- |||||||||| tilarginine (L-NMMA) / Arginox Pharma, Houston Methodist Research Institute, NN1213 / Novo Nordisk
Trial completion date, Trial suspension, Trial primary completion date: Mechanisms of Cerebrovascular Control (clinicaltrials.gov) - Jan 27, 2020
P1, N=60, Suspended,
Trial completion date: Jan 2020 --> Jul 2020 | Recruiting --> Suspended | Trial primary completion date: Jan 2020 --> Jul 2020
- |||||||||| ambrisentan / Generic mfg., Opsumit (macitentan) / Nippon Shinyaku, J&J, Tracleer (bosentan) / J&J, Roche
Preclinical, Journal: Role of endothelin-1 clearance in the haemodynamic responses to endothelin-1 in the pulmonary and hindquarter vasculature of anaesthetised rats. (Pubmed Central) - Dec 23, 2019
Similarly, macitentan (30 mg/kg) or ambrisentan (10 mg/kg) caused significant block of responses to endothelin-1...Our work confirms the role of ET receptors in the pulmonary vasculature that decrease the circulating levels of endothelin-1. This has important consequences in selecting an appropriate ET and ET dual receptor antagonist to effectively block endothelin-1-mediated pulmonary vasoconstriction.
- |||||||||| ambrisentan / Generic mfg., sildenafil / Generic mfg.
[VIRTUAL] A RARE CASE OF CONGENITAL STENOSIS OF THE COMMON RIGHT PULMONARY VENOUS OSTIUM (FIT Clinical Decision Making Moderated Poster Theater 3_eAbstract Virtual Hall) - Dec 22, 2019 - Abstract #ACC2020ACC_3468;
Treatment for pulmonary arterial hypertension was initiated with Sildenafil and Ambrisentan without significant improvement. This case describes a rare congenital stenosis of the common right pulmonary vein ostium that lead to severe pulmonary hypertension and severe right ventricular dilation.
- |||||||||| ambrisentan / Generic mfg.
Trial completion, Trial completion date, Trial primary completion date: ABS-LT: Study of Ambrisentan in Participants With Pulmonary Hypertension (clinicaltrials.gov) - Dec 13, 2019
P3, N=140, Completed,
Trial completion date: Oct 2018 --> Oct 2020 Active, not recruiting --> Completed | Trial completion date: May 2020 --> Sep 2019 | Trial primary completion date: May 2020 --> Sep 2019
- |||||||||| ambrisentan / Generic mfg.
Enrollment closed, Trial completion date, Trial primary completion date: Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529 (clinicaltrials.gov) - Dec 9, 2019
P2, N=66, Active, not recruiting,
Active, not recruiting --> Completed | Trial completion date: May 2020 --> Sep 2019 | Trial primary completion date: May 2020 --> Sep 2019 Recruiting --> Active, not recruiting | Trial completion date: Oct 2024 --> Jun 2024 | Trial primary completion date: Oct 2022 --> Jun 2022
- |||||||||| ambrisentan / Generic mfg.
Phase-I Study of ETA Receptor Antagonist Ambrisentan in Sickle Cell Disease (W304ABCD, Level 3 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_4846;
Data collected for secondary end points including, TCD, TRV, inflammatory cytokines, markers of glomerular and tubular injury, quantitative sensory testing (QST) with pressure pain measurements, and von Frey monofilament readings, as well as quality of life measures (ASCQMe) are in the process of being analyzed. These data suggest that ETA receptor blockade is safe, well tolerated and has the potential to impact various aspects of disease pathophysiology in SCD.
- |||||||||| ambrisentan / Generic Mfg.
WHEN OIL MEETS AIR: A NEW CAUSE OF HYPERSENSITIVITY PNEUMONITIS (Ernest N. Morial Convention Center - Exhibit Hall - Poster Area 4) - Sep 25, 2019 - Abstract #CHEST2019CHEST_3800;
This case demonstrates the importance of obtaining a good social history of exposures in the setting of new or worsening lung disease. Furthermore, more research needs to be done in the area of essential oils and the potential consequences of their use with or without a diffuser.
- |||||||||| LESSONS LEARNED FROM TRIPLE COMBINATION THERAPY IN PULMONARY ARTERIAL HYPERTENSION (Ernest N. Morial Convention Center - Exhibit Hall - Poster Area 5) - Sep 25, 2019 - Abstract #CHEST2019CHEST_1930;
Significant hemodynamic improvement was noted when ERA choice was changed within its class and sildenafil was changed to a SGCs (2) (See Table 1, Patient 2)...When the patient developed angioedema to ambrisentan, she was switched to macitentan with subsequent improvement in 6MWD and hemodynamics (see Table 1, Patient 3).Classically, it is considered of limited efficacy to switch ERAs within the class and there is limited information in added benefit of switching PDE-5 inhibitors to Riociguat, a sGC stimulator...Triple combination therapy may lead to dramatic clinical and hemodynamic improvement. Further studies need to be performed to determine if triple therapy might lead to better long-term survival.
- |||||||||| ambrisentan / Generic Mfg., hydroxychloroquine / Generic Mfg., hydroxychloroquine / VG Lifesciences
PULMONARY HYPERTENSION IN SICKLE CELL DISEASE: LOOKING BEYOND THE USUAL SUSPECT (Ernest N. Morial Convention Center - Exhibit Hall - Poster Area 5) - Sep 25, 2019 - Abstract #CHEST2019CHEST_1928;
Patient was initiated on hydroxychloroquine, losartan, and ambrisentan.Hemoglobin O Arab is an uncommon hemoglobinopathy due to substitution of lysine for glutamic acid at a position 121 of beta globin chain. This case demonstrates importance of increased awareness of coexisting etiologies for PAH leading to a rapid progression and increased morbidity.
- |||||||||| ambrisentan / Generic mfg.
Trial completion: Ambrisentan in Single Ventricle (clinicaltrials.gov) - Sep 12, 2019
P2, N=16, Completed,
We propose that early use of VA ECMO, weaned with pulmonary vasodilators in addition to inotropes is a reasonable supportive strategy as a bridge to recovery in PFE-induced PH and RV failure. Active, not recruiting --> Completed
- |||||||||| Uptravi (selexipag) / J&J, Nippon Shinyaku
Journal: T cell Large Granular Lymphocytic Leukemia with Pulmonary Hypertension. (Pubmed Central) - Sep 11, 2019
He was treated for his leukemia with methotrexate and simultaneously treated for his pulmonary hypertension with selexipag and ambrisentan. As his leukemia improved, we also noticed an improvement in his pulmonary hypertension from a NYHA class IV to class I. Hence, we believe there is an etiopathological link between the T cell large granular leukemia and associated pulmonary hypertension.
- |||||||||| A decade of activity in treating patients with pulmonary arterial hypertension in Timisoara center (TP-43) - Aug 26, 2019 - Abstract #ERS2019ERS_5010;
Retrospective analysis between 2008-2018 on the evolution of adult PAH patients included in the local vasodilator treatment registry (Sildenafil / Bosentan / Ambrisentan / Macitentan / Riociguat / Ralinepag / Treprostinil). Psychological evaluation and social support become mandatory because their prognosis depends on these issues.
- |||||||||| NN1213 / Novo Nordisk
Enrollment closed, Trial completion date: The Role of Endothelin-1 in Sickle Cell Disease (clinicaltrials.gov) - Jul 16, 2019
P1, N=26, Active, not recruiting,
ADMA could be used as a biomarker for the monitoring of the effect of treatments in precapillary PH. Recruiting --> Active, not recruiting | Trial completion date: May 2019 --> Nov 2019
- |||||||||| ambrisentan / Generic mfg.
Enrollment change, Trial termination: Efficacy and Safety of Ambrisentan in Children 8-18yrs (clinicaltrials.gov) - Jul 5, 2019
P2, N=41, Terminated,
Different monitoring parameters should be considered for individual ERA. N=66 --> 41 | Suspended --> Terminated; Ongoing juvenile rat toxicology studies.
- |||||||||| Adempas (riociguat) / Bayer, Opsumit (macitentan) / Nippon Shinyaku, J&J, Tracleer (bosentan) / J&J, Roche
Journal: Pulmonary arterial hypertension in Russia: six-year observation analysis of the National Registry. (Pubmed Central) - Jun 25, 2019
The registry data indirectly indicates the need to increase efforts aimed at improving the diagnosis of systemic connective tissue diseases in adults, as well as congenital heart defects in children for timely surgical treatment. In recent years, PAH-specific drugs of the new generation have been introduced into clinical practice, but currently in Russia there are no parenteral prostanoids, which are recommended for the most severe patients.
