NITRIC OXIDE ( DrugBank: Nitric Oxide )


7 diseases
告示番号疾患名(ページ内リンク)臨床試験数
85特発性間質性肺炎4
86肺動脈性肺高血圧症22
88慢性血栓塞栓性肺高血圧症1
210単心室症1
251尿素サイクル異常症3
294先天性横隔膜ヘルニア7
299嚢胞性線維症5

85. 特発性間質性肺炎


臨床試験数 : 627 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05052229
(ClinicalTrials.gov)
April 21, 20222/9/2021Inhaled Nitric Oxide (iNO) in Idiopathic Pulmonary Fibrosis (IPF).Pulmonary Gas Exchange and Neuro-sensory Abnormalities in Patients With Idiopathic Pulmonary Fibrosis and Mild Mechanical Restriction. Implications for Dyspnea and Exercise IntoleranceIdiopathic Pulmonary FibrosisDrug: Nitric Oxide;Drug: Medical airQueen's UniversityBoehringer IngelheimRecruiting40 YearsN/AAll40Early Phase 1Canada
2NCT02267655
(ClinicalTrials.gov)
May 20157/10/20143 Part Study to Assess Inhaled Nitric Oxide on Functional Pulmonary Imaging in Subj. Pulmonary Hypertension Associated w/ COPD and IPFAn Exploratory, 3-Part, Clinical Study to Assess the Effect of Pulsed, Inhaled Nitric Oxide (iNO) on Functional Pulmonary Imaging Parameters in Subjects With World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated With Chronic Obstructive Pulmonary Disease (COPD) on Long-Term Oxygen Therapy (LTOT) (Part 1) and in Subjects With WHO Group 3 PH Associated With Idiopathic Pulmonary Fibrosis (IPF) on LTOT (Part 2 and Part 3)Pulmonary Hypertension;Chronic Obstructive Pulmonary Disease;Idiopathic Pulmonary FibrosisDrug: inhaled Nitric Oxide - 30 mcg/kg IBW/hr;Drug: inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr;Drug: inhaled nitric oxide 75 mcg/kg IBW/hrBellerophonNULLCompleted40 Years80 YearsAll8Phase 1Belgium
3EUCTR2014-003423-21-BE
(EUCTR)
29/09/201429/08/2014Evaluation of impact of inhaled nitric oxide on pulmonary vessel blood volume measured by high resolution computed tomography (HRCT) in subjects with World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) on Long-Term Oxygen Therapy (LTOT) (Part 1) and in subjects with WHO Group 3 Pulmonary Hypertension (PH) Associated with Idiopathic pulmonary fibrosis (IPF) on Long-Term Oxygen Therapy (LTOT) (Part 2).An Exploratory, Two-Part, Clinical Study to Assess the Effect of Pulsed, Inhaled Nitric Oxide (iNO) on Functional Pulmonary Imaging Parameters in Subjects with World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) on Long-Term Oxygen Therapy (LTOT) (Part 1) and in Subjects with WHO Group 3 PH associated with Idiopathic pulmonary fibrosis (IPF) on LTOT (Part 2). Part 1: Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) Part 2: Pulmonary Hypertension (PH) Associated with Idiopathic pulmonary fibrosis (IPF)
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 18.1;Level: LLT;Classification code 10010952;Term: COPD;Classification code 10009033;Term: Chronic obstructive pulmonary disease;Classification code 10037400;Term: Pulmonary hypertension;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: INOmax 400ppm mol/mol inhalation gas
Product Name: INO
INN or Proposed INN: NITRIC OXIDE
Bellerophon Pulse Technologies LLCNULLNot RecruitingFemale: yes
Male: yes
Phase 1;Phase 2Belgium
4NCT01265888
(ClinicalTrials.gov)
March 201120/12/2010Study in Subjects With PAH and PH Secondary to IPF Using Inhaled GeNOsyl.A Phase 2, Open-Label, Dose-Escalation Study in Subjects With Pulmonary Arterial Hypertension, (PAH, WHO Group 1) and Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis, (PH-IPF WHO Group 3) Using Inhaled GeNOsyl.Pulmonary Arterial Hypertension;Idiopathic Pulmonary FibrosisDrug: Inhaled Nitric OxideGeno LLCNULLCompleted18 Years80 YearsBoth31Phase 2United States

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
1NCT05587400
(ClinicalTrials.gov)
July 27, 202223/9/2022Consistency of Electrical Cardiometry and Pulmonary Artery CatheterThe Consistency of Cardiac Output Measured by Electrical Cardiometry and Pulmonary Artery Catheter in Cardiac Surgery Patients With Pulmonary Arterial Hypertension or Right Heart DysfunctionPulmonary Arterial Hypertension;Right Ventricular DysfunctionBehavioral: passive leg raising;Drug: dobutamine test;Drug: inhaled nitric oxideShanghai Zhongshan HospitalNULLRecruiting18 Years80 YearsAll199N/AChina
