Navigation Links
Alexza's AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophrenic Patients
Date:9/2/2008

w therapies that provide rapid onset of predictable effect and are delivered in a patient-friendly, non-invasive manner."

Phase 3 Clinical Trial Design

The AZ-004 clinical trial enrolled 344 schizophrenic patients with acute agitation at 24 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 their 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 statistically significant improvement in the 2-hour post-dose PEC score, compared to placebo.

PEC Scores (Mean Values)

p-Value for Change

from Baseline

Study Arm Baseline 2-Hour Post-Dose vs. Placebo

10 mg AZ-004<
'/>"/>

SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. Alexza Initiates Second Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)
2. Alexza Completes Enrollment in Phase 3 Clinical Trial with AZ-004 (Staccato(R) Loxapine) for Acute Agitation
3. Alexza Pharmaceuticals to Present AZ-004 Phase 2a Clinical Data at the American Psychiatric Association Annual Meeting
4. Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder
5. Alexza Completes Enrollment in Phase 2a Clinical Trial With AZ-002 (Staccato(R) Alprazolam) in Panic Disorder Patients
6. Alexza Announces Positive Phase 1 Results With AZ-007 (Staccato(R) Zaleplon)
7. Alexzas AZ-104 (Staccato(R) Loxapine) Phase 2a Trial Meets Primary Endpoint of 2-Hour Pain Relief in Patients with Migraine Headache
8. Alexza Initiates AZ-007 (Staccato(R) Zaleplon) Phase 1 Clinical Trial and Updates Clinical Pipeline Development Status
9. Calabar AB Today Announced New Financing for Continuation of the Phase II Program in Patients With Dry Mouth
10. Intercell Announces Initiation of Further Phase II Clinical Trial of V710 an Investigational Vaccine to Prevent S. aureus Infection
11. Algeta Reports Positive Headline Phase II Data on Pain Palliation With Alpharadin
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2014)... , 11. Juli 2014  Dilon ... für die molekulare Bildgebung, einschließlich molekularer ... die CE-Zulassung für sein Navigator ® ... Dilon das Produkt jetzt europaweit vertreiben. ... Großteil der europäischen Länder ausgedehnt und ...
(Date:7/10/2014)... -- RESMED INC. (NYSE: RMD ) today announced that ... June 30, 2014 results on Thursday, July 31, 2014, after ... with ResMed,s results will be issued after 1:00 p.m. US ... discuss operating results and future outlook. The earnings ... Time and the live webcast of the call can be ...
(Date:7/10/2014)... 10, 2014   Ventana Medical Systems, Inc.  (Ventana), ... has entered into an agreement with Merck KGaA, Darmstadt, ... Serono in the United States ... Merck KGaA,s biopharmaceutical division on the development and commercialization ... using Ventana,s proprietary diagnostic assays. In alignment with Merck ...
Breaking Medicine Technology:Dilon erhält CE-Zulassung für sein Navigator-Gamma-Sondensystem 2ResMed To Announce Fourth Quarter And Fiscal Year-End 2014 Results 2Ventana Medical Systems, Inc. and Merck KGaA, Darmstadt, Germany to develop companion diagnostic test for cancer treatment 2Ventana Medical Systems, Inc. and Merck KGaA, Darmstadt, Germany to develop companion diagnostic test for cancer treatment 3
(Date:7/12/2014)... Response Management Systems is a crucial peak load management ... energy supply and demand. With the help of DRMS, ... increasing pressure on the grid) and replaced by Advanced ... and thermostats for load reduction. , DRMS is ... government mandates and benefits for energy efficiency and conservation ...
(Date:7/12/2014)... (PRWEB) July 12, 2014 Casinos ... years, despite rising competition from international and online casinos. ... 2.9% over the five years through 2014-15. Greater per ... demanding more gaming services. Rises in discretionary income levels ... more money on non-essential items such as casino gambling ...
(Date:7/12/2014)... Canada (PRWEB) July 12, 2014 Sean Francis, owner ... throwing out special challenges to his clients. He’s also known for ... He recently found a way to combine the two and is ... raised $2,000 for the Boys and Girls Club. , The funds ... which started on June 23rd. Francis sent out emails and asked ...
(Date:7/12/2014)... With prom shopping reaching its final days, VogueQueen.com, a ... showcase its new and trendy apparels. Recently, the company ... its online shop. Additionally, it is now providing huge ... According to the company’s sales manager, the promotion will ... , He says, “Now, worldwide clients can order cheap ...
