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• Authorised

• Exelon bei dementiellem Syndrom bei Patienten mit Progressiver Supranukleärer Parese - offene, prospektive Phase II-Studie -
• Progressive supranuclear palsy (PSP) is a neurodegenerative disorder with hardly any therapeutical option to ameliorate the course of the disease. Results of first trials with physostigmine and donepezil did not point out a definite benefit. In contrast, first clinical observations concerning an effect with rivastigmine in PSP with dementia were promising. This may be due to the fact, that rivastigmine excerts a double action inhibiting both the acetylcholin- and the buturylcholinesterase.
• Germany
• 2007-01-02

• Authorised

• Effects of allopregnanolone in women with PMDD, depression, PCOS och oral contraceptives
• PMDD (premenstrual dysphoric disorder) includes depressed mood and anxiety but occurs only during the late phase of the menstrual cycle. Major depression are more common in women and especially post partum and during the menopause. PCOS (polycystic ovary syndrome) include symptoms like hirsutism, amenorrhoea and obesity but depressive symptom also occur. Mental side effects from oral contraceptives are common.
• Sweden
• 2004-10-01

• Authorised

• A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis. - Randomized trial of insulin detemir in CF associated pre-diabetes
• Individuals with cystic fibrosis develop diabetes. They exhibit abnormal glucose handling (impaired glucose tolerance), poor growth and a decline in lung function before overt diabetes develops. Early treatment with insulin before diabetes develops may improve weight gain and lung function and delay progression to overt diabetes.
• United Kingdom
• 2005-11-09

• Authorised

• Efficacy and Safety of Niaspan in South Asian Stroke Survivors: NIASTAR TRIAL (Niaspan: Indo-Asian Stroke patienT Atherosclerotic Regression trial) - NIASTAR
• 1. Patients diagnosed as having a stroke based on the WHO Criteria Patients with transient ischaemic attacks will be included if symptoms of motor or sensory loss were demonstrable with full recovery within 24 hours. Only strokes and TIA that are ischaemic in nature (thrombo-embolic) will be included in the study
• United Kingdom
• 2005-10-03

• Authorised

• A PHASE II, MULTI-CENTER, OPEN-LABEL STUDY OF YM155 IN SUBJECTS WITH HORMONE REFRACTORY PROSTATE CANCER (HRPC) PREVIOUSLY TREATED WITH AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN
• Male adults with Hormone Refractory Prostate Cancer who have progressed, as evidenced by PSA progression or progression of measurable disease, after at least 1 prior chemotherapy regimen. MedDRA version: 8.0 Level: LLT Classification code 10062904
• Czech Republic, United Kingdom
• 2005-09-12

• Authorised

• Infusion of a single dose of erythropoietin to Prevent Injury in an Ischemia Reperfusion forearm model - A randomised cross-over study to evaluate if infusion of a single dose of EPO protects against ischemia-reperfusion injury in man. - IPIIR
• Myocardial ischemia-reperfusion injury. MedDRA version: 9.1 Level: LLT Classification code 10059512 Term: Apoptosis MedDRA version: 9.1 Level: LLT Classification code 10028601 Term: Myocardial ischemia MedDRA version: 9.1 Level: LLT Classification code 10051624 Term: Myocardial reperfusion injury
• Netherlands
• 2008-05-29

• Authorised

• A randomised, placebo controlled, double blind study to evaluate the effect of 300mcg testosterone patches in addition to HRT on arterial compliance, insulin resistance and sexual desire. - Testosterone Patch's effect on the Cardiovascular system and libido.
• - arterial compliance - insulin resistance - decreased sexual desire after menopause MedDRA version: 9.1 Level: LLT Classification code 10020112 Term: Hirsutism MedDRA version: 9.1 Level: LLT Classification code 10001763 Term: Alopecia reversible br>MedDRA version: 9.1 Level: LLT Classification code 10000496 Term: Acne MedDRA version: 9.1 Level: LLT Classification code 10059294 Term: Oily skin MedDRA version: 9.1 Level: LLT Classification code 10028813 Term: Nausea MedDRA version: 9.1 Level: LLT Classification code 10040880 Term: Skin irritation
• United Kingdom
• 2008-05-09

• Authorised

• More creative on cocaine?
• It is not really a medical condition that is being investigated. The present research proposal has been designed 1) to assess creativity during cocaine intoxication, and 2) to define the potentially different effect of cocaine on divergent and convergent thinking in cocaine users;Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]
• Netherlands
• 2013-05-24

• Authorised

• Study to determine the recommended dose, the safety and the efficacy of lenalidomide administered in association with obinutuzumab (GA101) for the treatment of relapsed/refractory B-cell Lymphoma.
• Phase IB: CD20 positive Follicular Lymphoma, WHO grade 1, 2 or 3a relapsed/refractory after =1 prior R-containing regimen Phase II: - CD20 positive follicular not previously treated - CD20 positive follicular relapsed/refractory after =1 prior R-containing regimen - agressive B-cell lymphoma (Diffuse Large B-Cell Lymphoma and Mantle Cell Lymphoma) relapsed/refractory after =1 prior R-containing regimen MedDRA version: 20.0 Level: PT Classification code 10016906 Term: Follicle centre lymphoma, follicular grade I, II, III refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10012822 Term: Diffuse large B-cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10026801 Term: Mantle cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
• Belgium, France
• 2013-05-21

• Authorised

• Secured access to crizotinib for patients with tumors harboring a genomic alteration on one of the biological targets of the drug - AcSé crizotinib
• Patients with metastatic or unresectable locally advanced malignancies harboring specific genomic alterations regarding the biological crizotinib targets, and who are no more amenable to curative treatment MedDRA version: 14.1 Level: LLT Classification code 10007050 Term: Cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10029260 Term: Neuroblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10002227 Term: Anaplastic large cell lymphoma T- and null-cell types System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10067917 Term: Inflammatory myofibroblastic tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10008593 Term: Cholangiocarcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10067946 Term: Renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10039022 Term: Rhabdomyosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10017758 Term: Gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classification code 10024658 Term: Liver carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10061873;Therapeutic area: Diseases [C] - Cancer [C04]
• France
• 2013-04-22

• Authorised

• A single arm, multicentre, phase IIIb study to evaluate safety, efficacy and pharmacokinetic (PK) of subcutaneous (SC) rituximab administered during induction phase or maintenance in previously untreated patients with CD20+ diffuse large B cell lymphoma (DLBCL) or follicular lymphoma (FL)
• CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkin’s lymphoma grade 1, 2 or 3a;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
• Italy
• 2013-04-19

• Authorised

• The dose and genital tract concentration of Maraviroc needed for protection from HIV infection
• HIV MedDRA version: 17.0 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
• United Kingdom
• 2013-04-05

• Authorised

• What is the effect of nicardipine on the pregnant woman with severe hypertension and how is nicardipine excreted?
• Pregnant patients with preeclampsia (hypertension and protein/creatinine ratio = 30mg/mmol or = 300mg protein/24hours) complicated with severe hypertension (systolic bloodpressure = 160mmHg and/or diastolic blood pressure = 110mmHg). Gestational age = 20 weeks ;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
• Netherlands
• 2013-03-13

• Authorised

• Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV co-infected patients
• Early Chronic Hepatitis C in HIV/HCV co-infected patients MedDRA version: 19.0 Level: LLT Classification code 10065949 Term: HCV coinfection System Organ Class: 100000004862 MedDRA version: 19.0 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Virus Diseases [C02]
• Spain
• 2016-07-08

• Authorised

• A Phase 2, Open-Label, Single-Agent, Multicenter Study to investigate the Efficacy and Safety of INCB054828 in Subjects Advanced Bladder cancer with FGF/FGFR Alterations
• Subjects with metastatic or surgically unresectable urothelial cancer (may include primary site from ureters, upper tract, renal pelvis, and bladder) with an FGF/FGFR alteration, who failed at least 1 previous treatment or are platinum ineligible. MedDRA version: 20.0 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
• Belgium, European Union, France, Israel, Netherlands, Spain, United Kingdom, United States
• 2016-10-18

• Authorised

• A Study to Evaluate the Effectiveness and Safety of Prophylactic Emicizumab Versus no Prophylaxis in Haemophilia A Patients Without Inhibitors
• Haemophilia A without factor VIII inhibitors MedDRA version: 19.0 Level: LLT Classification code 10053753 Term: Hemophilia A without inhibitors System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
• Australia, Costa Rica, France, Germany, Ireland, Italy, Japan, Korea, Republic of, Poland, South Africa, Spain, Taiwan, United Kingdom, United States
• 2016-03-07

• Authorised

• OXYGEN in high pressure in treatment of severe sepsis
• Patients > 18 yr. with diagnostic criteria for severe sepsis, within 6 hours of admission in the Emergency Room, defined as hypotension after hemodynamic resuscitation, initial lactate > 4, or persistence of organ dysfunction (oliguria 1, 2 or 3);Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
• Spain
• 2018-08-02

• Authorised

• Comparación de un régimen de insulina lispro premezclada (proporción baja, 25/75; y proporción media, 50/50) con un régimen de inyecciones separadas de insulina basal y en bolos, en pacientes con diabetes tipo 2 que consumen un desayuno ligero y presentan un control glucémico insuficiente con tratamiento oral Comparison of Premixed Insulin Lispro Low Mixture and Mid Mixture Regimens with Separate Basal and Bolus Insulin Injections in Patients with Type 2 Diabetes with Inadequate Glycemic Control on Oral Therapy who Consume Light Breakfast
• Diabetes Mellitus tipo 2 MedDRA version: 9.1 Level: LLT Classification code 10063624 Term: Type II diabetes mellitus inadequate control
• Portugal, Spain
• 2007-12-27

• Authorised

• A phase III, four-armed, randomised, double blind, parallel study to compare the efficacy and safety in type 2 diabetic patients with combined hyperlipidemia of a 12-week administration of Fenofibrate 160mg/Pravastatin 40mg combination versus Simvastatin 20mg in patients without Cardiovascular disease (CVD) (group 1) and of Fenofibrate 160mg/Pravastatin 40mg combination+Ezetimibe 10mg versus Simvastatin 20mg+Ezetimibe 10mg in patients with CVD (group 2), followed by a 12-week safety phase of Fenofibrate 160mg/Pravastatin 40mg combination in group 1 and of Fenofibrate 160mg/Pravastatin 40 mg combination+Ezetimibe 10mg in group 2. - PREFED "PRavastatin, Ezetimibe and FEnofibrate in Diabetic patients"
• Type 2 diabetic patients, as defined by the WHO without CVD and with CVD (Cardiovascular disease), with combined hyperlipidemia. MedDRA version: 9.1 Level: LLT Classification code 10027763 Term: Mixed hyperlipidemia
• France, Germany, Hungary
• 2007-03-06

• Authorised

• SPACE trial SMA and Pyridostigmine in Adults and Children; Experimental trial to assess effect of pyridostigmine compared to placebo in patients with spinal muscular atrophy types 2, 3 and 4
• Proximal spinal muscular atrophy (SMA) is characterized by weakness of predominantly axial and proximal muscle groups and is caused by homozygous deletion of the survival motor neuron 1 (SMN1)-gene. There are 4 SMA types (type 1-4), with a descending order of severity. Age at onset and achieved motor milestones are the characteristics to define severity. Treatment of SMA is exclusively supportive. MedDRA version: 17.1 Level: LLT Classification code 10068209 Term: Spinal muscular atrophy adult onset System Organ Class: 100000004850 MedDRA version: 17.1 Level: LLT Classification code 10051203 Term: Spinal muscular atrophy congenital System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
• Netherlands
• 2014-11-03