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

SILVER SPRING, Md., June 6, 2011 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) announced today the completion of its FREEDOM-M Phase 3 trial of treprostinil diethanolamine (oral treprostinil), an investigational sustained release oral formulation of treprostinil, a stable synthetic form of prostacyclin, in patients with pulmonary arterial hypertension (PAH).  Preliminary analysis demonstrates that the trial has met its primary endpoint.

FREEDOM-M was a randomized, double-blind, placebo-controlled trial of patients with PAH, a chronic, life-threatening illness.  The study enrolled 349 patients who were not receiving any approved PAH medication, with the population for the primary analysis consisting of the 228 patients who had access to the 0.25 mg tablet at randomization.  These patients were administered oral treprostinil or placebo twice daily, with the doses titrated to effect over the course of the 12-week trial.  The majority of patients were in World Health Organization (WHO) Functional Class II (~33%) and Class III (~66%) of varied etiologies, including idiopathic or familial PAH (~75%), collagen vascular disease associated PAH (~19%), and PAH associated with HIV or other associated conditions (~6%).  The patients’ mean baseline six-minute walk distance (6MWD) was approximately 330 meters.

The primary efficacy endpoint of the trial was the change in 6MWD at 12 weeks for the 228 patients.  Preliminary analysis of the FREEDOM-M results demonstrates that those patients receiving oral treprostinil improved their median 6MWD by approximately 23 meters (p=0.0125, Hodges-Lehmann estimate and non-parametric analysis of covariance in accordance with the trial’s pre-specified statistical analysis plan) as compared to patients receiving placebo.  The median change from baseline was 25 meters for oral treprost
'/>"/>

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

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:8/4/2015)... , Aug. 4, 2015  Rigel Pharmaceuticals, Inc. (Nasdaq: ... quarter and six months ended June 30, 2015. ... ITP are progressing and we continue to expect results ... , president and chief executive officer of Rigel. "We ... clinical programs, including evaluating fostamatinib for new treatment indications, ...
(Date:8/4/2015)... 2015  Dr. Keesha Ewers of ... approval of flibanserin, or what is being touted ... of decreased female sexual desire back several decades. ... and addressing libido as a singular symptom with ... Photo - ...
(Date:8/4/2015)...  MEI Pharma, Inc. (Nasdaq: MEIP ), an oncology ... cancer, announced today that Daniel P. Gold , Ph.D., ... Wedbush PacGrow Healthcare Conference on Tuesday, August 11, 2015 at ... in New York . A live webcast ... A replay will be available approximately one hour after the ...
Breaking Medicine Technology:Rigel Announces Second Quarter 2015 Financial Results 2Rigel Announces Second Quarter 2015 Financial Results 3Rigel Announces Second Quarter 2015 Financial Results 4Rigel Announces Second Quarter 2015 Financial Results 5Rigel Announces Second Quarter 2015 Financial Results 6Potential FDA Approval of "Pink Viagra" Sends Wrong Message 2Potential FDA Approval of "Pink Viagra" Sends Wrong Message 3Potential FDA Approval of "Pink Viagra" Sends Wrong Message 4Potential FDA Approval of "Pink Viagra" Sends Wrong Message 5MEI Pharma to Present at Wedbush PacGrow Healthcare Conference 2
... FORT MYERS, Fla., May 11, 2011 Radiation ... radiation therapy centers, today announced financial results for the first ... the first quarter of 2011 were $156.5 million, an increase ... same quarter of 2010. The increase in revenue was principally ...
... 2011 Doctors in Germany are among the first ... with the REVIVE™ SE, a new self-expanding blood clot ... and restore blood flow to the brain in patients ... Inc., a global neuroscience and neurovascular company, received Conformite ...
Cached Medicine Technology:Radiation Therapy Services Holdings, Inc. Reports First Quarter 2011 Financial Results 2Radiation Therapy Services Holdings, Inc. Reports First Quarter 2011 Financial Results 3Radiation Therapy Services Holdings, Inc. Reports First Quarter 2011 Financial Results 4Radiation Therapy Services Holdings, Inc. Reports First Quarter 2011 Financial Results 5Radiation Therapy Services Holdings, Inc. Reports First Quarter 2011 Financial Results 6Radiation Therapy Services Holdings, Inc. Reports First Quarter 2011 Financial Results 7Radiation Therapy Services Holdings, Inc. Reports First Quarter 2011 Financial Results 8Radiation Therapy Services Holdings, Inc. Reports First Quarter 2011 Financial Results 9Radiation Therapy Services Holdings, Inc. Reports First Quarter 2011 Financial Results 10Radiation Therapy Services Holdings, Inc. Reports First Quarter 2011 Financial Results 11Doctors in Germany Among First to Use New Self-Expanding Clot Removal Device for Ischemic Stroke 2Doctors in Germany Among First to Use New Self-Expanding Clot Removal Device for Ischemic Stroke 3
(Date:8/4/2015)... ... August 04, 2015 , ... Worldwide Power ... Products is expanding its reach in Texas. Effective July 1st of this year, ... Texas generator division. With the North Texas acquisition, Worldwide Power Products (“WPP”) ...
(Date:8/4/2015)... ... 04, 2015 , ... Recent studies in the ... in binge drinking among certain populations and specific locations. Researchers, who ... examine trends and evidence to help facilitate health care treatment to meet current ...
(Date:8/4/2015)... NJ (PRWEB) , ... August 04, 2015 , ... Members ... on quality care metrics – at a cost that is nine percent lower -- ... Blue Cross Blue Shield of New Jersey’s patient-centered programs. , “The promise of ...
(Date:8/4/2015)... Ohio (PRWEB) , ... August 04, 2015 , ... ... have up-to-date immunizations, especially those entering kindergarten. All required immunizations are covered for ... rules, which means that children who aren’t caught up with their immunizations may ...
(Date:8/4/2015)... ... August 04, 2015 , ... NutraScience Labs , a ... services, joined over 200 other Long Island-based corporations as participants in the 10th ... at Jones Beach State Park in Wantagh, New York. , According to Mindy ...
Breaking Medicine News(10 mins):Health News:North Texas Acquisition Press Release 2Health News:DARA Responds To International Trends in Binge Drinking 2Health News:DARA Responds To International Trends in Binge Drinking 3Health News:Horizon BCBSNJ: 2014 Results Show Patient-Centered Care Continues to Deliver on Promise of Better Quality Care at a Lower Cost 2Health News:Horizon BCBSNJ: 2014 Results Show Patient-Centered Care Continues to Deliver on Promise of Better Quality Care at a Lower Cost 3Health News:Buckeye Health Plan Reminds Parents to Keep Immunizations In Mind As School Year Kicks Off 2Health News:NutraScience Labs "Steps Up" to the 2015 Marcum Workplace Challenge 2
... , NEW YORK, Dec. 11 Often called "the ... Miracle,s for their significant contribution to today,s beauty industry ... Award in the mass skin care market category. ... My Goodbye Acne System , the first ...
... The National Medical Association (NMA) applauds the announcement ... Tom Daschle as the Secretary of Health and Human ... of Health and Human Services. , We ... to provide a comprehensive national health care reform benefiting ...
... WASHINGTON, Dec. 11 Speaker Nancy Pelosi released the following ... Leader Tom Daschle as Secretary of Health and Human Services ... Office of Health Reform: , , ... Services and his selection as Director of the new White ...
... Dec. 11 The American Academy of Orthopaedic Surgeons ... guideline on "Treatment of Osteoarthritis of the Knee". These ... less invasive than knee replacement surgery. While a wide ... tailored to individual patients after discussions with their physicians. ...
... Clinic researchers have discovered that a chemical known as ... the effectiveness of tamoxifen in treating breast cancer, and ... way. , Their study, being presented at the Cancer ... 31st annual San Antonio Breast Cancer Symposium, finds that, ...
... MINNEAPOLIS/ST. PAUL (Dec. 11, 2008) The University of Minnesota has received ... Family Foundation. Goals for the funding, to be paid over five ... to accelerate the timeline to translate it into a viable cure for ... The gift is the ...
Cached Medicine News:Health News:DR. MIRACLE'S Wins 2008 WWD Beauty Biz Award: Breakthrough Product of the Year!!! 2Health News:National Medical Association Applauds Choice of Health and Human Services Secretary 2Health News:AAOS Issues New Clinical Practice Guideline for Osteoarthritis of the Knee 2Health News:AAOS Issues New Clinical Practice Guideline for Osteoarthritis of the Knee 3Health News:Mayo Clinic researchers find tamoxifen's power comes from endoxifen 2Health News:Mayo Clinic researchers find tamoxifen's power comes from endoxifen 3Health News:University of Minnesota receives $40 million for type 1 diabetes research 2Health News:University of Minnesota receives $40 million for type 1 diabetes research 3Health News:University of Minnesota receives $40 million for type 1 diabetes research 4
... Designed To Safely And Easily ... Smaller Incision.,Specially Designed To Cut And ... With Ease With One Instrument.,New Miniaturized ... Phaco Incision For Explantation Of A ...
... 8-12108 : Designed To Be Used ... Length Radials Placed On The Cornea For Making ... Be Used With The Gills Nomograms. 6mm & ... For Making Limbal Relaxing Incisions.5mm Inner Circle Assists ...
... Designed To Rest Either Nasally Or ... Over, Allowing Eyelids To Be Opened ... Widest Possible Aperture., ,Open And Close ... Access To The Globe During Clear ...
... Jaw Design Holds The Lens Securely ... Polished Blades Keep The Optic From ... Control Over Release Of The Optic.,Wide ... Tilting During Insertion.,Reusable, Autoclaveable, Made In ...
Medicine Products: