Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hyperplasia
Intervention: Dutasteride 0.5mg capsule (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trial, MD, 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)
Clinical Details
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)
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Bio-availability Study
Primary outcome: prostate volume at 6 months.
Secondary outcome: - [Dihydrotestosterone (DHT)]
- [American Urological Association Symptom Index (AUA-SI)]
- [maximum urinary flow (Qmax)]
- safety and tolerability
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Male.
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.
Locations and Contacts
GSK Clinical Trials Call Center, Shanghai 200127, Argentina; Not yet recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
GSK Clinical Trials Call Center, Beijing 100034, China; Not yet recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
GSK Clinical Trials Call Center, Beijing 100853, China; Not yet recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
GSK Clinical Trials Call Center, Beijing 100050, China; Not yet recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
GSK Clinical Trials Call Center, shanghai 200040, China; Not yet recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
GSK Clinical Trials Call Center, Hangzhou 310003, China; Not yet recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
GSK Clinical Trials Call Center, Suzhou 215006, China; Not yet recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
GSK Clinical Trials Call Center, guangzhou 510000, China; Not yet recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
GSK Clinical Trials Call Center, Wuhan 430030, China; Not yet recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
GSK Clinical Trials Call Center, shanghai 200031, China; Not yet recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718
Additional Information
Starting date: September 2007
Ending date: February 2009
Last updated: April 4, 2008
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