51. 全身性強皮症 Scleroderma Clinical trials / Disease details
臨床試験数 : 523 / 薬物数 : 608 - (DrugBank : 156) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 215
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2014-002796-28-NL (EUCTR) | 12/04/2016 | 23/04/2015 | Does therapy with bosentan tablets have positive effects on the stiffness of the vessels in patients with scleroderma who have ulcers of the fingers of toes? | The Clinical Efficacy And Subclinical Effects on arterial STIFFNESS of bosentan therapy added to usual care in patients with systemic sclerosis with digital ulcers. - CEASE STIFFNESS | Systemic sclerosis (SSc) is characterized by skin fibrosis and visceral disease, mainly of the lungs, kidneys and the heart, accompanied by microvascular damage ultimately leading to digital ischemia. Digital ischaemia, digital ulceration (DU) or amputation are well-known manifestations of SSc. Still over 50% of the SSc patients suffer from DU. Despite effort and treatment modalities that have emerged, DU remain an important complication in SSc, even in those with mild disease.;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Tracleer INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE | University Medical Center Groningen (UMCG) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 2 | EUCTR2004-000632-82-GB (EUCTR) | 16/09/2004 | 11/02/2005 | Long term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extension | Long term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extension | SSc is a multi-system disorder of unknown etiology characterized by fibrosis and vascular obliteration in the skin and visceral organs. The pathogenesis of SSc involves immunologic mechanisms vascular damage and excessive accumulation of fibrosis in the skin and internal organs. As vascular damage progresses the microvascular bed in the skin and other sites is impaired, producing a state of chronic ischemia. SSc is commonly divided into the diffuse and limited form of the disease | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Italy;United Kingdom |