海外の治験の状況「1」での検索結果
259件の検索結果
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Authorised
- Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)
- Ulcerative colitis or Crohn's Disease MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Lithuania, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Switzerland, Ukraine, United Kingdom, United States
- 2017-09-04
Authorised
- This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) which provides active therapy to all subjects completing the first 18 weeks.
- Pulmonary Arterial Hypertension MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Australia, Austria, Belgium, Canada, Colombia, Croatia, Czech Republic, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Netherlands, Portugal, Serbia, Spain, Ukraine, United Kingdom, United States
- 2016-04-11
Authorised
- EFFICACY AND SAFETY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN SUBJECTS =1 MONTH TO <4 YEARS WITH PARTIAL-ONSET SEIZURES
- Epilepsy with partial onset seizures MedDRA version: 18.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Lithuania, Mexico, Moldova, Republic of, Poland, Romania, Serbia, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States
- 2015-03-10
Authorised
- A Phase 1 dose-finding and Phase 2 randomized double-blinded study evaluating if veliparib compared to placebo improves efficacy of caboplatin and etoposide combination in patients with untreated extensive stage small cell lung cancer
- Extensive Stage Disease Small Cell Lung Cancer (ED SCLC) MedDRA version: 17.0 Level: PT Classification code 10041068 Term: Small cell lung cancer extensive stage System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
- Australia, Belarus, Canada, Korea, Democratic People's Republic of, Netherlands, New Zealand, Puerto Rico, Russian Federation, Spain, Taiwan, United States
- 2014-09-22
Authorised
- A Phase 1 dose-finding and Phase 2 randomized double-blinded study evaluating if veliparib compared to placebo improves efficacy of caboplatin and etoposide combination in patients with untreated extensive stage small cell lung cancer
- Extensive Stage Disease Small Cell Lung Cancer (ED SCLC) MedDRA version: 19.1 Level: PT Classification code 10041068 Term: Small cell lung cancer extensive stage System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
- Belgium, Canada, Czech Republic, France, Hungary, Netherlands, Romania, Russian Federation, Spain, United States
- 2014-10-30
Authorised
- Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)
- Ulcerative colitis or Crohn's Disease MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Lithuania, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Switzerland, Ukraine, United Kingdom, United States
- 2017-10-25
Authorised
- Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Premixed Insulin on Top of Metformin in Patients With Type 2 Diabetes and ± Sodium-glucose Cotransporter 2 Inhibitors (SGLT2i)
- Patients with Type 2 Diabetes who have failed to achieve glycemic control with basal insulin and oral antidiabetic agents(OADs) MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Algeria, Argentina, Austria, Bulgaria, Czech Republic, Greece, India, Korea, Republic of, Kuwait, Macedonia, the former Yugoslav Republic of, Mexico, Romania, Saudi Arabia, Serbia, Spain, Sweden, Taiwan, Turkey, United Arab Emirates
- 2018-07-30
Authorised
- Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Premixed Insulin on Top of Metformin in Patients With Type 2 Diabetes and ± Sodium-glucose Cotransporter 2 Inhibitors (SGLT2i)
- Patients with Type 2 Diabetes who have failed to achieve glycemic control with basal insulin and oral antidiabetic agents(OADs) MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Algeria, Argentina, Austria, Bulgaria, Czech Republic, Greece, India, Korea, Republic of, Kuwait, Macedonia, the former Yugoslav Republic of, Mexico, Romania, Saudi Arabia, Serbia, Spain, Sweden, Taiwan, Turkey, United Arab Emirates
- 2018-06-26
Authorised
- An International Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)
- Epidermolysis Bullosa Simplex (EBS) MedDRA version: 20.0 Level: PT Classification code 10014989 Term: Epidermolysis bullosa System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Australia, Austria, France, Germany, Israel, Italy, Netherlands, United Kingdom, United States
- 2017-11-29
Authorised
- Pembrolizumab in Subjects with Advanced Recurrent Ovarian Cancer
- A:platinum-resistant or partially platinum-sensitive recurrent ovarian cancer (OC) who received 1 but no more than 3 prior lines of anticancer regimens/local standard following primary or interval debulking surgery with a platinum free interval or treatment-free interval of 3-12 months based on last regimen received B:recurrent OC who received 3-5 prior lines of anticancer regimens/local standard with a platinum-free interval or treatment-free interval >or=3months based on last regimen received MedDRA version: 18.1 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
- Australia, Canada, Finland, France, Germany, Israel, Japan, Lithuania, Netherlands, Russian Federation, South Africa, Spain, Sweden, United States
- 2015-12-16
