Remodulin (DrugBank: -)
2 diseases| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 86 | Pulmonary arterial hypertension | 21 |
| 88 | Chronic thromboembolic pulmonary hypertension | 2 |
| 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 | NCT03833323 (ClinicalTrials.gov) | August 1, 2021 | 5/2/2019 | Implantable System for Remodulin Post-Approval Study | Implantable System for Remodulin Post-Approval Study | Pulmonary Arterial Hypertension | Combination Product: Implantable System for Remodulin (treprostinil) | Medtronic Cardiac Rhythm and Heart Failure | United Therapeutics | Not yet recruiting | 22 Years | N/A | All | 50 | NULL | |
| 2 | NCT04309838 (ClinicalTrials.gov) | March 2020 | 20/2/2020 | Observation Study With Implantable Medication Pump for Intravenous Treprostinil Therapy in Patients With Pulmonary Arterial Hypertension | LENUS Pro® Study (LPS-II) - Observation Study With Implantable Medication Pump for Intravenous REMODULIN® (Treprostinil) Therapy in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;PAH | Combination Product: Treprostinil via implanted pump | University Medicine Greifswald | OMT GmbH & Co. KG | Not yet recruiting | 18 Years | N/A | All | 30 | Germany | |
| 3 | NCT03497689 (ClinicalTrials.gov) | September 21, 2018 | 20/3/2018 | EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial Hypertension | EXPEDITE: A 16-Week, Multicenter, Open-label Study of Remodulin Induction Followed by Orenitram Optimization in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Intravenous/Subcutaneous Treprostinil; Oral Treprostinil | United Therapeutics | NULL | Recruiting | 17 Years | 85 Years | All | 30 | Phase 4 | United States |
| 4 | NCT02882126 (ClinicalTrials.gov) | June 2017 | 24/8/2016 | An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial Hypertension | An Open-Label Extension Trial to Evaluate the Safety of Continued Therapy With Subcutaneous Remodulin® in Subjects With Pulmonary Arterial Hypertension Who Completed Study CVT-CV-003 | Pulmonary Arterial Hypertension | Drug: Subcutaneous Treprostinil | United Therapeutics | CVie Therapeutics Co. Ltd. | Withdrawn | 18 Years | N/A | All | 0 | Phase 4 | China |
| 5 | NCT03016468 (ClinicalTrials.gov) | May 2017 | 6/1/2017 | Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Adult PAH | A Multicenter, 16-Week, Open-label Study Evaluating the Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Parenteral Remodulin (treprostinil) injection;Drug: Oral Treprostinil | United Therapeutics | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 2 | 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 | NCT02893995 (ClinicalTrials.gov) | February 2017 | 24/8/2016 | Safety, Tolerability, Pharmacokinetics and Efficacy of Two Different Rates of Subcutanous Remodulin® Dose Titration in Pulmonary Arterial Hypertension | A 16-Week, Open-Label, Multi-Center, Parallel, Randomized Controlled Study to Compare the Safety, Tolerability, Pharmacokinetics and Efficacy of Slow and Rapid Dose Titration Regimens of Subcutaneous Remodulin Therapy in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Slow Dose Titration Group of Subcutaneous Treprostinil;Drug: Rapid Dose Titration Group of Subcutaneous Treprostinil | United Therapeutics | CVie Therapeutics Co. Ltd. | Withdrawn | 18 Years | N/A | All | 0 | Phase 4 | China |
| 7 | NCT02276872 (ClinicalTrials.gov) | December 18, 2014 | 21/10/2014 | Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years | A Multicenter, Open-Label, 24-Week, Uncontrolled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil Extended Release Tablets Following Transition From Remodulin or Inhaled Prostacyclin Therapy or as Add-on to Current PAH Therapy in De Novo Prostacyclin Pediatric Subjects Aged 7 to 17 Years With Pulmonary Arterial Hypertension | PAH | Drug: oral treprostinil | United Therapeutics | NULL | Completed | 7 Years | 17 Years | All | 32 | Phase 2 | United States |
| 8 | NCT02847260 (ClinicalTrials.gov) | April 2012 | 25/7/2016 | Safety and Tolerability of Rapid Dose Titration of Subcutaneous Remodulin® Therapy in PAH Subjects (RAPID) | A 16 Week, Open Label, Multi-centre, Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of a Rapid Dose Titration Regimen of Subcutaneous Remodulin® Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Remodulin | United Therapeutics | NULL | Completed | 18 Years | N/A | All | 39 | Phase 4 | NULL |
| 9 | NCT01588405 (ClinicalTrials.gov) | April 2012 | 6/1/2012 | Remodulin® to Oral Treprostinil Transition | A Multicenter, Open-Label Study of the Safety and Tolerability of Transitioning From Remodulin® to Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: UT-15C SR | United Therapeutics | NULL | Completed | 15 Years | 80 Years | All | 33 | Phase 2 | United States |
| 10 | EUCTR2011-004631-31-DE (EUCTR) | 13/03/2012 | 10/02/2012 | 16 week study is to assess the safety, tolerability and the effects on the body of a rapid dosing regimen using subcutaneous Remodulin® | A 16 Week, Open Label, Multi-Centre, Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of a Rapid Dose Titration Regimen of Subcutaneous Remodulin® Therapy in Subjects with Pulmonary Arterial Hypertension - RAPID study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Remodulin® (treprostinil) 1 mg/ml solution for infusion INN or Proposed INN: Treprostinil Other descriptive name: TREPROSTINIL SODIUM, UT-15 Trade Name: Remodulin® (treprostinil) 2.5 mg/ml solution for infusion INN or Proposed INN: Treprostinil Other descriptive name: TREPROSTINIL SODIUM, UT-15 Trade Name: Remodulin® (treprostinil) 5 mg/ml solution for infusion INN or Proposed INN: Treprostinil Other descriptive name: TREPROSTINIL SODIUM, UT-15 Trade Name: Remodulin® (treprostinil) 10 mg/ml solution for infusion INN or Proposed INN: Treprostinil Other descriptive name: TREPROSTINIL SODIUM, UT-15 | United Therapeutics Corp. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Germany | |||
| 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 | NCT01393795 (ClinicalTrials.gov) | August 2011 | 22/6/2011 | Qutenza®-Remodulin® in Pulmonary Arterial Hypertension Patients | A Double-blind, Randomized, Crossover Clinical Study to Assess the Efficacy of Qutenza® for the Reduction of Site Pain Caused by Continuous Subcutaneous Infusion of Remodulin®, in Pulmonary Arterial Hypertension Patients | Pulmonary Hypertension;Pain | Drug: Qutenza;Drug: Tegaderm | Imperial College London | United Therapeutics | Completed | 18 Years | N/A | Both | 11 | Phase 2 | United Kingdom |
| 12 | EUCTR2011-001312-59-GB (EUCTR) | 24/06/2011 | 15/04/2011 | A double-blinded, randomized, crossover clinical study to assess the efficacy of Qutenza (capsaicin 8% patches) for the reduction of site pain caused by continuous subcutaneous infusion of Remodulin (treprostinil sodium), in Pulmonary Arterial Hypertension Patients - Efficacy of capsaicin 8% patches in Pulmonary Arterial Hypertension | A double-blinded, randomized, crossover clinical study to assess the efficacy of Qutenza (capsaicin 8% patches) for the reduction of site pain caused by continuous subcutaneous infusion of Remodulin (treprostinil sodium), in Pulmonary Arterial Hypertension Patients - Efficacy of capsaicin 8% patches in Pulmonary Arterial Hypertension | Pulmonary arterial hypertension (PAH) is a rare life-threatening disease characterised by high blood pressure in the arteries to the lungs, rapidly evolving in a clinical syndrome of dyspnoea and fatigue and eventually leading to right ventricular failure and death. MedDRA version: 13.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Trade Name: Qutenza Product Name: Qutenza INN or Proposed INN: Capsaicin | Imperial College London | NULL | Not Recruiting | Female: yes Male: yes | 0 | United Kingdom | |||
| 13 | NCT01260454 (ClinicalTrials.gov) | November 2010 | 9/12/2010 | The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain | The Qutenza® Patch for Disabling Treprostinil Infusion Site Pain | Pulmonary Hypertension;Pulmonary Arterial Hypertension | Drug: Qutenza (8% capsaicin) | University of Rochester | United Therapeutics | Completed | 15 Years | 80 Years | All | 6 | Phase 2 | United States |
| 14 | NCT00643604 (ClinicalTrials.gov) | March 2008 | 20/3/2008 | Rapid Switch From Flolan to Remodulin in the Outpatient Clinic | Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension in the Outpatient Clinic: Safety, Efficacy and Treatment Satisfaction | Hypertension, Pulmonary | Drug: treprostinil sodium | United Therapeutics | NULL | Terminated | 18 Years | 70 Years | All | 7 | Phase 4 | United States |
| 15 | NCT00458042 (ClinicalTrials.gov) | March 2007 | 5/4/2007 | Transitioning To IV Remodulin From Ventavis in Patients With PAH: Safety, Efficacy and Treatment Satisfaction | Transitioning To Intravenous Remodulin® (Treprostinil Sodium) From Inhaled Iloprost (Ventavis®) in Patients With Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment Satisfaction | Hypertension, Pulmonary | Drug: treprostinil sodium | United Therapeutics | NULL | Terminated | 18 Years | 65 Years | Both | 10 | Phase 4 | United States |
| 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 |
| 16 | NCT00439946 (ClinicalTrials.gov) | February 2007 | 22/2/2007 | Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH | Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) Using the Crono Five Ambulatory Infusion Pump in Patients With Stable Pulmonary Arterial Hypertension (PAH): Safety, Efficacy and Treatment Satisfaction | Pulmonary Arterial Hypertension | Drug: treprostinil;Device: Crono Five ambulatory pump | United Therapeutics | NULL | Terminated | 18 Years | 65 Years | All | 8 | Phase 4 | United States |
| 17 | NCT00373360 (ClinicalTrials.gov) | September 2006 | 7/9/2006 | Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to Remodulin | Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment Satisfaction | Pulmonary Hypertension | Drug: treprostinil sodium | United Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 10 | Phase 4 | United States |
| 18 | NCT03055221 (ClinicalTrials.gov) | June 10, 2005 | 9/2/2017 | TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH) | TRUST-2: An Open-label Continuation Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Intravenous Treprostinil | United Therapeutics | NULL | Completed | 16 Years | 75 Years | All | 20 | Phase 4 | NULL |
| 19 | NCT00494533 (ClinicalTrials.gov) | March 2005 | 27/6/2007 | Study of Intravenous Remodulin in Patients in India With Pulmonary Arterial Hypertension | Treprostinil for Untreated Symptomatic PAH Trial: A 12-Week Multicenter Randomized Double-Blind Placebo-Controlled Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Remodulin (treprostinil sodium) | United Therapeutics | Asian Clinical Trials | Terminated | 16 Years | 75 Years | Both | 45 | Phase 4 | India |
| 20 | EUCTR2004-003847-37-IT (EUCTR) | 21/12/2004 | 16/02/2006 | An Open label uncontrolled study of the safety and efficacy of chronic intravenous Remodulin in patients with pulmonary Arterial Hypertension | An Open label uncontrolled study of the safety and efficacy of chronic intravenous Remodulin in patients with pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension MedDRA version: 6.1;Level: PT;Classification code 10037400 | BIOPROJET | NULL | Not Recruiting | Female: yes Male: yes | Italy | |||||
| 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 |
| 21 | NCT00058929 (ClinicalTrials.gov) | October 2002 | 14/4/2003 | A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial Hypertension | A Multicenter, Randomized, Parallel Placebo-Controlled Study of the Safety and Efficacy of Subcutaneous Remodulin® Therapy After Transition From Flolan® in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Pulmonary Hypertension | Drug: treprostinil sodium | United Therapeutics | NULL | Completed | 18 Years | 75 Years | Both | 39 | Phase 4 | United States |
| 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 | EUCTR2008-006441-10-DE (EUCTR) | 27/05/2010 | 28/01/2010 | Double Blind Controlled Clinical Investigation into the Efficacy and Tolerability of subcutaneously administered Treprostinil Sodium in Patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension | Double Blind Controlled Clinical Investigation into the Efficacy and Tolerability of subcutaneously administered Treprostinil Sodium in Patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension | Patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension | Trade Name: Remodulin 1mg/ml 20ml Other descriptive name: TREPROSTINIL SODIUM Trade Name: Remodulin 2.5mg/ml 20ml Other descriptive name: TREPROSTINIL SODIUM Trade Name: Remodulin 5mg/ml 20ml Other descriptive name: TREPROSTINIL SODIUM Trade Name: Remodulin 10mg/ml 20ml Other descriptive name: TREPROSTINIL SODIUM | MRN-Medical Research Network GmbH | NULL | Not Recruiting | Female: yes Male: yes | 100 | Czech Republic;Germany;Austria | |||
| 2 | EUCTR2008-006441-10-SK (EUCTR) | 31/08/2009 | 09/09/2009 | Double Blind Controlled Clinical Investigation into the Efficacy and Tolerability of subcutaneously administered Treprostinil Sodium in Patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension | Double Blind Controlled Clinical Investigation into the Efficacy and Tolerability of subcutaneously administered Treprostinil Sodium in Patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension | Patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension | Trade Name: Remodulin (R) Trade Name: Remodulin (R) | MRN-Medical Research Network GmbH | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Czech Republic;Slovakia;Austria;Germany |