2JPRN-jRCT2051220042
07/06/202209/06/2022Clinical trial of Nitric Oxide inhalation therapy in patients with severe PHA Single-Center, Randomised, Controlled Trial of the Efficacy and Safety of Inhaled Nitric Oxide therapy in the patients with severe right heart failure due to pulmonary hypertension Pulmonary arterial hypertension (PAH), and Chronic thromboembolic pulmonary hypertension (CTEPH)
PH, Nitric oxide, PAH, CTEPH, Right heart failure;D006976
Study drug: Nitric Oxide (INOflo for inhalation 800ppm)
Start inhalation at a concentration of 20 ppm, and if the blood methemoglobin concentration is below 2%, increase the dose by 10 ppm every 5 minutes to a maximum concentration of 40 ppm.
On withdrawal from inhalation, if hemodynamics and oxygenation are stable, reduce inhalation dose by half every 5 minutes, gradually decreasing to 5 ppm. And then, If hemodynamics and oxygenation are stable at 1 ppm, attempt inhalation withdrawal every 5 minutes.
Ogo TakeshiNULLPending>= 18age oldNot applicableBoth30Phase 2Japan
3EUCTR2018-003414-40-DE
(EUCTR)
31/01/201906/11/2018A Two Part Clinical Study to Evaluate the Effect of Different Doses and the Safety of Inhaled Treprostinil Dry Powder in Pulmonary Arterial Hypertension PatientsA Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects Pulmonary Arterial Hypertension (WHO Group 1)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: LIQ861 26.5 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 53 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 79.5 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: LIQ861 106 µg
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Product Name: Nitric Oxide
INN or Proposed INN: NITRIC OXIDE
Liquidia Technologies, Inc.NULLNot RecruitingFemale: yes
Male: yes
32Phase 2France;Germany
4EUCTR2015-005223-90-BE
(EUCTR)
16/08/201824/05/2016This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: NITRIC OXIDE
Other descriptive name: inhaled NO with pulsed delivery
Bellerophon Pulse Technologies LLCNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
5NCT03602781
(ClinicalTrials.gov)
August 20186/7/2018Study of PAH Subjects With LTOT Use That Have Demonstrated Improved Exercise Tolerance With the Use of Inhaled NitricPhase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Withdrawal Study of Pulmonary Arterial Hypertension(PAH) Subjects With LTOT Use That Have Demonstrated Improved Exercise Tolerance With the Use of Inhaled Nitric Oxide (INO)Pulmonary Arterial HypertensionDrug: Placebo;Drug: iNOBellerophon Pulse TechnologiesWorldwide Clinical TrialsWithdrawn18 YearsN/AAll0Phase 3United States;Canada
6EUCTR2015-005223-90-HR
(EUCTR)
23/08/201712/09/2017This is a multicenter, double-blind, randomized, placebo-controlled,parallel-group study to investigate the efficacy, tolerability and safety ofpulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longerfor 18 weeks in symptomatic subjects with pulmonary arterialhypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED,CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: NITRIC OXIDE
Other descriptive name: inhaled NO with pulsed delivery
Bellerophon Pulse Technologies LLCNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
7EUCTR2015-005223-90-AT
(EUCTR)
28/02/201716/01/2017This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: NITRIC OXIDE
Other descriptive name: inhaled NO with pulsed delivery
Bellerophon Pulse Technologies LLCNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
8EUCTR2015-005223-90-NL
(EUCTR)
17/01/201705/09/2016This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) which provides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: NITRIC OXIDE
Other descriptive name: inhaled NO with pulsed delivery
Bellerophon Pulse Technologies LLCNULLNot Recruiting Female: yes
