Efficacy and Safety of VA106483 in Elderly Males

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A double blind, placebo-controlled, dose ranging study in males over the age of 65, who have a history of nocturia. The study will investigate pharmacodynamic outcomes (urine volumes and osmolality, circulating coagulation factors and haemodynamics) and pharmacokinetics, of both single and multiple oral doses of VA106483 at three dose levels, under conditions of controlled hydration.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy Study of VA106483 in Males With Nocturia.

NCT01038843

Nocturia

COMPLETED PHASE2

VA106483 Dose Response Study in Elderly Males

NCT00922740

Nocturia

COMPLETED PHASE1

VA106483 and Alpha Blocker Interaction Study in Elderly Males

NCT00879216

Nocturia

COMPLETED PHASE1

Dose Response Study of VA106483 in Males With Nocturia and Benign Prostatic Hypertrophy (BPH)

NCT01330927

Nocturia Benign Prostatic Hypertrophy (BPH)

COMPLETED PHASE1

VA106483 Dose Response in Females

NCT01171391

Nocturia

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

VA106483 is a selective vasopressin V2 receptor agonist which is currently under development for the treatment of nocturia in males. This study examines the pharmacological action of VA106483 on markers of clinical efficacy (urine volumes and osmolality) and safety markers (coagulation factors and haemodynamics). The study will also assess the pharmacokinetics in the study population. The study design includes both cross-over and parallel phases so that pharmacodynamic and pharmacokinetic parameters can be assessed following both single and repeat dosing. Three dose levels will be given.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nocturia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sugar pill

Group Type PLACEBO_COMPARATOR

Sugar pill

Intervention Type DRUG

VA106483 2 mg

Group Type EXPERIMENTAL

VA106483

Intervention Type DRUG

VA106483 4 mg

Group Type EXPERIMENTAL

VA106483

Intervention Type DRUG

VA106483 8 mg

Group Type EXPERIMENTAL

VA106483

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VA106483

Intervention Type DRUG

Sugar pill

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Males 65 years and above with history of nocturia

Exclusion Criteria

* Any clinically significant concomitant medical disease, condition or abnormal laboratory test result
* Participation in any other clinical study within 30 days
* Intake of non-prescription medication within 14 days

Minimum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No