DDrare: Database of Drug Development for Rare Diseases

Searched query = "Chronic thromboembolic pulmonary hypertension", "CTEPH", "Idiopathic chronic pulmonary thromboembolism"
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.

Drug = 11C-ACETATE; 11C-acetate; ACT-064992; ACT-293987; AMBRISENTAN; Acetate; Adempas; Adempas (Riociguat, BAY63-2521); Adempas®; Ambrisentan; Ambrisentan 5 mg; Ammonia; Atorvastatin; BARNASCAN; BAY 63-2521; BAY 63-2521 IR coated tablet 1.0 mg; BAY 63-2521 IR coated tablet 1.5 mg; BAY 63-2521 IR coated tablet 2.0 mg; BAY 63-2521 IR coated tablet 2.5 mg; BAY 63-2521 IR tablet 0.5 mg; BAY 63-2521 IR tablet 1.0 mg; BAY 63-2521 IR tablet 1.5 mg; BAY 63-2521 IR tablet 2.0 mg; BAY 63-2521 IR tablet 2.5 mg; BAY 63-2521 coated tablets 0.5 mg; BAY 63-2521 coated tablets 1 mg; BAY 63-2521 coated tablets 1.5 mg; BAY 63-2521 coated tablets 2 mg; BAY 63-2521 coated tablets 2.5 mg; BAY 63-2521 tablets 0.5 mg; BAY 63-2521 tablets 1 mg; BAY 63-2521 tablets 1.5 mg; BAY 63-2521 tablets 2 mg; BAY 63-2521 tablets 2.5 mg; BAY1237592; BOSENTAN; BPA; Barnascan; Behavioral: respiratory and exercise therapy; Behavioral: respiratory and exercise therapy with supplemental oxygen; Bosentan; Bosentan monohydrate; Cysteine; D-glucose; Diagnostic Test: Endogenous thrombin potential; Diagnostic Test: Light transmission aggregometry; Diagnostic Test: Platelet function analyzer-100; Diagnostic Test: Rotational thromboelastometry; Edoxaban; FLUDEOXYGLUCOSE; Fludeoxyglucose; GSK1325760; Glucose; Imatinib; Imatinib mesilate; Iodine; JNJ-67896062 / ACT-064992; MACITENTAN; Macitentan; Macitentan 10 mg; Macitentan tablets; Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb; Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth; MultiHance; N-acetyl cysteine; NS-304; NS-304 Placebo; OXYGEN; Opsumit; Opsumit®; Oxygen; Oxygen, liquid; PH-combination therapy; PH-monotherapy; Placebo; Procedure: Ballon Pulmonary Angioplasty; Procedure: Balloon Pulmonary Angioplasty (BPA); Procedure: NO gas; Procedure: Pulmonary Endarteriectomy; Procedure: Pulmonary endarterectomy; Procedure: Supplemental oxygen via a mask; Procedure: long term oxygen therapy; RIOCIGUAT; Radiation: Cardiac PET imaging using F-18-FDG, N-13 ammonia( NH3); Radiation: Computed tomography lung subtraction iodine mapping; Remodulin; Remodulin (R); Remodulin 10mg/ml 20ml; Remodulin 1mg/ml 20ml; Remodulin 2.5mg/ml 20ml; Remodulin 5mg/ml 20ml; Riociguat; Riociguat (ADEMPAS, BAY63-2521); Riociguat (Adempas, BAY63-2521); Riociguat Oral Tablet; Ro 47-0203; SELEXIPAG; Sauerstoff; Selexipag; TRACLEER; TRACLEER 125MG 56CPR RIV.; TRACLEER*56CPR RIV 125MG; TREPROSTINIL SODIUM; Thrombin; Tracleer; Treprostinil; Treprostinil Sodium; Treprostinil sodium; Uptravi; Volibris; Warfarin; [18F]Fluoro-2-deoxy-2-D-glucose

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2019-004131-24-GB (EUCTR)	23/11/2020	26/05/2020	A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.	A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH	Chronic thromboembolic pulmonary 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]	Trade Name: Opsumit ® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992	ACTELION Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	230	Phase 3	United States;United Arab Emirates;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;France;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan
2	EUCTR2019-004131-24-LT (EUCTR)	10/11/2020	22/09/2020	A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.	A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH	Chronic thromboembolic pulmonary 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]	Trade Name: Opsumit ® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992	ACTELION Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	230	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;France;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan
3	EUCTR2019-004131-24-DE (EUCTR)	10/08/2020	26/05/2020	A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.	A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH	Chronic thromboembolic pulmonary 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]	Trade Name: Opsumit ® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992	ACTELION Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	230	Phase 3	Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan;Saudi Arabia;Serbia;United States;United Arab Emirates
4	EUCTR2019-004131-24-HU (EUCTR)	27/07/2020	28/05/2020	A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.	A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH	Chronic thromboembolic pulmonary 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]	Trade Name: Opsumit ® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992	ACTELION Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	230	Phase 3	Serbia;United States;United Arab Emirates;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan
5	EUCTR2019-004131-24-PL (EUCTR)	02/07/2020	02/06/2020	A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.	A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH	Chronic thromboembolic pulmonary 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]	Trade Name: Opsumit ® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992	ACTELION Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	230	Phase 3	United States;United Arab Emirates;Serbia;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan

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

EUCTR2019-004131-24-GB
(EUCTR)

23/11/2020

26/05/2020

A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.

A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH

Chronic thromboembolic pulmonary 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]

Trade Name: Opsumit ®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992

ACTELION Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

230

Phase 3

United States;United Arab Emirates;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;France;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan

EUCTR2019-004131-24-LT
(EUCTR)

10/11/2020

22/09/2020

A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.

ACTELION Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

230

Phase 3

United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;France;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan

EUCTR2019-004131-24-DE
(EUCTR)

10/08/2020

26/05/2020

A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.

ACTELION Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

230

Phase 3

Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan;Saudi Arabia;Serbia;United States;United Arab Emirates

EUCTR2019-004131-24-HU
(EUCTR)

27/07/2020

28/05/2020

A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.

ACTELION Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

230

Phase 3

Serbia;United States;United Arab Emirates;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan

EUCTR2019-004131-24-PL
(EUCTR)

02/07/2020

02/06/2020

A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.

ACTELION Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

230

Phase 3

United States;United Arab Emirates;Serbia;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan