Dose Range Finding Study of Fedovapagon in Men With Nocturia | NCT01656239

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Jul 31, 2012

First Submission Date that Met QC Criteria

Aug 1, 2012

First Posted Date

Aug 2, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jun 18, 2014

Certification/Extension First Submitted that Passed QC Review

Jun 18, 2014

Certification/Extension First Posted Date

Jun 20, 2014Estimated

Last Update Submitted Date

Jun 18, 2014

Last Update Posted Date

Jun 20, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the dose level(s) of fedovapagon which result in a decrease in the mean nocturnal void frequency.

Detailed Description

Fedovapagon is a selective vasopressin V2 receptor (V2 receptor) agonist that is being developed for the treatment of Nocturia.

The antidiuretic effect of V2 receptor stimulation in the kidneys is well established through the use of the peptide agonist, desmopressin, which shows clinical benefit in diabetes insipidus, primary nocturnal enuresis and Nocturia.

Nocturia, defined as the complaint that the individual has to wake at night one or more times to void, is a common complaint and shows an age-dependent increase in both prevalence and severity (number of Nocturnal Voids). It is the most bothersome symptom of benign prostatic hypertrophy (BPH) and has been linked to an age-dependent loss in circadian release of endogenous nocturnal vasopressin and consequent over production of urine at night (Nocturnal Polyuria).

The purpose of this Phase IIb study is to determine the efficacy of different doses of fedovapagon in reducing the number of times subjects with Nocturia void during the night together with other parameters including increasing the time between going to bed and waking to first void. By establishing the effective doses of fedovapagon on these clinical endpoints, the data from this study will determine the most appropriate dose(s) of fedovapagon for the treatment of Nocturia to be taken forward into further studies.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

358Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fedovapagon 1 mg	Experimental	Once daily oral dose of 1 mg fedovapagon for 12 weeks	Drug: fedovapagon 1 mg
fedovapagon 2 mg	Experimental	Once daily oral dose of 2 mg fedovapagon for 12 weeks	Drug: fedovapagon 2 mg
fedovapagon 4 mg	Experimental	Once daily oral dose of 4 mg fedovapagon for 12 weeks	Drug: fedovapagon 4 mg
sugar pill	Placebo Comparator	Once daily oral dose of placebo for 12 weeks	Drug: Placebo ( sugar pill)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fedovapagon 1 mg	Drug		fedovapagon 1 mg
fedovapagon 2 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the mean nocturnal urine voids		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in the mean nocturnal urine voids		4 weeks
Change in the mean time to first nocturnal void		4 weeks
Change in the mean time to first nocturnal void

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males aged 55 or over
History and/ or symptoms of Nocturia (2 - 5 voids per night)
Generally well (concomitant illness / conditions well controlled)
Serum sodium, potassium, chloride and bicarbonate within normal limits
No clinically significant abnormalities in other laboratory parameters, urinalysis, electrocardiogram (ECG) or physical examination
Prostate specific antigen (PSA) within the normal range or not considered clinically significant
Ability to comply with the requirements of the study
Written informed consent.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hilary McElwaine-Johnn, BSc, ASM, MBBS, MRCP, MFPM	Vantia Ltd	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vantia Investigative Center		Birmingham	Alabama		United States
Vantia Investigative Center

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D059411	Lower Urinary Tract Symptoms
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms