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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Conditions: |
Benign Prostatic Hyperplasia Prostatic Hyperplasia |
| Interventions: |
Drug: Dutasteride 0.5mg capsule Drug: Dutasteride matched placebo |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| Description | |
|---|---|
| Dutasteride 0.5 mg | Oral dutasteride 0.5 milligrams (mg) once a day for 6 months |
| Placebo | Matching oral placebo once a day for 6 months |
| Dutasteride 0.5 mg | Placebo | |
|---|---|---|
| STARTED | 126 | 127 |
| COMPLETED | 113 | 116 |
| NOT COMPLETED | 13 | 11 |
| Adverse Event | 3 | 0 |
| Withdrawal by Subject | 3 | 7 |
| Lost to Follow-up | 6 | 2 |
| Protocol Violation | 1 | 2 |
Baseline Characteristics
| Description | |
|---|---|
| Dutasteride 0.5 mg | Oral dutasteride 0.5 milligrams (mg) once a day for 6 months |
| Placebo | Matching oral placebo once a day for 6 months |
| Dutasteride 0.5 mg | Placebo | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
126 | 127 | 253 |
|
Age
[units: years] Mean ± Standard Deviation |
65.8 ± 7.7 | 66.9 ± 8.2 | 66.4 ± 7.9 |
|
Gender
[units: participants] |
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| Female | 0 | 0 | 0 |
| Male | 126 | 127 | 253 |
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Race/Ethnicity, Customized
[units: participants] |
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| Chinese | 126 | 127 | 253 |
Outcome Measures
| 1. Primary: | Percent Change From Baseline in the Prostate Volume at Month 6 [ Time Frame: Baseline and Month 6 ] |
| 2. Secondary: | Percent Change From Baseline in the Prostate Volume at Month 3 [ Time Frame: Baseline and Month 3 ] |
| 3. Secondary: | Change From Baseline in the Prostate Volume at Month 6 [ Time Frame: Baseline and Month 6 ] |
| 4. Secondary: | Change From Baseline in the Prostate Volume at Month 3 [ Time Frame: Baseline and Month 3 ] |
| 5. Secondary: | Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6 [ Time Frame: Baseline and Month 6 ] |
| 6. Secondary: | Percent Change From Baseline in the Serum DHT at Month 3 [ Time Frame: Baseline and Month 3 ] |
| 7. Secondary: | Change From Baseline in the Serum DHT at Month 6 [ Time Frame: Baseline and Month 6 ] |
| 8. Secondary: | Change From Baseline in the Serum DHT at Month 3 [ Time Frame: Baseline and Month 3 ] |
| 9. Secondary: | Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6 [ Time Frame: Baseline and Month 6 ] |
| 10. Secondary: | Percent Change From Baseline in the AUA-SI Score at Month 3 [ Time Frame: Baseline and Month 3 ] |
| 11. Secondary: | Change From Baseline in the AUA-SI Score at Month 6 [ Time Frame: Baseline and Month 6 ] |
| 12. Secondary: | Change From Baseline in the AUA-SI Score at Month 3 [ Time Frame: Baseline and Month 3 ] |
| 13. Secondary: | Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6 [ Time Frame: Baseline and Month 6 ] |
| 14. Secondary: | Percent Change From Baseline in Qmax at Month 3 [ Time Frame: Baseline and Month 3 ] |
| 15. Secondary: | Change From Baseline in Qmax at Month 6 [ Time Frame: Baseline and Month 6 ] |
| 16. Secondary: | Change From Baseline in Qmax at Month 3 [ Time Frame: Baseline and Month 3 ] |
More Information
| 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:
|
| 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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| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00527605 History of Changes |
| Other Study ID Numbers: | ARI108898 |
| Study First Received: | September 10, 2007 |
| Results First Received: | February 22, 2010 |
| Last Updated: | May 19, 2011 |
| Health Authority: | China: State Food and Drug Administration |