210. Single Ventricle Clinical trials / Disease details
Clinical trials : 51 / Drugs : 53 - (DrugBank : 22) / Drug target genes : 32 - Drug target pathways : 67
| 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 | NCT01292551 (ClinicalTrials.gov) | February 2011 | 8/2/2011 | Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology. | Treatment With Endothelin Antagonist to Tcpc Patients; a Multicenter, Randomized, Prospective Study Measuring Maximal O2 Uptake in Ergometer Bicycle Test | Hypoplastic Left Heart Syndrome;Tricuspid Atresia;Other Specified Congenital Anomalies of Heart | Drug: Bosentan;Drug: Placebo | Rigshospitalet, Denmark | Aarhus University Hospital;Bispebjerg Hospital;Actelion | Completed | 15 Years | N/A | Both | 75 | Phase 2 | Denmark;Sweden |
| 2 | NCT00989911 (ClinicalTrials.gov) | May 2010 | 5/10/2009 | Endothelin Blockade in Patients With Single Ventricle Physiology | Endothelin Blockade in Patients With Single Ventricle Physiology | Congenital Heart Disease | Drug: Bosentan | University of California, Los Angeles | Actelion | Completed | 12 Years | N/A | All | 10 | N/A | United States |
| 3 | NCT01662037 (ClinicalTrials.gov) | January 2010 | 5/8/2012 | Bosentan Therapy in Children With Functional Single Ventricle | Bosentan Therapy for High Risk Staged Fontan Procedure in Children With Functional Single Ventricle | Congenital Heart Defects;Functional Single Ventricle | Drug: Bosentan | Shanghai Jiao Tong University School of Medicine | NULL | Completed | 4 Months | 18 Years | Both | 34 | Phase 2 | China |
| 4 | EUCTR2005-005898-29-GB (EUCTR) | 04/07/2008 | 09/05/2008 | The effect of bosentan, a selective endothelin antagonist, on cardiovascular performance in patients with a Fontan circulation - Bosentan therapy in Fontans | The effect of bosentan, a selective endothelin antagonist, on cardiovascular performance in patients with a Fontan circulation - Bosentan therapy in Fontans | Patients with a Fontan circulation (that is they have had a Fontan operation for a functionally univentricular heart) MedDRA version: 9.1;Level: LLT;Classification code 10045545;Term: Univentricular heart MedDRA version: 9.1;Classification code 10065950;Term: Cavopulmonary anastomosis MedDRA version: 9.1;Classification code 10037456;Term: Pulmonary vascular resistance abnormality | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: Bosentan INN or Proposed INN: Bosentan | University Hospital Birmingham | NULL | Not Recruiting | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom |