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Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00090103
First received: August 24, 2004
Last updated: August 25, 2016
Last verified: August 2016
  Purpose
This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.

Condition Intervention Phase
Prostatic Hyperplasia
Drug: dutasteride 0.5mg once daily for 4 years
Drug: tamsulosin 0.4mg once daily for 4 years
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Parallel Group Study to Investigate the Efficacy and Safety of Treatment With Dutasteride (0.5mg) and Tamsulosin (0.4mg), Administered Once Daily for 4 Years, Alone and Combination, on the Improvement of Symptoms and Clinical Outcome in Men With Moderate to Severe Symptomatic Benign Prostatic Hyperplasia

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. [ Time Frame: Years 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
    A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant-reported or identified, they were recorded in the participants' clinic record.

  • Number of Participants With AUR or BPH-related Surgery [ Time Frame: Baseline (Day 1) through Year 4 ] [ Designated as safety issue: No ]
    A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant reported or identified, they were recorded in the participants' clinic record.


Secondary Outcome Measures:
  • Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4 [ Time Frame: Years 1, 2, 3, and 4 ] [ Designated as safety issue: No ]
    The time when the first symptom/event of BPH clinical progression has occurred (i.e. AUR, incontinence) was measured. Summaries are based on the first occuring event after treatment start. The time period is from treatment start to each participant's last treatment visit. The Year 4 events include all those that occur during the fourth year and beyond.

  • The Number of Participants With Each of the Five Components of BPH Clinical Progression [ Time Frame: Baseline (Day 1) to Year 4 ] [ Designated as safety issue: No ]
    The five components measured were symptom deterioration, BPH-related AUR, BPH-related incontinence, recurrent BPH-related Urinary Tract Infection (UTI), and BPH-related renal insufficiency.

  • Number of Events of Symptom Deterioration at the Indicated Time Periods [ Time Frame: Years 1, 2, 3, and 4 (from treatment start until each participant's last treatment-phase visit) ] [ Designated as safety issue: No ]
    The number of participants (par.) with symptom deterioration of International Prostate Symptom Score (IPSS) ≥4 points on two consecutive visits post-baseline are presented. Data are based on the first occurrence of an event after treatment start. The year-4 events include all that occured during the 4th year and beyond. The IPSS is a 7-item questionnaire measuring the level of urinary symptoms reported as the total score. Each question has a 6-point response scale (0=none/not at all to 5=almost always), with a total score ranging from 0-35: mild (0-7), moderate (8-19), or severe (20-35).

  • Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria [ Time Frame: Baseline (Day 1) through Year 4 ] [ Designated as safety issue: No ]
    A participant was considered to have macroscopic hematuria when there was presence of blood in the urine. The event of macroscopic hematuria was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related macroscopic hematuria. Participants may appear in both categories.

  • Number of Participants With an Event of Post-baseline BPH-related Hematospermia [ Time Frame: Baseline (Day 1) through Year 4 ] [ Designated as safety issue: No ]
    A participant was considered to have hematospermia when there was presence of blood in the semen. Hematospermia can occur from prostatitis (prostate infection), from cancer, or after a prostate biopsy. The event of hematospermia was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related hematospermia. Participants may appear in both categories.

  • Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48 [ Time Frame: Baseline and Months 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted (least squares) means from the general linear model: change from baseline IPSS = Treatment + Cluster + Baseline IPSS.

  • Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48 [ Time Frame: Baseline and Months 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    Peak maximum urinary flow (Qmax) of urinary flow using a Medtronic (formerly Dantec) Uroflow Meter (Urodyn 1000 or Duet models) with a Thompson filter was measured. Estimates are based on adjusted (least squares) means from the general linear model: Change from baseline Qmax = treatment + cluster + baseline Qmax.

  • Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48 [ Time Frame: Baseline and Months 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    Prostate volume measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total prostate volume centimeters (cc). Percent change from baseline = [(post-baseline - baseline)/baseline value] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: log(post-baseline/baseline value) + treatment + cluster + log(baseline value) and are reported as percent change from baseline.

  • Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48 [ Time Frame: Baseline and Months 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    Prostate volume (PV) measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total PV in centimeters (cc). Results are for the transition zone measurements of the prostate in a small subset of participants. Percent change from baseline (BL) = [(post-BL - BL)/BL value] x 100. Estimates are based on the adjusted (least squares) means for the general linear model: log(post-BL/BL value) = treatment + cluster + log(BL value) and are reported as percent change from BL.

  • Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit [ Time Frame: Every 3 months from Month 3 to Month 48 ] [ Designated as safety issue: No ]
    At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: "Has the participant needed to make any unscheduled visits to his general practitioner (GP)/Urologist regarding AUR symptoms since the last study visit?" If the answer to the question was "yes," the number of visits was recorded.

  • Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?. [ Time Frame: Every 3 months from Month 3 to Month 48 ] [ Designated as safety issue: No ]
    At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: "Would the participant have paid a visit to his GP/Urologist regarding AUR symptoms if this study visit had not been planned?". If the answer to the question was "yes," the number of Yes responses was recorded.

  • Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit [ Time Frame: Every 3 months from Month 3 to Month 48 ] [ Designated as safety issue: No ]
    At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: "Has the participant needed to visit his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?". If the answer to the question was "yes," the number of visits was recorded.

  • Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?" [ Time Frame: Every 3 months from Month 3 to Month 48 ] [ Designated as safety issue: No ]
    At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: "Would the participant have paid a visit to his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?". If the answer to the question was "yes," the number of Yes responses was recorded.

  • Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) [ Time Frame: Every 3 months from Month 3 to Month 48 ] [ Designated as safety issue: No ]
    At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: "Has the participant had any unplanned GP/Urologist (outpatient) visits that would have taken place if a scheduled study visit had not been planned (this can include visits resulting from UTI, UI macroscopic haematuria, etc?". If the answer to the question was "yes," the number of visits was recorded.

  • Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) [ Time Frame: Every 3 months from Month 3 to Month 48 ] [ Designated as safety issue: No ]
    At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: "Does the participant have any unscheduled GP/Urologist (outpatients) visits planned, not relating to the study (this can include visits resulting from UTI, UI, macroscopic haematuria, etc.?". If the answer to the question was "yes," the number of visits was recorded.

  • Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48 [ Time Frame: Baseline and Months 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    The BII is a 4-item questionnaire, score range of 0 (best) to 12 (worst) for questions 1-3, and 0 (best) to 13 (worst) for question 4, that assesses the overall impact of BPH on a participant's general sense of well being and measures aspects of physical discomfort, worry, and bother, all of which can be affected by BPH and its symptoms. BII score = sum of questions 1-4. Change from baseline = Post-Baseline Value. Estimates are based on the adjusted (least squares) means from the general linear model: change from baseline BII = treatment + cluster + baseline BII.

  • Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48 [ Time Frame: Baseline and Months 12, 24, 36, 48 ] [ Designated as safety issue: No ]
    The effect of study treatment on BHS was assessed by using three self-administered questionnaires: the International Prostate Symptom Score (IPSS), the BPH Impact Index (BII), and Patient Perception of Study Medication (PPSM). The BHS score was collected on the IPPS questionnaire and ranged from 0 (best) to 6 (worst). Percent change from baseline = [(post-baseline - baseline)/baseline value] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: change from baseline BPH-related health status = treatment + cluster + baseline BPH-Related health status.

  • Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) [ Time Frame: Baseline and Months 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has control of your urinary problems changed?".

  • Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) [ Time Frame: Baseline and Months 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect of the study medication on control of your urinary problems?" Satisfact., satisfaction.

  • Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) [ Time Frame: Baseline and Months 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has the strength of your urinary stream changed?".

  • Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) [ Time Frame: Baseline and Months 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect of the study medication on the strength of your urinary stream?". Satisfact., satisfaction.

  • Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) [ Time Frame: Baseline and Months 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has your pain prior to urinating changed?".

  • Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) [ Time Frame: Baseline and Months 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect the study medication has on your pain prior to urinating?". Satisfact., satisfaction.

  • Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) [ Time Frame: Baseline and Months 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has your pain during urination changed?".

  • Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) [ Time Frame: Baseline and Months 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect the study medication has on your pain during urination?". Satisfact., satisfaction.

  • Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) [ Time Frame: Baseline and Months 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has the way your urinary problems interfere with your ability to go about your usual activities changed?".

  • Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) [ Time Frame: Baseline and Months 12, 24, 36, and 48 ] [ Designated as safety issue: Yes ]
    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect the study medication has on your ability to go about your usual activities without interference from your urinary problems?". Satisfact., satisfaction.

  • Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) [ Time Frame: Baseline and Months 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Overall, how satisfied are you with the study medication and it's effect on your urinary problems?". Satisfact., satisfaction.

  • Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) [ Time Frame: Baseline and Months 12, 24, 36, and 48 ] [ Designated as safety issue: No ]
    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Would you ask your doctor for the medication you received in this study?".


Enrollment: 4844
Study Start Date: November 2003
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: dutasteride
dutasteride 0.5mg once daily
Drug: dutasteride 0.5mg once daily for 4 years
combination or single agent
Experimental: Combo
Combination of dutasteride (0.5mg) and tamsulosin (0.4mg), once daily
Drug: dutasteride 0.5mg once daily for 4 years
combination or single agent
Drug: tamsulosin 0.4mg once daily for 4 years
combination agent or single agent
Other Names:
  • dutasteride
  • tamsulosin
Active Comparator: tamsulosin
tamsulosin 0.4mg once daily
Drug: tamsulosin 0.4mg once daily for 4 years
combination agent or single agent
Other Names:
  • dutasteride
  • tamsulosin

Detailed Description:
A randomised, double-blind, parallel group study to investigate the efficacy and safety of treatment with Dutasteride (0.5 mg) and Tamsulosin (0.4 mg), administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia.
  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
  • males, aged ≥50 years
  • clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE)
  • International Prostate Symptom Score (IPSS) ≥12 points at Screening
  • prostate volume ≥30 cc by transrectal ultrasonography; (TRUS)
  • total serum Prostate Specific Antigen (PSA) ≥1.5ng/mL at Screening
  • maximum flow rate (Qmax) >5 mL/sec and ≤15 mL/sec and minimum voided volume of ≥125 mL at Screening (based on two voids)
  • willing and able to give written informed consent and comply with study procedures
  • fluent and literate in local language with the ability to read, comprehend and record information on the IPSS, BII and Patient Perception of Study Medication
  • able to swallow and retain oral medication
  • willing and able to participate in the study for the full 4 years.

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

  • total serum PSA >10.0ng/mL at Screening
  • history or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious DRE). Patients with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable PSA are eligible for the study.

Note: If total serum PSA is >4ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to exclude the possibility of prostate cancer, e.g. further DRE, review TRUS taken within previous month, consider 8-12 core prostate biopsy in accordance with routine clinical practice.

  • previous prostatic surgery (including TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive procedures to treat BPH.
  • history of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to the Screening Visit. Routine catheterisation is acceptable with no time restriction.
  • history of AUR within 3 months prior to Screening Visit.
  • post-void residual volume >250mL (suprapubic ultrasound) at Screening.
  • any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections).
  • history of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy.
  • use of any 5-alpha-reductase inhibitor (e.g. Proscar®, Propecia®, Avodart®), any drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, metronidazole, progestational agents), or other drugs which affect prostate volume, within past 6 months of the Screening Visit and throughout the study (other than as study medication).
  • concurrent use of anabolic steroids
  • use of phytotherapy for BPH within 2 weeks of Screening Visit and/or predicted to need phytotherapy during the study.
  • use of any alpha-adrenoreceptor blockers (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) within 2 weeks of Screening Visit and/or predicted to need any alpha blockers other than tamsulosin during the study.

Note: the purpose of this criteria is to be able to standardise baseline symptom severity for all enrolled patients prior to randomisation and not to specifically exclude current alpha-adrenoreceptor blocker users from participation in the study.

