Benign Prostatic HyperplasiaPhase 3NCT00527605

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

A Phase 3 study testing Dutasteride 0.5mg capsule in people with Benign Prostatic Hyperplasia and Prostatic Hyperplasia, run by GlaxoSmithKline at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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 Read more about this study

Who is it for?: Ages 50 years and older, men only
Conditions the study is for: Benign Prostatic Hyperplasia, Prostatic Hyperplasia
What is being tested?: Dutasteride 0.5mg capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 253 participants
Where: 12 sitesChina
Study dates: Oct 2007to Mar 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Show all 20Show fewer

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.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

China12 sites

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

Other trials in China

About this study

Official title: 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

Conditions: Benign Prostatic Hyperplasia, Prostatic Hyperplasia
Being tested: Dutasteride 0.5mg capsule, Dutasteride matched placebo
Keywords: placebo control, Chinese, Dutasteride, Randomized, Benign Prostatic Hyperplasia, Double blind
Medical subject headings: Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dutasteride 0.5mg capsuleDrug
Dutasteride 0.5mg once daily orally
Dutasteride matched placeboDrug
Dutasteride matched placebo once daily orally

Study groups in NCT00527605
Study group	Role	What they receive
A	Experimental	dutasteride 0.5mg once daily orally Receives: Drug: Dutasteride 0.5mg capsule
B	Placebo comparator	Placebo matched once daily orally Receives: Drug: Dutasteride matched placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in the Prostate Volume at 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.
Measured: Baseline and Month 6

Secondary outcomes (15)

Percent Change From Baseline in the Prostate Volume at 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.
Measured: Baseline and Month 3
Change From Baseline in the Prostate Volume at 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.
Measured: Baseline and Month 6
Change From Baseline in the Prostate Volume at 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.
Measured: Baseline and Month 3
Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at 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.
Measured: Baseline and Month 6
Percent Change From Baseline in the Serum DHT at 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.
Measured: Baseline and Month 3
Change From Baseline in the Serum DHT at Month 6
Change from baseline was calculated as the value of DHT at Month 6 minus the baseline value.
Measured: Baseline and Month 6
Change From Baseline in the Serum DHT at Month 3
Change from baseline was calculated as the value of DHT at Month 3 minus the baseline value.
Measured: Baseline and Month 3
Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at 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.
Measured: Baseline and Month 6
Percent Change From Baseline in the AUA-SI Score at 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.
Measured: Baseline and Month 3
Change From Baseline in the AUA-SI Score at 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.
Measured: Baseline and Month 6
Change From Baseline in the AUA-SI Score at 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.
Measured: Baseline and Month 3
Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at 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.
Measured: Baseline and Month 6
Percent Change From Baseline in Qmax at 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.
Measured: Baseline and Month 3
Change From Baseline in Qmax at 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.
Measured: Baseline and Month 6
Change From Baseline in Qmax at 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.
Measured: Baseline and Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Mar 2009

First posted11 Sep 2007 (estimated)
Study startOct 2007
Primary completionMar 2009
Study completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 253 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00527605
Sponsor's protocol ID: ARI108898
Status last verified: May 2011
First submitted: 10 Sep 2007
Last updated: 21 Mar 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Na Y, Ye Z, Zhang S. 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;32(1):29-39. doi: 10.2165/11593750-000000000-00000.
PubMed 27933597
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. doi: 10.2165/11593750-000000000-00000.
PubMed 22017520

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Benign Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00527605
Acronym / sponsor ID: ARI108898
Conditions: Benign Prostatic Hyperplasia, Prostatic Hyperplasia
Keywords: placebo control, Chinese, Dutasteride, Randomized, Benign Prostatic Hyperplasia, Double blind
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 253 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 11 Sep 2007 (estimated)
Results: Posted 11 Mar 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: Dutasteride 0.5mg capsuledutasteride 0.5mg once daily orally
B	Placebo comparator	Drug: Dutasteride matched placeboPlacebo matched once daily orally

Who may qualify

Ages: 50 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (20 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dutasteride 0.5mg capsuleDutasteride 0.5mg once daily orally	Drug	A
Dutasteride matched placeboDutasteride matched placebo once daily orally	Drug	B

Primary outcome

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.

15 secondary outcomes

Percent Change From Baseline in the Prostate Volume at Month 3
Time frame: Baseline and Month 3
Change From Baseline in the Prostate Volume at Month 6
Time frame: Baseline and Month 6
Change From Baseline in the Prostate Volume at Month 3
Time frame: 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 in the Serum DHT at Month 3
Time frame: Baseline and Month 3
Change From Baseline in the Serum DHT at Month 6
Time frame: Baseline and Month 6
Change From Baseline in the Serum DHT at Month 3
Time frame: 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 in the AUA-SI Score at Month 3
Time frame: Baseline and Month 3
Change From Baseline in the AUA-SI Score at Month 6
Time frame: Baseline and Month 6
Change From Baseline in the AUA-SI Score at Month 3
Time frame: 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 in Qmax at Month 3
Time frame: Baseline and Month 3
Change From Baseline in Qmax at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Qmax at Month 3
Time frame: Baseline and Month 3

Results and safety

Results posted to the registry on 11 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dutasteride 0.5 mg	126	113
Placebo	127	116

Primary outcome: Percent Change From Baseline in the Prostate Volume at Month 6

Time frame: Baseline and Month 6. Mean (Standard Deviation). Unit: percent change in volume

Measure	Dutasteride 0.5 mg n = 114	Placebo n = 120
Value	-17.00 (21.41)	-2.77 (24.96)

Dutasteride 0.5 mg vs Placebo: Median Difference (Final Values): -14.23 (95% CI -20.23 to -8.22), p <0.0001, t-test, 2 sided

Population analysed: Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment (after the 4-week placebo run-in) and received at least one dose of study treatment. Some participants were missing Month 6 measurements.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dutasteride 0.5 mg	0 of 126 (0%)	27 of 126 (21.4%)	Not reported
Placebo	1 of 127 (0.8%)	25 of 127 (19.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27933597Na Y, Ye Z, Zhang S. 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;32(1):29-39. doi: 10.2165/11593750-000000000-00000.
Derived from this study: PubMed 22017520Na 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. doi: 10.2165/11593750-000000000-00000.

Related trials for Benign Prostatic Hyperplasia

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dutasteride 0.5mg capsule in people with Benign Prostatic Hyperplasia and Prostatic Hyperplasia, run by GlaxoSmithKline at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in the Prostate Volume at Month 6 (time frame: Baseline and Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00527605, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2012.