Prostatic HyperplasiaPhase 1NCT00814736

A Randomized, Double-Blinded, Placebo-Controlled, Two-Way Crossover Study to Investigate the Safety and Toleration of Single Dose Sildenafil in Subjects Receiving Chronic UK-369,0031

A Phase 1 study testing UK369,003 and sildenafil in people with Prostatic Hyperplasia and Urinary Bladder, Overactive, run by Pfizer at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate the safety and overall tolerability of co-administration two PDE5 inhibitors UK369,003 and sildenafil Read more about this study

Who is it for?: Ages 40 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Prostatic Hyperplasia, Urinary Bladder, Overactive, Erectile Dysfunction
What is being tested?: UK369,003 and sildenafil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 1 siteSingapore
Study dates: Aug 2008to Sep 2008
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 40 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Healthy male subjects between the ages of 40 and 55 years, inclusive
Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).

Who cannot join

Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Loss of vision in one eye due to non-arteritic ischemic optic neuropathy (NAION) regardless of whether or not this event was temporally associated with the use of a PDE5 inhibitor.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

Pfizer Investigational Site
Singapore, 188770

Other trials in Singapore

About this study

Official title: A Randomized, Double-Blinded, Placebo-Controlled, Two-Way Crossover Study to Investigate The Safety And Toleration Of Single Dose Sildenafil In Subjects Receiving Chronic UK-369,003.

To investigate the safety and overall tolerability of co-administration two PDE5 inhibitors UK369,003 and sildenafil

Conditions: Prostatic Hyperplasia, Urinary Bladder, Overactive, Erectile Dysfunction
Being tested: UK369,003, sildenafil, sildenafil matching placebo
Medical subject headings: Prostatic Hyperplasia, Urinary Bladder, Overactive, Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UK369,003Drug
oral tablet, once a day
sildenafilDrug
Also called viagra
single oral dose on day 14 or day 17
sildenafil matching placeboDrug
single oral dose on day 14 or day 17

Study groups in NCT00814736
Study group	Role	What they receive
UK369,003 + Placebo or sildenafil	Experimental	All subjects will receive 17 days daily dosing of UK-369,003 100 mg MR Subjects will receive single oral doses of the following interactant treatments in a randomized order On Day 14, a single dose of sildenafil-matching placebo or 100 mg sildenafil and on Day 17 a single dose of 100 mg sildenafil or a sildenafil matching placebo Receives: Drug: UK369,003; Drug: sildenafil; Drug: sildenafil matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and toleration assessed by non-leading questioning, incidence of adverse events and laboratory testing.
Measured: hours

Secondary outcomes (3)

Incidence of postural hypotension.
Measured: hours
Standing and supine pulse rate (PR) at each postdose time.
Measured: hours
Standing systolic and diastolic blood pressure (BP) and supine systolic and diastolic BP at each postdose time.
Measured: hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Sep 2008

First posted25 Dec 2008 (estimated)
Study startAug 2008
Primary completionSep 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00814736
Sponsor's protocol ID: A3711051
Status last verified: Dec 2008
First submitted: 3 Nov 2008
Last updated: 25 Dec 2008
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Comparing Rezum and Urolift
Benign Prostatic Hyperplasia
Recruiting
Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
BPH (Benign Prostatic Hyperplasia)
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Not yet recruitingPhase 3
Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. (BENIPRO)
Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms

All Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blinded, Placebo-Controlled, Two-Way Crossover Study to Investigate The Safety And Toleration Of Single Dose Sildenafil In Subjects Receiving Chronic UK-369,003.
ClinicalTrials.gov ID: NCT00814736
Acronym / sponsor ID: A3711051
Conditions: Prostatic Hyperplasia, Urinary Bladder, Overactive, Erectile Dysfunction
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 25 Dec 2008 (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.

To investigate the safety and overall tolerability of co-administration two PDE5 inhibitors UK369,003 and sildenafil

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 1

Arm	Type	Receives
UK369,003 + Placebo or sildenafil	Experimental	Drug: UK369,003, Drug: sildenafil, Drug: sildenafil matching placeboAll subjects will receive 17 days daily dosing of UK-369,003 100 mg MR Subjects will receive single oral doses of the following interactant treatments in a randomized order On Day 14, a single dose of sildenafil-matching placebo or 100 mg sildenafil and on Day 17 a single dose of 100 mg sildenafil or a sildenafil matching placebo

Who may qualify

Ages: 40 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Healthy male subjects between the ages of 40 and 55 years, inclusive
Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).

Key exclusion criteria (2 listed)

Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Loss of vision in one eye due to non-arteritic ischemic optic neuropathy (NAION) regardless of whether or not this event was temporally associated with the use of a PDE5 inhibitor.

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
UK369,003oral tablet, once a day	Drug	UK369,003 + Placebo or sildenafil
sildenafilAlso: viagrasingle oral dose on day 14 or day 17	Drug	UK369,003 + Placebo or sildenafil
sildenafil matching placebosingle oral dose on day 14 or day 17	Drug	UK369,003 + Placebo or sildenafil

Primary outcome

Safety and toleration assessed by non-leading questioning, incidence of adverse events and laboratory testing.
Time frame: hours

3 secondary outcomes

Incidence of postural hypotension.
Time frame: hours
Standing and supine pulse rate (PR) at each postdose time.
Time frame: hours
Standing systolic and diastolic blood pressure (BP) and supine systolic and diastolic BP at each postdose time.
Time frame: hours

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 Dec 2008.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Prostatic Hyperplasia

Recruiting
Comparing Rezum and Urolift
Benign Prostatic Hyperplasia
Recruiting
Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
BPH (Benign Prostatic Hyperplasia)
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Not yet recruitingPhase 3
Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. (BENIPRO)
Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms

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.

Pfizer CT.gov Call Center study director

Pfizer

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 UK369,003 and sildenafil in people with Prostatic Hyperplasia and Urinary Bladder, Overactive, run by Pfizer at 1 site in Singapore.

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 3 inclusion and 2 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 Dec 2008. 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 Singapore. 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. 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?

Safety and toleration assessed by non-leading questioning, incidence of adverse events and laboratory testing. (time frame: hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00814736.

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 Dec 2008.