  • use of any alpha-adrenoreceptor agonists (e.g. pseudoephedrine, phenylephrine, ephedrine) or anticholinergics (e.g. oxybutynin, propantheline) or cholinergics (e.g. bethanecol chloride) within 48 hours prior to all uroflowmetry assessments.
  • hypersensitivity to any alpha-/beta- adrenoreceptor blocker or 5-alpha-reductase inhibitor, or other chemically-related drugs.
  • concurrent use of drugs known or thought to have an interaction with tamsulosin, e.g. cimetidine and warfarin.
  • history of hepatic impairment or abnormal liver function tests at Screening defined as alanine aminotransferase (ALT), aspartate aminotranferase (AST), and/or alkaline phosphatase >2 times the upper limit of normal, or total bilirubin >1.5 times the upper limit of normal (unless associated with predominantly indirect bilirubin elevation or Gilbert's syndrome).
  • history of renal insufficiency, or serum creatinine >1.5 times the upper limit of normal or serum creatinine ≥1.5 mg/dL at Screening.
  • prior history of malignancies other than basal cell carcinoma or squamous cell carcinoma of the skin within the past 5 years. Subjects with a prior malignancy who have had no evidence of disease for at least the past 5 years are eligible.
  • history of any illness that in the opinion of the investigator might confound the results of the study or poses additional risk to the patient.
  • any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
  • history of postural hypotension, dizziness, vertigo or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury.
  • history of unsuccessful treatment with tamsulosin or 'first dose' hypotensive episode on initiation of alpha-1-adrenoreceptor antagonist therapy.
  • history of unsuccessful treatment with finasteride or dutasteride
  • history or current evidence of drug or alcohol abuse within the previous 12 months.
  • participation in any investigational or marketed drug trial within 30 days (or 5 half-lives whichever is the longer) preceding the Screening Visit and/or during the course of this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090103

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35209
GSK Investigational Site
Birmingham, Alabama, United States, 35234
GSK Investigational Site
Birmingham, Alabama, United States, 35242
GSK Investigational Site
Birmingham, Alabama, United States, 35294
GSK Investigational Site
Columbiana, Alabama, United States, 35051
GSK Investigational Site
Hoover, Alabama, United States, 35216
United States, Alaska
GSK Investigational Site
Anchorage, Alaska, United States, 99508
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, Arizona, United States, 86106
GSK Investigational Site
Phoenix, Arizona, United States, 85032
United States, California
GSK Investigational Site
Beverly Hills, California, United States, 90212
GSK Investigational Site
Concord, California, United States, 94520
GSK Investigational Site
Glendora, California, United States, 91741
GSK Investigational Site
Greenbrae, California, United States, 94904
GSK Investigational Site
Irvine, California, United States, 92618
GSK Investigational Site
La Jolla, California, United States, 92093
GSK Investigational Site
Laguna Woods, California, United States, 92637
GSK Investigational Site
Los Angelas, California, United States, 90017
GSK Investigational Site
Los Angeles, California, United States, 90048
GSK Investigational Site
los Angeles, California, United States, 90057
GSK Investigational Site
Modesto, California, United States, 95350
GSK Investigational Site
Sacramento, California, United States, 95821
GSK Investigational Site
San Diego, California, United States, 91405
GSK Investigational Site
San Diego, California, United States, 92103
GSK Investigational Site
San Diego, California, United States, 92108
GSK Investigational Site
Torrance, California, United States, 90506
GSK Investigational Site
Vista, California, United States, 92084
United States, Florida
GSK Investigational Site
Aventura, Florida, United States, 33180
GSK Investigational Site
Bay Pines, Florida, United States, 33744
GSK Investigational Site
Coral Gables, Florida, United States, 33134
GSK Investigational Site
Daytona Beach, Florida, United States, 32114
GSK Investigational Site
Lake Worth, Florida, United States, 33461
GSK Investigational Site
Miami, Florida, United States, 33156
GSK Investigational Site
New Smyrna Beach, Florida, United States, 32168
GSK Investigational Site
Ocala, Florida, United States, 34471
GSK Investigational Site
Orange City, Florida, United States, 32763
GSK Investigational Site
Pensacola, Florida, United States, 32503
GSK Investigational Site
Pinecrest, Florida, United States, 33156
GSK Investigational Site
Spring Hill, Florida, United States, 34609
GSK Investigational Site
St. Augustine, Florida, United States, 32086
GSK Investigational Site
St. Petersburg, Florida, United States, 33702
GSK Investigational Site
St. Petersburg, Florida, United States, 33710
GSK Investigational Site
Stuart, Florida, United States, 34996
GSK Investigational Site
Tallahassee, Florida, United States, 32308
GSK Investigational Site
Wellington, Florida, United States, 33414
GSK Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30342
GSK Investigational Site
Blue Ridge, Georgia, United States, 30513
GSK Investigational Site
Calhoun, Georgia, United States, 30701
GSK Investigational Site
Decatur, Georgia, United States, 30033
GSK Investigational Site
Marietta, Georgia, United States, 30066
United States, Idaho
GSK Investigational Site
Meridian, Idaho, United States, 83642
United States, Illinois
GSK Investigational Site
Belleville, Illinois, United States, 62220
GSK Investigational Site
Peoria, Illinois, United States, 61602
GSK Investigational Site
Peoria, Illinois, United States, 61614
GSK Investigational Site
Wheaton, Illinois, United States, 60187
GSK Investigational Site
Winfield, Illinois, United States, 60190
United States, Indiana
GSK Investigational Site
Evansville, Indiana, United States, 47714
GSK Investigational Site
Jeffersonville, Indiana, United States, 47130
GSK Investigational Site
Newburgh, Indiana, United States, 47630
GSK Investigational Site
South Bend, Indiana, United States, 46601
United States, Iowa
GSK Investigational Site
Des Moines, Iowa, United States, 50309
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67207
United States, Kentucky
GSK Investigational Site
Murray, Kentucky, United States, 42071
United States, Louisiana
GSK Investigational Site
Bossier City, Louisiana, United States, 71111
United States, Maryland
GSK Investigational Site
Laurel, Maryland, United States, 20724
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55417
United States, Mississippi
GSK Investigational Site
Picayune, Mississippi, United States, 39466
United States, Missouri
GSK Investigational Site
Kansas City, Missouri, United States, 64114
United States, Montana
GSK Investigational Site
Missoula, Montana, United States, 59802
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68102
United States, Nevada
GSK Investigational Site
Henderson, Nevada, United States, 89014
United States, New Jersey
GSK Investigational Site
Hillsborough, New Jersey, United States, 08844
GSK Investigational Site
Perth Amboy, New Jersey, United States, 08861
GSK Investigational Site
Somerville, New Jersey, United States, 08876
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
United States, New York
GSK Investigational Site
Bayshore, New York, United States, 11706
GSK Investigational Site
Garden City, New York, United States, 11530
GSK Investigational Site
Great Neck, New York, United States, 11021
GSK Investigational Site
Lewiston, New York, United States, 14092
United States, North Carolina
GSK Investigational Site
Asheboro, North Carolina, United States, 27203
GSK Investigational Site
Cary, North Carolina, United States, 27511
GSK Investigational Site
Charlotte, North Carolina, United States, 28262
GSK Investigational Site
Durham, North Carolina, United States, 27710
GSK Investigational Site
Fayetteville, North Carolina, United States, 28304
GSK Investigational Site
Greensboro, North Carolina, United States, 27403
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
United States, North Dakota
GSK Investigational Site
Bismarck, North Dakota, United States, 58501
United States, Ohio
GSK Investigational Site
Bellbrook, Ohio, United States, 45305
GSK Investigational Site
Cincinnati, Ohio, United States, 45249
GSK Investigational Site
Columbus, Ohio, United States, 43212
GSK Investigational Site
Columbus, Ohio, United States, 43214
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
GSK Investigational Site
Fleetwood, Pennsylvania, United States, 19522
United States, Rhode Island
GSK Investigational Site
Providence, Rhode Island, United States, 02904
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
GSK Investigational Site
Athes, Texas, United States, 75751
GSK Investigational Site
Dallas, Texas, United States, 75230
GSK Investigational Site
Dallas, Texas, United States, 75234
GSK Investigational Site
Dallas, Texas, United States, 75390
GSK Investigational Site
Fort Worth, Texas, United States, 76107
GSK Investigational Site
Houston, Texas, United States, 77024
GSK Investigational Site
Houston, Texas, United States, 77030
GSK Investigational Site
New Brunfels, Texas, United States, 78130
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
Temple, Texas, United States, 76508
GSK Investigational Site
Texarkana, Texas, United States, 75503
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84132
United States, Virginia
GSK Investigational Site
Alexandria, Virginia, United States, 22304
United States, Washington
GSK Investigational Site
Bellevue, Washington, United States, 98004
GSK Investigational Site
Mountlake Terrace, Washington, United States, 98043
GSK Investigational Site
Seattle, Washington, United States, 98104
GSK Investigational Site
Spokane, Washington, United States, 99204
GSK Investigational Site
Tacoma, Washington, United States, 98405
Argentina
GSK Investigational Site
Buenos Aires, Argentina, 1111
GSK Investigational Site
Buenos Aires, Argentina, 1120
GSK Investigational Site
Buenos Aires, Argentina, 1416
GSK Investigational Site
Buenos Aires, Argentina, C1181ACI
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, 1405
GSK Investigational Site
Ciudad de Buenos Aires, Argentina, 1118
Belgium
GSK Investigational Site
Antwerpen, Belgium, 2020
GSK Investigational Site
Brussels, Belgium, 1070
GSK Investigational Site
Brussel, Belgium, 1090
GSK Investigational Site
Edegem, Belgium, 2650
GSK Investigational Site
Genk, Belgium, 3600
GSK Investigational Site
La Louvière, Belgium, 7100
GSK Investigational Site
Liège, Belgium, 4000
GSK Investigational Site
Roeselare, Belgium, 8800
Brazil
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30130-008
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90470-340
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
GSK Investigational Site
Rio de Janeiro, Brazil, 20 551-030
GSK Investigational Site
São Paulo, Brazil, 04262-000
Bulgaria
GSK Investigational Site
Pleven, Bulgaria, 5800
GSK Investigational Site
Sofia, Bulgaria, 1000
GSK Investigational Site
Sofia, Bulgaria, 1431/1000
GSK Investigational Site
Sofia, Bulgaria, 1606
GSK Investigational Site
Varna, Bulgaria, 9002
Canada, British Columbia
GSK Investigational Site
Surrey, British Columbia, Canada, V3V 1N1
Canada, Manitoba
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3C 0N2
Canada, New Brunswick
GSK Investigational Site
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
GSK Investigational Site
Saint John's, Newfoundland and Labrador, Canada, A1B 4S8
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3H 3A7
GSK Investigational Site
Kentville, Nova Scotia, Canada, B4N 4K9
Canada, Ontario
GSK Investigational Site
Barrie, Ontario, Canada, L4M 7G1
GSK Investigational Site
Brantford, Ontario, Canada, N3R 4N3
GSK Investigational Site
Courtice, Ontario, Canada, L1E 3C3
GSK Investigational Site
Guelph, Ontario, Canada, N1H 5J1
GSK Investigational Site
Hamilton, Ontario, Canada, L8N 4A6
GSK Investigational Site
Kingston, Ontario, Canada, K7L 2V7
GSK Investigational Site
London, Ontario, Canada, M6A 4G5
GSK Investigational Site
London, Ontario, Canada, N6A 4V2
GSK Investigational Site
North Bay, Ontario, Canada, P1B 7K8
GSK Investigational Site
Oakville, Ontario, Canada, L6H 3P1
GSK Investigational Site
Oshawa, Ontario, Canada, L1H 7K4
GSK Investigational Site
Ottawa, Ontario, Canada, K1Y 4E9
GSK Investigational Site
Scarborough, Ontario, Canada, M1P 2T7
GSK Investigational Site
Scarborough, Ontario, Canada, M1S 4V5
GSK Investigational Site
Sudbury, Ontario, Canada, P3E 4T3
GSK Investigational Site
Toronto, Ontario, Canada, M2K 2W1
GSK Investigational Site
Toronto, Ontario, Canada, M4C 5T2
GSK Investigational Site
Toronto, Ontario, Canada, M5T 2S8
GSK Investigational Site
Toronto, Ontario, Canada, M6A 3B5
GSK Investigational Site
Toronto, Ontario, Canada, M6S 4W4
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H2X 1N8
GSK Investigational Site
Montreal, Quebec, Canada, H3A 1A1
GSK Investigational Site
Montreal, Quebec, Canada, H3S 1Z1
GSK Investigational Site
Saint Charles-Borromee, Quebec, Canada, J6E 6J2
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 5N4
GSK Investigational Site
St-Jerome, Quebec, Canada, J7Z 5T3
GSK Investigational Site
Trois Rivieres, Quebec, Canada, G9A 3V7
Czech Republic
GSK Investigational Site
Hradec Kralove, Czech Republic, 536 00
GSK Investigational Site
Ostrava - Poruba, Czech Republic, 708 52
GSK Investigational Site
Praha 3, Czech Republic, 130 00
GSK Investigational Site
Praha 5, Czech Republic, 150 18
GSK Investigational Site
Praha 8, Czech Republic, 180 71
GSK Investigational Site
Roudnice nad Labem, Czech Republic, 413 01
Denmark
GSK Investigational Site
Aalborg, Denmark, 9100
GSK Investigational Site
Aarhus N, Denmark, 8200
GSK Investigational Site
Fredericia, Denmark, 7000
GSK Investigational Site
Randers, Denmark, 8900
Estonia
GSK Investigational Site
Tallinn, Estonia, 1162
GSK Investigational Site
Tallinn, Estonia, 13419
GSK Investigational Site
Tartu, Estonia, 51014
GSK Investigational Site
Tartu, Estonia
Finland
GSK Investigational Site
Helsinki, Finland, 00150
GSK Investigational Site
Kouvola, Finland, 45200
GSK Investigational Site
Kuopio, Finland, 70100
GSK Investigational Site
