A Randomised, Double-blind, Placebo-controlled, Multi-centre Study to Investigate the Efficacy and Safety of Fedovapagon in the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia (BPH) (EQUINOC Study)

This study will investigate the efficacy and safety of fedovapagon in the treatment of nocturia in men with BPH.

开始日期2016-03-01

申办/合作机构

Vantia Ltd.

NCT02537288 / Completed临床1期

A Phase I Single Centre, Randomized, Double Blind (Except For Moxifloxacin), Placebo And Active Controlled, Four Way Cross Over Study Investigating The Effect Of Single Therapeutic And Supra Therapeutic Doses Of Fedovapagon On The QT/QTC Interval In Healthy Volunteers Using Oral Moxifloxacin To Confirm Assay Sensitivity

The purpose of this study is to assess the electrocardiogram (ECG) effects of fedovapagon dose administration relative to placebo in healthy adult male and female subjects.

开始日期2015-10-01

申办/合作机构

Vantia Ltd.

NCT02440841 / Completed临床1期

Single Center, Open-Label, Single-Sequence, Within-Subject Study In Two Cohorts Of Healthy Male Subjects Comparing Single-Dose Pharmacokinetics Of Fedovapagon Alone And In Combination With A CYP3A4 Inhibitor, Itraconazole, Or A CYP3A4 Inducer, Rifampicin

The purpose of this study is to investigate the potential for co-administration of strong inhibitors or inducers of CYP3A4 to alter the pharmacokinetics of fedovapagon.

开始日期2015-05-01

申办/合作机构

Vantia Ltd.

100 项与 Fedovapagon 相关的临床结果

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100 项与 Fedovapagon 相关的转化医学

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100 项与 Fedovapagon 相关的专利（医药）

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项与 Fedovapagon 相关的文献（医药）

2018-01-01·European Urology Focus2区 · 医学

Lower Urinary Tract Symptoms: What’s New in Medical Treatment?

2区 · 医学

Review

作者: Michel, Martin C ; Peyronnet, Benoit ; Brucker, Benjamin M

CONTEXTPharmacological treatment is a cornerstone in the management of patients with lower urinary tract symptoms (LUTS).OBJECTIVETo review emerging evidence in the medical treatment of LUTS.EVIDENCE ACQUISITIONAn Embase/Pubmed-based literature search was conducted in December 2017, screening for randomized controlled trials (RCTs), prospective and retrospective series, animal model studies, and reviews on medical treatment of LUTS.EVIDENCE SYNTHESISThe main medical innovation in recent years in overactive bladder (OAB) has been the approval of the first β₃-adrenoceptor agonists (mirabegron) and intradetrusor onabotulinum toxin A, while several other drugs such as antiepileptics, phosphodiesterase inhibitors, or other β₃-agonists have brought promising results in phase 3 trials. Intraprostatic injections of various drugs for LUTS/benign prostatic hyperplasia have been investigated, but results of phase 3 trials are still pending, while combination therapies of phosphodiesterase type 5 inhibitors+α-blockers or finasteride have been proved as superior to single therapies in RCTs conducted in these patients. Two new formulations of desmopressin have been approved for nocturia in the USA (desmopressin nasal spray) and Europe/Canada/Australia (desmopressin orally disintegrated tablet). Fedovapagon, a vasopressin V₂ receptor agonist, has recently completed a large phase 3 trial in male patients with nocturia. Other phase 3 trials are ongoing in bladder pain syndrome (AQX 11-25, a SHIP-1 activator) and in neurogenic detrusor overactivity (mirabegron and abobotulinum toxin A).CONCLUSIONSMedical treatment of LUTS is a very active research field with recently approved drugs for nocturia (desmopressin acetate nasal spray/orally disintegrated tablet) and numerous emerging drugs currently investigated in OAB, LUTS/benign prostatic hyperplasia, nocturia, bladder pain syndrome, and neurogenic detrusor overactivity.PATIENT SUMMARYMedical treatment of lower urinary tract symptoms is a very active research field with recently approved drugs for nocturia (desmopressin acetate nasal spray/orally disintegrated tablet) and numerous emerging drugs in overactive bladder, nocturia, neurogenic detrusor overactivity, bladder pain syndrome, or benign prostatic hyperplasia.

100 项与 Fedovapagon 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB11734

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
夜尿	临床3期	-	Ferring BV	-
夜尿	临床3期	-	Vantia Ltd.	-
前列腺增生症	临床1期	美国	Vantia Ltd.	2016-03-01

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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


2270 (AUA2013)	N/A	多尿	-	0.5 mg fedovapagon	鑰觸餘觸蓋艱艱膚構膚(鹽遞顧簾夢鏇選鹹鑰夢) = 衊範齋製鏇鬱觸積繭夢壓糧夢積顧齋齋遞齋製 (齋顧構襯膚膚網積鹹壓 )	-	2013-04-01
				4 mg fedovapagon	鑰觸餘觸蓋艱艱膚構膚(鹽遞顧簾夢鏇選鹹鑰夢) = 夢艱製鬱簾糧積膚鑰鹽壓糧夢積顧齋齋遞齋製 (齋顧構襯膚膚網積鹹壓 )