(Date:7/12/2014)... Doylestown Hospital recently conducted an interview with ... questions. Paddock tackles topics including main men's health ... longer than men, and testosterone replacement therapy, among others. ... featured on Doylestown Hospital’s website, Dr. Brad Paddock says, ... If you notice pain, bulging, or asymmetry in your ...
Breaking Medicine News(10 mins):Health News:North America Demand Response Management System Worth $12,522.4 Million by 2019 - New Report by MicroMarket Monitor 2Health News:North America Demand Response Management System Worth $12,522.4 Million by 2019 - New Report by MicroMarket Monitor 3Health News:North America Demand Response Management System Worth $12,522.4 Million by 2019 - New Report by MicroMarket Monitor 4Health News:Casinos in Australia Industry Market Research Report Now Updated by IBISWorld 2Health News:Casinos in Australia Industry Market Research Report Now Updated by IBISWorld 3Health News:Casinos in Australia Industry Market Research Report Now Updated by IBISWorld 4Health News:Kawartha Lakes Fit Body Boot Camp’s Successful Fat Loss Challenge Results in $2,000 to Boys and Girls Club 2Health News:Kawartha Lakes Fit Body Boot Camp’s Successful Fat Loss Challenge Results in $2,000 to Boys and Girls Club 3Health News:VogueQueen.com Updates Its Summer Collection With New And Trendy Evening Dresses 2Health News:Ivyland Medical Center’s Dr. Brad Paddock Offers Tips for Men’s Health 2
... Hospital investigators have found that an electrically powered amplification ... to the acute hearing of humans and other mammals. ... loss can result from malfunction of this amplification machinery ... as aspirin. , Sound entering the cochlea is detected ...
... May 7 The following is a,statement by ... The guidelines for smoking cessation released today ... reminder to the nation,s 45 million,smokers that they ... quit smoking and protect their health than ever ...
... Presbyterian Hospital of,Plano has been named a recipient ... state,s highest honor for quality and organizational,performance., ... health care facility,in Collin County to receive this ... is the first hospital in parent company Texas ...
... thwarted rewiring needed for neural development, mouse study shows ... class of weight-loss drugs that suppresses appetite by blocking ... caution in children, U.S. scientists report. , In research ... suppresses the adaptive rewiring of the brain necessary for ...
... GAINESVILLE, Fla. Retinas in newborn mice appear perfectly fine ... microRNAs except for one thing the retinas do not ... the absence of microRNAs in the mammalian eye, an international ... the Italian National Research Council describes a gradual structural decline ...
... As part of its ongoing,commitment to providing the ... is excited to welcome Katherine Anne Binns as ... New York office. KN will,draw particularly on her ... growing list of clients., "Katherine possesses the ...
Cached Medicine News:Health News:St. Jude finds 'dancing' hair cells are key to humans' acute hearing 2Health News:St. Jude finds 'dancing' hair cells are key to humans' acute hearing 3Health News:New Guidelines Show Smokers Have More Tools to Quit Than Ever, But Elected Officials Must Do More to Help 2Health News:New Guidelines Show Smokers Have More Tools to Quit Than Ever, But Elected Officials Must Do More to Help 3Health News:New Guidelines Show Smokers Have More Tools to Quit Than Ever, But Elected Officials Must Do More to Help 4Health News:Presbyterian Hospital of Plano Receives Prestigious Texas Award for Performance Excellence 2Health News:MicroRNAs appear essential for retinal health 2Health News:MicroRNAs appear essential for retinal health 3Health News:Senior Researcher With Extensive Healthcare Experience Joins Knowledge Networks 2
... throughput primary or backup instrument, this ... and reliability equal to or greater ... advanced technology of the AUTION JET ... reproducible and accurate results, limiting interference ...
... (E3) is one of the 3 major ... and estrone). In terms of estrogenic activity, ... [1]. Estriol is produced almost exclusively during ... in the normal human fetus. During pregnancy, ...
Assay uses highly specific rabbit anti-estriol antibody reparation - negligible cross-reactivity with other estrogen metabolites. Excellent assay precision and reproducibility. Superior sensitivity ...
... Estrone (E1) is one of the ... include estradiol and estriol. Estrone is produced ... adrenal cortex or gonads [1,2]. In premenopausal ... is secreted by the ovary. In prepubertal ...
Medicine Products: