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46 Diseases |  |
10 Trials |
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10 Trials |  |
738 News |  |
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- | Letairis (ambrisentan) / GSK, Gilead, Tracleer (bosentan) / J&J, Roche
Clinical, Journal: Transition from Ambrisentan to Bosentan in Pulmonary Arterial Hypertension: A Single-Center Prospective Study. (Pubmed Central) - Apr 5, 2019
It is safe for stable PAH patients to transition from ambrisentan to bosentan without hemodynamic or hematologic deterioration.
- | Letairis (ambrisentan) / GSK, Gilead
Journal: Isolation, identification, characterization, synthesis and quality control strategy of new process-related impurities in ambrisentan. (Pubmed Central) - Apr 5, 2019
The formation mechanisms that yield these impurities are discussed for the first time. Quality control strategies to deal with these impurities are developed to obtain bulk drug of ICH-grade quality.
- ||| Letairis (ambrisentan) / GSK, Gilead
FDA event: FDA approves 4 generic versions of Letairis, an endothelin receptor antagonist for PAH. https://t.co/dIbqxoC3gY (Twitter) - Apr 3, 2019
- || Letairis (ambrisentan) / GSK, Gilead
FDA event: FDA Approves Letairis (Ambrisentan) Generics for PAH https://t.co/AIobZ3oR2n via @medscape (Twitter) - Apr 1, 2019
- | Letairis (ambrisentan) / GSK, Gilead
Biomarker, Journal: Role of ambrisentan (selective endothelin-A receptor antagonist) on cigarette smoke exposure induced cognitive impairment in Danio rerio. (Pubmed Central) - Mar 29, 2019
Quality control strategies to deal with these impurities are developed to obtain bulk drug of ICH-grade quality. Therefore, ambrisentan can be considered for the attenuation of CSE induced impairment neurocognitive functions due to its reduction of free radical scavenging and neuroinflammatory actions as well as regulation of cholinergic neurotransmitter functions.
- ||| Letairis (ambrisentan) / GSK, Gilead
FDA event: #FDAapproves first generic versions of Letairis (ambrisentan): https://t.co/xohjwWAlnQ. Access PIs at: https://t.co/xyMMKFEscy. (Twitter) - Mar 29, 2019
- | Letairis (ambrisentan) / GSK, Gilead
Clinical, Journal, Combination therapy: A prospective, open-label, non-comparative study of ambrisentan with anti-fibrotic agent combination therapy in the treatment of diffuse systemic sclerosis. (Pubmed Central) - Mar 20, 2019
P=N/A
Patients who tolerated the combination of an antifibrotic with ambrisentan had an improvement of their mRSS over the course of the study as well as an improvement of their perceived health. Clinicaltrials.gov, NCT01093885; March 2010.
- | ambrisentan / Generic mfg.
New P2 trial: A Study Evaluating the Utility of Ambrisentan in Lowering Portal Pressure in Patients With Liver Cirrhosis (clinicaltrials.gov) - Feb 1, 2019
P2, N=24, Not yet recruiting, Sponsor: Noorik Biopharmaceuticals AG
- | Adempas (riociguat) / Bayer, Merck (MSD)
New P4 trial, Combination therapy: Upfront Combination Pulmonary Arterial Hypertension Therapy (clinicaltrials.gov) - Jan 18, 2019
P4, N=20, Recruiting, Sponsor: University of Calgary
- | ambrisentan / Generic mfg., spironolactone / Generic mfg.
