Navigation Links
Cardiome Announces Positive Interim Phase 2b Results for Oral Vernakalant and Engages Merrill Lynch as Strategic Advisor
Date:3/17/2008

n (n=537), which includes patients randomized who did not enter the maintenance phase of the study. During the dosing period under analysis, there was no difference in the incidence of serious adverse events between treatment groups. Potentially drug-related serious adverse events occurred in 1% of placebo patients, 2% of patients in the 150mg dosing group, 0% of patients in the 300mg dosing group and 1% of patients in the 500mg dosing group. There were no cases of drug-related "Torsades de Pointes", a well-characterized arrhythmia which is an occasional side effect of some current anti-arrhythmic drugs. There were 2 deaths during this period, both unrelated to vernakalant (oral), comprising a patient in the 150mg dosing group who died of cervical cancer at day 79, and a patient in the placebo group who died at day 86 after suffering an ischemic stroke.

"Our strategic intent with this study was to pave the way to Phase 3 and provide efficacy and safety data to support business discussions," said Bob Rieder, Chairman and Chief Executive Officer of Cardiome. "This strong interim data set clearly enables us to move forward in planning the Phase 3 program and continue our discussions with interested parties."

The double-blind, placebo-controlled, randomized, dose-ranging study was designed to explore safety and tolerability, pharmacokinetics and efficacy of vernakalant (oral) over 90 days of dosing in patients at risk of recurrent atrial fibrillation. Patients received a 150mg, 300mg or 500mg dose of vernakalant (oral) or placebo twice per day. After the first 3 days, patients still in atrial fibrillation were electrically cardioverted. Successfully cardioverted patients continued to receive vernakalant (oral) or placebo for the remainder of the 90-day trial and were monitored throughout the dosing period.

Cardiome initiated the Phase 2b in the first quarter of 2007. Enrollment has completed, with a total of 735 patients randomized of which approxim
'/>"/>

SOURCE Cardiome Pharma Corp.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine news :

1. Cardiome And Astellas Announce Regulatory Update
2. Cardiome to Hold Investor Update Call
3. Cardiome Updates Guidance
4. Cardiome Initiates Phase 1 Study for GED-aPC
5. Cardiome To Release Third Quarter Results
6. Cardiome to Present at CIBC Conference
7. Cardiome to Present at ThinkEquity Conference
8. Cardiome to Present at Bear Stearns Conference
9. Weight Watchers Announces Election of Kim Roy to Board of Directors
10. MedQuist Announces Entry Into Settlement Term Sheet Resolving South Broward Litigation
11. Exelixis Announces March 19 Webcast of Presentation at the Lehman Brothers Annual Global Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2015)... R.I. (PRWEB) May 04, 2015 Johnson & ... $40 million engineering and science academic center on Wednesday, April ... the ground for land made available by the re-alignment of ... the corner of Friendship and Chestnut streets in Providence, is ... built on a parcel of land the university purchased in ...
(Date:5/4/2015)... 2015 TROY Healthcare Solutions is proud ... Regional User Group (RUG) Conference in Baltimore, MD from ... Regional User Group provides an opportunity for clients to ... exhibitor gallery. , In addition to sponsoring the event, ... North Atlantic RUG Conference. Attendees can stop by the ...
(Date:5/4/2015)... (PRWEB) May 04, 2015 The American ... critical state policy reports which identify gaps in coverage ... “After ATA issued the State Telemedicine Gaps Reports last ... how their laws and regulations impact healthcare delivery in ... a result of state actions across the nation, ATA ...
(Date:5/4/2015)... Baptist Medical Center Jacksonville has received ... The Guidelines®-Stroke Gold Plus Quality Achievement Award along ... recognizes the hospital’s commitment and success in ensuring ... according to nationally recognized, research-based guidelines based on ... Gold Plus Quality Achievement Award, hospitals must achieve ...
(Date:5/4/2015)... Greifensee, Switzerland (PRWEB) May 04, 2015 ... entitled “ The Importance of Data Integrity in ... Bob McDowall as guest presenter. This webinar will ... EDT (15:00 GMT). , Data integrity is a ... information submitted to regulatory agencies. However, in recent ...
Breaking Medicine News(10 mins):Health News:Johnson & Wales University “Breaks Ground” On New $40 Million Engineering and Science Academic Center 2Health News:Johnson & Wales University “Breaks Ground” On New $40 Million Engineering and Science Academic Center 3Health News:TROY Healthcare to Exhibit at the Cerner North Atlantic Regional User Group Conference 2Health News:TROY Healthcare to Exhibit at the Cerner North Atlantic Regional User Group Conference 3Health News:American Telemedicine Association Delivers New State Report Cards on Telemedicine 2Health News:American Telemedicine Association Delivers New State Report Cards on Telemedicine 3Health News:Baptist Medical Center Jacksonville Receives Top Honor for Stroke Care 2Health News:Baptist Medical Center Jacksonville Receives Top Honor for Stroke Care 3Health News:Baptist Medical Center Jacksonville Receives Top Honor for Stroke Care 4Health News:METTLER TOLEDO Announces Live Webinar on the Importance of Data Integrity in a GXP Regulated Laboratory 2
... Results Capture Perspectives of People Living with Rheumatoid, ... a Span of 30 Years, HORSHAM, Pa., ... challenges cited by people diagnosed with,rheumatoid arthritis (RA), ... groundbreaking parallel surveys. According to the GeneRAtions(TM),surveys -- ...
... Budget Challenge, SACRAMENTO, Calif., July 29 ... organization Next 10 has just released,a newly updated ... voters,can try their hand at dealing with the ... re-released 2008 Budget Challenge, an online,interactive educational game, ...
... BEDFORD, Mass., July 29 Insulet Corporation,(Nasdaq: PODD ... OmniPod(R),Insulin Management System, announced plans to release its financial ... 2008 after the close of,the financial markets., Insulet ... Eastern Time on,Tuesday, August 12, 2008 to discuss its ...
... American Media, Inc. (AMI), the,leading publisher of celebrity ... provided dial-in information for the conference call it,plans to ... for the holders of,the senior subordinated notes of its ... conference call will be to update,noteholders with respect to ...
... Infants Died in 2005, WHITE PLAINS, N.Y., July ... for a growing proportion of infant deaths,according to new ... (NCHS)., Babies who died of preterm-related causes accounted ... 34.6 percent in 2000, according to "Infant,Mortality Statistics from ...
... cancer screening program in Norway and an approach to ... are equally sensitive for detecting cancer, researchers report in ... of the National Cancer Institute . But the recall ... Breast cancer screening in the United States is usually ...
Cached Medicine News:Health News:New Survey Findings Reveal Emotional and Physical Toll of Rheumatoid Arthritis and the Advancement of Treatment Through 'Generations' 2Health News:New Survey Findings Reveal Emotional and Physical Toll of Rheumatoid Arthritis and the Advancement of Treatment Through 'Generations' 3Health News:New Survey Findings Reveal Emotional and Physical Toll of Rheumatoid Arthritis and the Advancement of Treatment Through 'Generations' 4Health News:New Survey Findings Reveal Emotional and Physical Toll of Rheumatoid Arthritis and the Advancement of Treatment Through 'Generations' 5Health News:As Budget Stalemate Wears On - Voters Can Set Their Own Priorities 2Health News:Insulet Corporation to Report Second Quarter 2008 Financial Results on Tuesday, August 12, 2008 2Health News:Preterm Birth Contributes to Growing Number of Infant Deaths 2Health News:2 different breast cancer screening strategies are equally effective 2
(Date:5/4/2015)... FRAMINGHAM, Mass. , May 4, 2015   HeartWare ... of less invasive, miniaturized circulatory support technologies that are revolutionizing ... and CEO, Doug Godshall , is scheduled to present ... Conference in Las Vegas on Thursday, ... The live webcast of the Company,s presentation at ...
(Date:5/4/2015)... CARLSBAD, Calif. , May 4, 2015  Isis ... an exclusive license agreement with Bayer HealthCare (Bayer) to ... of thrombosis. Under the terms of the agreement, Isis ... near-term payments, including an immediate $100 million up-front payment ... program following a Phase 2 study in patients with ...
(Date:5/4/2015)... , May 4, 2015 MEI Pharma, ... focused on the clinical development of novel therapies ... mitochondria-specific effects of the Company,s investigational drug candidate ... activity when combined with a tyrosine-kinase inhibitor (TKI). ... to be a potent inhibitor of mitochondrial oxidative ...
Breaking Medicine Technology:HeartWare Presentation At Bank Of America Merrill Lynch 2015 Health Care Conference To Be Webcast 2Isis Pharmaceuticals Licenses ISIS-FXI Rx to Bayer to Develop and Commercialize for the Prevention of Thrombosis 2Isis Pharmaceuticals Licenses ISIS-FXI Rx to Bayer to Develop and Commercialize for the Prevention of Thrombosis 3Isis Pharmaceuticals Licenses ISIS-FXI Rx to Bayer to Develop and Commercialize for the Prevention of Thrombosis 4Isis Pharmaceuticals Licenses ISIS-FXI Rx to Bayer to Develop and Commercialize for the Prevention of Thrombosis 5MEI Pharma's Mitochondrial Inhibitor ME-344 Shows Enhanced Anti-Tumor Activity in Combination with Tyrosine-Kinase Inhibitor in Pre-Clinical Studies 2MEI Pharma's Mitochondrial Inhibitor ME-344 Shows Enhanced Anti-Tumor Activity in Combination with Tyrosine-Kinase Inhibitor in Pre-Clinical Studies 3MEI Pharma's Mitochondrial Inhibitor ME-344 Shows Enhanced Anti-Tumor Activity in Combination with Tyrosine-Kinase Inhibitor in Pre-Clinical Studies 4MEI Pharma's Mitochondrial Inhibitor ME-344 Shows Enhanced Anti-Tumor Activity in Combination with Tyrosine-Kinase Inhibitor in Pre-Clinical Studies 5
... 27 Due to rising patient responsibility for ... state laws requiring disclosure of information on hospital charges, ... estimates for healthcare services. Competitive hospitals also realize they ... accountability to key stakeholders, protect against compliance risks, focus ...
... , , ... 280,000 external defibrillators used worldwide in health care facilities, public places, or in the home ... Drug Administration warned today. , , , ... , , , ...
Cached Medicine Technology:Craneware Shares Patient Estimation Revenue Integrity Insights 2Craneware Shares Patient Estimation Revenue Integrity Insights 3Craneware Shares Patient Estimation Revenue Integrity Insights 4FDA Warns Users About Faulty Components in 14 External Defibrillator Models 2FDA Warns Users About Faulty Components in 14 External Defibrillator Models 3
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: