Navigation Links
Alexza's AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Phase 3 Trial
Date:12/9/2008

The AZ-004 clinical trial enrolled 314 acutely-agitated patients with bipolar I disorder at 17 U.S. clinical centers. The trial was designed as an in-clinic, multi-center, randomized, double-blind, placebo-controlled study and tested AZ-004 at two dose levels, 5 mg and 10 mg. Patients were eligible to receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. Only one dose of study drug was allowed during the first 2 hours of the study period.

The primary endpoint for the study was the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component score (also known as PEC score), measured at 2 hours after the first dose. The key secondary endpoint was the Clinical Global Impression-Improvement (CGI-I) score, measured at 2 hours after the first dose. All results were considered statistically significant at the p < 0.05 level, as compared to placebo, and all analyses were made on an intent-to-treat basis. Various additional assessments of a patient's agitation state were conducted at serial time points using the PEC scale over the first 4-hour post-dose time period, with follow-up assessments at the end of the 24-hour study period. Side effects were recorded for each patient throughout the 24-hour study period.

Primary Efficacy Endpoint

Both the 5 mg and the 10 mg dose of AZ-004 met the primary endpoint of the clinical trial, showing a highly statistically significant improvement in the 2-hour post-dose PEC score, compared to placebo.


                           PEC Scores (Mean Values)

                                                       p-Value for Change from
    Study Arm             Baseline   2-Hour Post-Dose    Baseline vs. Placebo
    10 mg AZ-004 (n=105)    17.3           8.3              < 0.0001
    5 mg AZ-004 (n=104)     17.4           9.3              < 0.0001
    Placebo (n=105)         17.7  
'/>"/>
SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10

Related medicine technology :

