Flolan® ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
86肺動脈性肺高血圧症9

86. 肺動脈性肺高血圧症


臨床試験数 : 1,205 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
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PhaseCountries
1NCT01462565
(ClinicalTrials.gov)
November 1, 201113/10/2011Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH)A Single-arm, Open Label Study Evaluating the Impact on Lifestyle of a New Thermo Stable Formulation of FLOLAN® in Subjects With Pulmonary Arterial Hypertension (PAH). (FLOLAN® is a Registered Trademark of the GlaxoSmithKline Group of Companies.)Hypertension, PulmonaryDrug: current marketed FLOLAN (epoprostenol sodium);Drug: new thermo stable formulation of epoprostenol sodiumGlaxoSmithKlineNULLCompleted18 Years75 YearsAll16Phase 4United States;Canada;Netherlands
2EUCTR2010-018322-40-NL
(EUCTR)
11/07/201119/07/2011A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2 Pulmonary Arterial Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
ACTELION Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
35Phase 3Netherlands;Belgium;France;Spain;Italy
3EUCTR2010-018322-40-ES
(EUCTR)
17/06/201103/11/2011Estudio de investigación clínica para evaluar la seguridad de cambiar el Flolan por un nuevo fármaco llamado Epoprostenol-Actelion en pacientes que padecen hipertensión arterial pulmonarEstudio de fase 3b multicéntrico, de una única rama, abierto para evaluar los efectos de cambiar de Flolan® a ACT-385781A en pacientes con hipertensión arterial pulmonar // A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2 Hipertensión Arterial Pulmonar (HAP)
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]
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODICO
Other descriptive name: EPOPROSTENOL SODIUM
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODICO
Other descriptive name: EPOPROSTENOL SODIUM
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
35Phase 3France;Canada;Belgium;Spain;Netherlands;Italy
4NCT01431716
(ClinicalTrials.gov)
March 20117/9/2011Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial HypertensionA Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to EFI/ACT-385781A in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: EFI/ACT-385781AActelionNULLCompleted18 YearsN/AAll42Phase 3Belgium;Canada;France;Italy;Netherlands;Spain
5EUCTR2010-018322-40-BE
(EUCTR)
02/07/201007/04/2010A clinical research study to evaluate the safety of changing from Flolan to a new drug called Epoprostenol-Actelion in patients suffering from pulmonary arterial hypertensionA Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2 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]
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
ACTELION Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
40Phase 3France;Canada;Spain;Belgium;Netherlands;Italy
6EUCTR2010-018322-40-FR
(EUCTR)
20/05/201029/03/2010A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2 Pulmonary Arterial Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Epoprostenol-Actelion
Product Name: Epoprostenol-Actelion
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
ACTELION Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
20Phase 3France;Spain;Belgium;Netherlands;Italy
7NCT01105117
(ClinicalTrials.gov)
May 201015/4/2010Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401An Open-label Extension of Study AC-066A401 Investigating the Safety and Tolerability of ACT-385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: ACT-385781A (Actelion Epoprostenol);Drug: Flolan®ActelionNULLCompleted18 Years65 YearsAll2Phase 4United States
8NCT01105091
(ClinicalTrials.gov)
March 201015/4/2010Epoprostenol for Injection in Pulmonary Arterial HypertensionA Phase IV, Open-label, Randomized, Multicenter Study of the Safety, Tolerability,and Pharmacokinetics of ACT- 385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: ACT-385781A (Actelion Epoprostenol);Drug: Flolan®ActelionNULLCompleted18 Years65 YearsAll30Phase 4United States
9NCT00058929
(ClinicalTrials.gov)
October 200214/4/2003A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial HypertensionA Multicenter, Randomized, Parallel Placebo-Controlled Study of the Safety and Efficacy of Subcutaneous Remodulin® Therapy After Transition From Flolan® in Patients With Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;Pulmonary HypertensionDrug: treprostinil sodiumUnited TherapeuticsNULLCompleted18 Years75 YearsBoth39Phase 4United States