NCT00879216

Brief Summary

The main purpose of this study is to investigate whether the hypotensive effects of an alpha-blocker are increased when VA106483 is given at the same time.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2009

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

Enrollment Period

1 month

First QC Date

April 8, 2009

Last Update Submit

November 24, 2009

Conditions

Nocturia

Keywords

NocturiaHyptotensionElderlyMales

Outcome Measures

Primary Outcomes (1)

  • Blood pressure, Heart rate

    For 8 hours after dosing

Study Arms (2)

Sugar pill

PLACEBO COMPARATOR
Drug: Placebo

VA106483

EXPERIMENTAL
Drug: VA106483

Interventions

VA106483DRUG

4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.

VA106483
PlaceboDRUG

4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.

Sugar pill

Eligibility Criteria

Age65 Years+
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Male aged 65 years of age and above
  • No clinically important abnormal physical, laboratory or vital sign findings in the opinion of the Investigator
  • Provision of written informed consent to participate
  • No recent alpha-blocker therapy
  • Not taking any concomitant medication known to be a cytochrome 3A4 inhibitor
  • Not taking any prescribed or over the counter medications unless agreed with the Investigator and Sponsor
  • No evidence of serious pathology or disease including poorly controlled endocrine disorders; active liver or biliary disease or severe kidney problems; syndrome of inappropriate antidiuretic hormone secretion
  • No history of orthostatic hypotension or syncope.
  • No known hypersensitivity to the IMP or alpha blocker, including severe lactose intolerance.
  • No history of drug or alcohol abuse
  • Negative for HIV, hepatitis B or C

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles River Clinical Services

Edinburgh, EH12 1DF, United Kingdom

Location

MeSH Terms

Conditions

Nocturia

Condition Hierarchy (Ancestors)

Lower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Director

    Charles River Clinical Services, Edinburgh, UK

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 8, 2009

First Posted

April 9, 2009

Study Start

April 1, 2009

Primary Completion

May 1, 2009

Study Completion

July 1, 2009

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations

GB(1)