DDrare: Database of Drug Development for Rare Diseases

88. 慢性血栓塞栓性肺高血圧症
［臨床試験数：145，薬物数：112（DrugBank：22），標的遺伝子数：13，標的パスウェイ数：52］

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_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2006-003520-10-DE (EUCTR)	20/10/2006	23/08/2006	Long-term study to collect additional information to evaluate the saftey and tolerability of BAY 63-2521 in different doses	A multicenter, non-randomized, non-blinded, non-controlled study to investigate the impact of multiple doses of BAY 63 2521 on safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with pulmonary hypertension in a 12 week 3 times a day individual dose titration scheme	Subjects with PH due to• Pulmonary arterial hypertension (PAH) [Venice protocol] or• Chronic thrombembolic PH (CTEPH) MedDRA version: 19.0;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: BAY 63-2521 Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Product Name: BAY 63-2521 Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Product Name: BAY 63-2521 Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Product Name: BAY 63-2521 Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Product Name: BAY 63-2521 Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	0	Phase 1;Phase 2	Germany

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

EUCTR2006-003520-10-DE
(EUCTR)

20/10/2006

23/08/2006

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

A multicenter, non-randomized, non-blinded, non-controlled study to investigate the impact of multiple doses of BAY 63 2521 on safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with pulmonary hypertension in a 12 week 3 times a day individual dose titration scheme

Subjects with PH due to• Pulmonary arterial hypertension (PAH) [Venice protocol] or• Chronic thrombembolic PH (CTEPH)
MedDRA version: 19.0;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: BAY 63-2521
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth
Product Name: BAY 63-2521
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth
Product Name: BAY 63-2521
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth
Product Name: BAY 63-2521
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth
Product Name: BAY 63-2521
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth

Bayer HealthCare AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1;Phase 2

Germany