Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects

This study has been completed.

Study NCT00368979 Information provided by GlaxoSmithKline

First Received on August 24, 2006. Last Updated on July 26, 2011 History of Changes

Results First Received: December 5, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Benign Prostatic Hyperplasia Prostatic Hyperplasia
Interventions:	Drug: Dutasteride Drug: 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
Placebo	Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
Dutasteride	Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.

Participant Flow: Overall Study

	Placebo	Dutasteride
STARTED	185	193
COMPLETED	160	163
NOT COMPLETED	25	30
Adverse Event	9	16
Lack of Efficacy	5	3
Not specified	3	1
Lost to Follow-up	1	0
Protocol Violation	2	1
Withdrawal by Subject	5	9

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
Dutasteride	Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.

Baseline Measures

	Placebo	Dutasteride	Total
Number of Participants [units: participants]	181	184	365
Age [units: years] Mean ± Standard Deviation	66.9 ± 6.76	68.0 ± 6.07	67.4 ± 6.44
Gender [units: participants]
Female	0	0	0
Male	181	184	365
Race/Ethnicity, Customized [units: participants]
Asian-Japanese	181	184	365

Outcome Measures

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1. Primary:

Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52 [ Time Frame: Baseline and Week 52 ]

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2. Secondary:

Percent Change From Baseline in Prostate Volume at Week 52 [ Time Frame: Baseline and Week 52 ]

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3. Secondary:

Number of Participants With IPSS Improvement From Baseline at Week 52 [ Time Frame: Baseline and Week 52 ]

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4. Secondary:

Change From Baseline in Maximum Urine Flow Rate (Qmax) at Week 52 [ Time Frame: Baseline and Week 52 ]

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5. Secondary:

Number of Participants With Qmax Improvement From Baseline at Week 52 [ Time Frame: Baseline and Week 52 ]

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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

Publications:

Tsukamoto T, Endo Y, Narita M. Efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia. Int J Urol. 2009 Sep;16(9):745-50. Epub 2009 Aug 5.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00368979 History of Changes
Other Study ID Numbers:	ARI105326
Study First Received:	August 24, 2006
Results First Received:	December 5, 2008
Last Updated:	July 26, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare