Prostatic HyperplasiaPhase 2NCT00457457
Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms.
A Phase 2 study testing Tamsulosin and UK-369,003 in people with Prostatic Hyperplasia, run by Pfizer at 46 sites in 15 countries.
Trial summary
This is a 12 week study in which different doses and formulations of UK-369,003 will be administered to patients with a diagnosis of enlarged prostate. Patients will complete a series of questionnaires before, during and after treatment to assess if UK-369,003 has improved their urinary symptoms and erectile function… Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Tamsulosin and UK-369,003
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 609 participants
- Where
- 46 sitesin 15 countries
- Study dates
- May 2007to Apr 2008
- Phase
- Phase 2
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subjects aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13
- Clinical diagnosis of BPH.
- Qmax 5 to 15ml/sec with a voided volume of ≥150ml at visit 1 (screening).
Who cannot join
- Urinary tract infection
- Primary neurological conditions affecting bladder function
Trial locations and contacts
46 sites in 15 countries.
46 sites in 15 countries
Poland6 sites
Pfizer Investigational Site
Bydgoszcz, 85-092
Pfizer Investigational Site
Bydgoszcz, 85-168
Pfizer Investigational Site
Gdansk, 80-402
Pfizer Investigational Site
Gdynia, 81-393
Pfizer Investigational Site
Mysłowice, 41-400
Pfizer Investigational Site
Wejherowo, 84-200
Colombia5 sites
Pfizer Investigational Site
Barranquilla, Atlántico, 0
Pfizer Investigational Site
Bogota, Cundinamarca, 0
Pfizer Investigational Site
Bogota, Cundinamarca
Pfizer Investigational Site
Cali, Valle del Cauca Department, 0
Pfizer Investigational Site
Medellín, Antioquia, 0
Slovakia5 sites
Pfizer Investigational Site
Bratislava, 851 01
Pfizer Investigational Site
Malacky, 901 01
Pfizer Investigational Site
Nitra, 949 01
Pfizer Investigational Site
Prešov, 080 01
Pfizer Investigational Site
Skalica, 909 82
Finland4 sites
Pfizer Investigational Site
Helsinki, 00100
Pfizer Investigational Site
Kuopio, 70100
Pfizer Investigational Site
Oulu, 90100
Pfizer Investigational Site
Tampere, 33100
Belgium3 sites
Pfizer Investigational Site
Brussels, B-1090
Pfizer Investigational Site
Brussels
Pfizer Investigational Site
Edegem, B-2650
Canada3 sites
Pfizer Investigational Site
Calgary, Alberta, T2V 4R6
Pfizer Investigational Site
London, Ontario, N6A 4V2
Pfizer Investigational Site
Pointe-Claire, Quebec, H9R 4S3
Denmark3 sites
Pfizer Investigational Site
Aalborg, 9100
Pfizer Investigational Site
Aarhus N, 8200
Pfizer Investigational Site
Gentofte Municipality, 2820
Greece3 sites
Pfizer Investigational Site
Larissa, 41110
Pfizer Investigational Site
Rio, 26500
Pfizer Investigational Site
Thessaloniki, 56403
Lithuania3 sites
Pfizer Investigational Site
Kaunas, 47144
Pfizer Investigational Site
Kaunas, 50009
Pfizer Investigational Site
Vilnius, 08661
Spain3 sites
Pfizer Investigational Site
Madrid, 28035
Pfizer Investigational Site
Málaga, 29010
Pfizer Investigational Site
Valencia, 46010
Australia2 sites
Pfizer Investigational Site
Adelaide, South Australia, 5000
Pfizer Investigational Site
Herston, Queensland
Chile2 sites
Pfizer Investigational Site
Santiago
Pfizer Investigational Site
Temuco, Araucania, 4810371
Italy2 sites
Pfizer Investigational Site
Foggia, 71100
Pfizer Investigational Site
Siena, 53100
About this study
Official title: A Multi-center, Randomized, Parallel Group, Double-blind, Placebo Controlled Proof of Concept and Dose Ranging Study With an Active Control to Assess the Efficacy and Safety/Tolerability of UK-369,003 Immediate Release (IR) and Modified Release (MR) in the Treatment of Men With Lower Urinary Tract Symptoms (LUTS) With and Without Erectile Dysfunction (ED)
This is a 12 week study in which different doses and formulations of UK-369,003 will be administered to patients with a diagnosis of enlarged prostate. Patients will complete a series of questionnaires before, during and after treatment to assess if UK-369,003 has improved their urinary symptoms and erectile function . There will be several blood samples taken during the study to asses the level of drug in the blood and correlate it with the responses to the questionnaires.
