DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Benign Prostatic Hyperplasia; Prostatic Hyperplasia

Intervention: Dutasteride 0.5mg capsule (Drug); Dutasteride matched placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome:

Percent Change From Baseline in the Prostate Volume at Month 3

Change From Baseline in the Prostate Volume at Month 6

Change From Baseline in the Prostate Volume at Month 3

Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6

Percent Change From Baseline in the Serum DHT at Month 3

Change From Baseline in the Serum DHT at Month 6

Change From Baseline in the Serum DHT at Month 3

Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6

Percent Change From Baseline in the AUA-SI Score at Month 3

Change From Baseline in the AUA-SI Score at Month 6

Change From Baseline in the AUA-SI Score at Month 3

Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6

Percent Change From Baseline in Qmax at Month 3

Change From Baseline in Qmax at Month 6

Change From Baseline in Qmax at Month 3

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Male.

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.

Locations and Contacts

GSK Investigational Site, Beijing 100050, China

GSK Investigational Site, Beijing 100853, China

GSK Investigational Site, Beijing, China

GSK Investigational Site, Beijing 100034, China

GSK Investigational Site, Shanghai 200001, China

GSK Investigational Site, Shanghai 200025, China

GSK Investigational Site, Shanghai 200030, China

GSK Investigational Site, Tianjin 300211, China

GSK Investigational Site, Guangzhou, Guangdong 510180, China

GSK Investigational Site, Wuhan, Hubei 430030, China

GSK Investigational Site, Nanjing, Jiangsu 210006, China

GSK Investigational Site, Hangzhou, Zhejiang 310003, China

Additional Information

Related publications:

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.

Starting date: October 2007
Last updated: March 15, 2012

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017