海外の治験の状況「1」での検索結果
2039件の検索結果
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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
Authorised
- BAX 326 (recombinant factor Nine): A Phase 3 Prospective, Multicenter Study Evaluating Efficacy and Safety in Previously Treated Patients with Severe or Moderately Severe level Hemophilia B undergoing Surgical or Other Invasive Procedures
- Previously treated patients with severe (FIX level 1%) or moderately severe (FIX level = 2%) hemophilia B undergoing surgical or other invasive procedures MedDRA version: 14.1 Level: LLT Classification code 10018939 Term: Haemophilia B (Factor IX) System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15];Previously treated patients with severe (FIX level 1%) or moderately severe (FIX level = 2%) hemophilia B undergoing surgical or other invasive procedures MedDRA version: 14.1 Level: LLT Classification code 10018939 Term: Haemophilia B (Factor IX) System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Argentina, Brazil, Chile, Colombia, Czech Republic, Japan, Poland, Russian Federation, Sweden, Ukraine, United Kingdom, United States
- 2011-07-18
Authorised
- Study of the efficiency of brentuximab vedotin in the Hodgkin lymphoma treatment for the patients not cured by standard chemotherapy.
- Patients aged from 18 to 70 years with supradiaphragmatic Ann Arbor clinical stage I or II classical Hodgkin lymphoma CD30+, FDG-PET positive score 4 & 5 according to Deauville criteria after 2 courses of ABVD will be included in the trial. MedDRA version: 19.1 Level: LLT Classification code 10020328 Term: Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
- Belgium
- 2017-03-14
Authorised
- Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects with CML
- Subjects with Chronic Myeloid Leukemia (CML) in Accelerated Phase (AP) or in Myeloid (My) or Lymphoid (Ly) Blast Phase (BP) or with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) who are Resistant or Intolerant to Imatinib Mesylate;Therapeutic area: Diseases [C] - Cancer [C04]
- Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, United States
- 2005-05-11
Authorised
- Assessing the efficacy and safety of the GLP1-agonist liraglutide in patients who developed diabetes as a consequence of the use of anti-psychotic drugs
- antipsychotic-drugs-associated diabetes mellitus MedDRA version: 17.0 Level: LLT Classification code 10029505 Term: Non-insulin-dependent diabetes mellitus System Organ Class: 100000004861 MedDRA version: 17.0 Level: LLT Classification code 10012612 Term: Diabetes mellitus non insulin-dep System Organ Class: 100000004861 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Netherlands
- 2014-09-10
Authorised
- A Phase I/IIa gene therapy clinical trial in LHON patients
- Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene MedDRA version: 16.1 Level: LLT Classification code 10062951 Term: Leber's hereditary optic atrophy neuropathy System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Eye Diseases [C11]
- France
- 2014-02-18
Authorised
- Safety, tolerability and pharmacokinetics of regorafenib in pediatric subjects.
- RMS and other solid malignant tumors (Ewing sarcoma, hepatoblastoma, neuroblastoma and Wilms tumor) in which treatment with vincristine/irinotecan is considered backbone chemotherapy at relapse and a scientific rationale to combine irinotecan with regorafenib exists. MedDRA version: 20.0 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
- France, Italy, Spain, United Kingdom
- 2013-12-20
Authorised
- A clinical trial comparing the use of endovenous laser ablation and mechanochemical ablation in the management of varicose veins in the legs.
- Varicose veins (VVs) or Superficial Venous Insufficiency (SVI) of the legs results from inflammation mediated damage to vein structure, allowing reverse flow. SVI affects 30% of adults and is associated with symptoms causing pain and disability; furthermore 3-10% have soft tissue damage and 1-2% suffer with venous ulcer disease.;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- United Kingdom
- 2015-04-14
Authorised
- An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A
- Hemophilia A Severe hemophilia A MedDRA version: 20.0 Level: LLT Classification code 10060613 Term: Hemophilia A (Factor VIII) System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Australia, Austria, Canada, Czech Republic, European Union, Georgia, Germany, Hungary, Ireland, Italy, Japan, Lebanon, Malaysia, Netherlands, Philippines, Poland, Portugal, South Africa, Spain, Switzerland, Thailand, Ukraine, United Kingdom, United States
- 2014-05-06
Authorised
- Evaluation of safety of celular therapy derived of bone marrow to help bone healing in patients with avascular necrosis of the hip
- Early avascular necrosis of the femoral head (MRI diagnosis): Ficat and Arlet 0, 1, or 2 (Steinberg stages 0, I, IIA, IIB, or IIC) MedDRA version: 14.1 Level: SOC Classification code 10028395 Term: Musculoskeletal and connective tissue disorders System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1 Level: LLT Classification code 10003860 Term: Avascular necrosis femoral head System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Germany, Spain
- 2013-12-09
Authorised
- ORAL SODIUM BICARBONATE SUPPLEMENTATION IN PATIENTS WITH CHRONIC METABOLIC ACIDOSIS AND CHRONIC KIDNEY DISEASE
- Patients classified to have chronic kidney disease of stage 3 and 4 and chronic metabolic acidosis (venous serum HCO3- of 1 day apart) should be included into the study. The effect of sodium bicarbonate supplementation on renal function should be evaluated. MedDRA version: 14.1 Level: LLT Classification code 10066569 Term: Chronic acidosis System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.1 Level: LLT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Austria
- 2012-06-11
Authorised
- Imaging study in patients with Crohn`s Disease
- Investigation of magnetic resonance enterography (MRE) with/without dye for evaluation of disease status in Crohn's disease MedDRA version: 14.1 Level: HLGT Classification code 10017969 Term: Gastrointestinal inflammatory conditions System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Belgium, France, Spain, United States
- 2012-04-17
Authorised
- Effect of metformin and clomiphene in obese hypogonadal men with or without type 2 diabetes on plasma levels of testosterone and metabolic parameters
- obese subjects with type 2 diabetes and hypogonadism MedDRA version: 14.1 Level: LLT Classification code 10049746 Term: Insulin-requiring type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.1 Level: PT Classification code 10021011 Term: Hypogonadism male System Organ Class: 10014698 - Endocrine disorders MedDRA version: 14.1 Level: PT Classification code 10033307 Term: Overweight System Organ Class: 10027433 - Metabolism and nutrition disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Italy
- 2012-03-29
Authorised
- Long-term Follow-up of ND4 LHON Subjects Treated With GS010
- Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene MedDRA version: 20.1 Level: LLT Classification code 10062951 Term: Leber's hereditary optic atrophy neuropathy System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Eye Diseases [C11]
- France, Germany, Italy, United Kingdom, United States
- 2017-11-20
Authorised
- A study comparing whether the new drug comprising fluticasone propionate and salmeterol doses of 125µg and 25µg HFA MDI inhaler (spray pressure) applied two puffs twice daily is not less effective than the dose of 500µg / 50µg applied one puff twice daily as powder inhaler (DPI) in patients with asthma
- Asthma is a common, chronic respiratory disease affecting 1–18% of the population in different countries. Asthma is characterized by variable symptoms of wheeze, shortness of breath, chest tightness and/or cough, and by variable expiratory airflow limitation. Both symptoms and airflow limitation characteristically vary over time and in intensity. These variations are often triggered by factors such as exercise, allergen or irritant exposure, change in weather, or viral respiratory infections.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Poland
- 2017-10-20
Authorised
- A Clinical Trial to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors
- Hemophilia A MedDRA version: 20.0 Level: LLT Classification code 10060612 Term: Hemophilia A System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10053751 Term: Hemophilia A with anti factor VIII System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Australia, Belgium, Brazil, Bulgaria, Canada, Colombia, Denmark, Dominican Republic, Finland, Germany, Guatemala, Hungary, Israel, Italy, Mexico, Netherlands, Panama, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Spain, Sweden, Switzerland, United Kingdom
- 2017-06-12
Authorised
- Efficacy and Safety of Targeting Lower Arterial Oxygen Saturations to Reduce Oxygen Toxicity and Oxidative Stress in Very Preterm Infants
- Study population: Children born extremely preterm (before 28 weeks of gestation). Primary outcome: 1) Death before a corrected age of 18 months and survival with severe disability. 2) The growth of the brain cortex using NMR at term. 3) The neurodevelopmental outcome at 8–10 years of age. Secondary outcome: Retinopathy of prematurity, bronchopulmonary dysplasia and brain injury as well as growth, general and cardiopulmonary health to corrected age of 18 months. MedDRA version: 9.1 Level: LLT Classification code 10036615 Term: Prematurity
- Finland
- 2008-03-10
Authorised
- Etude pilote multicentrique de phase IV, en ouvert, randomisée, en groupe parallèles destinée à évaluer l'éfficacité d'un protocole de rééducation fonctionnelle des patients atteints d'une forme récurrente/rémittente de sclérose en plaques et traités par Betaferon. - KinéSEP
- Patients des deux sexes, d'un âge égal ou supérieur à 18 ans, présentant un diagnostic confirmé de sclérose en plaques récurrente/remittente (SEP-RR) selon les critères de Mac Donald ou de Poser avec un score EDSS supérieur à 1 et inférieur ou égal à 4 et démarrant un traitement avec Betaferon.
- France
- 2008-01-24