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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00457457




Registration number
NCT00457457
Ethics application status
Date submitted
5/04/2007
Date registered
6/04/2007
Date last updated
19/12/2018

Titles & IDs
Public title
Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms.
Scientific 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)
Secondary ID [1] 0 0
A3711044
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Hyperplasia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Mental Health 0 0 0 0
Other mental health disorders
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tamsulosin
Treatment: Drugs - UK-369,003

Active Comparator: Comparator - Tamsulosin 0.4 mg prolonged release

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),


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

Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in international prostate symptom score
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Erectile Function (EF) domain of International Index of Erectile
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Function (IIEF)
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Qmax
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Quality of Erection questionnaire (QEQ)
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
Population pharmacokinetics
Timepoint [5] 0 0
12 weeks

Eligibility
Key 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).
Minimum age
40 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Urinary tract infection

2. Primary neurological conditions affecting bladder function

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2008
Sample size
Target
Accrual to date
Final
609
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Herston
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
- Herston
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Belgium
State/province [2] 0 0
Edegem
Country [3] 0 0
Canada
State/province [3] 0 0
Alberta
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Chile
State/province [6] 0 0
IX Region
Country [7] 0 0
Chile
State/province [7] 0 0
Santiago
Country [8] 0 0
Colombia
State/province [8] 0 0
Antioquia
Country [9] 0 0
Colombia
State/province [9] 0 0
Atlantico
Country [10] 0 0
Colombia
State/province [10] 0 0
Cundinamarca
Country [11] 0 0
Colombia
State/province [11] 0 0
Valle Del Cauca
Country [12] 0 0
Denmark
State/province [12] 0 0
Aalborg
Country [13] 0 0
Denmark
State/province [13] 0 0
Aarhus N
Country [14] 0 0
Denmark
State/province [14] 0 0
Gentofte
Country [15] 0 0
Finland
State/province [15] 0 0
Helsinki
Country [16] 0 0
Finland
State/province [16] 0 0
Kuopio
Country [17] 0 0
Finland
State/province [17] 0 0
Oulu
Country [18] 0 0
Finland
State/province [18] 0 0
Tampere
Country [19] 0 0
Greece
State/province [19] 0 0
Larissa
Country [20] 0 0
Greece
State/province [20] 0 0
Rio
Country [21] 0 0
Greece
State/province [21] 0 0
Thessaloniki
Country [22] 0 0
Italy
State/province [22] 0 0
Foggia
Country [23] 0 0
Italy
State/province [23] 0 0
Siena
Country [24] 0 0
Latvia
State/province [24] 0 0
Riga
Country [25] 0 0
Lithuania
State/province [25] 0 0
Kaunas
Country [26] 0 0
Lithuania
State/province [26] 0 0
Vilnius
Country [27] 0 0
Poland
State/province [27] 0 0
Bydgoszcz
Country [28] 0 0
Poland
State/province [28] 0 0
Gdansk
Country [29] 0 0
Poland
State/province [29] 0 0
Gdynia
Country [30] 0 0
Poland
State/province [30] 0 0
Myslowice
Country [31] 0 0
Poland
State/province [31] 0 0
Wejherowo
Country [32] 0 0
Slovakia
State/province [32] 0 0
Bratislava
Country [33] 0 0
Slovakia
State/province [33] 0 0
Malacky
Country [34] 0 0
Slovakia
State/province [34] 0 0
Nitra
Country [35] 0 0
Slovakia
State/province [35] 0 0
Prešov
Country [36] 0 0
Slovakia
State/province [36] 0 0
Skalica
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
Spain
State/province [38] 0 0
Malaga
Country [39] 0 0
Spain
State/province [39] 0 0
Valencia
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Bristol

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00457457
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00457457