Last updated: 11/04/2018 04:44:01
Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Percent change from baseline in the prostate volume at Month 6
Timeframe: Baseline and Month 6
Secondary outcomes:
Percent change from baseline in the prostate volume at Month 3
Timeframe: Baseline and Month 3
Change from baseline in the prostate volume at Month 6
Timeframe: Baseline and Month 6
Change from baseline in the prostate volume at Month 3
Timeframe: Baseline and Month 3
Percent change from baseline in the serum dihydrotestosterone (DHT) at Month 6
Timeframe: Baseline and Month 6
Percent change from baseline in the serum DHT at Month 3
Timeframe: Baseline and Month 3
Change from baseline in the serum DHT at Month 6
Timeframe: Baseline and Month 6
Change from baseline in the serum DHT at Month 3
Timeframe: Baseline and Month 3
Percent change from baseline in the American Urological Association Symptom Index (AUA-SI) score at Month 6
Timeframe: Baseline and Month 6
Percent change from baseline in the AUA-SI score at Month 3
Timeframe: Baseline and Month 3
Change from baseline in the AUA-SI score at Month 6
Timeframe: Baseline and Month 6
Change from baseline in the AUA-SI score at Month 3
Timeframe: Baseline and Month 3
Percent change from baseline in Maximum Urinary Flow Rate (Qmax) at month 6
Timeframe: Baseline and Month 6
Percent change from baseline in Qmax at Month 3
Timeframe: Baseline and Month 3
Change from baseline in Qmax at Month 6
Timeframe: Baseline and Month 6
Change from baseline in Qmax at Month 3
Timeframe: Baseline and Month 3
Interventions:
Drug: Dutasteride 0.5mg capsule
Drug: Dutasteride matched placebo
Enrollment:
253
Observational study model:
Not applicable
Primary completion date:
2009-23-03
Time perspective:
Not applicable
Clinical publications:
Na Y, Ye Z, Zhang S on behalf of the Chinese Dutasteride Phase III Trial (ARIA108898) Study Group. Efficacy and safety of dutasteride in Chinese adults with symptomatic benign prostatic hyperplasia. [Clin Drug Invest]. 2012;32(1):29-39.
Na Y, Ye Z, Zhang S on behalf of the Chinese Dutasteride Phase III Trial (ARIA108898) Study Group. Efficacy and safety of dutasteride in Chinese adults with symptomatic benign prostatic hyperplasia. [Clin Drug Invest]. 2012;32(1):29-39.
Medical condition
Benign Prostatic Hyperplasia
Product
dutasteride
Collaborators
Not applicable
Study date(s)
October 2007 to March 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Male
Age
50+ years
Accepts healthy volunteers
No
- Inclusion:
- Clinical diagnosis of BPH
Inclusion and exclusion criteria
Inclusion 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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-23-03
Actual study completion date
2009-23-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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