Pietarsaari, Finland, 68600
GSK Investigational Site
Tampere, Finland, 33520
France
GSK Investigational Site
Bully Les Mines, Nord-Pas-de-Calais, France, 62160
GSK Investigational Site
Agny, France, 62217
GSK Investigational Site
Angers, France, 49000
GSK Investigational Site
Annecy, France, 74000
GSK Investigational Site
Arras, France, 62000
GSK Investigational Site
Athis Mons Cedex, France, 91200
GSK Investigational Site
Besançon, France, 25000
GSK Investigational Site
Bouchemaine, France, 49080
GSK Investigational Site
Broglie, France, 27270
GSK Investigational Site
Castelneau Le Nez, France, 34170
GSK Investigational Site
Chambery, France, 73000
GSK Investigational Site
Chambéry, France, 73000
GSK Investigational Site
Chilly Mazarin, France, 91380
GSK Investigational Site
Cournonterral, France, 34460
GSK Investigational Site
Créteil cedex, France, 94010
GSK Investigational Site
Domarin, France, 38300
GSK Investigational Site
Epinay sur Orge, France, 91360
GSK Investigational Site
Evreux Cedex, France, 27025
GSK Investigational Site
Evreux, France, 27000
GSK Investigational Site
Gif-sur-Yvette, France, 91190
GSK Investigational Site
Grenoble, France, 38100
GSK Investigational Site
La Seyne sur Mer, France, 83500
GSK Investigational Site
Lamarque, France, 33460
GSK Investigational Site
Laval, France, 53000
GSK Investigational Site
Le Brusc, France, 83140
GSK Investigational Site
Le Kremlin-Bicêtre, France, 94275
GSK Investigational Site
Les Mureaux, France, 78130
GSK Investigational Site
Lesparre Médoc, France, 33340
GSK Investigational Site
Linas, France, 91310
GSK Investigational Site
Longpont sur Orge, France, 91310
GSK Investigational Site
Lyon, France, 69008
GSK Investigational Site
Melun, France, 77007
GSK Investigational Site
Meudon, France, 92190
GSK Investigational Site
Meylan, France, 38240
GSK Investigational Site
Mont de Marsan, France, 40000
GSK Investigational Site
Montauban, France, 82017
GSK Investigational Site
Montpelier, France, 34000
GSK Investigational Site
Montpellier, France, 34000
GSK Investigational Site
Montpellier, France, 34100
GSK Investigational Site
Orléans Cedex 2, France, 45067
GSK Investigational Site
Paris, France, 75019
GSK Investigational Site
Pontonx Sur Adour, France, 40465
GSK Investigational Site
Roanne, France, 42300
GSK Investigational Site
Saint Chamond, France, 42400
GSK Investigational Site
Saint Denis, France, 93200
GSK Investigational Site
Saint Galmier, France, 42330
GSK Investigational Site
Saint Germain Lespinasse, France, 42640
GSK Investigational Site
Saint Sebastien de Morsent, France, 27180
GSK Investigational Site
Saint-Egrève, France, 38120
GSK Investigational Site
Saint-Georges d'Orques, France, 34680
GSK Investigational Site
Sainte Suzanne, France, 53270
GSK Investigational Site
Sanary, France, 83110
GSK Investigational Site
Sarlat la Canéda, France, 24200
GSK Investigational Site
Seysses, France, 31600
GSK Investigational Site
Six-Fours les Plages, France, 83140
GSK Investigational Site
Suresnes Cedex, France, 92151
GSK Investigational Site
Toulon, France, 83200
GSK Investigational Site
Tours, France, 37044
GSK Investigational Site
Vaucresson, France, 92420
GSK Investigational Site
Verneuil-sur-Seine, France, 78480
GSK Investigational Site
Villejuif Cedex, France, 94804
GSK Investigational Site
Villeneuve-Les-Maguelone, France, 34750
GSK Investigational Site
Vourey, France, 38210
Germany
GSK Investigational Site
Aalen, Baden-Wuerttemberg, Germany, 73430
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
GSK Investigational Site
Konstanz, Baden-Wuerttemberg, Germany, 78464
GSK Investigational Site
Mosbach, Baden-Wuerttemberg, Germany, 74821
GSK Investigational Site
Rottweil, Baden-Wuerttemberg, Germany, 78628
GSK Investigational Site
Stockach, Baden-Wuerttemberg, Germany, 78333
GSK Investigational Site
Aichach, Bayern, Germany, 86551
GSK Investigational Site
Amberg, Bayern, Germany, 92224
GSK Investigational Site
Augsburg, Bayern, Germany, 86150
GSK Investigational Site
Graefeling, Bayern, Germany, 82166
GSK Investigational Site
Neu-Ulm, Bayern, Germany, 89231
GSK Investigational Site
Schongau, Bayern, Germany, 86956
GSK Investigational Site
Wertingen, Bayern, Germany, 86637
GSK Investigational Site
Hagenow, Brandenburg, Germany, 19230
GSK Investigational Site
Lauchhammer, Brandenburg, Germany, 01979
GSK Investigational Site
Oranienburg, Brandenburg, Germany, 16515
GSK Investigational Site
Senftenberg, Brandenburg, Germany, 01968
GSK Investigational Site
Alzenau, Hessen, Germany, 63755
GSK Investigational Site
Frankfurt, Hessen, Germany, 60326
GSK Investigational Site
Fulda, Hessen, Germany, 36037
GSK Investigational Site
Giessen, Hessen, Germany, 35390
GSK Investigational Site
Kassel, Hessen, Germany, 34123
GSK Investigational Site
Koenigstein, Hessen, Germany, 61462
GSK Investigational Site
Marburg, Hessen, Germany, 35039
GSK Investigational Site
Schwalbach, Hessen, Germany, 65824
GSK Investigational Site
Grimmen, Mecklenburg-Vorpommern, Germany, 18507
GSK Investigational Site
Parchim, Mecklenburg-Vorpommern, Germany, 19370
GSK Investigational Site
Delmenhorst, Niedersachsen, Germany, 27753
GSK Investigational Site
Holzminden, Niedersachsen, Germany, 37603
GSK Investigational Site
Oldenburg, Niedersachsen, Germany, 26121
GSK Investigational Site
Osnabrueck, Niedersachsen, Germany, 49074
GSK Investigational Site
Duelmen, Nordrhein-Westfalen, Germany, 48249
GSK Investigational Site
Stadtlohn, Nordrhein-Westfalen, Germany, 48703
GSK Investigational Site
Koblenz, Rheinland-Pfalz, Germany, 56068
GSK Investigational Site
Halle, Sachsen-Anhalt, Germany, 06114
GSK Investigational Site
Hettstedt, Sachsen-Anhalt, Germany, 06333
GSK Investigational Site
Merseburg, Sachsen-Anhalt, Germany, 06217
GSK Investigational Site
Hohenstein-Ernsttal, Sachsen, Germany, 09337
GSK Investigational Site
Leipzig, Sachsen, Germany, 04105
GSK Investigational Site
Leipzig, Sachsen, Germany, 04109
GSK Investigational Site
Leipzig, Sachsen, Germany, 04277
GSK Investigational Site
Husum, Schleswig-Holstein, Germany, 25813
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24103
GSK Investigational Site
Apolda, Thueringen, Germany, 99510
GSK Investigational Site
Berlin, Germany, 10627
GSK Investigational Site
Berlin, Germany, 10719
GSK Investigational Site
Berlin, Germany, 12167
GSK Investigational Site
Berlin, Germany, 12347
GSK Investigational Site
Berlin, Germany, 12681
GSK Investigational Site
Berlin, Germany, 13053
GSK Investigational Site
Berlin, Germany, 13055
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Berlin, Germany, 13439
GSK Investigational Site
Berlin, Germany, 14197
GSK Investigational Site
Hamburg, Germany, 20253
GSK Investigational Site
Hamburg, Germany, 22415
Greece
GSK Investigational Site
Athens, Greece, 115 21
GSK Investigational Site
Athens, Greece, 115 22
GSK Investigational Site
Athens, Greece, 15126
GSK Investigational Site
Athens, Greece, 154 52
GSK Investigational Site
Patra, Greece, 265 00
GSK Investigational Site
Polygyros, Greece, 63 100
GSK Investigational Site
Thassaloniki, Greece, 564 34
Hungary
GSK Investigational Site
Budapest, Hungary, 1036.
GSK Investigational Site
Sopron, Hungary, 9400
GSK Investigational Site
Székesfehérvár, Hungary, 8000
GSK Investigational Site
Veszprém, Hungary, 8200
Iceland
GSK Investigational Site
Reykjavik, Iceland, 101
Israel
GSK Investigational Site
Haifa, Israel, 31048
GSK Investigational Site
Haifa, Israel
GSK Investigational Site
Holon, Israel, 58100
GSK Investigational Site
Kfar Saba, Israel, 44281
GSK Investigational Site
Ramat Gan, Israel, 52621
GSK Investigational Site
Zrifin, Israel, 70300
Italy
GSK Investigational Site
Catanzaro, Calabria, Italy, 88100
GSK Investigational Site
Avellino, Campania, Italy, 83100
GSK Investigational Site
Castellamare di Stabia (NA), Campania, Italy, 80053
GSK Investigational Site
Napoli, Campania, Italy, 80131
GSK Investigational Site
San Felice a Cancello Caserta, Campania, Italy, 81027
GSK Investigational Site
Torre del Greco (NA), Campania, Italy, 80059
GSK Investigational Site
Modena, Emilia-Romagna, Italy, 41100
GSK Investigational Site
Udine, Friuli-Venezia-Giulia, Italy, 33100
GSK Investigational Site
Roma, Lazio, Italy, 00189
GSK Investigational Site
Genova, Liguria, Italy, 16128
GSK Investigational Site
Lecco, Lombardia, Italy, 23100
GSK Investigational Site
Milano, Lombardia, Italy, 20132
GSK Investigational Site
Ivrea (TO), Piemonte, Italy, 10015
GSK Investigational Site
Novara, Piemonte, Italy, 28100
GSK Investigational Site
Torino, Piemonte, Italy, 10126
GSK Investigational Site
Cagliari, Sardegna, Italy, 09134
GSK Investigational Site
Acireale (CT), Sicilia, Italy, 95124
GSK Investigational Site
Bagno a Ripoli (FI), Toscana, Italy, 50126
GSK Investigational Site
Firenze, Toscana, Italy, 50139
GSK Investigational Site
Siena, Toscana, Italy, 53100
GSK Investigational Site
Portogruaro (VE), Veneto, Italy, 30026
Korea, Republic of
GSK Investigational Site
Pusan, Korea, Republic of, 602-739
GSK Investigational Site
Seoul, Korea, Republic of, 135-710
GSK Investigational Site
Seoul, Korea, Republic of, 135-720
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
GSK Investigational Site
Seoul, Korea, Republic of, 150-015
Lithuania
GSK Investigational Site
Kaunas, Lithuania, LT-47144
GSK Investigational Site
Kaunas, Lithuania, LT-49287
GSK Investigational Site
Klaipeda, Lithuania, LT-92231
GSK Investigational Site
Klaipeda, Lithuania, LT-92288
GSK Investigational Site
Vilnius, Lithuania, LT-10207
Mexico
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44340
GSK Investigational Site
Zapopan, Jalisco, Jalisco, Mexico, 45100
GSK Investigational Site
Zapopan, Jalisco, Mexico, 45170
GSK Investigational Site
Mexico DF, Mexico, 06720
GSK Investigational Site
Mexico, D.F., Mexico, 14050
GSK Investigational Site
Mexico, Mexico, 06700
Netherlands
GSK Investigational Site
Alkmaar, Netherlands, 1815 JD
GSK Investigational Site
Amstelveen, Netherlands, 1186 AM
GSK Investigational Site
Amsterdam, Netherlands, 1034 CS
GSK Investigational Site
Amsterdam, Netherlands, 1105 AZ
GSK Investigational Site
Arnhem, Netherlands, 6842 CV
GSK Investigational Site
Den Haag, Netherlands, 2566 MJ
GSK Investigational Site
Doetinchem, Netherlands, 7009 BL
GSK Investigational Site
Enschede, Netherlands, 7511JX
GSK Investigational Site
Etten-leur, Netherlands, 4872 LA
GSK Investigational Site
Groningen, Netherlands, 9713 GZ
GSK Investigational Site
Groningen, Netherlands, 9721 SW
GSK Investigational Site
Heerlen, Netherlands, 6419 PC
GSK Investigational Site
Hilversum, Netherlands, 1213 XZ
GSK Investigational Site
Hoofddorp, Netherlands, 2134 TM
GSK Investigational Site
Maastricht, Netherlands, 6229 HX
GSK Investigational Site
Tilburg, Netherlands, 5022 GC
GSK Investigational Site
Tilburg, Netherlands, 5042 AD
GSK Investigational Site
Veldhoven, Netherlands, 5504 DB
GSK Investigational Site
Winterswijk, Netherlands, 7101 BN
GSK Investigational Site
Zwijndrecht, Netherlands, 3331 LZ
Norway
GSK Investigational Site
Aalesund, Norway, N-6026
GSK Investigational Site
Bergen, Norway, 5094
GSK Investigational Site
Bodø, Norway, N-8009
GSK Investigational Site
Haugesund, Norway, 5507
GSK Investigational Site
Moelv, Norway, N-2390
GSK Investigational Site
Nøtterøy, Norway, 3128
GSK Investigational Site
Oslo, Norway, 0257 OSLO
GSK Investigational Site
Oslo, Norway, 0514
GSK Investigational Site
Porsgrunn, Norway, N-3922
GSK Investigational Site
Tønsberg, Norway, 3116
Philippines
GSK Investigational Site
Manila, Philippines, 1003
GSK Investigational Site
Quezon City, Philippines, 1101
Poland
GSK Investigational Site
Gdansk, Poland, 80-402
GSK Investigational Site
Krakow, Poland, 31-221
GSK Investigational Site
Krakow, Poland, 31-826
GSK Investigational Site
Lublin, Poland, 20-950
GSK Investigational Site
Wroclaw, Poland, 50-043
Portugal
GSK Investigational Site
Abrantes, Portugal, 2200 Abrantes
GSK Investigational Site
Lisboa, Portugal, 1069-166
GSK Investigational Site
Lisboa, Portugal, 1269-098 Lisboa
GSK Investigational Site
Porto, Portugal, 4099-004
GSK Investigational Site
Porto, Portugal, 4150-113 PORTO
GSK Investigational Site
S. Martinho do Bispo, Portugal, 3040-316 Coimbra
Puerto Rico
GSK Investigational Site
Ponce, Puerto Rico, 00716
GSK Investigational Site
