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NCT00457457 Clinical Trial

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

Prostatic Hyperplasia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00457457
Other study ID # A3711044
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 2007
Est. completion date April 2008

Study information
Verified date December 2018
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 . 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.

Recruitment information / eligibility
Status Completed
Enrollment 609
Est. completion date April 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Male
Age group 40 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Australia Pfizer Investigational Site Adelaide South Australia
Australia Pfizer Investigational Site Herston Queensland
Belgium Pfizer Investigational Site Brussels
Belgium Pfizer Investigational Site Brussels
Belgium Pfizer Investigational Site Edegem
Canada Pfizer Investigational Site Calgary Alberta
Canada Pfizer Investigational Site London Ontario
Canada Pfizer Investigational Site Pointe-Claire Quebec
Chile Pfizer Investigational Site Santiago
Chile Pfizer Investigational Site Temuco IX Region
Colombia Pfizer Investigational Site Barranquilla Atlantico
Colombia Pfizer Investigational Site Bogota Cundinamarca
Colombia Pfizer Investigational Site Bogota Cundinamarca
Colombia Pfizer Investigational Site Cali Valle Del Cauca
Colombia Pfizer Investigational Site Medellin Antioquia
Denmark Pfizer Investigational Site Aalborg
Denmark Pfizer Investigational Site Aarhus N
Denmark Pfizer Investigational Site Gentofte
Finland Pfizer Investigational Site Helsinki
Finland Pfizer Investigational Site Kuopio
Finland Pfizer Investigational Site Oulu
Finland Pfizer Investigational Site Tampere
Greece Pfizer Investigational Site Larissa
Greece Pfizer Investigational Site Rio
Greece Pfizer Investigational Site Thessaloniki
Italy Pfizer Investigational Site Foggia
Italy Pfizer Investigational Site Siena
Latvia Pfizer Investigational Site Riga
Lithuania Pfizer Investigational Site Kaunas
Lithuania Pfizer Investigational Site Kaunas
Lithuania Pfizer Investigational Site Vilnius
Poland Pfizer Investigational Site Bydgoszcz
Poland Pfizer Investigational Site Bydgoszcz
Poland Pfizer Investigational Site Gdansk
Poland Pfizer Investigational Site Gdynia
Poland Pfizer Investigational Site Myslowice
Poland Pfizer Investigational Site Wejherowo
Slovakia Pfizer Investigational Site Bratislava
Slovakia Pfizer Investigational Site Malacky
Slovakia Pfizer Investigational Site Nitra
Slovakia Pfizer Investigational Site Prešov
Slovakia Pfizer Investigational Site Skalica
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Malaga
Spain Pfizer Investigational Site Valencia
United Kingdom Pfizer Investigational Site Bristol

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

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

Outcome
Type Measure Description Time frame Safety issue
Primary Change in international prostate symptom score 12 weeks
Secondary Erectile Function (EF) domain of International Index of Erectile 12 weeks
Secondary Function (IIEF) 12 weeks
Secondary Qmax 12 weeks
Secondary Quality of Erection questionnaire (QEQ) 12 weeks
Secondary Population pharmacokinetics 12 weeks
See also
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Terminated NCT04398966 - Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia N/A
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Completed NCT02947958 - Teleconsultation in Counter-reference Between Tertiary and Primary Care for Patients With Benign Prostatic Hyperplasia N/A
Completed NCT01937871 - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED) Phase 3
Completed NCT00427882 - Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study Phase 4
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Recruiting NCT05686525 - Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men With BPH N/A
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Completed NCT00316732 - Observational AVODART (Dutasteride) Study In Benign Prostatic Hyperplasia Subjects - OASIS N/A
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Recruiting NCT02278679 - Digital Rectal Exam Proficiency Tool N/A
Completed NCT01482676 - The Role of microRNAs in Organ Remodeling in Lower Urinary Tract Dysfunction N/A
Completed NCT01376258 - Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database N/A
Completed NCT00822952 - Prostate Mechanical Imager (PMI) Clinical Bridging Study N/A
Completed NCT00527605 - Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH) Phase 3
Terminated NCT00563654 - Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up N/A

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