Male: yes
188 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
9EUCTR2015-005223-90-DE
(EUCTR)
16/12/201609/05/2016This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part2) which provides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: NITRIC OXIDE
Other descriptive name: inhaled NO with pulsed delivery
Bellerophon Pulse Technologies LLCNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Colombia;Hungary;United States;Ukraine;United Kingdom;Portugal;Spain;Canada;Czech Republic;Netherlands;Austria;Belgium;Korea, Republic of;Italy;Israel;Australia;France;Serbia;Germany;Croatia
10EUCTR2015-005223-90-PT
(EUCTR)
30/11/201609/05/2016This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 16 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 Pulmonary Arterial Hypertension
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: NITRIC OXIDE
Other descriptive name: inhaled NO with pulsed delivery
Bellerophon Pulse Technologies LLCNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
11EUCTR2015-005223-90-CZ
(EUCTR)
27/09/201622/06/2016This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) whichprovides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: NITRIC OXIDE
Other descriptive name: inhaled NO with pulsed delivery
Bellerophon Pulse Technologies LLCNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
12EUCTR2015-005223-90-IT
(EUCTR)
15/09/201622/06/2021This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) which provides active therapy to all subjects completing the first 18 weeks.A phase 3, placebo controlled, double-blind, randomized, clinical study to determine efficacy, safety and tolerability of pulsed, inhaled nitric oxide (iNO) versus placebo in symptomatic subjects with pulmonary arterial hypertension (PAH): INOvation-1 (Part 1 and Part 2) - Efficacy and safety of iNO in Pulmonary Arterial Hypertension, v1.0 Pulmonary Arterial 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] - Respiratory Tract Diseases [C08]
Product Name: Inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: Ossido Nitrico
Other descriptive name: inhaled NO with pulsed delivery
BELLEROPHON PULSE TECHNOLOGIES LLCNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Portugal;Serbia;United States;Czechia;Spain;Ukraine;Austria;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
13EUCTR2015-005223-90-GB
(EUCTR)
12/07/201611/04/2016This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) which provides active therapy to all subjects completing the first 18 weeks.A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: inhaled nitric oxide & INOpulse delivery
Product Code: iNO
INN or Proposed INN: NITRIC OXIDE
Other descriptive name: inhaled NO with pulsed delivery
Bellerophon Pulse Technologies LLCNULLNot RecruitingFemale: yes
Male: yes
188Phase 3United States;Serbia;Portugal;Spain;Ukraine;Austria;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of
14NCT02734953
(ClinicalTrials.gov)
April 201626/3/2016Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAHEffects of iNO on Invasively Derived Pulmonary Vascular Parameters in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Nitric OxideAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)NULLCompleted18 Years80 YearsAll10Phase 2United States
15NCT02725372
(ClinicalTrials.gov)
April 201619/1/2016Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAHA Phase 3, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine Efficacy, Safety, and Tolerability of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo in Symptomatic Subjects With PAH (Part 1 and Part 2)Pulmonary Arterial HypertensionDrug: Inhaled Nitric Oxide 75 mcg/kg IBW/hr;Drug: PlaceboBellerophon Pulse TechnologiesWorldwide Clinical TrialsTerminated18 Years85 YearsAll207Phase 3United States;Australia;Austria;Belgium;Canada;Colombia;Croatia;Czechia;France;Germany;Israel;Italy;Netherlands;Portugal;Serbia;Spain;Ukraine;United Kingdom
