Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)

This study has been completed.

Study NCT00527605 Information provided by GlaxoSmithKline

First Received on September 10, 2007. Last Updated on May 19, 2011 History of Changes

Results First Received: February 22, 2010

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

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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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	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

Participant Flow: Overall Study

	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

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Reporting Groups

	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

Baseline Measures

	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]
Female	0	0	0
Male	126	127	253
Race/Ethnicity, Customized [units: participants]
Chinese	126	127	253

Outcome Measures

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1. Primary:

Percent Change From Baseline in the Prostate Volume at Month 6 [ Time Frame: Baseline and Month 6 ]

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2. Secondary:

Percent Change From Baseline in the Prostate Volume at Month 3 [ Time Frame: Baseline and Month 3 ]

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3. Secondary:

Change From Baseline in the Prostate Volume at Month 6 [ Time Frame: Baseline and Month 6 ]

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4. Secondary:

Change From Baseline in the Prostate Volume at Month 3 [ Time Frame: Baseline and Month 3 ]

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5. Secondary:

Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6 [ Time Frame: Baseline and Month 6 ]

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6. Secondary:

Percent Change From Baseline in the Serum DHT at Month 3 [ Time Frame: Baseline and Month 3 ]

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7. Secondary:

Change From Baseline in the Serum DHT at Month 6 [ Time Frame: Baseline and Month 6 ]

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8. Secondary:

Change From Baseline in the Serum DHT at Month 3 [ Time Frame: Baseline and Month 3 ]

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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 ]

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10. Secondary:

Percent Change From Baseline in the AUA-SI Score at Month 3 [ Time Frame: Baseline and Month 3 ]

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11. Secondary:

Change From Baseline in the AUA-SI Score at Month 6 [ Time Frame: Baseline and Month 6 ]

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12. Secondary:

Change From Baseline in the AUA-SI Score at Month 3 [ Time Frame: Baseline and Month 3 ]

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13. Secondary:

Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6 [ Time Frame: Baseline and Month 6 ]

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14. Secondary:

Percent Change From Baseline in Qmax at Month 3 [ Time Frame: Baseline and Month 3 ]

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15. Secondary:

Change From Baseline in Qmax at Month 6 [ Time Frame: Baseline and Month 6 ]

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16. Secondary:

Change From Baseline in Qmax at Month 3 [ Time Frame: Baseline and Month 3 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Na Y, Ye Z, Zhang S; Chinese Dutasteride Phase III Trial (ARIA108898) Study Group. Efficacy and safety of dutasteride in Chinese adults with symptomatic benign prostatic hyperplasia: a randomized, double-blind, parallel-group, placebo-controlled study with an open-label extension. Clin Drug Investig. 2012 Jan 1;32(1):29-39.

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