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	EUCTR2008-003539-19-DK (EUCTR)	15/01/2010	04/11/2009	Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different doses	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2	Chronic Thromboembolic Pulmonary Hypertension MedDRA version: 17.0;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT	Bayer HealthCare AG	NULL	Not Recruiting	Female: yes Male: yes	270	Phase 3	Portugal;United States;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Japan
2	EUCTR2008-003539-19-PT (EUCTR)	03/11/2009	21/09/2009	Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different doses	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2	Chronic Thromboembolic Pulmonary Hypertension MedDRA version: 19.0;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521	Bayer AG	NULL	Not Recruiting	Female: yes Male: yes	270	Phase 3	United States;Portugal;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Germany;Japan
3	EUCTR2008-003539-19-AT (EUCTR)	13/03/2009	18/11/2008	Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different doses	Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2	Chronic Thromboembolic Pulmonary Hypertension MedDRA version: 17.0;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521	Bayer HealthCare AG	NULL	Not Recruiting	Female: yes Male: yes	270	Phase 3	Portugal;United States;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;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

EUCTR2008-003539-19-DK
(EUCTR)

15/01/2010

04/11/2009

Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different doses

Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2

Chronic Thromboembolic Pulmonary Hypertension
MedDRA version: 17.0;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 1 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 2 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: RIOCIGUAT
INN or Proposed INN: riociguat
Other descriptive name: RIOCIGUAT

Bayer HealthCare AG

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 3

Portugal;United States;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Japan

EUCTR2008-003539-19-PT
(EUCTR)

03/11/2009

21/09/2009

Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different doses

Chronic Thromboembolic Pulmonary Hypertension
MedDRA version: 19.0;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: BAY 63-2521
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 1 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: BAY 63-2521
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: BAY 63-2521
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 2 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: BAY 63-2521
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: BAY 63-2521

Bayer AG

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 3

United States;Portugal;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Germany;Japan

EUCTR2008-003539-19-AT
(EUCTR)

13/03/2009

18/11/2008

Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different doses

Bayer HealthCare AG

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 3