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

March 15, 2012 updated by: GlaxoSmithKline

A Randomized, Double-blind, Placebo-controlled, Six-month Parallel-group Study to Assess Efficacy and Safety of Dutasteride 0.5mg Once Daily in Chinese Patients With Benign Prostatic Hyperplasia (BPH), Followed by a 12-month Open-label Treatment Phase

This randomized, double-blind, placebo-controlled, six-month parallel-group study assess efficacy and safety of dutasteride 0.5mg once daily in Chinese patients with Benign Prostatic Hyperplasia (BPH) , followed by a 12-month open-label treatment phase

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
253

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100034
        • GSK Investigational Site
      • Beijing, China
        • GSK Investigational Site
      • Beijing, China, 100050
        • GSK Investigational Site
      • Beijing, China, 100853
        • GSK Investigational Site
      • Shanghai, China, 200025
        • GSK Investigational Site
      • Shanghai, China, 200030
        • GSK Investigational Site
      • Shanghai, China, 200001
        • GSK Investigational Site
      • Tianjin, China, 300211
        • GSK Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • GSK Investigational Site
    • Hubei
      • Wuhan, Hubei, China, 430030
        • GSK Investigational Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • GSK Investigational Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion:

  • Clinical diagnosis of BPH
  • AUA-SI >=12 [American Urological Association Symptom Index]
  • Qmax > 5ml/sec and <=15ml/sec and minimum voided volume of >=125ml
  • Prostate volume >=30cm(3)

Exclusion:

  • Post void residual volume >250ml
  • History or evidence of prostate cancer
  • Total serum PSA <1.5ng/ml or >10.0ng/ml (Prostate specific antigen)
  • Previous prostatic surgery or other invasive procedures to treat BPH.
  • History of AUR (Acute Urinary Retention) within 3 months
  • History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days
  • Any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate
  • History of hepatic impairment or abnormal liver function tests
  • Use of any 5a-reductase inhibitors ,any drugs with antiandrogenic properties or other drugs noted for gynaecomastia effects, or could affect prostate volume, within past 6 months and throughout the study
  • Use of alpha-receptor blockers within 2 weeks and throughout the study.
  • Use of phytotherapy for BPH within 2 weeks and/or predicted to need phytotherapy during the study.
  • Concurrent use of anabolic steroids
  • Use of any alpha-adrenergic agonists or cholinergics within 48 hours prior to uroflowmetry assessment.
  • Hypersensitivity to any 5a-reductase inhibitor or other chemically-related drugs.
  • Actively trying to procreate or unwilling to wear a condom during intercourse with a woman of childbearing potential for duration of participation in this study and 16 weeks following treatment.
  • History or current evidence of drug or alcohol abuse within the previous 12 months.
  • History of any illness that in the opinion of the investigator might confound the results of the study or poses additional risk to the patient.
  • Any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, of cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
  • History of renal insufficiency, or serum creatinine >1.5xULN (Upper Limit of Normal )
  • Participation in any investigational or marketed drug trial within 30 days and during the course of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A
dutasteride 0.5mg once daily orally
Drug: Dutasteride 0.5mg capsule
Dutasteride 0.5mg once daily orally
Placebo Comparator: B
Placebo matched once daily orally
Drug: Dutasteride matched placebo
Dutasteride matched placebo once daily orally

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in the Prostate Volume at Month 6
Time Frame: Baseline and Month 6
Percent change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.
Baseline and Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in the Prostate Volume at Month 3
Time Frame: Baseline and Month 3
Percent change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.
Baseline and Month 3
Change From Baseline in the Prostate Volume at Month 6
Time Frame: Baseline and Month 6
Change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline. Prostate volume was measured by transrectal ultrasound.
Baseline and Month 6
Change From Baseline in the Prostate Volume at Month 3
Time Frame: Baseline and Month 3
Change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline. Prostate volume is measured by transrectal ultrasound.
Baseline and Month 3
Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6
Time Frame: Baseline and Month 6
Percent change from baseline was calculated as serum DHT at month 6 minus the value at baseline ,divided by the baseline value and multiplied by 100.
Baseline and Month 6
Percent Change From Baseline in the Serum DHT at Month 3
Time Frame: Baseline and Month 3
Percent change from baseline was calculated as the DHT at Month 3 minus the value at baseline, divided by the baseline value and multiplied by 100.
Baseline and Month 3
Change From Baseline in the Serum DHT at Month 6
Time Frame: Baseline and Month 6
Change from baseline was calculated as the value of DHT at Month 6 minus the baseline value.
Baseline and Month 6
Change From Baseline in the Serum DHT at Month 3
Time Frame: Baseline and Month 3
Change from baseline was calculated as the value of DHT at Month 3 minus the baseline value.
Baseline and Month 3
Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6
Time Frame: Baseline and Month 6
Percent change from baseline is calculated as the AUA-SI score at month 6 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.
Baseline and Month 6
Percent Change From Baseline in the AUA-SI Score at Month 3
Time Frame: Baseline and Month 3
Percent change from baseline is calculated as the AUA-SI score at month 3 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.
Baseline and Month 3
Change From Baseline in the AUA-SI Score at Month 6
Time Frame: Baseline and Month 6
Change from baseline was calculated as the AUS-SI score at month 6 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.
Baseline and Month 6
Change From Baseline in the AUA-SI Score at Month 3
Time Frame: Baseline and Month 3
Change from baseline was calculated as the AUA-SI score at month 3 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostate hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.
Baseline and Month 3
Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6
Time Frame: Baseline and Month 6
Percent change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.
Baseline and Month 6
Percent Change From Baseline in Qmax at Month 3
Time Frame: Baseline and Month 3
Percent change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.
Baseline and Month 3
Change From Baseline in Qmax at Month 6
Time Frame: Baseline and Month 6
Change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.
Baseline and Month 6
Change From Baseline in Qmax at Month 3
Time Frame: Baseline and Month 3
Change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.
Baseline and Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ARI108898

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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