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Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms.

NCT ID: NCT00457457

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

609 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostatic Hyperplasia

Keywords

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With or without erectile dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Comparator

Tamsulosin 0.4 mg prolonged release

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

Tamsulosin hydrochloride capsules, 0.4 mg. Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate

Treatment Arm

There are 5 possible UK-369,003 arms as follows: UK-369,003 MR (10mg, 25mg, 50mg \& 100mg), UK-369,003 IR (40mg),

Group Type EXPERIMENTAL

UK-369,003

Intervention Type DRUG

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

Interventions

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Tamsulosin

Tamsulosin hydrochloride capsules, 0.4 mg. Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate

Intervention Type DRUG

UK-369,003

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male subjects aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13
2. Clinical diagnosis of BPH.
3. Qmax 5 to 15ml/sec with a voided volume of ≥150ml at visit 1 (screening).

Exclusion Criteria

1. Urinary tract infection
2. Primary neurological conditions affecting bladder function
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Herston, Queensland, Australia

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Adelaide, South Australia, Australia

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Brussels, , Belgium

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Brussels, , Belgium

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Edegem, , Belgium

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Calgary, Alberta, Canada

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London, Ontario, Canada

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Pointe-Claire, Quebec, Canada

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Temuco, Región de la Araucanía, Chile

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Santiago, , Chile

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Medellín, Antioquia, Colombia

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Barranquilla, Atlántico, Colombia

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Bogota, Cundinamarca, Colombia

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Bogota, Cundinamarca, Colombia

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Cali, Valle del Cauca Department, Colombia

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Aalborg, , Denmark

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Aarhus N, , Denmark

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Gentofte Municipality, , Denmark

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Helsinki, , Finland

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Kuopio, , Finland

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Oulu, , Finland

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Tampere, , Finland

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Larissa, , Greece

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Rio, , Greece

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Thessaloniki, , Greece

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Foggia, , Italy

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Siena, , Italy

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Riga, , Latvia

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Kaunas, , Lithuania

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Kaunas, , Lithuania

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Vilnius, , Lithuania

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Bydgoszcz, , Poland

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Bydgoszcz, , Poland

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Gdansk, , Poland

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Gdynia, , Poland

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Mysłowice, , Poland

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Wejherowo, , Poland

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Bratislava, , Slovakia

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Malacky, , Slovakia

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Nitra, , Slovakia

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Prešov, , Slovakia

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Skalica, , Slovakia

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Madrid, , Spain

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Málaga, , Spain

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Valencia, , Spain

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Bristol, , United Kingdom

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Countries

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Australia Belgium Canada Chile Colombia Denmark Finland Greece Italy Latvia Lithuania Poland Slovakia Spain United Kingdom

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3711044&StudyName=Study%20the%20effects%20of%20different%20doses%20of%20UK-369%2C003%20in%20men%20with%20lower%20urinary%20tract%20symptoms.%20%20

To obtain contact information for a study center near you, click here.

Other Identifiers

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A3711044

Identifier Type: -

Identifier Source: org_study_id