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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00457457
First received: April 5, 2007
Last updated: October 27, 2010
Last verified: October 2010
History of Changes
  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:

U.S. FDA Resources

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:

  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457457

  Show 46 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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 22, 2013