- |||||||||| Tracleer (bosentan) / J&J, Roche
Review, Journal, HEOR: Cost Effectiveness of Bosentan for Pulmonary Arterial Hypertension: A Systematic Review. (Pubmed Central) - Jun 22, 2019
...Among them were two studies comparing bosentan with epoprostenol and treprostinil...Four studies compared bosentan with other endothelin receptor antagonists, which indicated ambrisentan might be the drug of choice for its economic advantages and improved safety profile...There was unanimous agreement that bosentan was not a cost-effective front-line therapy compared with sildenafil and other endothelin receptor antagonists. However, high-quality cost-effectiveness analyses that utilize long-term follow-up data and have no conflicts of interest are still needed.
- |||||||||| ambrisentan / generics
Journal: Pre-clinical assessment of a water-in-fluorocarbon emulsion for the treatment of pulmonary vascular diseases. (Pubmed Central) - Jun 17, 2019
...Treatment groups: intrapulmonary delivery (PUL) of (1) saline; (2) ambrisentan in saline (0.1 mg/kg); (3) empty emulsion; (4) emulsion encapsulating ambrisentan or sodium nitrite (NaNO) (0.1 and 0.5 mg/kg each); and intravenous (5) ambrisentan (0.1 mg/kg) or (6) NaNO (0.5 mg/kg)...We demonstrate proof-of-concept for delivering pulmonary vasodilators via aerosolized water-in-PFOB emulsion. This concept opens a potentially feasible and effective route of treating pulmonary vascular pathologies via pMDI.
- |||||||||| ambrisentan / Generic mfg.
Trial completion date, Trial primary completion date: ABS-LT: Study of Ambrisentan in Participants With Pulmonary Hypertension (clinicaltrials.gov) - May 24, 2019
P3, N=140, Active, not recruiting,
However, the expression level of NOX4 remained unaffected after ambrisentan treatment. Trial completion date: Oct 2019 --> May 2020 | Trial primary completion date: Oct 2019 --> May 2020
- |||||||||| Journal: German Guideline for Idiopathic Pulmonary Fibrosis - Update on Pharmacological Therapies 2017 (Pubmed Central) - May 22, 2019
A less clear but still negative recommendation (B, 1-b) was attributed to the treatment of IPF with the phosphodiesterase-5-inhibitor sildenafil and acetyl-cysteine monotherapy...An unanimous positive recommendation was granted for the antifibrotic drugs nintedanib and pirfenidone for the treatment of IPF (A, 1-a). For some open questions in the management of IPF patients for which firm evidence is lacking the guideline also offers recommendations based on expert consensus.
- |||||||||| ambrisentan / generics
Clinical, Journal: Safety and ergogenic properties of combined aminophylline and ambrisentan in hypoxia. (Pubmed Central) - May 22, 2019
Single-dose ambrisentan increased blood oxygenation in resting, hypoxic subjects. We conclude that combined aminophylline and ambrisentan offer promise to safely increase exercise capacity in hypoxemic humans without relying on increasing blood oxygen availability.
- |||||||||| Journal: German Guideline for Idiopathic Pulmonary Fibrosis - Update on Pharmacological Therapies 2017. (Pubmed Central) - May 8, 2019
A less clear but still negative recommendation (B, 1-b) was attributed to the treatment of IPF with the phosphodiesterase-5-inhibitor sildenafil and acetyl-cysteine monotherapy...An unanimous positive recommendation was granted for the antifibrotic drugs nintedanib and pirfenidone for the treatment of IPF (A, 1-a). For some open questions in the management of IPF patients for which firm evidence is lacking the guideline also offers recommendations based on expert consensus.
- |||||||||| Adempas (riociguat) / Bayer, Tyvaso (treprostinil) / United Therapeutics, Tracleer (bosentan) / J&J, Roche
Clinical, Journal: Pulmonary Arterial Hypertension: A Case Study in FDA Expedited Program Designations. (Pubmed Central) - Apr 19, 2019
Based on these results, it is recommended that drug developers be encouraged to revisit traditional endpoint measures, explore novel biological mechanisms, and/or effectively differentiate in other dimensions (eg, safety). Developers should also consider engaging the FDA early in development (ideally prior to first-in-human) to agree on the kind and amount of data to meet the statutory bar with the intention of increasing the probability of securing a Fast Track or Breakthrough Designation.
- |||||||||| Opsumit (macitentan) / Nippon Shinyaku, J&J, Tracleer (bosentan) / J&J, Roche
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Letairis: Crossover Study From Macitentan or Bosentan Over to Ambrisentan (clinicaltrials.gov) - Apr 8, 2019
P4, N=3, Terminated,
No abstract available N=50 --> 3 | Trial completion date: Jun 2019 --> Jul 2017 | Recruiting --> Terminated | Trial primary completion date: Jun 2018 --> Jul 2017; Study ending due to lack of enrollment.
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