16NCT02652429
(ClinicalTrials.gov)
March 201617/12/2015Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAHAn Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for PAH for Subjects in the PULSE-PAH-006 and PULSE-PAH-004 Studies Who Continue to Need iNO TherapyPulmonary Arterial HypertensionDrug: Inhaled Nitric OxideBellerophon Pulse TechnologiesNULLActive, not recruitingN/AN/AAll22Phase 3United States;Canada
17NCT02436512
(ClinicalTrials.gov)
June 201513/4/2015Study to Assess Acute Vasodilation Response of Inhaled Nitric OxideA Phase 3 Open-label Multi-Center, Two-Part Single-arm Study to Evaluate the Acute Vasodilation Response of Inhaled Nitric Oxide as a Predictor of Successful Wean From Parental Prostacyclins in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Inhaled Nitric OxideGeno LLCNULLWithdrawn18 Years70 YearsBoth0Phase 3United States
18NCT01645826
(ClinicalTrials.gov)
July 201218/10/2011Efficacy Study of Cardizem in Pulmonary Arterial HypertensionCalcium Channel Blockers in Nitric Oxide Non-responder Pulmonary Arterial Hypertension.Idiopathic Pulmonary Arterial Hypertension;Primary Pulmonary Hypertension;Pulmonary Arterial Hypertension;Familial Primary Pulmonary HypertensionDrug: Diltiazem Hydrochloride;Drug: Sugar PillUniversity of South FloridaNULLWithdrawn18 YearsN/AAll0N/AUnited States
19NCT01265888
(ClinicalTrials.gov)
March 201120/12/2010Study in Subjects With PAH and PH Secondary to IPF Using Inhaled GeNOsyl.A Phase 2, Open-Label, Dose-Escalation Study in Subjects With Pulmonary Arterial Hypertension, (PAH, WHO Group 1) and Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis, (PH-IPF WHO Group 3) Using Inhaled GeNOsyl.Pulmonary Arterial Hypertension;Idiopathic Pulmonary FibrosisDrug: Inhaled Nitric OxideGeno LLCNULLCompleted18 Years80 YearsBoth31Phase 2United States
20NCT01092559
(ClinicalTrials.gov)
October 201016/2/2010Pilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric OxideAn Open Label Pilot Study Evaluating Preliminary Safety and Performance of the GeNO Nitrosyl Delivery SystemPulmonary Arterial HypertensionDrug: Nitric Oxide generated by the GeNO nitrosyl delivery systemGeno LLCNULLCompleted18 YearsN/AAll10Phase 2United States
21NCT01165047
(ClinicalTrials.gov)
September 201016/7/2010Nitric Oxide, GeNO Nitrosyl Delivery SystemAn Open Label, Non-Randomized Pilot Study to Evaluate the Safety and Performance of the GeNO Nitrosyl Delivery System in Subjects Being Evaluated for Orthotopic Heart Transplantation (OHT), or Left Ventricular Assist Device (LVAD) ImplantationPulmonary Arterial HypertensionDrug: Nitric OxideAurora Health CareNULLCompleted18 YearsN/AAll10Phase 2United States
22NCT00626028
(ClinicalTrials.gov)
September 200420/2/2008Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator TestingComparison of Supplemental Oxygen and Nitric Oxide for Inhalation Plus Oxygen in the Evaluation of the Reactivity of the Pulmonary Vasculature During Acute Pulmonary Vasodilator TestingIdiopathic Pulmonary Arterial Hypertension;CardiomyopathyDrug: Nitric Oxide for inhalation;Drug: Oxygen;Drug: Nitric Oxide plus OxygenMallinckrodtNULLCompletedN/A18 YearsAll136Phase 3United States;France;Netherlands;Spain;United Kingdom

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
1JPRN-jRCT2051220042
07/06/202209/06/2022Clinical trial of Nitric Oxide inhalation therapy in patients with severe PHA Single-Center, Randomised, Controlled Trial of the Efficacy and Safety of Inhaled Nitric Oxide therapy in the patients with severe right heart failure due to pulmonary hypertension Pulmonary arterial hypertension (PAH), and Chronic thromboembolic pulmonary hypertension (CTEPH)
PH, Nitric oxide, PAH, CTEPH, Right heart failure;D006976
Study drug: Nitric Oxide (INOflo for inhalation 800ppm)
Start inhalation at a concentration of 20 ppm, and if the blood methemoglobin concentration is below 2%, increase the dose by 10 ppm every 5 minutes to a maximum concentration of 40 ppm.
On withdrawal from inhalation, if hemodynamics and oxygenation are stable, reduce inhalation dose by half every 5 minutes, gradually decreasing to 5 ppm. And then, If hemodynamics and oxygenation are stable at 1 ppm, attempt inhalation withdrawal every 5 minutes.
Ogo TakeshiNULLPending>= 18age oldNot applicableBoth30Phase 2Japan

210. 単心室症


臨床試験数 : 51 薬物数 : 53 - (DrugBank : 22) / 標的遺伝子数 : 32 - 標的パスウェイ数 : 67
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04292483
(ClinicalTrials.gov)
June 11, 202029/2/2020Pulmonary Capillary Recruitment in Fontan PatientsPulmonary Capillary Recruitment With Pulmonary Vasodilator Therapy in Patients With Univentricular Heart Physiology and Failing Total Cavo-pulmonary Connection.Congenital Heart DiseaseDrug: Nitric OxideJewish General HospitalNational and Kapodistrian University of Athens;Tel Aviv University;Old Dominion UniversityRecruiting18 Years60 YearsAll15Canada

251. 尿素サイクル異常症


臨床試験数 : 54 薬物数 : 61 - (DrugBank : 15) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 28
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03064048
(ClinicalTrials.gov)
September 15, 201710/2/2017Nitric Oxide Supplementation on Neurocognitive Functions in Patients With ASLDEffect of Nitric Oxide (NO) Supplementation on Neurocognitive Measures in Argininosuccinate Lyase Deficiency (ASLD)Argininosuccinate Lyase Deficiency;Urea Cycle Disorder;Urea Cycle Disorders, Inborn;Argininosuccinic AciduriaDietary Supplement: Neo-ASA;Dietary Supplement: PlaceboBaylor College of MedicineRare Diseases Clinical Research Network;Neogenis LaboratoriesCompleted6 Years50 YearsAll16N/AUnited States
2NCT02252770
(ClinicalTrials.gov)
September 201425/9/2014Nitric Oxide Supplementation in Argininosuccinic AciduriaNitric Oxide Supplementation as a Therapeutic Intervention in Argininosuccinic AciduriaArgininosuccinic Aciduria;Argininosuccinate Lyase Deficiency;Urea Cycle DisordersDietary Supplement: Nitric oxide supplement;Dietary Supplement: PlaceboBaylor College of MedicineNULLCompleted8 Years64 YearsAll12N/AUnited States
3NCT00345605
(ClinicalTrials.gov)
February 200826/6/2006Arginine and Buphenyl in Patients With Argininosuccinic Aciduria (ASA), a Urea Cycle DisorderA Randomized, Double-Blind, Crossover Study of Sodium Phenylbutyrate and Low-Dose Arginine Compared to High-Dose Arginine Alone on Liver Function, Ureagenesis and Subsequent Nitric Oxide Production in Patients With Argininosuccinic AciduriaArgininosuccinic Aciduria;Amino Acid Metabolism, Inborn Errors;Urea Cycle DisordersDrug: Sodium Phenylbutyrate;Drug: ArginineBrendan LeeOffice of Rare Diseases (ORD);Rare Diseases Clinical Research Network;Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Completed5 YearsN/AAll12Phase 2United States

294. 先天性横隔膜ヘルニア


臨床試験数 : 16 薬物数 : 26 - (DrugBank : 5) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 14
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05213676
(ClinicalTrials.gov)
January 1, 202327/1/2022Inhaled Nitric Oxide (iNO) for Congenital Diaphragmatic Hernia (CDH) - The NoNO Trial - a Multi-center, De-implementation, Stepped-wedge, Cluster-randomized Trial Within an Established CollaborativeInhaled Nitric Oxide (iNO) for Congenital Diaphragmatic Hernia (CDH) - The NoNO Trial - a Multi-center, De-implementation, Stepped-wedge, Cluster-randomized Trial Within an Established CollaborativeCongenital Diaphragmatic HerniaDrug: Inhaled Nitric Oxide (iNO) use;Other: De-implementation of Inhaled Nitric Oxide (iNO) useThe University of Texas Health Science Center, HoustonNULLNot yet recruitingN/A1 MonthAll600Phase 4United States
2EUCTR2017-000421-13-IT
(EUCTR)
20/03/202006/10/2020Newborns with Congenital diaphragmatic hernia; iNO versus sildenafilNewborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial - CoDiNOS Trial Congenital diaphragmatic hernia with pulmonary hypertension
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: REVATIO - 0.8 MG/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO(VETRO) 1 FLACONCINO DA 20 ML
Product Name: Sildenafil
Product Code: [na]
INN or Proposed INN: Sildenafil
Trade Name: INALOSSIN - 800 PPM MOL/MOL GAS MEDICINALE COMPRESSO BOMBOLA IN ALLUMINIO CON VALVOLA VI DA 20 LITRI
Product Name: INALOSSIN 800 PPM MOL/MOL GAS MEDICINALE COMPRESSO
Product Code: [na]
INN or Proposed INN: OSSIDO DI AZOTO
Other descriptive name: Nitric oxide
ERASMUS MEDICAL CENTERNULLNot RecruitingFemale: yes
Male: yes
330Phase 3Spain;Belgium;Austria;Norway;Netherlands;Germany;Italy;Sweden
3EUCTR2017-000421-13-BE
(EUCTR)
07/02/201919/02/2019Treatment of high blood pressure in the lungs in newborns with a defect in the diaphragm; inhaled Nitric Oxide compared to intravenous Sildenafil. Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial - CoDiNOS trial Congenital diaphragmatic hernia with pulmonary hypertension;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: revatio 0.8mg/ml solution for injection
Trade Name: INOmax 800ppm mol/mol inhalatiegas
INN or Proposed INN: NITRIC OXIDE
Trade Name: Neophyr 1000ppm mol/mol
Erasmus MCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
330 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelgium;Austria;Netherlands
4EUCTR2017-000421-13-AT
(EUCTR)
13/07/201808/05/2018Treatment of high blood pressure in the lungs in newborns with a defect in the diaphragm; inhaled Nitric Oxide compared to intravenous Sildenafil.Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial - CoDiNOS trial Congenital diaphragmatic hernia with pulmonary hypertension;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: revatio 0.8mg/ml solution for injection
INN or Proposed INN: Sildenafil
Trade Name: INOmax 800ppm mol/mol inhalatiegas
INN or Proposed INN: NITRIC OXIDE
Erasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
330Phase 4Austria;Netherlands
5EUCTR2017-000421-13-NL
(EUCTR)
27/07/201707/06/2017Treatment of high blood pressure in the lungs in newborns with a defect inthe diaphragm; inhaled Nitric Oxide compared to intravenous Sildenafil.Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxideversus intravenous Sildenafil:an international randomized controlled trial - CoDiNOS trial Congenital diaphragmatic hernia with pulmonary hypertension;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: revatio 0.8mg/ml solution for injection
Trade Name: INOmax 800ppm mol/mol inhalatiegas
Erasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3Belgium;Austria;Norway;Netherlands;Sweden
6EUCTR2017-000421-13-SE
(EUCTR)
11/09/2018Treatment of high blood pressure in the lungs in newborns with a defect in the diaphragm; inhaled Nitric Oxide compared to intravenous Sildenafil.Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial - CoDiNOS trial Congenital diaphragmatic hernia with pulmonary hypertension;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: revatio 0.8mg/ml solution for injection
