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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Dutasteride

Criteria

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.