MK-4836 ( DrugBank: - )


2 diseases
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3
88慢性血栓塞栓性肺高血圧症1

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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05339087
(ClinicalTrials.gov)
October 24, 202214/4/2022Efficacy and Safety of Riociguat in Incipient Pulmonary Vascular Disease as an Indicator for Early PAHEfficacy and Safety of Riociguat (MK-4836) in Incipient Pulmonary Vascular Disease as an Indicator for Early Pulmonary Arterial Hypertension Double-blind, Randomized, Multicenter, Multinational, Placebo-controlled Phase IIa Study (ESRA)Pulmonary Vascular Disorder;Primary Pulmonary Hypertension;Systemic Sclerosis;Other Systemic Involvement of Connective TissueDrug: Riociguat Oral Tablet;Other: PlaceboHeidelberg UniversityMerck Sharp & Dohme LLCRecruiting18 YearsN/AAll70Phase 2Germany
2EUCTR2021-001633-40-DE
(EUCTR)
07/03/202206/12/2021Clinical trial investigating the effect of riociguat among patients with slightly elevated blood pressure in lung vesselsEfficacy and safety of riociguat (MK-4836) in incipient pulmonary vascular disease as an indicator for early pulmonary arterial Hypertension Doubleblind, randomized, multicentre, multinational, placebo-controlled phase IIastudyESRA - ESRA early pulmonary vascular disease, defined as either a) mean pulmonary arterial pressure (mPAP) =25 mmHg with pulmonary vascular resistance (PVR) =2 to <3 WU and pulmonary arterial wedge pressure (PAWP) =15 mmHg or b) mPAP 21-<25 mmHg with PVR =2 WU, and PAWP =15 mmHg associated with connective tissue disease (CTD) or as idiopathic/heritable form.
MedDRA version: 20.0;Level: HLT;Classification code 10037455;Term: Pulmonary vascular disorders NEC;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Riociguat
Product Code: MK-4836
INN or Proposed INN: RIOCIGUAT
Other descriptive name: BAY 63-2521
Product Name: Riociguat
Product Code: MK-4836
INN or Proposed INN: RIOCIGUAT
Other descriptive name: BAY 63-2521
Product Name: Riociguat
Product Code: MK-4836
INN or Proposed INN: RIOCIGUAT
Other descriptive name: BAY 63-2521
Product Name: Riociguat
Product Code: MK-4836
INN or Proposed INN: RIOCIGUAT
Other descriptive name: BAY 63-2521
Product Name: Riociguat
Product Code: MK-4836
INN or Proposed INN: RIOCIGUAT
Other descriptive name: BAY 63-2521
Thoraxklinik Heidelberg gGmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 2France;Austria;Norway;Germany;United Kingdom;Switzerland;Italy
3EUCTR2020-005462-34-DE
(EUCTR)
23/06/202125/02/2021Study to investigate the effect of riociguat on right heart size and function in pulmonary hypertensionAn open-label, prospective, single centre study of the effects of Riociguat on RIght VEntricular size and function in Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension - RIVER II Symptomatic pulmonary arterial hypertension with a mean pulmonary artery pressure >20 mmHg and pulmonary vascular resistance =2 Wood Units, pulmonary arterial wedge pressure =15 mmHg (Group I / Nice Clinical Classification of Pulmonary Hypertension (PH)) or CTEPH (Group IV) with hemodynamics as stated above defined as inoperable measured at least 3 months after start of full anticoagulation or with persisting or recurrent PH after pulmonary endarterectomy at least 6 months after surgery
MedDRA version: 20.0;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Riociguat
Product Code: MK-4836
INN or Proposed INN: RIOCIGUAT
Other descriptive name: BAY 63-2521
Product Name: Riociguat
Product Code: MK-4836
INN or Proposed INN: RIOCIGUAT
Other descriptive name: BAY 63-2521
Product Name: Riociguat
Product Code: MK-4836
INN or Proposed INN: RIOCIGUAT
Other descriptive name: BAY 63-2521
Product Name: Riociguat
Product Code: MK-4836
INN or Proposed INN: RIOCIGUAT
Other descriptive name: BAY 63-2521
Thoraxklinik Heidelberg gGmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 4Germany

88. 慢性血栓塞栓性肺高血圧症


臨床試験数 : 157 薬物数 : 107 - (DrugBank : 22) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 54
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-005462-34-DE
(EUCTR)
23/06/202125/02/2021Study to investigate the effect of riociguat on right heart size and function in pulmonary hypertensionAn open-label, prospective, single centre study of the effects of Riociguat on RIght VEntricular size and function in Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension - RIVER II Symptomatic pulmonary arterial hypertension with a mean pulmonary artery pressure >20 mmHg and pulmonary vascular resistance =2 Wood Units, pulmonary arterial wedge pressure =15 mmHg (Group I / Nice Clinical Classification of Pulmonary Hypertension (PH)) or CTEPH (Group IV) with hemodynamics as stated above defined as inoperable measured at least 3 months after start of full anticoagulation or with persisting or recurrent PH after pulmonary endarterectomy at least 6 months after surgery
MedDRA version: 20.0;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Riociguat
Product Code: MK-4836
INN or Proposed INN: RIOCIGUAT
Other descriptive name: BAY 63-2521
Product Name: Riociguat
Product Code: MK-4836
INN or Proposed INN: RIOCIGUAT
Other descriptive name: BAY 63-2521
Product Name: Riociguat
Product Code: MK-4836
INN or Proposed INN: RIOCIGUAT
Other descriptive name: BAY 63-2521
Product Name: Riociguat
Product Code: MK-4836
INN or Proposed INN: RIOCIGUAT
Other descriptive name: BAY 63-2521
Thoraxklinik Heidelberg gGmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 4Germany