Navigation Links
FREEDOM-M Trial of Oral Treprostinil in Pulmonary Arterial Hypertension Meets Primary Endpoint
Date:6/6/2011

inil and -5 meters for placebo at week 12.  

The combined 6MWD and Borg Dyspnea Score rating (shortness of breath test) was significantly improved (p=0.0497).  Preliminary analysis of other secondary efficacy measures, including change in Borg Dyspnea Score rating, trough walk at Week 11, change in Dyspnea Fatigue Index, change in WHO functional class, time to clinical worsening (as defined by death, transplant, atrial septostomy, hospitalization due to PAH or at least a 20% decrease in six-minute walk and initiation of another approved PAH therapy), and PAH signs and symptoms did not differ significantly between oral treprostinil and placebo (p>0.05).

An analysis of all 349 FREEDOM-M patients demonstrates that those patients receiving oral treprostinil improved their median 6MWD by approximately 25.5 meters (p=0.0001, Hodges-Lehmann estimate and non-parametric analysis of covariance) as compared to patients receiving placebo.

Adverse events seen in the trial included headache, nausea, diarrhea, and flushing, which are common in patients receiving prostanoid therapy. Detailed analysis of adverse events is ongoing.  All patients in the trial had the option to continue receiving oral treprostinil in an open-label continuation study after completion of the 12-week period.  Of the 287 patients who were eligible to enroll, approximately 279 patients entered the open-label continuation study.  Of these, approximately 183 patients are currently being treated with oral treprostinil, with the longest duration of treatment exceeding three years.

“This is my dream come true,” said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics.  “PAH patients have approved therapies available to them by only three routes of administration – parenteral, inhaled and oral – and no therapy other than treprostinil is available by two of these.  
'/>"/>

