Status:
COMPLETED
VA106483 and Alpha Blocker Interaction Study in Elderly Males
Lead Sponsor:
Vantia Ltd
Conditions:
Nocturia
Eligibility:
MALE
65+ years
Phase:
PHASE1
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.
Detailed Description
VA106483 is intended to be used as a treatment for patients suffering from nocturia (defined as waking to urinate at least once per night between periods of sleep). Nocturia is a condition that often ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00879216
Start Date
April 1 2009
End Date
July 1 2009
Last Update
November 25 2009
Active Locations (1)
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1
Charles River Clinical Services
Edinburgh, United Kingdom, EH12 1DF