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

NCT00457457 | Completed Phase 2

• 1 other identifier: A3711044
• Study Type: interventional
• Target: 609
• Locations: 15 countries
• Sites: 46

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.

Conditions

Prostatic Hyperplasia

Keywords

With or without erectile dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in international prostate symptom score

  12 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

Comparator

ACTIVE COMPARATOR

Tamsulosin 0.4 mg prolonged release

Drug: Tamsulosin

Treatment Arm

EXPERIMENTAL

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

Interventions

Tamsulosin DRUG

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

Comparator

UK-369,003 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

Treatment Arm

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Urinary tract infection
• Primary neurological conditions affecting bladder function

Sponsors & Collaborators

• Pfizer: lead

Study Sites (46)

Pfizer Investigational Site

Herston, Queensland, Australia

Location

Pfizer Investigational Site

Adelaide, South Australia, 5000, Australia

Location

Pfizer Investigational Site

Brussels, B-1090, Belgium

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Pfizer Investigational Site

Brussels, Belgium

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Pfizer Investigational Site

Edegem, B-2650, Belgium

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Pfizer Investigational Site

Calgary, Alberta, T2V 4R6, Canada

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Pfizer Investigational Site

London, Ontario, N6A 4V2, Canada

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Pfizer Investigational Site

Pointe-Claire, Quebec, H9R 4S3, Canada

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Pfizer Investigational Site

Temuco, Región de la Araucanía, 4810371, Chile

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Pfizer Investigational Site

Santiago, Chile

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Pfizer Investigational Site

Medellín, Antioquia, 0, Colombia

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Pfizer Investigational Site

Barranquilla, Atlántico, 0, Colombia

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Pfizer Investigational Site

Bogota, Cundinamarca, 0, Colombia

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Pfizer Investigational Site

Bogota, Cundinamarca, Colombia

Location

Pfizer Investigational Site

Cali, Valle del Cauca Department, 0, Colombia

Location

Pfizer Investigational Site

Aalborg, 9100, Denmark

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Pfizer Investigational Site

Aarhus N, 8200, Denmark

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Pfizer Investigational Site

Gentofte Municipality, 2820, Denmark

Location

Pfizer Investigational Site

Helsinki, 00100, Finland

Location

Pfizer Investigational Site

Kuopio, 70100, Finland

Location

Pfizer Investigational Site

Oulu, 90100, Finland

Location

Pfizer Investigational Site

Tampere, 33100, Finland

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Pfizer Investigational Site

Larissa, 41110, Greece

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Pfizer Investigational Site

Rio, 26500, Greece

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Pfizer Investigational Site

Thessaloniki, 56403, Greece

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Pfizer Investigational Site

Foggia, 71100, Italy

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Pfizer Investigational Site

Siena, 53100, Italy

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Pfizer Investigational Site

Riga, LV-1002, Latvia

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Pfizer Investigational Site

Kaunas, 47144, Lithuania

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Pfizer Investigational Site

Kaunas, 50009, Lithuania

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Pfizer Investigational Site

Vilnius, 08661, Lithuania

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Pfizer Investigational Site

Bydgoszcz, 85-092, Poland

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Pfizer Investigational Site

Bydgoszcz, 85-168, Poland

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Pfizer Investigational Site

Gdansk, 80-402, Poland

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Pfizer Investigational Site

Gdynia, 81-393, Poland

Location

Pfizer Investigational Site

Mysłowice, 41-400, Poland

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Pfizer Investigational Site

Wejherowo, 84-200, Poland

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Pfizer Investigational Site

Bratislava, 851 01, Slovakia

Location

Pfizer Investigational Site

Malacky, 901 01, Slovakia

Location

Pfizer Investigational Site

Nitra, 949 01, Slovakia

Location

Pfizer Investigational Site

Prešov, 080 01, Slovakia

Location

Pfizer Investigational Site

Skalica, 909 82, Slovakia

Location

Pfizer Investigational Site

Madrid, 28035, Spain

Location

Pfizer Investigational Site

Málaga, 29010, Spain

Location

Pfizer Investigational Site

Valencia, 46010, Spain

Location

Pfizer Investigational Site

Bristol, BS2 8HW, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin; 1-(6-ethoxy-5-(3-ethyl-6,7-dihydro-2-(2-methoxyethyl)-7-oxo-2H-pyrazolo(4,3-d)pyrimidin-5-yl)-3-pyridyl sulphonyl)-4-ethylpiperazine

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 5, 2007
• First Posted: April 6, 2007
• Study Start: May 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

CO (5); ES (3); CA (3); PL (6); AU (2); BE (3); GR (3); CL (2); GB (1); FI (4); LI (3); LA (1); IT (2); DK (3); SL (5)