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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00457457

Collaborator

(none)

609

Enrollment

Locations

Arms

Duration (Months)

13.2

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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 . 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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Hyperplasia	Drug: Tamsulosin Drug: UK-369,003	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

609 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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)

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Apr 1, 2008

Actual Study Completion Date :

Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Comparator Tamsulosin 0.4 mg prolonged release	Drug: Tamsulosin Tamsulosin hydrochloride capsules, 0.4 mg. Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate
Experimental: 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),	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

Arm

Intervention/Treatment

Active Comparator: Comparator

Tamsulosin 0.4 mg prolonged release

Drug: Tamsulosin

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

Experimental: 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),

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

Outcome Measures

Primary Outcome Measures

Change in international prostate symptom score [12 weeks]

Secondary Outcome Measures

Erectile Function (EF) domain of International Index of Erectile [12 weeks]
Function (IIEF) [12 weeks]
Qmax [12 weeks]
Quality of Erection questionnaire (QEQ) [12 weeks]
Population pharmacokinetics [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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).

Exclusion Criteria:

Urinary tract infection
Primary neurological conditions affecting bladder function

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Herston	Queensland	Australia
2	Pfizer Investigational Site	Adelaide	South Australia	Australia	5000
3	Pfizer Investigational Site	Brussels		Belgium	B-1090
4	Pfizer Investigational Site	Brussels		Belgium
5	Pfizer Investigational Site	Edegem		Belgium	B-2650
6	Pfizer Investigational Site	Calgary	Alberta	Canada	T2V 4R6
7	Pfizer Investigational Site	London	Ontario	Canada	N6A 4V2
8	Pfizer Investigational Site	Pointe-Claire	Quebec	Canada	H9R 4S3
9	Pfizer Investigational Site	Temuco	IX Region	Chile	4810371
10	Pfizer Investigational Site	Santiago		Chile
11	Pfizer Investigational Site	Medellin	Antioquia	Colombia	0
12	Pfizer Investigational Site	Barranquilla	Atlantico	Colombia	0
13	Pfizer Investigational Site	Bogota	Cundinamarca	Colombia	0
14	Pfizer Investigational Site	Bogota	Cundinamarca	Colombia
15	Pfizer Investigational Site	Cali	Valle Del Cauca	Colombia	0
16	Pfizer Investigational Site	Aalborg		Denmark	9100
17	Pfizer Investigational Site	Aarhus N		Denmark	8200
18	Pfizer Investigational Site	Gentofte		Denmark	2820
19	Pfizer Investigational Site	Helsinki		Finland	00100
20	Pfizer Investigational Site	Kuopio		Finland	70100
21	Pfizer Investigational Site	Oulu		Finland	90100
22	Pfizer Investigational Site	Tampere		Finland	33100
23	Pfizer Investigational Site	Larissa		Greece	41110
24	Pfizer Investigational Site	Rio		Greece	26500
25	Pfizer Investigational Site	Thessaloniki		Greece	56403
26	Pfizer Investigational Site	Foggia		Italy	71100
27	Pfizer Investigational Site	Siena		Italy	53100
28	Pfizer Investigational Site	Riga		Latvia	LV-1002
29	Pfizer Investigational Site	Kaunas		Lithuania	47144
30	Pfizer Investigational Site	Kaunas		Lithuania	50009
31	Pfizer Investigational Site	Vilnius		Lithuania	08661
32	Pfizer Investigational Site	Bydgoszcz		Poland	85-092
33	Pfizer Investigational Site	Bydgoszcz		Poland	85-168
34	Pfizer Investigational Site	Gdansk		Poland	80-402
35	Pfizer Investigational Site	Gdynia		Poland	81-393
36	Pfizer Investigational Site	Myslowice		Poland	41-400
37	Pfizer Investigational Site	Wejherowo		Poland	84-200
38	Pfizer Investigational Site	Bratislava		Slovakia	851 01
39	Pfizer Investigational Site	Malacky		Slovakia	901 01
40	Pfizer Investigational Site	Nitra		Slovakia	949 01
41	Pfizer Investigational Site	Prešov		Slovakia	080 01
42	Pfizer Investigational Site	Skalica		Slovakia	909 82
43	Pfizer Investigational Site	Madrid		Spain	28035
44	Pfizer Investigational Site	Malaga		Spain	29010
45	Pfizer Investigational Site	Valencia		Spain	46010
46	Pfizer Investigational Site	Bristol		United Kingdom	BS2 8HW