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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00527605
First received: September 10, 2007
Last updated: March 15, 2012
Last verified: May 2011
  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) , followed by a 12-month open-label treatment phase


Condition Intervention Phase
Benign Prostatic Hyperplasia
Prostatic Hyperplasia
Drug: Dutasteride 0.5mg capsule
Drug: Dutasteride matched placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percent Change From Baseline in the Prostate Volume at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Percent change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.


Secondary Outcome Measures:
  • Percent Change From Baseline in the Prostate Volume at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    Percent change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.

  • Change From Baseline in the Prostate Volume at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline. Prostate volume was measured by transrectal ultrasound.

  • Change From Baseline in the Prostate Volume at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    Change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline. Prostate volume is measured by transrectal ultrasound.

  • Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Percent change from baseline was calculated as serum DHT at month 6 minus the value at baseline ,divided by the baseline value and multiplied by 100.

  • Percent Change From Baseline in the Serum DHT at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    Percent change from baseline was calculated as the DHT at Month 3 minus the value at baseline, divided by the baseline value and multiplied by 100.

  • Change From Baseline in the Serum DHT at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Change from baseline was calculated as the value of DHT at Month 6 minus the baseline value.

  • Change From Baseline in the Serum DHT at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    Change from baseline was calculated as the value of DHT at Month 3 minus the baseline value.

  • Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Percent change from baseline is calculated as the AUA-SI score at month 6 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.

  • Percent Change From Baseline in the AUA-SI Score at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    Percent change from baseline is calculated as the AUA-SI score at month 3 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.

  • Change From Baseline in the AUA-SI Score at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Change from baseline was calculated as the AUS-SI score at month 6 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.

  • Change From Baseline in the AUA-SI Score at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    Change from baseline was calculated as the AUA-SI score at month 3 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostate hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.

  • Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Percent change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.

  • Percent Change From Baseline in Qmax at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    Percent change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.

  • Change From Baseline in Qmax at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.

  • Change From Baseline in Qmax at Month 3 [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    Change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.


Enrollment: 253
Study Start Date: October 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
dutasteride 0.5mg once daily orally
Drug: Dutasteride 0.5mg capsule
Dutasteride 0.5mg once daily orally
Other Name: Dutasteride 0.5mg capsule
Placebo Comparator: B
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 [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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
China
GSK Investigational Site
Beijing, China, 100034
GSK Investigational Site
Beijing, China
GSK Investigational Site
Beijing, China, 100050
GSK Investigational Site
Beijing, China, 100853
GSK Investigational Site
Shanghai, China, 200025
GSK Investigational Site
Shanghai, China, 200030
GSK Investigational Site
Shanghai, China, 200001
GSK Investigational Site
Tianjin, China, 300211
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00527605     History of Changes
Other Study ID Numbers: ARI108898
Study First Received: September 10, 2007
Results First Received: February 22, 2010
Last Updated: March 15, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
placebo control
Chinese
Dutasteride
Randomized
Benign Prostatic Hyperplasia
Double blind

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014