate of moderate-to-severe asthma exacerbations) of at least one dose lev...
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EU Clinical Trial 2013-004766-34 – EMA – Aug 1, 2014

A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease

Main objective of the trial: To compare the complete response rate at the end of the 8-week period of randomized withdrawal (Week 34) between patients randomized to continued LCI699 therapy vs. placebo.
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EU Clinical Trial 2014-001017-61 – EMA – Nov 8, 2014

A MULTI-CENTRE RANDOMISED CLINICAL TRIAL OF BIOMARKER-DRIVEN MAINTENANCE TREATMENT FOR FIRST-LINE METASTATIC COLORECTAL CANCER (MODUL)

Main objective of the trial: • To evaluate progression-free survival (PFS)
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EU Clinical Trial 2008-007944-33 – EMA – Mar 13, 2009

A phase IIIb multicenter, 52 week treatment, randomized, blinded, double dummy, parallel group efficacy study comparing the effect of inhaled indacaterol 150 μg o.d. vs inhaled tiotropium 18 μg o.d. on lung function, rate of exacerbations and related outcomes in patients with COPD

Main objective of the trial: To demonstrate superiority of 150 µg o.d. of indacaterol versus tiotropium 18 µg o.d. with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment. Trough is defined as the mean of FEV1 measurements at 23h...
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EU Clinical Trial 2008-006914-62 – EMA – Apr 23, 2009

A Phase III, multi-center, placebo–controlled trial of Sorafenib (BAY 43-9006) in patients with relapsed or refractory advanced predominantly non squamous Non-Small Cell Lung Cancer (NSCLC) after 2 or 3 previous treatment regimens

Main objective of the trial: The objective of this phase III study is to compare the efficacy and safety of sorafenib monotherapy plus best supportive care (BSC) versus placebo plus BSC for the treatment of patients with relapsed or refractory advanc...
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EU Clinical Trial 2007-004219-75 – EMA – May 27, 2008

Open-label, randomized, controlled, multicenter phase III study investigating cetuximab in combination with capecitabine (Xeloda, X) and cisplatin (P) versus XP alone as first-line treatment for subjects with advanced gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction.

Main objective of the trial: The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with XP chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma inclu...
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EU Clinical Trial 2007-000175-42 – EMA – Dec 21, 2007

A double-blind, randomised, multicenter, phase III study of bevacizumab in combination with capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin, as first-line therapy in patients with advanced gastric cancer.

Main objective of the trial: To compare overall survival
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EU Clinical Trial 2013-000833-11 – EMA – Jul 11, 2013

A Phase Ib/II study of docetaxel with or without buparlisib as second line therapy for patients with advanced or metastatic squamous non-small cell lung cancer

Main objective of the trial: For phase Ib: To determine the maximum-tolerated dose (MTD) / recommended Phase II dose (RP2D) of buparlisib when administered orally in combination with every-3-week administration of docetaxel to adult patients with Sta...
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EU Clinical Trial 2015-000454-38 – EMA – Oct 13, 2015

A phase II, open-label, randomized controlled study of PDR001 in patients with moderately differentiated/undifferentiated locally advanced recurrent or metastatic nasopharyngeal carcinoma who progressed on standard treatment

Main objective of the trial: To assess the efficacy of PDR001 versus investigator’s choice of chemotherapy in patients with moderately differentiated / undifferentiated locally advanced recurrent or metastatic NPC who progressed on or after first-lin...
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EU Clinical Trial 2011-001643-79 – EMA – Jan 24, 2012

A 6-month safety and benefit study of inhaled fluticasone propionate/ salmeterol combination versus inhaled fluticasone propionate in the treatment of 6,200 pediatric subjects 4-11 years old with persistent asthma

Main objective of the trial: The primary objective is to evaluate whether the addition of a LABA to an ICS (FSC) therapy is non-inferior in terms of risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and...
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EU Clinical Trial 2013-004813-41 – EMA – May 26, 2014

A Phase III, case series clinical study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5.0 g idarucizumab (BI 655075) in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures. RE-VERSE-AD (A study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) trial

Main objective of the trial: Evaluate the reversal of the anticoagulant effect of dabigatran in patients after administration of idarucizumab
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EU Clinical Trial 2013-000626-63 – EMA – Nov 21, 2013

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Negative, Chronic Hepatitis B.

Main objective of the trial: The primary objectives of this study are as follows: To compare the efficacy of tenofovir alafenamide (TAF) 25 mg QD versus tenofovir disoproxil fumarate (TDF) 300 mg QD for the treatment of HBeAg-negative, chronic hepati...
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EU Clinical Trial 2011-004106-16 – EMA – Jan 1, 2011

A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension

Main objective of the trial: The primary objective is to demonstrate that 12 weeks of treatment with either dose (0.5 mg/kg b.i.d or 2 mg/kg b.i.d) of the bosentan dispersible tablet formulation improves PVRi in pediatric patients with PAH, aged from...
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