1. Alexzas AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophrenic Patients
2. Alexza Initiates Second Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)
3. Alexza Completes Enrollment in Phase 3 Clinical Trial with AZ-004 (Staccato(R) Loxapine) for Acute Agitation
4. Alexza Pharmaceuticals to Present AZ-004 Phase 2a Clinical Data at the American Psychiatric Association Annual Meeting
5. Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder
6. Alexza Completes Enrollment in Phase 2a Clinical Trial With AZ-002 (Staccato(R) Alprazolam) in Panic Disorder Patients
7. Alexza Announces Positive Phase 1 Results With AZ-007 (Staccato(R) Zaleplon)
8. Alexzas AZ-104 (Staccato(R) Loxapine) Phase 2a Trial Meets Primary Endpoint of 2-Hour Pain Relief in Patients with Migraine Headache
9. Alexza Initiates AZ-007 (Staccato(R) Zaleplon) Phase 1 Clinical Trial and Updates Clinical Pipeline Development Status
10. TorreyPines Therapeutics Muscarinic Agonist NGX267 Meets Primary Endpoint in a Phase II Clinical Trial in Patients with Xerostomia
11. Schering-Plough Reports Preladenant Meets Primary Endpoint in Phase II Dose-Finding Trial for Parkinsons Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... 11, 2014 /PRNewswire-iReach/ -- VAPETEK™, Inc. has announced ... for use in portable vaporizers, which contains CBD, ... in cannabis, cannabidiol offers consumers a THC-free product ... other vaporizer technology. Photo - ... 483 different compounds which are currently known, two ...
(Date:7/11/2014)... HILL, N.C. , July 11, 2014 /PRNewswire/ ... of pharmaceutical marketing and, consequently, organizations are turning ... for patients. As part of this ... it,s important to educate, communicate and engage patients ... disease awareness to patient empowerment. By mapping the ...
(Date:7/11/2014)... N.C. , July 11, 2014 ... approaches are evolving across industry sectors to better ... examining better ways to engage with and understand ... inform themselves and make critical purchasing decisions. ... firm, Best Practices, LLC, one area where organizations ...
Breaking Medicine Technology:VAPETEK Releases CBD-Infused eLiquid For The Consumer Market 2New Study Uses Six-Step Patient Journey as Framework for Consumer-Focused Marketing Opportunities 2New Technologies Transforming Consumer Marketing Research Playbook 2
... SimplyGo Portable Oxygen Concentrator by Philips Resironics is ... and pulse does at a weight of only 10 pounds.  ... continuous flow portable concentrator weighed in at a hefty 19 ... anywhere you go in the world you can plug the ...
... federal judge in New York has thrown out the case [1] ... of investment fund manager Porton Group, in the latest development in ... 3M that Mr Boulter had attempted to "blackmail" the company were ... follows the decision earlier this month of a court in Washington ...
Cached Medicine Technology:SimplyGo Portable Oxygen Concentrator Now Available 2Blackmail Claims Against Harvey Boulter Thrown out of Court 2
(Date:7/12/2014)... The Chicken Egg Production ... years, buoyed by stable demand for industry products as ... are a relatively affordable staple for most families across ... grows in line with the size of the population,” ... for new specialty egg products with enriched qualities, such ...
(Date:7/12/2014)... The Passenger Information System market is estimated ... million by 2019, at an expected CAGR of 26.5% ... public transport infrastructure in North America is well developed ... every corner of the region. The growing ridership figures ... service providers are driving the North American Passenger Information ...
(Date:7/12/2014)... Miami, FL (PRWEB) July 12, 2014 Fresh ... Brazil and Colombia will meet on September 5th at ... allowed the world to see some of the brightest stars ... Diehard soccer fans in Miami will be treated to some ... , Brazil is currently ranked as the third best team ...
(Date:7/12/2014)... 12, 2014 The rise in the ... for new advanced network architectures to suit the upsurge. ... industry with increasing cloud storage technologies. The data traffic ... more mobility devices. This has resulted in larger and ... driving forces for the SDN market. , The North ...
(Date:7/12/2014)... report, "Phthalic Anhydride and Derivatives (Plasticizers, Unsaturated Polyester Resins, ... Trends & Forecast to 2018," defines and segments phthalic ... and value. The report also estimates the demand and ... anhydride is projected to grow from an estimated $6,130.55 ... a CAGR of 5.24% from 2013 to 2018. , ...
Breaking Medicine News(10 mins):Health News:Chicken Egg Production in Canada Industry Market Research Report Now Available from IBISWorld 2Health News:Chicken Egg Production in Canada Industry Market Research Report Now Available from IBISWorld 3Health News:North America Passenger Information System (ICT) Market worth $5,486.88 Million by 2019 - New Report by MicroMarket Monitor 2Health News:North America Passenger Information System (ICT) Market worth $5,486.88 Million by 2019 - New Report by MicroMarket Monitor 3Health News:North America Passenger Information System (ICT) Market worth $5,486.88 Million by 2019 - New Report by MicroMarket Monitor 4Health News:Brazil Vs. Colombia Tickets Sun Life Stadium: Ticket Down Slashes Ticket Prices for Friendly Match Between Colombia and Brazil 2Health News:Brazil Vs. Colombia Tickets Sun Life Stadium: Ticket Down Slashes Ticket Prices for Friendly Match Between Colombia and Brazil 3Health News:North America Software Defined Network (SDN) Market Worth $1,443.8 Million by 2019 - New Report by MicroMarket Monitor 2Health News:North America Software Defined Network (SDN) Market Worth $1,443.8 Million by 2019 - New Report by MicroMarket Monitor 3Health News:North America Software Defined Network (SDN) Market Worth $1,443.8 Million by 2019 - New Report by MicroMarket Monitor 4Health News:North America Software Defined Network (SDN) Market Worth $1,443.8 Million by 2019 - New Report by MicroMarket Monitor 5Health News:Phthalic Anhydride Market Projected to Reach $8.42 Billion by 2018 – Report by MarketsandMarkets 2Health News:Phthalic Anhydride Market Projected to Reach $8.42 Billion by 2018 – Report by MarketsandMarkets 3Health News:Phthalic Anhydride Market Projected to Reach $8.42 Billion by 2018 – Report by MarketsandMarkets 4
... Minister Dr Anbumani Ramadoss has decided to launch a ban on ... happens, very soon the colas and junk food may be out ... that: “Colas and junk food are bad for children’s health. Hence, ... school premises,” is in talk with Union Human Resource Development Ministry ...
... children who are intelligent are more likely to turn ... though researchers are unclear about vegetarianism's link to IQ ... Catharine Gale at England's University of Southampton, studied 8,170 ... edition of health magazine WebMD., ,Participants took an ...
... cancer were almost four times as successful when they took ... more likely to spot polyps, according to the study. ... tube with a tiny camera into the colon. The colonoscopy ... cancerous and pre-cancerous growths. ,On an average, it ...
... a chemical treatment to remove lead from the body -- ... lead exposure, a// Cornell study of young rats finds. ... the treatment of autistic children, the researchers say that when ... the lead-removing chemical, they showed declines in their learning and ...
... schools, such as soft drink ads; the use ... from soft drink bottlers; and exclusive// beverage contracts ... researchers. ,Dr. Claudia Probart, Penn ... the study, says, 'Schools' newly created wellness policies ...
... Researchers at the University of Pennsylvania’s School of Medicine ... on Medicare quality measures// had little difference in the ... hospitals, indicating that the performance measures may not accurately ... PhD, Assistant Professor of Medicine at the University of ...
Cached Medicine News:Health News:Colonoscopies Can Help Prevent Colon Cancer; Only When Done Properly 2Health News:Pros and Cons of Therapy for Lead Exposure 2Health News:Marketing in Schools may Discourage Healthy Nutrition among Students 2Health News:Hospital Performance Measures May Not Make Much Difference When It Comes to Mortality 2
... Series 1000 Power Instrument System is ... offers versatility and convenience with modular ... Module, without hand throttle, for use ... foot pedal. Accepts all 1000 and ...
... The Brasseler USA™ Battery Packs contain ... age have a great impact upon battery ... is necessary. Any deviation from these recommendations ... are sensitive to heat. Any exposure of ...
Pneumatic High-speed Drill, Throttleless, 90k Rpm, Microaire Connector....
Pneumatic oscillating saw, 35k cpm, available with various hose connector styles....
Medicine Products: