Treprostinil diethanolamine    (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5
86肺動脈性肺高血圧症52

51. 全身性強皮症 [臨床試験数:466,薬物数:536(DrugBank:142),標的遺伝子数:110,標的パスウェイ数:210
Searched query = "Scleroderma", "Systemic sclerosis", "SSc", "dcSSc", "lcSSc"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
5 / 466 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00848107
(ClinicalTrials.gov)
September 200916/2/2009Open-Label Study of Oral Treprostinil in Digital UlcersDigital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: An Open-label Multicenter Extension StudySystemic SclerosisDrug: treprostinil diethanolamineUnited TherapeuticsNULLTerminated18 YearsN/AAll115Phase 2United States;Canada;United Kingdom
2NCT00775463
(ClinicalTrials.gov)
May 200917/10/2008Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil DiethanolamineDISTOL-1: Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: A Randomized, Double-blind, Placebo-controlled, Multicenter StudySystemic Sclerosis;SclerodermaDrug: treprostinil diethanolamine;Drug: placeboUnited TherapeuticsNULLCompleted18 YearsN/AAll148Phase 2United States;Canada;United Kingdom
3EUCTR2008-005018-39-GB
(EUCTR)
05/03/200922/05/2009DISTOL-1:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: A randomized, double-blind, placebo controlled, multicenter study - DISTOL-1DISTOL-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 CorporationNULLNot RecruitingFemale: yes
Male: yes
150United Kingdom
4EUCTR2008-006978-15-GB
(EUCTR)
05/03/200922/05/2009DISTOL-EXT:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: An open-label multicenter extension study - DISTOL-EXTDISTOL-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 CorporationNULLNot RecruitingFemale: yes
Male: yes
450United Kingdom;Canada;United States
5NCT00848939
(ClinicalTrials.gov)
December 200819/2/2009Pharmacokinetics of Oral Treprostinil in Patients With Systemic SclerosisAn Evaluation of the Pharmacokinetics and Safety of Fixed and Escalating Doses of Oral Treprostinil Diethanolamine (UT-15C) Sustained Release Tablets in Patients With Systemic SclerosisSystemic SclerosisDrug: treprostinil diethanolamineUnited TherapeuticsNULLCompleted18 YearsN/ABoth28Phase 1United States

86. 肺動脈性肺高血圧症 [臨床試験数:1,083,薬物数:667(DrugBank:122),標的遺伝子数:98,標的パスウェイ数:185
Searched query = "Pulmonary arterial hypertension", "PAH", "IPAH", "HPAH", "Eisenmenger syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
52 / 1,083 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-000097-26-PL
(EUCTR)
27/02/201620/01/2016International, 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 monotherapyA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
850Phase 3Israel;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
2EUCTR2012-000098-21-FR
(EUCTR)
24/11/201526/09/2012An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial HypertensionAn 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
MedDRA version: 15.0;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 CorporationNULLNot RecruitingFemale: yes
Male: yes
858Phase 3United States;Taiwan;Greece;Austria;Israel;Italy;United Kingdom;France;Mexico;Canada;Poland;Belgium;Brazil;Denmark;Australia;Germany;Netherlands;Sweden;Korea, Republic of
3EUCTR2012-000098-21-GR
(EUCTR)
05/08/201410/06/2014An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial HypertensionAn 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
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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
858United States;Taiwan;Greece;Austria;Israel;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Denmark;Peru;Australia;Netherlands;Germany;China;Korea, Republic of;Sweden
4EUCTR2012-000097-26-GR
(EUCTR)
05/08/201411/06/2014International, 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 monotherapyA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
858Phase 3France;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
5EUCTR2012-000097-26-DK
(EUCTR)
31/07/201422/05/2014International, 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 monotherapyA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
850Phase 3United 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2012-000098-21-DK
(EUCTR)
31/07/201422/05/2014An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial HypertensionAn 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
MedDRA version: 21.1;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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
850Phase 3United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Denmark;Australia;Netherlands;Germany;China;Korea, Republic of;Sweden
7EUCTR2012-000097-26-BE
(EUCTR)
18/06/201414/04/2014International, 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 monotherapyA 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
858Phase 3United 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
8EUCTR2012-000098-21-BE
(EUCTR)
18/06/201414/04/2014An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial HypertensionAn 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
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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
858United 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
9NCT01934582
(ClinicalTrials.gov)
August 201329/8/2013A Pharmacokinetic Substudy of the TDE-PH-304 ProtocolA Pharmacokinetic Substudy of Subjects Transitioning From Twice Daily to Three Times Daily Dosing of UT-15C SR (Treprostinil Diethanolamine) in the TDE-PH-304 ProtocolPulmonary Arterial HypertensionDrug: UT-15C SR;Drug: treprostinil diethanolamineUnited TherapeuticsNULLCompleted12 Years75 YearsAll13Phase 3United States
10EUCTR2012-000098-21-IT
(EUCTR)
22/05/201311/01/2013An Open Label Extension Study of UT-15C in subjects with PulmonaryArterial HypertensionAn Open Label Extension Study of UT-15C in subjects with PulmonaryArterial Hypertension- A long term follow up to protocol TDE-PH-310 Pulmonary Arterial Hypertension
