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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00527605

Purpose

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)

Condition	Intervention	Phase
Benign Prostatic Hyperplasia	Drug: Dutasteride matched placebo Drug: Dutasteride 0.5mg capsule	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Bio-availability Study
Official Title:	A 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)

Resource links provided by NLM:

Drug Information available for: Dutasteride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

prostate volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

[Dihydrotestosterone (DHT)] - [American Urological Association Symptom Index (AUA-SI)] - [maximum urinary flow (Qmax)] - safety and tolerability [ Time Frame: At 6 month, 12 month, and 18 month ] [ Designated as safety issue: No ]

Enrollment:	240
Study Start Date:	November 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
dutasteride: Experimental dutasteride 0.5mg once daily orally	Drug: Dutasteride 0.5mg capsule Dutasteride 0.5mg once daily orally
Placebo: Placebo Comparator Placebo matched once daily orally	Drug: Dutasteride matched placebo Dutasteride matched placebo once daily orally

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Clinical diagnosis of BPH
AUA-SI >12
Qmax > 5ml/sec and <15ml/sec and minimum voided volume of >125ml
Prostate volume >30cm3

Exclusion:

Post void residual volume >250ml
History or evidence of prostate cancer
Total serum PSA <1.5ng/ml or >10.0ng/ml (
Previous prostatic surgery or other invasive procedures to treat BPH.
History of AUR 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
Participation in any investigational or marketed drug trial within 30 days and during the course of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527605

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	ARI108898
Study First Received:	September 10, 2007
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00527605 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Dutasteride
placebo control
Double blind

Randomized
Benign Prostatic Hyperplasia
Chinese

Additional relevant MeSH terms:

Dutasteride
Hyperplasia
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases

Prostatic Hyperplasia
Enzyme Inhibitors
Genital Diseases, Male
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010