Trial completion date, Trial termination, Trial primary completion date: The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study (clinicaltrials.gov) - Jan 16, 2019
P4, N=30, Terminated, Sponsor: Brigham and Women's Hospital
Clinicaltrials.gov, NCT01093885; March 2010. Trial completion date: Jan 2019 --> Feb 2018 | Recruiting --> Terminated | Trial primary completion date: Jan 2019 --> Feb 2018; Low enrollment
- | NN1213 / Novo Nordisk
Trial completion date, Trial primary completion date: The Role of Endothelin-1 in Sickle Cell Disease (clinicaltrials.gov) - Jan 15, 2019
P1, N=30, Recruiting, Sponsor: Augusta University
Trial completion date: Jan 2019 --> Feb 2018 | Recruiting --> Terminated | Trial primary completion date: Jan 2019 --> Feb 2018; Low enrollment Trial completion date: May 2018 --> May 2019 | Trial primary completion date: May 2018 --> May 2019
- | ambrisentan / Generic mfg.
Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date: Efficacy and Safety of Combination Ambrisentan and Tadalafil in Patients With Portopulmonary Hypertension (clinicaltrials.gov) - Dec 7, 2018
P4, N=0, Withdrawn, Sponsor: Ochsner Health System
Trial completion date: May 2018 --> May 2019 | Trial primary completion date: May 2018 --> May 2019 N=20 --> 0 | Trial completion date: May 2019 --> Nov 2018 | Recruiting --> Withdrawn | Trial primary completion date: May 2019 --> Nov 2018
- | ambrisentan / Generic mfg.
Enrollment change: ABS-LT: Study of Ambrisentan in Participants With Pulmonary Hypertension (clinicaltrials.gov) - Nov 20, 2018
P3, N=140, Active, not recruiting, Sponsor: Gilead Sciences
N=20 --> 0 | Trial completion date: May 2019 --> Nov 2018 | Recruiting --> Withdrawn | Trial primary completion date: May 2019 --> Nov 2018 N=300 --> 140
- | tilarginine (L-NMMA) / Arginox Pharma, Houston Methodist Research Institute, NN1213 / Novo Nordisk
Trial completion date, Trial primary completion date: Mechanisms of Cerebrovascular Control (clinicaltrials.gov) - Nov 2, 2018
P1, N=60, Recruiting, Sponsor: University of Wisconsin, Madison
N=300 --> 140 Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2018 --> Dec 2019
- | ambrisentan / Generic mfg.
Trial completion date, Trial primary completion date: Drug Use Investigation for VOLIBRIS (clinicaltrials.gov) - Sep 10, 2018
P=N/A, N=900, Active, not recruiting, Sponsor: GlaxoSmithKline
Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2018 --> Dec 2019 Trial completion date: Aug 2020 --> Jan 2020 | Trial primary completion date: Aug 2020 --> Jan 2020
- | ambrisentan / Generic mfg.
Trial completion, Enrollment change: Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension (clinicaltrials.gov) - Aug 2, 2018
P2/3, N=16, Completed, Sponsor: Medical University of South Carolina
Trial completion date: Aug 2020 --> Jan 2020 | Trial primary completion date: Aug 2020 --> Jan 2020 Recruiting --> Completed | N=24 --> 16
- ambrisentan / Generic mfg.
Enrollment open: Efficacy and Safety of Combination Ambrisentan and Tadalafil in Patients With Portopulmonary Hypertension (clinicaltrials.gov) - Jun 20, 2018
P4, N=20, Recruiting, Sponsor: Ochsner Health System
Recruiting --> Completed | N=24 --> 16 Not yet recruiting --> Recruiting
- ambrisentan / Generic mfg.
Trial primary completion date: Efficacy and Safety of Ambrisentan in Children 8-18yrs (clinicaltrials.gov) - Jun 2, 2018
P2, N=66, Suspended, Sponsor: GlaxoSmithKline
Not yet recruiting --> Recruiting Trial primary completion date: May 2018 --> Nov 2018
- || ambrisentan / Generic mfg.
Enrollment change: A Phase 1 Relative Bioavailability Study of Ambrisentan and Tadalfil Fixed Dose Combination Tablets in Healthy Subjects (clinicaltrials.gov) - Apr 27, 2018
P1, N=174, Completed, Sponsor: GlaxoSmithKline
Trial primary completion date: May 2018 --> Nov 2018 N=106 --> 174
- ambrisentan / Generic mfg.
Trial completion date: Portopulm: Ambrisentan in Patients With Porto-pulmonary Hypertension A Multicenter Open Label Trial (clinicaltrials.gov) - Apr 24, 2018
P=N/A, N=30, Active, not recruiting, Sponsor: Tufts Medical Center
N=106 --> 174 Trial completion date: Sep 2017 --> Oct 2018
- | ambrisentan / Generic mfg.
Trial completion date, Trial primary completion date: AMERICA-PAH: Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension (clinicaltrials.gov) - Apr 3, 2018
P=N/A, N=7, Terminated, Sponsor: National Jewish Health
Trial completion date: Sep 2017 --> Oct 2018 Trial completion date: Aug 2018 --> May 2017 | Trial primary completion date: Aug 2018 --> May 2017
- | ambrisentan / Generic mfg.
Trial completion: Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan (clinicaltrials.gov) - Mar 6, 2018
P4, N=15, Completed, Sponsor: University of California, Los Angeles
Trial completion date: Aug 2018 --> May 2017 | Trial primary completion date: Aug 2018 --> May 2017 Recruiting --> Completed
- | ambrisentan / Generic mfg.
Trial completion date, Trial initiation date, Trial primary completion date: Efficacy and Safety of Ambrisentan in Children 8-18yrs (clinicaltrials.gov) - Feb 13, 2018
P2, N=66, Suspended, Sponsor: GlaxoSmithKline
Recruiting --> Completed Trial primary completion date: Nov 2018 --> May 2018 | Trial completion date: Nov 2018 --> May 2018 | Initiation date: Jan 2011 --> Jan 2011
- ambrisentan / Generic mfg., spironolactone / Generic mfg.
Trial primary completion date: The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study (clinicaltrials.gov) - Jan 18, 2018
P4, N=30, Recruiting, Sponsor: Brigham and Women's Hospital
Trial primary completion date: Nov 2018 --> May 2018 | Trial completion date: Nov 2018 --> May 2018 | Initiation date: Jan 2011 --> Jan 2011 Trial primary completion date: Jan 2017 --> Jan 2019
- | ambrisentan / Generic mfg.
Enrollment closed, Trial primary completion date: EDITA: Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) (clinicaltrials.gov) - Nov 27, 2017
P2, N=38, Active, not recruiting, Sponsor: Heidelberg University
Trial primary completion date: Jan 2017 --> Jan 2019 Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2016 --> Dec 2017
- Orenitram (treprostinil diethanolamine oral) / United Therapeutics Corp
Enrollment change, Trial withdrawal: Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension (clinicaltrials.gov) - Nov 1, 2017
P3, N=0, Withdrawn, Sponsor: United Therapeutics
Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2016 --> Dec 2017 N=600 --> 0 | Not yet recruiting --> Withdrawn
- | ambrisentan / Generic mfg.
New P4 trial: Efficacy and Safety of Combination Ambrisentan and Tadalafil in Patients With Portopulmonary Hypertension (clinicaltrials.gov) - Oct 13, 2017
P4, N=20, Not yet recruiting, Sponsor: Ochsner Health System
- | ambrisentan / Generic mfg.
Enrollment change, Trial termination: AMERICA-PAH: Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension (clinicaltrials.gov) - Sep 14, 2017
P=N/A, N=7, Terminated, Sponsor: National Jewish Health
N=600 --> 0 | Not yet recruiting --> Withdrawn N=20 --> 7 | Recruiting --> Terminated; PI left National Jewish Health
- |||| ambrisentan / Generic mfg.
Trial primary completion date, Combination therapy: AMBITION: A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) (clinicaltrials.gov) - Sep 13, 2017
P3, N=610, Completed, Sponsor: GlaxoSmithKline
N=20 --> 7 | Recruiting --> Terminated; PI left National Jewish Health Trial primary completion date: Apr 2014 --> Jul 2014
- ||| ambrisentan / Generic mfg.
Trial completion: A Phase 1 Relative Bioavailability Study of Ambrisentan and Tadalfil Fixed Dose Combination Tablets in Healthy Subjects (clinicaltrials.gov) - Aug 9, 2017
P1, N=106, Completed, Sponsor: GlaxoSmithKline
Trial primary completion date: Apr 2014 --> Jul 2014 Recruiting --> Completed
- | ambrisentan / Generic mfg.
Phase classification: Influence of Cytochrome CYP3A4-induction by St. John's Wort on the Steady State Pharmacokinetics of Ambrisentan (clinicaltrials.gov) - May 31, 2017
P=N/A, N=20, Completed, Sponsor: Gerd Mikus
Recruiting --> Completed Phase classification: P1 --> P=N/A
- ||||| Orenitram (treprostinil diethanolamine oral) / United Therapeutics Corp
Trial initiation date: Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension (clinicaltrials.gov) - May 22, 2017
P3, N=600, Not yet recruiting, Sponsor: United Therapeutics
Phase classification: P1 --> P=N/A Initiation date: Apr 2017 --> Oct 2017
- | ambrisentan / Generic mfg.
Trial primary completion date: Ambrisentan in Single Ventricle (clinicaltrials.gov) - May 3, 2017
P2, N=20, Recruiting, Sponsor: Kevin Hill
Initiation date: Apr 2017 --> Oct 2017 Trial primary completion date: Jan 2017 --> Jun 2018
- | ambrisentan / Generic mfg.
Trial completion, Combination therapy: Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic Sclerosis (clinicaltrials.gov) - May 2, 2017
P=N/A, N=15, Completed, Sponsor: University of Pennsylvania
Trial primary completion date: Jan 2017 --> Jun 2018 Active, not recruiting --> Completed
- || ambrisentan / Generic mfg.
Enrollment change, Trial primary completion date: A Phase 1 Relative Bioavailability Study of Ambrisentan and Tadalfil Fixed Dose Combination Tablets in Healthy Subjects (clinicaltrials.gov) - Apr 6, 2017
P1, N=106, Recruiting, Sponsor: GlaxoSmithKline
Active, not recruiting --> Completed N=60 --> 106 | Trial primary completion date: Apr 2017 --> Aug 2017
- ambrisentan / Generic mfg.
Trial primary completion date: Efficacy and Safety of Ambrisentan in Children 8-18yrs (clinicaltrials.gov) - Mar 22, 2017
P2, N=66, Suspended, Sponsor: GlaxoSmithKline
N=60 --> 106 | Trial primary completion date: Apr 2017 --> Aug 2017 Trial primary completion date: Nov 2016 --> Nov 2018
- tilarginine (L-NMMA) / Arginox Pharma, Houston Methodist Research Institute
Enrollment open, Trial initiation date: Mechanisms of Cerebrovascular Control (clinicaltrials.gov) - Feb 7, 2017
P1, N=60, Recruiting, Sponsor: University of Wisconsin, Madison
Trial primary completion date: Nov 2016 --> Nov 2018 Not yet recruiting --> Recruiting | Initiation date: Nov 2016 --> Jan 2017
- |||||||||| Orenitram (treprostinil diethanolamine oral) / United Therapeutics Corp
New P3 trial: Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension (clinicaltrials.gov) - Dec 21, 2016
P3, N=600, Not yet recruiting, Sponsor: United Therapeutics
- ambrisentan / Generic mfg.
New trial: FDG Uptake and Lung Blood Flow in PAH Before and After Treatment With Ambrisentan (clinicaltrials.gov) - Nov 15, 2016
P=N/A, N=0, Withdrawn, Sponsor: Robert Scott Harris, M.D.
- ambrisentan / Generic mfg.
Phase classification: A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma). (clinicaltrials.gov) - Nov 4, 2016
P=N/A, N=20, Completed, Sponsor: Stanford University
Not yet recruiting --> Recruiting | Initiation date: Nov 2016 --> Jan 2017 Phase classification: P1 --> P=N/A
- tilarginine (L-NMMA) / Arginox Pharma, Houston Methodist Research Institute
New P1 trial: Mechanisms of Cerebrovascular Control (clinicaltrials.gov) - Oct 17, 2016
P1, N=60, Not yet recruiting, Sponsor: University of Wisconsin, Madison
- | ambrisentan / Generic mfg.
Trial completion: EiPAH: An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Participants With Exercise-Induced Pulmonary Arterial Hypertension (PAH) (clinicaltrials.gov) - Jul 28, 2016
P=N/A, N=41, Completed, Sponsor: Brigham and Women's Hospital
Phase classification: P1 --> P=N/A Recruiting --> Completed
- ambrisentan / Generic mfg.
Enrollment change, Trial withdrawal, Trial primary completion date: Ambrisentan for Treatment of Portopulmonary Hypertension (clinicaltrials.gov) - Jun 18, 2016
P1/2, N=0, Withdrawn, Sponsor: Medical University of Graz
Recruiting --> Completed N=10 --> 0 | Recruiting --> Withdrawn | Trial primary completion date: Jun 2015 --> Apr 2016
- ambrisentan / Generic mfg.
Enrollment closed: Portopulm: Ambrisentan in Patients With Porto-pulmonary Hypertension A Multicenter Open Label Trial (clinicaltrials.gov) - May 23, 2016
P=N/A, N=30, Active, not recruiting, Sponsor: Tufts Medical Center
N=10 --> 0 | Recruiting --> Withdrawn | Trial primary completion date: Jun 2015 --> Apr 2016 Recruiting --> Active, not recruiting
- ambrisentan / Generic mfg.
Enrollment closed, Trial primary completion date, Combination therapy: Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic Sclerosis (clinicaltrials.gov) - May 23, 2016
P=N/A, N=15, Active, not recruiting, Sponsor: University of Pennsylvania
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2015 --> Jun 2016
- || ambrisentan / Generic mfg.
Trial primary completion date: Drug Use Investigation for VOLIBRIS (clinicaltrials.gov) - Apr 25, 2016
P=N/A, N=900, Active, not recruiting, Sponsor: GlaxoSmithKline
Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2015 --> Jun 2016 Trial primary completion date: Jan 2020 --> Aug 2020
- || ambrisentan / Generic mfg.
Enrollment change: A Phase 1 Relative Bioavailability Study of Ambrisentan and Tadalfil Fixed Dose Combination Tablets in Healthy Subjects (clinicaltrials.gov) - Apr 11, 2016
P1, N=60, Recruiting, Sponsor: GlaxoSmithKline
Trial primary completion date: Jan 2020 --> Aug 2020 N=20 --> 60
- ambrisentan / Generic mfg.
Enrollment open: A Phase 1 Relative Bioavailability Study of Ambrisentan and Tadalfil Fixed Dose Combination Tablets in Healthy Subjects (clinicaltrials.gov) - Apr 4, 2016
P1, N=20, Recruiting, Sponsor: GlaxoSmithKline
N=20 --> 60 Not yet recruiting --> Recruiting
- | ambrisentan / Generic mfg.
New P1 trial: The Role of Endothelin-1 in Sickle Cell Disease (clinicaltrials.gov) - Mar 18, 2016
P1, N=30, Recruiting, Sponsor: Georgia Regents University
- | ambrisentan / Generic mfg., spironolactone / Generic mfg.
Enrollment open, Trial initiation date: The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study (clinicaltrials.gov) - Mar 2, 2016
P4, N=30, Recruiting, Sponsor: Brigham and Women's Hospital
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Initiation date: Jan 2015 --> Sep 2015