MedDRA version: 14.1;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
Product Name: treprostinil diethanolamine
Product Code: UT-15C
Product Name: treprostinil diethanolamine
Product Code: UT-15C
Product Name: treprostinil diethanolamine
Product Code: UT-15C
Product Name: treprostinil diethanolamine
Product Code: UT-15C
UNITED THERAPEUTICSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
858United States;Taiwan;Austria;Israel;Italy;United Kingdom;Mexico;Canada;Brazil;Australia;Germany;Netherlands;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2012-000097-26-IT
(EUCTR)
22/05/201319/12/2012International, 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 monotherapyA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
610Phase 3United 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
12EUCTR2012-000098-21-NL
(EUCTR)
05/03/201310/08/2012An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial HypertensionAn 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
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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
850Phase 3United 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
13EUCTR2012-000097-26-NL
(EUCTR)
18/02/201329/08/2012International, 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 monotherapyA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
850Phase 3United 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
14EUCTR2012-000098-21-DE
(EUCTR)
14/11/201201/08/2012An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial HypertensionAn 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
MedDRA version: 21.1;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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
850Phase 3United States;Taiwan;Greece;Austria;Chile;Israel;United Kingdom;Italy;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Sweden;Korea, Republic of
15EUCTR2012-000098-21-AT
(EUCTR)
18/10/201207/09/2012An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial HypertensionAn 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
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
850Phase 3United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2012-000097-26-AT
(EUCTR)
21/09/201207/08/2012International, 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 monotherapyA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
850Phase 3United 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
17NCT01560637
(ClinicalTrials.gov)
May 20129/3/2012An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial HypertensionOpen-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310Pulmonary Arterial HypertensionDrug: UT-15C (treprostinil diethanolamine)United TherapeuticsNULLActive, not recruiting18 Years75 YearsAll471Phase 3United 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
18NCT01172496
(ClinicalTrials.gov)
August 201028/7/2010A Bioavailability Study Comparing Treprostinil Diethanolamine Oral Tablets and Oral Solution in Healthy VolunteersA Comparative Bioavailability Study of UT-15C SR (Treprostinil Diethanolamine, Sustained Release) Oral Tablets and UT-15C (Treprostinil Diethanolamine) Administered as an Oral Solution in Healthy VolunteersPulmonary Arterial HypertensionDrug: treprostinil diethanolamineUnited TherapeuticsNULLCompleted18 Years55 YearsBoth24Phase 1United States
19EUCTR2006-000804-18-PT
(EUCTR)
02/07/201025/01/2010An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXTAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV)
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
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-15C SR
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Portugal;Germany;United Kingdom;Netherlands;France;Spain;Ireland;Italy;Austria;Sweden
20NCT01165476
(ClinicalTrials.gov)
July 201015/7/2010Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent FacilitiesAn Evaluation of the Comparative Bioavailability of a Single Oral Dose of 1mg UT-15C (Treprostinil Diethanolamine) SR Tablets Manufactured by Two Independent Facilities Administered to Healthy Volunteers in the Fed StatePulmonary Arterial HypertensionDrug: Treprostinil diethanolamineUnited TherapeuticsNULLCompleted18 Years55 YearsBoth64Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT01153386
(ClinicalTrials.gov)
July 201028/6/2010Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil DiethanolamineAn Evaluation of the Pharmacokinetic Linearity and Comparative Bioavailability of a Single Oral Dose of 0.5 mg, 1 mg and 2.5 mg UT-15C (Treprostinil Diethanolamine) SR Tablets in Healthy Volunteers in the Fed StatePulmonary Arterial HypertensionDrug: Treprostinil diethanolamineUnited TherapeuticsNULLCompleted18 Years55 YearsBoth36Phase 1United States
22NCT01131845
(ClinicalTrials.gov)
May 201010/5/2010The Effect of Renal Impairment on the Pharmacokinetics of Oral TreprostinilAn 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 DysfunctionDrug: UT-15C SR (treprostinil diethanolamine)United TherapeuticsNULLCompleted18 Years79 YearsBoth16Phase 1United States
23EUCTR2009-009366-13-PT
(EUCTR)
05/03/201003/11/2009A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
300Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
24EUCTR2006-000804-18-SE
(EUCTR)
28/01/201003/12/2009An extension studyof UT-15C tablet in subjects with high blood pressure in the artery that carries blood to the lungsAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV)
MedDRA version: 13.1;Level: PT;Classification code 10037400;Term: Pulmonary 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 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-15C SR
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Netherlands;Germany;Sweden
25EUCTR2009-009366-13-SE
(EUCTR)
17/12/200922/10/2009A study to assess how safe and effective an oral UT-15C tablet is when given to subjects with high blood pressure in the artery that carries blood to the lungsA 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 Pulmonary Arterial Hypertension
MedDRA version: 14.0;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 SR
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
300Portugal;Germany;Netherlands;France;Italy;Austria;Sweden;Israel;United Kingdom;Mexico;Belgium;Puerto Rico;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2009-009366-13-FR
(EUCTR)
26/11/200906/11/2009A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
27EUCTR2009-009366-13-IT
(EUCTR)
17/11/200911/12/2009A 16-Week, International, Multicenter, Double-Blind, Randomized,Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C SustainedRelease Tablets in Subjects with Pulmonary ArterialHypertension - Freedom CA 16-Week, International, Multicenter, Double-Blind, Randomized,Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C SustainedRelease Tablets in Subjects with Pulmonary ArterialHypertension - Freedom C Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
UNITED THERAPEUTICSNULLNot RecruitingFemale: yes
Male: yes
300Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
28EUCTR2009-009366-13-NL
(EUCTR)
04/11/200918/08/2009A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
300Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
29EUCTR2009-009366-13-BE
(EUCTR)
23/10/200904/09/2009A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 Pulmonary Arterial Hypertension
MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
300France;Portugal;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
30EUCTR2009-009366-13-AT
(EUCTR)
22/10/200923/09/2009A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
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
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
300Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2009-009366-13-GB
(EUCTR)
02/09/200907/08/2009A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 Pulmonary Arterial Hypertension
MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
300Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
32NCT00963027
(ClinicalTrials.gov)
September 200919/8/2009Effect of Esomeprazole on the Pharmacokinetics of Oral TreprostinilAn Evaluation of Single Dose UT-15C SR (Treprostinil Diethanolamine) Pharmacokinetics Following Repeated Dosing With the Proton Pump Inhibitor Esomeprazole in Healthy Adult VolunteersHypertension, Pulmonary;Pulmonary Arterial HypertensionDrug: Treprostinil diethanolamine;Drug: EsomeprazoleUnited TherapeuticsNULLCompleted18 Years55 YearsBoth30Phase 1United States
33NCT00963001
(ClinicalTrials.gov)
September 200919/8/2009Effect of Food on the Pharmacokinetics of Oral TreprostinilEffect of Different Meal Types on the Pharmacokinetics of a Single 1 mg Oral Dose of UT-15C (Treprostinil Diethanolamine) Sustained Release Tablets in Healthy VolunteersHypertension, Pulmonary;Pulmonary Arterial HypertensionDrug: Treprostinil diethanolamine;Other: Standardized mealsUnited TherapeuticsNULLCompleted18 Years55 YearsBoth32Phase 1United States
34EUCTR2006-000804-18-DE
(EUCTR)
10/04/200812/12/2007An extension study of UT-15C tablet in subjects with high blood pressure inthe artery that carries blood to the lungsAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use) or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or3) Collagen Vascular Disease (CVD)4) Human Immunosufficiency Virus (HIV)
MedDRA version: 20.0;Level: PT;Classification code 10037400;Term: Pulmonary 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 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-15C SR
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Germany;Netherlands;Sweden
35EUCTR2006-000800-17-DE
(EUCTR)
02/04/200819/05/2008A 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 - FREEDOM-CA 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 - FREEDOM-C Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease, or4) HIV
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
300United Kingdom;Germany;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2006-000800-17-IT
(EUCTR)
27/08/200710/05/2007A 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 - FREEDOM-CA 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 - FREEDOM-C Pulmonary Arterial Hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil Diethanolamine
UNITED THERAPEUTICSNULLNot RecruitingFemale: yes
Male: yes
300Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
37EUCTR2006-000801-50-NL
(EUCTR)
03/07/200702/04/2007A 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 - FREEDOM-MA 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 - FREEDOM-M Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV)
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Netherlands;Belgium;France;Italy;Austria
38EUCTR2006-000804-18-NL
(EUCTR)
19/06/200701/12/2006An extension studyof UT-15C tablet in subjects with high blood pressure in the artery that carries blood to the lungsAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV)
MedDRA version: 16.0;Level: PT;Classification code 10037400;Term: Pulmonary 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 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-15C SR
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Netherlands;Germany;Sweden
39EUCTR2006-000800-17-NL
(EUCTR)
19/06/200701/12/2006A 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 - FREEDOM-CA 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 - FREEDOM-C Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease, or4) HIV
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
300Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
40EUCTR2006-000804-18-FR
(EUCTR)
11/06/200719/01/2007An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXTAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV)
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2006-000800-17-ES
(EUCTR)
29/05/200702/03/2010Estudio internacional, multicéntrico, doble ciego, aleatorizado, controlado con placebo y de 16 semanas de duración para comparar la eficacia y la seguridad de UT-15C en comprimidos orales de liberación prolongada en combinación con un antagonista del receptor de la endotelina y/o con un inhibidor de la fosfodiesterasa-5 en sujetos con hipertensión arterial pulmonarA 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 - FREEDOM-CEstudio internacional, multicéntrico, doble ciego, aleatorizado, controlado con placebo y de 16 semanas de duración para comparar la eficacia y la seguridad de UT-15C en comprimidos orales de liberación prolongada en combinación con un antagonista del receptor de la endotelina y/o con un inhibidor de la fosfodiesterasa-5 en sujetos con hipertensión arterial pulmonarA 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 - FREEDOM-C HAP idiopática o familiar incluyendo HAP asociada a:1) Uso de un inhibidor del apetito2) Corticircuito sistémico-pulmonar congénito corregido (corrección = 5 años)3) HAP asociada a enfermedad del tejido conjuntivo vascular4) HIV
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Dietanolamina de treprostinilo
Product Code: UT-15C LP
INN or Proposed INN: Dietanolamina de treprostinilo
Product Name: Dietanolamina de treprostinilo
Product Code: UT-15C LP
INN or Proposed INN: Treprostinil diethanolamine
United Therapeutics CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Germany;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria
42EUCTR2006-000801-50-FR
(EUCTR)
21/05/200719/01/2007A 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 - FREEDOM-MA 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 - FREEDOM-M Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV)
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Netherlands;Belgium;France;Italy;Austria
43EUCTR2006-000800-17-FR
(EUCTR)
21/05/200719/01/2007A 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 - FREEDOM-CA 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 - FREEDOM-C Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV)
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
44EUCTR2006-000804-18-GB
(EUCTR)
04/05/200722/11/2006An extension study of UT-15C tablet in subjects with high blood pressure in the artery that carries blood to the lungsAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV)
MedDRA version: 20.0;Level: PT;Classification code 10037400;Term: Pulmonary 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 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-15C SR
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Netherlands;Germany;Sweden
45EUCTR2006-000804-18-BE
(EUCTR)
23/04/200725/01/2007An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXTAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV)
MedDRA version: 13.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
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-15C SR
INN or Proposed INN: Treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2006-000801-50-AT
(EUCTR)
19/02/200717/01/2007A 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 - FREEDOM-MA 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 - FREEDOM-M Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV)
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
Product Name: Treprostinil Diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: Treprostinil
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
150Netherlands;Belgium;France;Italy;Austria
47EUCTR2006-000804-18-AT
(EUCTR)
19/02/200717/01/2007An extension study of UT-15C tablet in subjects with high blood pressure inthe artery that carries blood to the lungsAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use) or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or3) Collagen Vascular Disease (CVD)4) Human Immunosufficiency Virus (HIV)
MedDRA version: 20.0;Level: PT;Classification code 10037400;Term: Pulmonary 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 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-15C SR
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Portugal;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Mexico;Puerto Rico;Belgium;Netherlands;Germany;Sweden
48EUCTR2006-000804-18-IE
(EUCTR)
15/02/200709/11/2006An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXTAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with :1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV)
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Portugal;France;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
49EUCTR2006-000800-17-IE
(EUCTR)
15/02/200713/11/2006A 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 - FREEDOM-CA 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 - FREEDOM-C Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV)
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
300Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
50EUCTR2006-000800-17-AT
(EUCTR)
19/01/200717/01/2007A 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 - FREEDOM-CA 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 - FREEDOM-C Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with:1) Appetite suppressant/toxin use, or2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or3) Collagen Vascular Disease, or4) HIV
MedDRA version: 8.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
300Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT01027949
(ClinicalTrials.gov)
May 20064/12/2009An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial HypertensionAn Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Treprostinil diethanolamineUnited TherapeuticsNULLActive, not recruiting12 YearsN/AAll900Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;India;Ireland;Israel;Italy;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Spain;Sweden;United Kingdom;Czech Republic
52EUCTR2009-009366-13-DE
(EUCTR)
23/09/2009A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
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 CorporationNULLNot RecruitingFemale: yes
Male: yes
300France;Portugal;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden