Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms.
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00457457
First received: April 5, 2007
Last updated: October 27, 2010
Last verified: October 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Prostatic Hyperplasia |
Drug: Tamsulosin Drug: UK-369,003 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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) |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change in international prostate symptom score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Erectile Function (EF) domain of International Index of Erectile [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Function (IIEF) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Qmax [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Quality of Erection questionnaire (QEQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Population pharmacokinetics [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 609 |
| Study Start Date: | May 2007 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457457
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Hide Study LocationsLocations
| Australia, Queensland | |
| Pfizer Investigational Site | |
| Herston, Queensland, Australia | |
| Australia, South Australia | |
| Pfizer Investigational Site | |
| Adelaide, South Australia, Australia, 5000 | |
| Belgium | |
| Pfizer Investigational Site | |
| Brussels, 1200, Belgium | |
| Pfizer Investigational Site | |
| Brussels, Belgium, B-1090 | |
| Pfizer Investigational Site | |
| Edegem, Belgium, B-2650 | |
| Canada, Alberta | |
| Pfizer Investigational Site | |
| Calgary, Alberta, Canada, T2V 4R6 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| London, Ontario, Canada, N6A 4V2 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Pointe-Claire, Quebec, Canada, H9R 4S3 | |
| Chile | |
| Pfizer Investigational Site | |
| Temuco, IX Region, Chile, 4810371 | |
| Pfizer Investigational Site | |
| Santiago, Chile | |
| Colombia | |
| Pfizer Investigational Site | |
| Medellin, Antioquia, Colombia, 0 | |
| Pfizer Investigational Site | |
| Barranquilla, Atlantico, Colombia, 0 | |
| Pfizer Investigational Site | |
| Bogota, Cundinamarca, Colombia, 0 | |
| Pfizer Investigational Site | |
| Bogota, Cundinamarca, Colombia | |
| Pfizer Investigational Site | |
| Cali, Valle del Cauca, Colombia, 0 | |
| Denmark | |
| Pfizer Investigational Site | |
| Aalborg, Denmark, 9100 | |
| Pfizer Investigational Site | |
| Aarhus N, Denmark, 8200 | |
| Pfizer Investigational Site | |
| Gentofte, Denmark, 2820 | |
| Finland | |
| Pfizer Investigational Site | |
| Helsinki, Finland, 00100 | |
| Pfizer Investigational Site | |
| Kuopio, Finland, 70100 | |
| Pfizer Investigational Site | |
| Oulu, Finland, 90100 | |
| Pfizer Investigational Site | |
| Tampere, Finland, 33100 | |
| Greece | |
| Pfizer Investigational Site | |
| Larissa, Greece, 41110 | |
| Pfizer Investigational Site | |
| Rio, Greece, 26500 | |
| Pfizer Investigational Site | |
| Thessaloniki, Greece, 56403 | |
| Italy | |
| Pfizer Investigational Site | |
| Foggia, Italy, 71100 | |
| Pfizer Investigational Site | |
| Siena, Italy, 53100 | |
| Latvia | |
| Pfizer Investigational Site | |
| Riga, Latvia, LV-1002 | |
| Lithuania | |
| Pfizer Investigational Site | |
| Kaunas, Lithuania, 47144 | |
| Pfizer Investigational Site | |
| Kaunas, Lithuania, 50009 | |
| Pfizer Investigational Site | |
| Vilnius, Lithuania, 08661 | |
| Poland | |
| Pfizer Investigational Site | |
| Bydgoszcz, Poland, 85-092 | |
| Pfizer Investigational Site | |
| Bydgoszcz, Poland, 85-168 | |
| Pfizer Investigational Site | |
| Gdansk, Poland, 80-402 | |
| Pfizer Investigational Site | |
| Gdynia, Poland, 81-393 | |
| Pfizer Investigational Site | |
| Myslowice, Poland, 41-400 | |
| Pfizer Investigational Site | |
| Wejherowo, Poland, 84-200 | |
| Slovakia | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 851 01 | |
| Pfizer Investigational Site | |
| Malacky, Slovakia, 901 01 | |
| Pfizer Investigational Site | |
| Nitra, Slovakia, 949 01 | |
| Pfizer Investigational Site | |
| Prešov, Slovakia, 080 01 | |
| Pfizer Investigational Site | |
| Skalica, Slovakia, 909 82 | |
| Spain | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28035 | |
| Pfizer Investigational Site | |
| Malaga, Spain, 29010 | |
| Pfizer Investigational Site | |
| Valencia, Spain, 46010 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Bristol, United Kingdom, BS2 8HW | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
| ClinicalTrials.gov Identifier: | NCT00457457 History of Changes |
| Other Study ID Numbers: | A3711044 |
| Study First Received: | April 5, 2007 |
| Last Updated: | October 27, 2010 |
| Health Authority: | Slovakia: State Institute for Drug Control |
Keywords provided by Pfizer:
|
With or without erectile dysfunction |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hyperplasia Erectile Dysfunction Prostatic Diseases Genital Diseases, Male Pathologic Processes Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders |
Tamsulosin Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013