PF-03049423(PF-03049423) - 药物靶点：PDE5A_专利_临床

概要

基本信息

药物类型

小分子化药

别名

靶点

PDE5A

作用方式

抑制剂

作用机制

PDE5A抑制剂(磷酸二酯酶-5A抑制剂)

治疗领域

神经系统疾病心血管疾病

在研适应症-

非在研适应症

缺血性卒中

原研机构

Pfizer Inc.

在研机构-

非在研机构

Pfizer Inc.

权益机构-

最高研发阶段终止临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 PF-03049423 相关的临床试验

NCT01208233

/ Terminated临床2期

A Phase 2 Multicenter, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of Pf-03049423 In Subjects With Ischemic Stroke

The purpose of this study is to evaluate the safety and tolerability of PF-03049423 following multiple dose administration to subjects with ischemic stroke. The study will also evaluate the efficacy of PF-03049423, relative to placebo, in subjects with ischemic stroke following 90 days of therapy. The study will also explore the relationship between PF-03049423 concentration and blood pressure.

开始日期2010-12-01

申办/合作机构

Pfizer Inc.

NCT01161069

/ Completed临床1期

A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Parallel Group, Multiple Dose Escalation Study To Evaluate The Safety, Toleration, Pharmacokinetics Of PF-03049423 In Healthy Young Adult Volunteers And Healthy Elderly Volunteers

The purpose this study is to evaluate the safety and toleration of PF-03049423 following multiple dose administration as an oral solution to healthy young adult volunteers and healthy elderly volunteers. The study will also evaluate the pharmacokinetics of PF-03049423 after multiple dose administration to healthy young adult volunteers and healthy elderly volunteers. The study will also explore the relationship between blood pressure (supine and standing) and PF-03049423 concentration.

开始日期2009-08-01

申办/合作机构

Pfizer Inc.

100 项与 PF-03049423 相关的临床结果

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100 项与 PF-03049423 相关的转化医学

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100 项与 PF-03049423 相关的专利（医药）

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2

项与 PF-03049423 相关的文献（医药）

2016-03-01·Journal of Stroke and Cerebrovascular Diseases4区 · 医学

Phosphodiesterase-5 Inhibitor PF-03049423 Effect on Stroke Recovery: A Double-Blind, Placebo-Controlled Randomized Clinical Trial

4区 · 医学

Article

作者: Di Cesare, Franco ; Woodward, Phil ; Bednar, Martin M ; Mancuso, Jessica ; Loudon, Peter T

BACKGROUNDThe therapeutic potential of phosphodiesterase-5 inhibitor PF-03049423 was evaluated in a phase 2, multicenter, randomized, double-blind, placebo-controlled study of subjects with acute ischemic stroke (CLINICAL TRIAL REGISTRATION INFORMATIONhttp://www.clinicaltrials.gov, unique identifier: NCT01208233; http://www.clinicaltrialsregister.eu, EudraCT number: 2010-021414-32).MATERIALS AND METHODSSubjects (N = 70) received PF-03049423 6 mg (or placebo, N = 67) once daily, orally, commencing between 24 and 78 hours of stroke onset, and continuing for 90 days. Postbaseline efficacy assessments were performed on Days 7, 14, 30, 60, and 90. Modified Rankin Scale (mRS), Barthel Index, National Institutes of Health Stroke Scale, Box and Blocks Test, Hand-Grip Strength Test, 10-Meter Walk Test, Repeatable Battery Assessment of Neuropsychological Status Naming and Coding Subtests, Line Cancellation Test, and Recognition Memory Test were administered to evaluate poststroke recovery. The primary endpoint was the mRS responder rate (score 0-2 at Day 90). The study included a planned interim analysis of efficacy data.RESULTSThe primary efficacy analysis using logistic regression showed no statistically significant difference between PF-03049423 6 mg and placebo (responder rate of 42.6% and 46.2%, respectively). Although PF-03049423 showed a satisfactory safety and tolerability profile, no signal of efficacy emerged from any of the outcome measures.CONCLUSIONSPF-03049423 showed no therapeutic potential for acute ischemic stroke.

Innovations in clinical neuroscience

Assessment of Cognitive and Neurologic Recovery in Ischemic Stroke Drug Trials: Results from a Randomized, Double-blind, Placebo-controlled Study.

Article

作者: Silver, Brian ; Di Cesare, Franco ; Mancuso, Jessica ; Loudon, Peter T

Objective. Ischemic stroke is a serious medical condition with limited therapeutic options. The evaluation of the therapeutic potential of novel pharmacological interventions is carried-out in Phase II trials. The study design, primarily intended to evaluate efficacy and safety, is a balance between utilizing as few patients as possible to minimize safety risk and enrolling sufficient patients to detect unambiguous efficacy signals. We sought to determine whether post-stroke recovery outcomes based on behavioral measures of cognitive and motor impairment yielded additional information beyond that of clinician-based methods. Design. This was a multicenter, multinational, randomized, parallel group, controlled versus placebo, efficacy, and safety study of PF-03049423 for treatment of acute ischemic stroke. Settings and participants. Our study subjects were acute ischemic stroke inpatients. Measurements. Outcome measures were derived from rating scales (Modified Rankin Scale, Barthel Index, and National Institutes of Health Stroke Scale) and behavioral tests (Box and Blocks Test, Hand Grip Strength Test, 10-Meter Walk Test, Repeatable Battery Assessment of Neuropsychological Status Naming and Coding Subtests, Line Cancellation Test, and Recognition Memory Test). Assessments were performed at Days 7, 14, 30, 60, and 90. Post-hoc analyses of correlations among the outcome measures at each measurement time point on a cohort of 137 subjects were conducted. Results. Results support the validity of measures from Box and Blocks Test, Hand Grip Strength Test, 10-Meter Walk Test, and Repeatable Battery Assessment of Neuropsychological Status Coding Subtests to monitor post-stroke recovery in clinical trial settings. Notably, the Recognition Memory Test did not show a correlation with the Modified Rankin Scale, and, in fact, did not show improvement over time. Conclusion. The behavioral measures of cognitive and motor functions included in this study may extend the evaluation of the therapeutic potential of new treatments for stroke recovery. The lack of correlation between Recognition Memory Test and the traditional efficacy endpoints, at least in part due to absence of any improvement in recognition memory, suggests that there may be cognitive elements not detected by the Modified Rankin Scale. This is clinically relevant and memory improvement has potential as an endpoint in future trials aiming to improve certain aspects of cognition.

100 项与 PF-03049423 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
缺血性卒中	临床2期	德国	Pfizer Inc.	2010-12-01
缺血性卒中	临床2期	匈牙利	Pfizer Inc.	2010-12-01
缺血性卒中	临床2期	加拿大	Pfizer Inc.	2010-12-01
缺血性卒中	临床2期	美国	Pfizer Inc.	2010-12-01
缺血性卒中	临床2期	韩国	Pfizer Inc.	2010-12-01
缺血性卒中	临床2期	法国	Pfizer Inc.	2010-12-01
缺血性卒中	临床2期	中国台湾	Pfizer Inc.	2010-12-01
缺血性卒中	临床2期	保加利亚	Pfizer Inc.	2010-12-01
缺血性卒中	临床2期	印度	Pfizer Inc.	2010-12-01
缺血性卒中	临床2期	捷克	Pfizer Inc.	2010-12-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01208233 (Pubmed \| J Stroke Cerebrovasc Dis) 人工标引	临床2期	脑卒中	137	PF-03049423	築繭醖廠繭網壓壓網製(構鏇廠艱窪艱繭艱窪齋) = 構鏇衊範觸獵築艱築壓顧餘鬱憲餘齋製艱壓鹹 (願膚艱艱壓遞襯艱膚艱 )	不佳	2016-03-01
				Placebo	築繭醖廠繭網壓壓網製(構鏇廠艱窪艱繭艱窪齋) = 構襯醖餘壓齋鹹鹹憲夢顧餘鬱憲餘齋製艱壓鹹 (願膚艱艱壓遞襯艱膚艱 )
NCT01208233 (CTgov)	临床2期	缺血性卒中	181	PF-03049423 (Cohort 1: PF-03049423 1 mg)	鹽壓網繭製膚鑰願繭鹽(鹽鬱餘鹽夢繭遞繭獵淵) = 願蓋繭鬱襯構憲醖餘獵範簾襯壓壓觸鑰醖糧壓 (繭鏇襯獵廠膚夢網鏇選, 鏇簾積壓鬱鏇鏇繭簾膚 ~ 襯衊獵糧鹽膚選衊選鏇) 更多	-	2016-02-19
				placebo+PF-03049423 (Cohort 1: Placebo)	鹽壓網繭製膚鑰願繭鹽(鹽鬱餘鹽夢繭遞繭獵淵) = 壓獵鑰網糧壓壓醖選壓範簾襯壓壓觸鑰醖糧壓 (繭鏇襯獵廠膚夢網鏇選, 糧網蓋繭選壓廠淵獵構 ~ 範選膚淵觸積蓋襯顧選) 更多