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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
Results First Received: February 26, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Prostatic Hyperplasia
Interventions: Drug: dutasteride 0.5mg once daily for 4 years
Drug: tamsulosin 0.4mg once daily for 4 years

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In a 4-week, single-blind placebo run-in period, all participants (par.) took two capsules consisting of one dutasteride-matched placebo capsule and one tamsulosin-matched placebo capsule once daily for 4 weeks. A safety follow-up was performed for all participants 16 weeks after the last dose of study drug.

Reporting Groups
  Description
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
Dutasteride 0.5 mg Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
Tamsulosin 0.4 mg Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks

Participant Flow for 2 periods

Period 1:   Four-Year Double-Blind Treatment Period
    Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg   Dutasteride 0.5 mg   Tamsulosin 0.4 mg
STARTED   1610   1623   1611 
COMPLETED   1113   1093   989 
NOT COMPLETED   497   530   622 
Adverse Event                211                185                210 
Withdrawal by Subject                114                160                148 
Lost to Follow-up                53                48                58 
Protocol Violation                29                29                34 
Lack of Efficacy                53                71                104 
Participant Relocated                7                2                8 
Site Closed/Sponsor Termination                7                7                4 
Non-compliant/Medication Interruption                6                4                7 
Prostate Surgery/TURP/Alt. Therapy                3                7                19 
Participant Decision/Withdrawn                2                0                4 
Acute Urinary Retention (AUR)                2                3                6 
Prohibited Medication                2                2                8 
Investigator Departure                2                0                0 
Alcohol Dependent                1                0                0 
Screen Failure                1                0                0 
No Improvement                1                0                0 
BPH/BPH symptoms worse/urinary incont.                1                0                5 
Financial Problems                1                0                0 
Loss of Libido                1                0                0 
Angina Pectoris                0                2                0 
Loss of Contact                0                1                0 
Neoplasm of Bladder/Prostate                0                1                1 
Cardiologist/Neurologist Decision                0                2                0 
Renal Insufficiency                0                1                0 
Back Pain                0                1                0 
Scheduling Issues                0                1                0 
Any Appreciable Improvement                0                1                0 
Investigator Decision                0                1                3 
Enrollment Error                0                0                2 
Urinary Tract Infection (UTI)                0                0                1 
Prostate Specific Antigen Rising                0                1                0 

Period 2:   16-Week Safety Follow-up Period
    Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg   Dutasteride 0.5 mg   Tamsulosin 0.4 mg
STARTED   1598 [1]   1615 [1]   1600 [1] 
COMPLETED   1224   1205   1143 
NOT COMPLETED   374   410   457 
Adverse Event                34                39                44 
Withdrawal by Subject                185                212                229 
Lost to Follow-up                101                97                111 
Protocol Violation                18                18                17 
Site Closed/Sponsor Termination                8                5                4 
Non-compliant/Medication Interruption                8                6                4 
Loss of Contact                4                0                2 
Disease Progression/Treatment Failure                3                1                1 
Participant relocated                2                3                1 
Participant Decision/Withdrawn                2                1                2 
Prohibited Medication                2                3                5 
Alcohol Dependent                1                0                1 
Prostate surgery/TURP/Alt. therapy                1                5                13 
Loss of Libido                1                0                0 
Enrollment Error                1                0                2 
Neoplasm of Bladder/Prostate Cancer                1                3                6 
Death                1                0                1 
Gyneomastia                1                0                0 
Acute Urinary Retention (AUR)                0                5                4 
BPH/BPH symptoms worse/urinary incont.                0                2                3 
Angina Pectoris                0                1                0 
Back Pain                0                1                0 
Scheduling Issues                0                2                4 
Investigator/Sponsor Decision                0                2                3 
Depression                0                1                0 
Diabetes Uncontrolled                0                1                0 
Jailed                0                1                0 
Other                0                1                0 
[1] Some par. didn't enter the Follow-up phase or dropped out before completing the treatment phase.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
Dutasteride 0.5 mg Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
Tamsulosin 0.4 mg Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
Total Total of all reporting groups

Baseline Measures
   Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg   Dutasteride 0.5 mg   Tamsulosin 0.4 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 1610   1623   1611   4844 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.0  (7.05)   66.0  (6.99)   66.2  (7.00)   66.1  (7.01) 
Gender 
[Units: Participants]
       
Female   0   0   0   0 
Male   1610   1623   1611   4844 
Race/Ethnicity, Customized 
[Units: Participants]
       
White   1421   1433   1405   4259 
Black   22   17   24   63 
Asian   107   106   112   325 
American Hispanic   44   48   55   147 
Unknown   16   19   15   50 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Primary:   Number of Participants With AUR or BPH-related Surgery   [ Time Frame: Baseline (Day 1) through Year 4 ]

3.  Secondary:   Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4   [ Time Frame: Years 1, 2, 3, and 4 ]

4.  Secondary:   The Number of Participants With Each of the Five Components of BPH Clinical Progression   [ Time Frame: Baseline (Day 1) to Year 4 ]

5.  Secondary:   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) ]

6.  Secondary:   Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria   [ Time Frame: Baseline (Day 1) through Year 4 ]

7.  Secondary:   Number of Participants With an Event of Post-baseline BPH-related Hematospermia   [ Time Frame: Baseline (Day 1) through Year 4 ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]

10.  Secondary:   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 ]

11.  Secondary:   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 ]

12.  Secondary:   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 ]

13.  Secondary:   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 ]

14.  Secondary:   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 ]

15.  Secondary:   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 ]

16.  Secondary:   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 ]

17.  Secondary:   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 ]

18.  Secondary:   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 ]

19.  Secondary:   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 ]

20.  Secondary:   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 ]

21.  Secondary:   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 ]

22.  Secondary:   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 ]

23.  Secondary:   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 ]

24.  Secondary:   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 ]

25.  Secondary:   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 ]

26.  Secondary:   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 ]

27.  Secondary:   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 ]

28.  Secondary:   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 ]

29.  Secondary:   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 ]

30.  Secondary:   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 ]

31.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:


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