Dose Range Finding Study of Fedovapagon in Men With Nocturia

June 18, 2014 updated by: Vantia Ltd

A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Dose Range Finding Study To Determine The Efficacy And Safety Of Fedovapagon In Men With Nocturia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
358

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Vantia Investigative Center
      • Huntsville, Alabama, United States
        • Vantia Investigative Center
      • Mobile, Alabama, United States
        • Vantia Investigative Center
    • Arizona
      • Glendale, Arizona, United States
        • Vantia Investigative Center
      • Tucson, Arizona, United States
        • Vantia Investigative Center
    • California
      • Anaheim, California, United States
        • Vantia Investigative Center
      • Long Beach, California, United States
        • Vantia Investigative Center
      • San Diego, California, United States
        • Vantia Investigative Center
    • Colorado
      • Denver, Colorado, United States
        • Vantia Investigative Center
      • Englewood, Colorado, United States
        • Vantia Investigative Center
    • Connecticut
      • Milford, Connecticut, United States
        • Vantia Investigative Center
    • Florida
      • Aventura, Florida, United States
        • Vantia Investigative Center
      • Clearwater, Florida, United States
        • Vantia Investigative Center
      • Daytona Beach, Florida, United States
        • Vantia Investigative Center
      • DeLand, Florida, United States
        • Vantia Investigative Center
      • Naples, Florida, United States
        • Vantia Investigative Center
      • Ocala, Florida, United States
        • Vantia Investigative Center
      • St. Petersburg, Florida, United States
        • Vantia Investigative Center
      • Tampa, Florida, United States
        • Vantia Investigative Center
    • Idaho
      • Coeur d'Alene, Idaho, United States
        • Vantia Investigative Center
      • Meridian, Idaho, United States
        • Vantia Investigative Center
    • Illinois
      • Chicago, Illinois, United States
        • Vantia Investigative Center
    • Indiana
      • Evansville, Indiana, United States
        • Vantia Investigative Center
      • Jeffersonville, Indiana, United States
        • Vantia Investigative Center
    • Kentucky
      • Paducah, Kentucky, United States
        • Vantia Investigative Center
    • Louisiana
      • Metairie, Louisiana, United States
        • Vantia Investigative Center
    • Maryland
      • Greenbelt, Maryland, United States
        • Vantia Investigative Center
    • Michigan
      • Rochester, Michigan, United States
        • Vantia Investigative Center
    • Minnesota
      • Edina, Minnesota, United States
        • Vantia Investigative Center
    • Nebraska
      • Omaha, Nebraska, United States
        • Vantia Investigative Center
    • New Jersey
      • Brick, New Jersey, United States
        • Vantia Investigative Center
      • Englewood, New Jersey, United States
        • Vantia Investigative Center
      • Lawrenceville, New Jersey, United States
        • Vantia Investigative Center
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Vantia Investigative Center
    • New York
      • Brooklyn, New York, United States
        • Vantia Investigative Center
      • Endwell, New York, United States
        • Vantia Investigative Center
      • Garden City, New York, United States
        • Vantia Investigative Center
      • New York, New York, United States
        • Vantia Investigative Center
      • Poughkeepsie, New York, United States
        • Vantia Investigative Center
    • North Carolina
      • Concord, North Carolina, United States
        • Vantia Investigative Center
      • Raleigh, North Carolina, United States
        • Vantia Investigative Center
      • Winston Salem, North Carolina, United States
        • Vantia Investigative Center
    • Ohio
      • Cincinnati, Ohio, United States
        • Vantia Investigative Center
    • Oklahoma
      • Bethany, Oklahoma, United States
        • Vantia Investigative Center
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States
        • Vantia Investigative Center
    • Rhode Island
      • Warwick, Rhode Island, United States
        • Vantia Investigative Center
    • South Carolina
      • Mytrle Beach, South Carolina, United States
        • Vantia Investigative Center
    • South Dakota
      • Dakota Dunes, South Dakota, United States
        • Vantia Investigative Center
    • Tennessee
      • Nashville, Tennessee, United States
        • Vantia Investigative Center
    • Texas
      • Dallas, Texas, United States
        • Vantia Investigative Center
      • Fort Worth, Texas, United States
        • Vantia Investigative Center
      • San Antonio, Texas, United States
        • Vantia Investigative Center
    • Virginia
      • Richmond, Virginia, United States
        • Vantia Investigative Center
      • Virginia Beach, Virginia, United States
        • Vantia Investigative Center
    • Washington
      • Burien, Washington, United States
        • Vantia Investigative Center
    • Wisconsin
      • Middleton, Wisconsin, United States
        • Vantia Investigative Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: fedovapagon 1 mg
Once daily oral dose of 1 mg fedovapagon for 12 weeks
Drug: fedovapagon 1 mg
Experimental: fedovapagon 2 mg
Once daily oral dose of 2 mg fedovapagon for 12 weeks
Drug: fedovapagon 2 mg
Experimental: fedovapagon 4 mg
Once daily oral dose of 4 mg fedovapagon for 12 weeks
Drug: fedovapagon 4 mg
Placebo Comparator: sugar pill
Once daily oral dose of placebo for 12 weeks
Drug: Placebo ( sugar pill)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in the mean nocturnal urine voids
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in the mean nocturnal urine voids
Time Frame: 4 weeks
4 weeks
Change in the mean time to first nocturnal void
Time Frame: 4 weeks
4 weeks
Change in the mean time to first nocturnal void
Time Frame: 12 weeks
12 weeks
Change in Nocturia-related quality of life (N-QOL)
Time Frame: 4 weeks
4 weeks
Change in Nocturia-related quality of life (N-QOL)
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vantia Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hilary McElwaine-Johnn, BSc, ASM, MBBS, MRCP, MFPM, Vantia Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 483-009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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