Santurce, Puerto Rico, 00907
Romania
GSK Investigational Site
Arad, Romania, 310175
GSK Investigational Site
Bucharest, Romania, 022328
GSK Investigational Site
Bucharest, Romania
GSK Investigational Site
Cluj-Napoca, Romania
GSK Investigational Site
Iasi, Romania
GSK Investigational Site
Timisoara, Romania
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 105229
GSK Investigational Site
Moscow, Russian Federation, 109472
GSK Investigational Site
Moscow, Russian Federation, 117 837
GSK Investigational Site
Moscow, Russian Federation, 125206
GSK Investigational Site
Moscow, Russian Federation, 125367
GSK Investigational Site
Moscow, Russian Federation
GSK Investigational Site
Rostov-na-Donu, Russian Federation
GSK Investigational Site
Saint Petersburg, Russian Federation
GSK Investigational Site
Smolensk, Russian Federation
Slovakia
GSK Investigational Site
Banska Bystrica, Slovakia, 975 17
GSK Investigational Site
Bratislava, Slovakia, 813 69
GSK Investigational Site
Bratislava, Slovakia, 833 05
GSK Investigational Site
Kosice, Slovakia, 041 66
GSK Investigational Site
Martin, Slovakia, 036 59
GSK Investigational Site
Skalica, Slovakia, 909 01
GSK Investigational Site
Zilina, Slovakia, 010 01
South Africa
GSK Investigational Site
Cape Town, South Africa, 8001
GSK Investigational Site
Claremont, South Africa, 7700
GSK Investigational Site
Somerset West, South Africa, 7130
GSK Investigational Site
Sunninghill, South Africa, 2157
Spain
GSK Investigational Site
Alava, Spain, 01004
GSK Investigational Site
Alcázar de San Juan (Ciudad Real), Spain, 13600
GSK Investigational Site
Badajoz, Spain, 6080
GSK Investigational Site
Barcelona, Spain, 08022
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Barcelona, Spain, 08221
GSK Investigational Site
Burgos, Spain, 09005
GSK Investigational Site
Ciudad Real, Spain, 13005
GSK Investigational Site
Elche (Alicante), Spain, 03202
GSK Investigational Site
Gijon, Spain, 33394
GSK Investigational Site
Guadalajara, Spain, 19002
GSK Investigational Site
Jerez de la Frontera, Spain, 11407
GSK Investigational Site
La Coruña, Spain, 15006
GSK Investigational Site
Langreo (Oviedo), Spain, 33920
GSK Investigational Site
Las Palmas De Gran Canaria, Spain, 35016
GSK Investigational Site
Las Palmas, Spain, 35020
GSK Investigational Site
Madrid, Spain, 28006
GSK Investigational Site
Madrid, Spain, 28016
GSK Investigational Site
Malaga, Spain, 29020
GSK Investigational Site
Manacor (Palma de Mallorca), Spain
GSK Investigational Site
Marbella, Spain, 29600
GSK Investigational Site
Mendaro, Guipuzcoa, Spain, 20850
GSK Investigational Site
Merida, Spain, 6800
GSK Investigational Site
Murcia, Spain, 30008
GSK Investigational Site
Palma de Mallorca, Spain, 07014
GSK Investigational Site
Pamplona, Spain, 31008
GSK Investigational Site
Pontevedra, Spain, 36071
GSK Investigational Site
Sabadell (Barcelona), Spain, 08208
GSK Investigational Site
San Sebastian, Spain, 20012
GSK Investigational Site
San Sebastián, Spain, 20014
GSK Investigational Site
Santa Cruz de Tenerife, Spain, 38010
GSK Investigational Site
Santander, Spain, 38008
GSK Investigational Site
Santander, Spain
GSK Investigational Site
Santiago de Compostela, Spain, 15706
GSK Investigational Site
Tortosa, Spain, 43500
GSK Investigational Site
Valencia, Spain, 46009
GSK Investigational Site
Vigo (Pontevedra), Spain, 30211
GSK Investigational Site
Vigo/Pontevedra, Spain, 36200
GSK Investigational Site
Vitoria, Spain, 01009
GSK Investigational Site
Vizcaya, Spain, 48902
Taiwan
GSK Investigational Site
Kaohsiung, Taiwan, 813
GSK Investigational Site
Taichung, Taiwan, 404
GSK Investigational Site
Tainan, Taiwan, 704
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Taipei, Taiwan, 112
GSK Investigational Site
Taipei, Taiwan, 114
GSK Investigational Site
Taoyuan, Taiwan, 333
Thailand
GSK Investigational Site
Bangkok, Thailand, 10330
GSK Investigational Site
Bangkok, Thailand, 10400
GSK Investigational Site
Bangkok, Thailand, 10700
GSK Investigational Site
Chiangmai, Thailand, 50200
Tunisia
GSK Investigational Site
Sousse, Tunisia, 4054
GSK Investigational Site
Tunis, Tunisia, 1007
GSK Investigational Site
Tunis, Tunisia, 1008
Turkey
GSK Investigational Site
Istanbul, Turkey, 34303
GSK Investigational Site
Izmir, Turkey, 35100
GSK Investigational Site
Sıhhiye/Ankara, Turkey, 06100
United Kingdom
GSK Investigational Site
Swansea, Glamorgan, United Kingdom, SA4 4NU
GSK Investigational Site
Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7NA
GSK Investigational Site
Northwood, Middlesex, United Kingdom, HA6 2RN
GSK Investigational Site
Edinburgh, Midlothian, United Kingdom, EH4 2XU
GSK Investigational Site
Oxford, Oxfordshire, United Kingdom, OX2 6PD
GSK Investigational Site
Chichester, Sussex West, United Kingdom, PO19 4SE
GSK Investigational Site
Clydebank, Glasgow, United Kingdom, G81 2DR
GSK Investigational Site
Dundee, United Kingdom, DD1 9SY
GSK Investigational Site
Edgbaston, Birmingham, United Kingdom, B15 2SQ
GSK Investigational Site
Manchester, United Kingdom, M15 6SX
GSK Investigational Site
Waterloo, Liverpool, United Kingdom, L22 0LG
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:

Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: ARI40005
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: ARI40005
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: ARI40005
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: ARI40005
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: ARI40005
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: ARI40005
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: ARI40005
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00090103     History of Changes
Other Study ID Numbers: ARI40005 
Study First Received: August 24, 2004
Results First Received: February 26, 2010
Last Updated: August 25, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Combination Therapy
dutasteride
BPH

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Dutasteride
Tamsulosin
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Urological Agents

ClinicalTrials.gov processed this record on December 02, 2016