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NCT02637960 Clinical Trial

Efficacy Study of Fedovapagon for Nocturia in Men With Benign Prostatic Hyperplasia (BPH)

Nocturia Clinical Trial

— EQUINOC  

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02637960
Other study ID # 483-013
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date March 2016
Est. completion date August 2017

Study information
Verified date October 2018
Source Vantia Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

Fedovapagon is a selective vasopressin V2 receptor (V2R) agonist that has an antidiuretic effect through stimulation of V2 receptors in the kidney and is being developed for the treatment of nocturia. Nocturia, defined as the complaint that the individual has to wake at night one or more times to void, is a common condition and shows an age-dependent increase in both prevalence and severity (number of nocturnal voids). It has a significant detrimental impact on the quality of life in patients with benign prostatic hyperplasia (BPH).

The purpose of this study is to determine the efficacy and safety of fedovapagon in the treatment of nocturia with BPH.

Recruitment information / eligibility
Status Completed
Enrollment 432
Est. completion date August 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult males =18 years [no upper limit]

- Benign prostatic hyperplasia

- Persistent nocturia despite previous lifestyle modification advice including appropriate fluid management

- Serum sodium not below lower limit of normal prior to randomization

- Provide signed and dated informed consent before any study-specific procedures are conducted.

- Able to comply with the requirements of the study.

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Fedovapagon 2 mg
One daily dose of 2 mg fedovapagon for 12 weeks
• Placebo
One daily dose of placebo (matched to fedovapagon) for 12 weeks

Locations
Country Name City State
United States Vantia Investigative Center Akron Ohio
United States Vantia Investigative Center Albuquerque New Mexico
United States Vantia Investigative Center Anniston Alabama
United States Vantia Investigative Center Aventura Florida
United States Vantia Investigative Center Avon Indiana
United States Vantia Investigative Center Bradenton Florida
United States Vantia Investigative Center Bristol Tennessee
United States Vantia Investigative Center Cary North Carolina
United States Vantia Investigative Center Charleston South Carolina
United States Vantia Investigative Center Clearwater Florida
United States Vantia Investigative Center Clinton Utah
United States Vantia Investigative Center Concord North Carolina
United States Vantia Investigative Center Coral Gables Florida
United States Vantia Investigative Center Dallas Texas
United States Vantia Investigative Center DeLand Florida
United States Vantia Investigative Center Englewood New Jersey
United States Vantia Investigative Center Garden City New York
United States Vantia Investigative Center Goodyear Arizona
United States Vantia Investigative Center Greenbelt Maryland
United States Vantia Investigative Center Greer South Carolina
United States Vantia Investigative Center Hialeah Florida
United States Vantia Investigative Center High Point North Carolina
United States Vantia Investigative Center Houston Texas
United States Vantia Investigative Center Lawrenceville New Jersey
United States Vantia Investigative Center Lincoln California
United States Vantia Investigative Center Miami Florida
United States Vantia Investigative Center Missoula Montana
United States Vantia Investigative Center Mount Pleasant South Carolina
United States Vantia Investigative Center Murrieta California
United States Vantia Investigative Center New York New York
United States Vantia Investigative Center Newburgh New York
United States Vantia Investigative Center Ocala Florida
United States Vantia Investigative Center Ogden Utah
United States Vantia Investigative Center Omaha Nebraska
United States Vantia Investigative Center Pembroke Pines Florida
United States Vantia Investigative Center Poughkeepsie New York
United States Vantia Investigative Center Raleigh North Carolina
United States Vantia Investigative Center Richmond Virginia
United States Vantia Investigative Center Saint Petersburg Florida
United States Vantia Investigative Center Salt Lake City Utah
United States Vantia Investigative Center San Antonio Texas
United States Vantia Investigative Center San Diego California
United States Vantia Investigative Center Tampa Florida
United States Vantia Investigative Center Topeka Kansas
United States Vantia Investigative Center Warwick Rhode Island
United States Vantia Investigative Center Wichita Kansas
United States Vantia Investigative Center Wilmington North Carolina
United States Vantia Investigative Center Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Vantia Ltd

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in the mean number of night-time voids 12 weeks
Primary Change in mean patient reported nocturia bother score 12 weeks
Secondary Change in the mean number of night-time voids 1 week
Secondary Change in the mean number of night-time voids 4 weeks
Secondary Change in mean patient reported nocturia bother score 1 week
Secondary Change in mean patient reported nocturia bother score 4 weeks
Secondary Change in mean night-time urine production, absolute and as a proportion of 24 hour urine production 2 months
Secondary Change in mean functional bladder capacity 2 months
Secondary Change in International Prostate Symptom Score (IPSS) 4 weeks
Secondary Change in International Prostate Symptom Score (IPSS) 12 weeks
Secondary Change in N-QOL Score 4 weeks
Secondary Change in N-QOL Score 12 weeks
Secondary Number and type of Adverse Events 12 weeks
See also
  Status Clinical Trial Phase
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Completed NCT02905682 - Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Female Subjects Phase 3
Completed NCT01520948 - Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease Phase 3
Completed NCT01684800 - Comparative Trial to Investigate the Efficacy and Safety of Desmopressin for the Treatment of Nocturia in Adult Women Phase 2
Completed NCT01694498 - Comparative Trial to Investigate the Efficacy and Safety of Desmopressin for the Treatment of Nocturia in Adult Men Phase 2
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Completed NCT01223937 - Investigation of the Superiority Effect of Desmopressin to Placebo in Terms of Night Voids Reduction in Nocturia Adult Female Patients Phase 3
Withdrawn NCT01018225 - Exploratory Study Evaluating the Effects of Darifenacin on Nocturia, Sleep and Daytime Wakefulness Phase 4
Completed NCT05222477 - Abdominal Muscle Exercises on Nocturia and Sleep Quality in Women With Type 2 Diabetes N/A
Withdrawn NCT02961114 - Use of Autologous Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Symptomatic Benign Prostate Hypertrophy Phase 1/Phase 2
Completed NCT02440841 - Study in Healthy Male Subjects to Evaluate the Effect of Itraconazole and Rifampicin on the PK of Fedovapagon Phase 1
Completed NCT02068560 - The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion N/A
Completed NCT02151253 - Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia Phase 2/Phase 3
Completed NCT01357356 - Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia Phase 2/Phase 3

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