Thelin (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 86 | 肺動脈性肺高血圧症 | 12 |
| 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 | NCT00995566 (ClinicalTrials.gov) | April 2010 | 17/9/2009 | A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin | Thelin (Sitaxentan Sodium) Patient Safety Registry A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin | Pulmonary Arterial Hypertension | Drug: Sitaxentan sodium | Pfizer | NULL | Terminated | 18 Years | N/A | All | 54 | N/A | Belgium;France;Germany;Sweden |
| 2 | EUCTR2008-005886-78-CZ (EUCTR) | 12/01/2010 | 10/12/2008 | A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION | A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION | PULMONARY ARTERIAL HYPERTENSION MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions | Trade Name: Thelin INN or Proposed INN: Sitaxsentan Sodium Trade Name: Revatio INN or Proposed INN: Sildenafil citrate | Pfizer Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Czech Republic;Bulgaria | ||
| 3 | EUCTR2008-005887-14-CZ (EUCTR) | 12/01/2010 | 10/12/2008 | A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001 | A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001 | Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Thelin INN or Proposed INN: Sitaxsentan Sodium Trade Name: Revatio INN or Proposed INN: Sildenafil Citrate | Pfizer Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Czech Republic;Bulgaria | ||
| 4 | EUCTR2008-005885-30-CZ (EUCTR) | 12/01/2010 | 10/12/2008 | A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION | A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION | Pulmonary arterial hypertension MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions | Trade Name: Thelin INN or Proposed INN: SITAXSENTAN SODIUM | Pfizer Ltd | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Czech Republic;Bulgaria | ||
| 5 | NCT01445873 (ClinicalTrials.gov) | December 1, 2009 | 30/9/2011 | Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH) | NON-INTERVENTIONAL (NI) DRUG STUDY PROTOCOL: THREE-COUNTRY PILOT STUDY FOR RETROSPECTIVE CHART REVIEW OF EFFECTIVENESS OF THELIN® (SITAXSENTAN) IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension | Drug: Sitaxentan sodium | Pfizer | NULL | Completed | 18 Years | N/A | All | 36 | NULL | |
| 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 |
| 6 | EUCTR2008-005886-78-BG (EUCTR) | 25/06/2009 | 19/06/2009 | A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION | A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION | PULMONARY ARTERIAL HYPERTENSION MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions | Trade Name: Thelin INN or Proposed INN: Sitaxsentan Sodium Trade Name: Revatio INN or Proposed INN: Sildenafil citrate | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Czech Republic;Bulgaria | ||
| 7 | EUCTR2008-005887-14-BG (EUCTR) | 25/06/2009 | 19/06/2009 | A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001 | A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001 | Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Thelin INN or Proposed INN: Sitaxsentan Sodium Trade Name: Revatio INN or Proposed INN: Sildenafil Citrate | Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Czech Republic;Bulgaria | ||
| 8 | EUCTR2008-005885-30-BG (EUCTR) | 25/06/2009 | 19/06/2009 | A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION | A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION | Pulmonary arterial hypertension MedDRA version: 13.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Trade Name: Thelin INN or Proposed INN: SITAXSENTAN SODIUM | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Czech Republic;Bulgaria | ||
| 9 | EUCTR2008-005886-78-SK (EUCTR) | 06/04/2009 | 20/02/2009 | A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION | A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION | PULMONARY ARTERIAL HYPERTENSION MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions | Trade Name: Thelin INN or Proposed INN: Sitaxsentan Sodium Trade Name: Revatio INN or Proposed INN: Sildenafil citrate | Pfizer Limited, Ramsgate Road, Sandwich, Kent UK | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Czech Republic;Slovakia;Bulgaria | ||
| 10 | EUCTR2008-005885-30-SK (EUCTR) | 06/04/2009 | 20/02/2009 | A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION | A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION | Pulmonary arterial hypertension MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions | Trade Name: Thelin INN or Proposed INN: SITAXSENTAN SODIUM | Pfizer Limited | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Czech Republic;Slovakia;Bulgaria | ||
| 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 |
| 11 | EUCTR2008-005887-14-SK (EUCTR) | 01/04/2009 | 20/02/2009 | A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001 | A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001 | Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Thelin INN or Proposed INN: Sitaxsentan Sodium Trade Name: Revatio INN or Proposed INN: Sildenafil Citrate | Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Czech Republic;Slovakia;Bulgaria | ||
| 12 | NCT00080457 (ClinicalTrials.gov) | May 2003 | 1/4/2004 | Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium (Thelin™) Treatment With an Open-Label Bosentan Arm in Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Hypertension | Drug: sitaxsentan sodium | Encysive Pharmaceuticals | NULL | Completed | 12 Years | 75 Years | Both | 240 | Phase 3 | United States |