Oral treprostinil (DrugBank: Treprostinil)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 51 | 全身性強皮症 | 6 |
| 86 | 肺動脈性肺高血圧症 | 23 |
| 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 | NCT02663895 (ClinicalTrials.gov) | October 2016 | 19/1/2016 | Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis | A Pilot Study to Evaluate the Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis | Systemic Sclerosis;Calcinosis | Drug: Oral treprostinil | Stanford University | United Therapeutics | Completed | 18 Years | N/A | All | 12 | Phase 2 | United States |
| 2 | NCT00848107 (ClinicalTrials.gov) | September 2009 | 16/2/2009 | Open-Label Study of Oral Treprostinil in Digital Ulcers | Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: An Open-label Multicenter Extension Study | Systemic Sclerosis | Drug: treprostinil diethanolamine | United Therapeutics | NULL | Terminated | 18 Years | N/A | All | 115 | Phase 2 | United States;Canada;United Kingdom |
| 3 | NCT00775463 (ClinicalTrials.gov) | May 2009 | 17/10/2008 | Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine | DISTOL-1: Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: A Randomized, Double-blind, Placebo-controlled, Multicenter Study | Systemic Sclerosis;Scleroderma | Drug: treprostinil diethanolamine;Drug: placebo | United Therapeutics | NULL | Completed | 18 Years | N/A | All | 148 | Phase 2 | United States;Canada;United Kingdom |
| 4 | EUCTR2008-005018-39-GB (EUCTR) | 05/03/2009 | 22/05/2009 | DISTOL-1:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: A randomized, double-blind, placebo controlled, multicenter study - DISTOL-1 | DISTOL-1:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: A randomized, double-blind, placebo controlled, multicenter study - DISTOL-1 | Systemic Sclerosis, scleroderma digital ulcers MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis MedDRA version: 9.1;Classification code 10039710;Term: Scleroderma | Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C-SR INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 150 | United Kingdom | |||
| 5 | EUCTR2008-006978-15-GB (EUCTR) | 05/03/2009 | 22/05/2009 | DISTOL-EXT:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: An open-label multicenter extension study - DISTOL-EXT | DISTOL-EXT:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: An open-label multicenter extension study - DISTOL-EXT | Systemic Sclerosis, scleroderma digital ulcers MedDRA version: 14.0;Level: PT;Classification code 10039710;Term: Scleroderma;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.0;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C-SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15 SR INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | United Kingdom;Canada;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 |
| 6 | NCT00848939 (ClinicalTrials.gov) | December 2008 | 19/2/2009 | Pharmacokinetics of Oral Treprostinil in Patients With Systemic Sclerosis | An Evaluation of the Pharmacokinetics and Safety of Fixed and Escalating Doses of Oral Treprostinil Diethanolamine (UT-15C) Sustained Release Tablets in Patients With Systemic Sclerosis | Systemic Sclerosis | Drug: treprostinil diethanolamine | United Therapeutics | NULL | Completed | 18 Years | N/A | Both | 28 | Phase 1 | 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 | 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 |
| 2 | NCT02999906 (ClinicalTrials.gov) | October 2017 | 19/12/2016 | Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Oral Treprostinil;Drug: Placebo | United Therapeutics | NULL | Withdrawn | 18 Years | 79 Years | All | 0 | Phase 3 | NULL |
| 3 | NCT03045029 (ClinicalTrials.gov) | July 18, 2017 | 2/2/2017 | ADAPT - A Patient Registry of the Real-world Use of Orenitram® | ADAPT - A Patient Registry of the Real-world Use of Orenitram® | Pulmonary Arterial Hypertension | Drug: Oral treprostinil | United Therapeutics | NULL | Recruiting | 18 Years | N/A | All | 300 | United States | |
| 4 | 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 |
| 5 | EUCTR2012-000097-26-PL (EUCTR) | 27/02/2016 | 20/01/2016 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. | 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] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | Israel;Chile;Italy;United Kingdom;India;United States;Taiwan;Greece;Austria;France;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden | ||
| 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 | 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 |
| 7 | EUCTR2012-000097-26-GR (EUCTR) | 05/08/2014 | 11/06/2014 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy | Pulmonary Arterial Hypertension MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 858 | Phase 3 | France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Peru;Australia;Netherlands;Germany;China;Korea, Republic of;Sweden;United States;Taiwan;Greece;Austria;Israel;Italy;United Kingdom;India | ||
| 8 | EUCTR2012-000097-26-DK (EUCTR) | 31/07/2014 | 22/05/2014 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. | Pulmonary Arterial Hypertension MedDRA version: 19.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Taiwan;Greece;Austria;Chile;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Australia;Netherlands;Germany;China;Sweden;Korea, Republic of | ||
| 9 | EUCTR2012-000097-26-BE (EUCTR) | 18/06/2014 | 14/04/2014 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy | Pulmonary Arterial Hypertension MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 858 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Australia;Peru;Netherlands;Germany;China;Korea, Republic of;Sweden | ||
| 10 | EUCTR2012-000097-26-SE (EUCTR) | 09/06/2014 | 10/04/2014 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. | 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] - Cardiovascular Diseases [C14] | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden | |||
| 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 | EUCTR2012-000097-26-IT (EUCTR) | 22/05/2013 | 19/12/2012 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy | Pulmonary Arterial Hypertension MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostin | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 610 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;Chile;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Sweden;Korea, Republic of | ||
| 12 | EUCTR2012-000097-26-NL (EUCTR) | 18/02/2013 | 29/08/2012 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. | 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] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Germany;Netherlands;China;Korea, Republic of;Sweden | ||
| 13 | EUCTR2012-000097-26-GB (EUCTR) | 06/11/2012 | 01/08/2012 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. | 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] - Cardiovascular Diseases [C14] | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden | |||
| 14 | EUCTR2012-000097-26-AT (EUCTR) | 21/09/2012 | 07/08/2012 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension receiving background oral monotherapy | 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] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden | ||
| 15 | EUCTR2012-000097-26-DE (EUCTR) | 17/09/2012 | 02/08/2012 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receivingbackground oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. | 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] - Cardiovascular Diseases [C14] | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden | |||
| 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 | NCT01560637 (ClinicalTrials.gov) | May 2012 | 9/3/2012 | An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension | Open-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310 | Pulmonary Arterial Hypertension | Drug: UT-15C (treprostinil diethanolamine) | United Therapeutics | NULL | Active, not recruiting | 18 Years | 75 Years | All | 471 | Phase 3 | United States;Argentina;Australia;Austria;Brazil;Canada;Chile;China;Denmark;France;Germany;Greece;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Singapore;Sweden;Taiwan;United Kingdom |
| 17 | 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 |
| 18 | NCT01131845 (ClinicalTrials.gov) | May 2010 | 10/5/2010 | The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil | An Evaluation of the Pharmacokinetics and Safety of a Single Dose of UT-15C SR (Treprostinil Diethanolamine) in Subjects With Renal Impairment. | Pulmonary Arterial Hypertension;Renal Dysfunction | Drug: UT-15C SR (treprostinil diethanolamine) | United Therapeutics | NULL | Completed | 18 Years | 79 Years | Both | 16 | Phase 1 | United States |
| 19 | NCT00963027 (ClinicalTrials.gov) | September 2009 | 19/8/2009 | Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil | An Evaluation of Single Dose UT-15C SR (Treprostinil Diethanolamine) Pharmacokinetics Following Repeated Dosing With the Proton Pump Inhibitor Esomeprazole in Healthy Adult Volunteers | Hypertension, Pulmonary;Pulmonary Arterial Hypertension | Drug: Treprostinil diethanolamine;Drug: Esomeprazole | United Therapeutics | NULL | Completed | 18 Years | 55 Years | Both | 30 | Phase 1 | United States |
| 20 | NCT00963001 (ClinicalTrials.gov) | September 2009 | 19/8/2009 | Effect of Food on the Pharmacokinetics of Oral Treprostinil | Effect of Different Meal Types on the Pharmacokinetics of a Single 1 mg Oral Dose of UT-15C (Treprostinil Diethanolamine) Sustained Release Tablets in Healthy Volunteers | Hypertension, Pulmonary;Pulmonary Arterial Hypertension | Drug: Treprostinil diethanolamine;Other: Standardized meals | United Therapeutics | NULL | Completed | 18 Years | 55 Years | Both | 32 | Phase 1 | 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 |
| 21 | NCT00760916 (ClinicalTrials.gov) | December 2008 | 25/9/2008 | FREEDOM DR: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor or as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH) | FREEDOM DR: An International, Multi-Center, 12-Week, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study Followed by a 12-Week Open-Label Extension Study to Assess the Efficacy, Safety, and Dose Response of UT-15C SR in Subjects With Pulmonary Hypertension | Pulmonary Hypertension | Drug: UT-15C 1 mg;Drug: UT-15C 0.25 mg;Drug: UT-15C 5 mg;Drug: Placebo | United Therapeutics | NULL | Withdrawn | 18 Years | 70 Years | Both | 0 | Phase 3 | United States;Australia;Mexico |
| 22 | NCT00325403 (ClinicalTrials.gov) | October 2006 | 11/5/2006 | FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH) | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Oral treprostinil (UT-15C) Sustained Release Tablets;Other: Placebo | United Therapeutics | NULL | Completed | 12 Years | 75 Years | All | 349 | Phase 3 | United States;Austria;Belgium;Canada;China;France;India;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico |
| 23 | NCT00325442 (ClinicalTrials.gov) | October 2006 | 11/5/2006 | FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH) | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Oral treprostinil (UT-15C) sustained release tablets;Drug: Placebo | United Therapeutics | NULL | Completed | 12 Years | 70 Years | All | 354 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Poland;Spain;United Kingdom |