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

NCT ID: NCT00527605

Last Updated: 2012-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 253 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-03-31

Brief 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

Conditions

Benign Prostatic Hyperplasia; Prostatic Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A

dutasteride 0.5mg once daily orally

Group Type: EXPERIMENTAL

Dutasteride 0.5mg capsule

Intervention Type: DRUG

Dutasteride 0.5mg once daily orally

B

Placebo matched once daily orally

Group Type: PLACEBO_COMPARATOR

Dutasteride matched placebo

Intervention Type: DRUG

Dutasteride matched placebo once daily orally

Interventions

Dutasteride 0.5mg capsule

Dutasteride 0.5mg once daily orally

Intervention Type: DRUG

Dutasteride matched placebo

Dutasteride matched placebo once daily orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Guangzhou, Guangdong, China

GSK Investigational Site

Wuhan, Hubei, China

GSK Investigational Site

Nanjing, Jiangsu, China

GSK Investigational Site

Hangzhou, Zhejiang, China

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Shanghai, , China

GSK Investigational Site

Shanghai, , China

GSK Investigational Site

Shanghai, , China

GSK Investigational Site

Tianjin, , China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 27933597 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22017520 (View on PubMed)

Other Identifiers

ARI108898

Identifier Type: -

Identifier Source: org_study_id