SOURCE United Therapeutics Corporation
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Progen Engages Leading CRO to Assist with Phase 3 Trial of PI-88
2. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
3. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
4. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
5. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
6. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
7. Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet
8. Clinical Trial Effectiveness: How Pharmas & Biotechs Save Cost with Savvy Investigator Management
9. TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
10. Iomai Trial Shows 100 Percent Immune Response in Elderly Subjects Vaccinated With Novel Travelers Diarrhea Patch Vaccine
11. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/17/2013)... , May 17, 2013 Medical devices are ... a biological product. In light of their different mechanisms, ... are much more complicated than drug trails due to ... MD safety instead of evaluating both safety and efficacy ... FDA (which is the same as the SFDA) evaluate ...
(Date:5/17/2013)... SAN DIEGO and CAMBRIDGE, Mass., May 17, 2013 ... announce that a purchaser of Aveo Pharmaceutical, Inc. (NASDAQGS: ... District Court for the District of Massachusetts ... of its officers violated the Securities Exchange Act of ... May 1, 2013 (the "Class Period"). (Logo: ...
(Date:5/17/2013)...  TechAtlas Group has announced the release of ... for the Chronic Kidney Disease (CKD) market. This ... drugs and devices currently on the market and ... (Logo:  http://photos.prnewswire.com/prnh/20130517/NE16011LOGO ) ... renal denervation , diabetic nephropathy - antifibrotics ...
Breaking Medicine Technology:Statistical Challenges in Medical Device Trail Evaluation 2Aveo Pharmaceuticals, Inc. Sued by Investor 2Aveo Pharmaceuticals, Inc. Sued by Investor 3TechAtlas Group Releases Innovative Chronic Kidney Disease Landscape Map 2
... Eli Lilly and Company,(NYSE: LLY ) ... with the,European Medicines Agency (EMEA) for centralised review ... for the,first-line treatment of advanced non-small cell lung ... more than 85 countries as a,second-line, single agent ...
... insulin glargine, exenatide offered added benefits of, ... with metformin --, AMSTERDAM, Netherlands, Sept. 21 ... Eli Lilly and Company (NYSE: LLY ),today ... insulin glargine on beta-cell function, glycemic control and ...
Cached Medicine Technology:Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 2Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 3Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 4Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 5Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 6Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 7Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 8Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 9Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 10Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 11Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 12One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function 2One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function 3One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function 4One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function 5One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function 6One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function 7
(Date:5/20/2013)... of Southampton has shown that blind and visually impaired ... that used by bats and dolphins, to determine the ... published in the journal Hearing Research , examined ... help blind people with spatial awareness and navigation. The ... and how to optimise echolocation ability in order to ...
(Date:5/20/2013)... Selexis SA, a serial innovation company ... line development for scale-up and manufacturing of therapeutic protein ... data on the Company’s core technology at the 2013 ... 20 - 23 at the Hyatt Regency La Jolla ... scientific advisory board member, Nicolas Mermod, PhD, Professor of ...
(Date:5/20/2013)... The International Distance Skateboard Association has elected ... the best long distance skaters to attend and compete. This ... venue of raising money for our local Boys & Girls ... is the authority on long distance races throughout the world ... is safe and organized for all who want to attend ...
(Date:5/20/2013)... 20, 2013 Gilman Law LLP, a ... investigating Byetta lawsuits, is troubled by a new study ... and similar type 2 diabetes drugs are growing. ... Practices (ISMP), found that 71 Byetta pancreatic cancer reports ... Administration (FDA) as of June 30, 2012. ...
(Date:5/20/2013)... OH (PRWEB) May 20, 2013 Humidifiers.com ... Form that will satisfy all summer home indoor air ... to carry Stadler Form products that will keep homes ... offers several elegant products designed specifically for the warm ... from Stadler Form are available: Otto and Charly. ...
Breaking Medicine News(10 mins):Health News:New study finds blind people have the potential to use their 'inner bat' to locate objects 2Health News:Selexis SA to Present Technology Platform Data at Cell Line Development & Engineering 2Health News:Selexis SA to Present Technology Platform Data at Cell Line Development & Engineering 3Health News:Byetta Lawyers at Gilman Law, a Leading Pharmacy Law and Defective Drug Plaintiffs’ Law Firm, Troubled by Growing Byetta Pancreatic Cancer Reports 2Health News:Byetta Lawyers at Gilman Law, a Leading Pharmacy Law and Defective Drug Plaintiffs’ Law Firm, Troubled by Growing Byetta Pancreatic Cancer Reports 3Health News:Humidifiers.com has Now Extended their Summer Line with the Sleek, Modern Product Line, Stadler Form 2
... Warwick Medical School found that premature babies face a greater ... included 120,000 children born between 1983 and 2001. The findings ... and were born premature are more often placed on the ... were born before 34 weeks. The findings were penned down ...
... Siteman Cancer Center are a part of the new ... Medicine's Medical Photography, Illustration and Computer Graphics (MedPIC) department. ... and their families to paint a 4-inch square ceramic ... have been painted in this manner. These unique artworks ...
... for a appointment a local clinic now you can take ... 10 minutes//, ,Chlamydia is the most common sexually transmitted ... can be passed on to others without knowing. However, complications ... pregnancy and infertility in both men and women., ,The ...
... group jogging or jogging with a friend will be more ... ,Researchers led by Professor Elizabeth Gould at Harvard University compared ... exercise in a group and found that contrary to accepted ... reported online edition of Daily Mail. ,The researchers ...
... the kingdom was untouched by the avian flu disease. // ... of both the public and the government. He said that there ... , The minister made the remarks during a ... that occasion to celebrate this great achievement the people were served ...
... in the majority of the cases is caused by viral ... could be prevented by vaccination. // Cancer of cervix, liver, ... leukemia are thought to be caused by viruses. Stomach cancer ... Campaign said that viruses can trigger the disease in combination ...
Cached Medicine News:Health News:Home Chlamydia Test 2
Stainless steel flexible ruler. graduated in 1/32 inches (.8 mm) fractions, as well as mm graduations....
Colorado Microneedles offer the surgeon precision in cutting and coagulation, without the expense and inconvenience of a laser. The needles may also be used for dissecting large areas such as the sca...
Endoscopes are also available in fully autoclavable models in 1.8, 2.7, 4.0. 5.0 and 10.0 mm diameters. Manufactured with precise swiss lenses. Built-in temperature measuring device to exactly determ...
Endoscopes are also available in fully autoclavable models in 1.8, 2.7, 4.0. 5.0 and 10.0 mm diameters. Manufactured with precise swiss lenses. Built-in temperature measuring device to exactly determ...
Medicine Products: