NocturiaPhase 1NCT00879216
VA106483 and Alpha Blocker Interaction Study in Elderly Males
A Phase 1 study testing VA106483 in people with Nocturia, run by Vantia Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nocturia
- What is being tested?
- VA106483
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2009to Jul 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Charles River Clinical Services
Edinburgh, EH12 1DF
About this study
Official title: A Single Centre, Double-blind, Placebo Controlled Crossover Study in Elderly Male Subjects to Investigate the Plarmacodynamic Interaction of VA106483 Administered Concomitanctly With Alpha-blocker Therapy
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.
Read the 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 worsens as sufferers get older. This may be due to an over-active bladder muscle, the bladder being able to hold less urine at night-time or over production of urine in the bladder at night. Some of the treatments available for nocturia have side-effects which make them unsuitable for elderly patients. These side-effects have not been seen in studies with VA106483, which makes it potentially suitable for treating elderly patients.
Nocturia is commonly associated with Benign Prostatic Hypertrophy (or BPH, a non-cancerous enlargement of the prostate gland, which often results in problems passing water). Of the patients who suffer from BPH, an estimated 40-85% experience the symptoms of waking at night to pass water.
Treatments which are commonly prescribed for BPH include alpha-blockers which work by improving urine flow by a muscle relaxant effect. Alpha-blockers are known to cause hypotension (lowering of blood pressure which can cause dizziness in some patients) . Since it is likely that subjects may be co-prescribed VA106483 and alpha-blockers, the purpose of this study is to determine that giving VA106483 does not increase the hypotensive effects of alpha-blockers
- Conditions
- Nocturia
- Being tested
- VA106483, Placebo
- Keywords
- Nocturia, Hyptotension, Elderly, Males
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA106483Drug
4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.
PlaceboDrug
4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | Not described Receives: Drug: Placebo |
| VA106483 | Experimental | Not described Receives: Drug: VA106483 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure, Heart rate
Measured: For 8 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study director, Charles River Clinical Services, Edinburgh, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879216
- Sponsor's protocol ID
- 483-003
- Status last verified
- Nov 2009
- First submitted
- 8 Apr 2009
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Double-blind, Placebo Controlled Crossover Study in Elderly Male Subjects to Investigate the Plarmacodynamic Interaction of VA106483 Administered Concomitanctly With Alpha-blocker Therapy
- ClinicalTrials.gov ID
- NCT00879216
- Acronym / sponsor ID
- 483-003
- Conditions
- Nocturia
- Keywords
- Nocturia, Hyptotension, Elderly, Males
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vantia LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 9 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 worsens as sufferers get older. This may be due to an over-active bladder muscle, the bladder being able to hold less urine at night-time or over production of urine in the bladder at night. Some of the treatments available for nocturia have side-effects which make them unsuitable for elderly patients. These side-effects have not been seen in studies with VA106483, which makes it potentially suitable for treating elderly patients.
Nocturia is commonly associated with Benign Prostatic Hypertrophy (or BPH, a non-cancerous enlargement of the prostate gland, which often results in problems passing water). Of the patients who suffer from BPH, an estimated 40-85% experience the symptoms of waking at night to pass water.
Treatments which are commonly prescribed for BPH include alpha-blockers which work by improving urine flow by a muscle relaxant effect. Alpha-blockers are known to cause hypotension (lowering of blood pressure which can cause dizziness in some patients) . Since it is likely that subjects may be co-prescribed VA106483 and alpha-blockers, the purpose of this study is to determine that giving VA106483 does not increase the hypotensive effects of alpha-blockers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | Drug: Placebo |
| VA106483 | Experimental | Drug: VA106483 |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VA1064834 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day. | Drug | VA106483 |
| Placebo4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day. | Drug | Sugar pill |
Primary outcome
Blood pressure, Heart rate
Time frame: For 8 hours after dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Charles River Clinical Services, Edinburgh, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VA106483 in people with Nocturia, run by Vantia Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure, Heart rate (time frame: For 8 hours after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2009.