Trade Name: INOmax 800ppm mol/mol inhalatiegas
INN or Proposed INN: NITRIC OXIDE
Erasmus MCNULLNAFemale: yes
Male: yes
330Phase 3Belgium;Austria;Norway;Netherlands;Sweden
7EUCTR2017-000421-13-NO
(EUCTR)
11/01/2018Treatment of high blood pressure in the lungs in newborns with a defect in the diaphragm; inhaled Nitric Oxide compared to intravenous Sildenafil.Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial - CoDiNOS trial Congenital diaphragmatic hernia with pulmonary hypertension;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: revatio 0.8mg/ml solution for injection
Trade Name: INOmax 800ppm mol/mol inhalatiegas
INN or Proposed INN: NITRIC OXIDE
Trade Name: Neophyr 1000ppm mol/mol
Erasmus MCNULLNAFemale: yes
Male: yes
330Phase 3Belgium;Austria;Netherlands;Norway

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02498535
(ClinicalTrials.gov)
February 22, 201712/7/2015Efficacy and Safety of Inhaled Nitric Oxide (NO) in Cystic Fibrosis (CF) PatientsProspective, Randomized, Placebo Controlled Trial of the Efficacy and Safety of Inhaled Nitric Oxide (NO) in Cystic Fibrosis (CF) PatientsCystic FibrosisDrug: Nitric Oxide 160 ppmNovoteris, LLCCystic Fibrosis Foundation;MallinckrodtTerminated18 YearsN/AAll49Phase 2United States;Canada
2NCT01958944
(ClinicalTrials.gov)
December 20136/10/2013Evaluation of the Safety and Tolerability of Inhaled Nitric Oxide to Subjects With Cystic FibrosisPhase II Prospective, Open Labeled, Multi-Center, Evaluation of the Safety and Tolerability of Nitric Oxide Given Intermittently Via Inhalation to Subjects With Cystic FibrosisCystic FibrosisDrug: Nitric oxideAdvanced Inhalation Therapies LtdSoroka University Medical Center;Schneider Children's Medical Center, IsraelCompleted10 YearsN/ABoth9Phase 1/Phase 2Israel
3NCT02295566
(ClinicalTrials.gov)
May 201120/8/2014RATNO, Reducing Antibiotic Tolerance Using Nitric Oxide in CF - a Phase 2 Pilot StudyRATNO (Reducing Antibiotic Tolerance Using NO) Reducing Antibiotic Tolerance Using Low Dose Nitric Oxide in Cystic Fibrosis - a Phase 2 Pilot StudyCystic FibrosisDrug: Nitric Oxide;Drug: ControlUniversity Hospital Southampton NHS Foundation Trust.University of SouthamptonCompleted12 YearsN/ABoth12Phase 2United Kingdom
4EUCTR2010-023529-39-GB
(EUCTR)
18/02/201131/12/2010Reducing antibiotic tolerance using low dose nitric oxide in cystic fibrosis – a phase 2 pilot study - RATNO (Reducing Antibiotic Tolerance using Nitric Oxide in CF) v 1.0Reducing antibiotic tolerance using low dose nitric oxide in cystic fibrosis – a phase 2 pilot study - RATNO (Reducing Antibiotic Tolerance using Nitric Oxide in CF) v 1.0 Cystic FibrosisTrade Name: INOmax 400ppm mol/mol inhalation gas
Product Name: Nitric Oxide
Product Code: NO
Southampton University Hopsitals NHS TrustNULLNot RecruitingFemale: yes
Male: yes
Phase 2United Kingdom
5NCT00570349
(ClinicalTrials.gov)
July 20046/12/2007Safety and Tolerability of Inhaled Nitric Oxide in Patients With Cystic FibrosisSafety and Tolerability of Inhaled Nitric Oxide in Patients With Cystic FibrosisCystic FibrosisDrug: Nitric Oxide for Inhalation;Drug: NitrogenMallinckrodtNULLCompleted12 YearsN/AAll18Phase 1/Phase 2United States