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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Prostatic Hyperplasia

Treatments: Drug: UK-369,003; Drug: Tamsulosin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00457457

A3711044

Details and patient eligibility

About

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.

Enrollment: 609 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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609 participants in 2 patient groups

Comparator

Active Comparator group

Description:

Tamsulosin 0.4 mg prolonged release

Treatment:

Drug: Tamsulosin

Treatment Arm

Experimental group

Description:

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

Treatment:

Drug: UK-369,003