- Conditions
- Prostatic Hyperplasia
- Being tested
- Tamsulosin, UK-369,003
- Keywords
- With or without erectile dysfunction
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Tamsulosin hydrochloride capsules, 0.4 mg. Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate
UK-369,003Drug
UK 369,003 is a highly selective and potent inhibitor of PDE5. It has increased selectivity for PDE5 over PDE6 (>80 fold) compared to sildenafil (~10 fold). Two recently completed trials have shown efficacy for UK-369,003 in treating subjects with ED
| Study group | Role | What they receive |
|---|---|---|
| Comparator | Active comparator | Tamsulosin 0.4 mg prolonged release Receives: Drug: Tamsulosin |
| Treatment Arm | Experimental | There are 5 possible UK-369,003 arms as follows: UK-369,003 MR (10mg, 25mg, 50mg \& 100mg), UK-369,003 IR (40mg), Receives: Drug: UK-369,003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in international prostate symptom score
Measured: 12 weeks
Secondary outcomes (5)
Erectile Function (EF) domain of International Index of Erectile
Measured: 12 weeks
Function (IIEF)
Measured: 12 weeks
Qmax
Measured: 12 weeks
Quality of Erection questionnaire (QEQ)
Measured: 12 weeks
Population pharmacokinetics
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionApr 2008
- Study completionApr 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 609 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457457
- Sponsor's protocol ID
- A3711044
- Status last verified
- Dec 2018
- First submitted
- 5 Apr 2007
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Parallel Group, Double-blind, Placebo Controlled Proof of Concept and Dose Ranging Study With an Active Control to Assess the Efficacy and Safety/Tolerability of UK-369,003 Immediate Release (IR) and Modified Release (MR) in the Treatment of Men With Lower Urinary Tract Symptoms (LUTS) With and Without Erectile Dysfunction (ED)
- ClinicalTrials.gov ID
- NCT00457457
- Acronym / sponsor ID
- A3711044
- Conditions
- Prostatic Hyperplasia
- Keywords
- With or without erectile dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 609 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 6 Apr 2007 (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.
This is a 12 week study in which different doses and formulations of UK-369,003 will be administered to patients with a diagnosis of enlarged prostate. Patients will complete a series of questionnaires before, during and after treatment to assess if UK-369,003 has improved their urinary symptoms and erectile function . There will be several blood samples taken during the study to asses the level of drug in the blood and correlate it with the responses to the questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparator | Active comparator | Drug: TamsulosinTamsulosin 0.4 mg prolonged release |
| Treatment Arm | Experimental | Drug: UK-369,003There are 5 possible UK-369,003 arms as follows: UK-369,003 MR (10mg, 25mg, 50mg \& 100mg), UK-369,003 IR (40mg), |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male subjects aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13
- Clinical diagnosis of BPH.
- Qmax 5 to 15ml/sec with a voided volume of ≥150ml at visit 1 (screening).
Key exclusion criteria (2 listed)
- Urinary tract infection
- Primary neurological conditions affecting bladder function
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 |
|---|---|---|
| TamsulosinTamsulosin hydrochloride capsules, 0.4 mg. Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate | Drug | Comparator |
| UK-369,003UK 369,003 is a highly selective and potent inhibitor of PDE5. It has increased selectivity for PDE5 over PDE6 (>80 fold) compared to sildenafil (~10 fold). Two recently completed trials have shown efficacy for UK-369,003 in treating subjects with ED | Drug | Treatment Arm |
Primary outcome
Change in international prostate symptom score
Time frame: 12 weeks
5 secondary outcomes
Erectile Function (EF) domain of International Index of Erectile
Time frame: 12 weeks
Function (IIEF)
Time frame: 12 weeks
Qmax
Time frame: 12 weeks
Quality of Erection questionnaire (QEQ)
Time frame: 12 weeks
Population pharmacokinetics
Time frame: 12 weeks
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 19 Dec 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
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Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
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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.
Pfizer CT.gov Call Center study director
Pfizer
46 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamsulosin and UK-369,003 in people with Prostatic Hyperplasia, run by Pfizer at 46 sites in 15 countries.
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 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Poland, Colombia, Slovakia, Finland, Belgium and 10 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in international prostate symptom score (time frame: 12 weeks). 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 19 Dec 2018.