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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: April 11, 2013
Last verified: March 2012
Results First Received: February 26, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   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
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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  
Unknown                 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  
Number of Participants  
[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
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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:
Oliver Haillot, Avelino Fraga, Piotr Maciukiewicz, Dmitry Pushkar, Teuvo Tammela, Klaus Höfner, Venancio Chantada, Paul Gagnier, Betsy Morrill. The effects of combination therapy with dutasteride plus tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year post hoc analysis of European men in the CombAT study. [Prostate Cancer Prostatic Dis]. 2011;14(4):302-6.
Francesco Montorsi, Thomas Henkel, Arno Geboers, Vincenzo Mirone, Peio Arrosagarai, Betsy Morrill, Libby Black. Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 4-year data from the CombAT study. [Int J Clinc Prac]. 2010;64(8):1042-1051.

Publications automatically indexed to this study:

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: April 11, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration