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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | dutasteride 0.5mg once daily orally |
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| B | Placebo Comparator | Placebo matched once daily orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dutasteride 0.5mg capsule | Drug | Dutasteride 0.5mg once daily orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in the Prostate Volume at Month 6 | 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. | Baseline and Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in the Prostate Volume at Month 3 | 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. | Baseline and Month 3 |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Guangzhou | Guangdong | 510180 | China | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27933597 | Background | Na Y, Ye Z, Zhang S. 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;32(1):29-39. doi: 10.2165/11593750-000000000-00000. | |
| 22017520 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dutasteride 0.5 mg | Oral dutasteride 0.5 milligrams (mg) once a day for 6 months |
| FG001 | Placebo | Matching oral placebo once a day for 6 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dutasteride matched placebo |
| Drug |
Dutasteride matched placebo once daily orally |
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| Change From Baseline in the Prostate Volume at Month 6 |
Change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline. Prostate volume was measured by transrectal ultrasound. |
| Baseline and Month 6 |
| Change From Baseline in the Prostate Volume at Month 3 | Change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline. Prostate volume is measured by transrectal ultrasound. | Baseline and Month 3 |
| Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6 | 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. | Baseline and Month 6 |
| Percent Change From Baseline in the Serum DHT at Month 3 | 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. | Baseline and Month 3 |
| Change From Baseline in the Serum DHT at Month 6 | Change from baseline was calculated as the value of DHT at Month 6 minus the baseline value. | Baseline and Month 6 |
| Change From Baseline in the Serum DHT at Month 3 | Change from baseline was calculated as the value of DHT at Month 3 minus the baseline value. | Baseline and Month 3 |
| Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6 | 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. | Baseline and Month 6 |
| Percent Change From Baseline in the AUA-SI Score at Month 3 | 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. | Baseline and Month 3 |
| Change From Baseline in the AUA-SI Score at Month 6 | 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. | Baseline and Month 6 |
| Change From Baseline in the AUA-SI Score at Month 3 | 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. | Baseline and Month 3 |
| Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6 | 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. | Baseline and Month 6 |
| Percent Change From Baseline in Qmax at Month 3 | 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. | Baseline and Month 3 |
| Change From Baseline in Qmax at Month 6 | 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. | Baseline and Month 6 |
| Change From Baseline in Qmax at Month 3 | 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. | Baseline and Month 3 |
| Wuhan |
| Hubei |
| 430030 |
| China |
| GSK Investigational Site | Nanjing | Jiangsu | 210006 | China |
| GSK Investigational Site | Hangzhou | Zhejiang | 310003 | China |
| GSK Investigational Site | Beijing | 100034 | China |
| GSK Investigational Site | Beijing | 100050 | China |
| GSK Investigational Site | Beijing | 100853 | China |
| GSK Investigational Site | Beijing | 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 |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dutasteride 0.5 mg | Oral dutasteride 0.5 milligrams (mg) once a day for 6 months |
| BG001 | Placebo | Matching oral placebo once a day for 6 months |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in the Prostate Volume at Month 6 | 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. | Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment (after the 4-week placebo run-in) and received at least one dose of study treatment. Some participants were missing Month 6 measurements. | Posted | Mean | Standard Deviation | percent change in volume | Baseline and Month 6 |
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| Secondary | Percent Change From Baseline in the Prostate Volume at Month 3 | 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. | ITT Population. Some participants were missing Month 3 measurements. | Posted | Mean | Standard Deviation | percent change in volume | Baseline and Month 3 |
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| Secondary | Change From Baseline in the Prostate Volume at Month 6 | Change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline. Prostate volume was measured by transrectal ultrasound. | ITT Population. Some participants were missing Month 6 measurements. | Posted | Mean | Standard Deviation | cubic centimeters | Baseline and Month 6 |
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| Secondary | Change From Baseline in the Prostate Volume at Month 3 | Change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline. Prostate volume is measured by transrectal ultrasound. | ITT Population. Some participants were missing Month 3 measurements. | Posted | Mean | Standard Deviation | cubic centimeters | Baseline and Month 3 |
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| Secondary | Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6 | 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. | ITT Population. Some participants were missing Month 6 measurements. | Posted | Mean | Standard Deviation | percent change | Baseline and Month 6 |
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| Secondary | Percent Change From Baseline in the Serum DHT at Month 3 | 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. | ITT Population. Some participants were missing Month 3 measurements. | Posted | Mean | Standard Deviation | percent change | Baseline and Month 3 |
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| Secondary | Change From Baseline in the Serum DHT at Month 6 | Change from baseline was calculated as the value of DHT at Month 6 minus the baseline value. | ITT Population. Some participants were missing Month 6 measurements. | Posted | Mean | Standard Deviation | picograms/milliliter (pg/ml) | Baseline and Month 6 |
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| Secondary | Change From Baseline in the Serum DHT at Month 3 | Change from baseline was calculated as the value of DHT at Month 3 minus the baseline value. | ITT Population. Some participants were missing Month 3 measurements. | Posted | Mean | Standard Deviation | pg/ml | Baseline and Month 3 |
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| Secondary | Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6 | 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. | ITT Population. Some participants were missing Month 6 measurements. | Posted | Mean | Standard Deviation | percent change | Baseline and Month 6 |
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| Secondary | Percent Change From Baseline in the AUA-SI Score at Month 3 | 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. | ITT Population. Some participants were missing Month 3 measurements. | Posted | Mean | Standard Deviation | percent change | Baseline and Month 3 |
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| Secondary | Change From Baseline in the AUA-SI Score at Month 6 | 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. | ITT Population. Some participants were missing Month 6 measurements. | Posted | Mean | Standard Deviation | points on a scale | Baseline and Month 6 |
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| Secondary | Change From Baseline in the AUA-SI Score at Month 3 | 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. | ITT Population. Some participants were missing Month 3 measurements. | Posted | Mean | Standard Deviation | points on a scale | Baseline and Month 3 |
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| Secondary | Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6 | 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. | ITT Population. Some participants were missing Month 6 measurements. | Posted | Mean | Standard Deviation | percent change | Baseline and Month 6 |
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| Secondary | Percent Change From Baseline in Qmax at Month 3 | 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. | ITT Population. Some participants were missing Month 3 measurements. | Posted | Mean | Standard Deviation | percent change | Baseline and Month 3 |
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| Secondary | Change From Baseline in Qmax at Month 6 | 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. | ITT Population. Some participants were missing Month 6 measurements. | Posted | Mean | Standard Deviation | milliliters/second (ml/s) | Baseline and Month 6 |
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| Secondary | Change From Baseline in Qmax at Month 3 | 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. | ITT Population. Some participants were missing Month 3 measurements. | Posted | Mean | Standard Deviation | ml/s | Baseline and Month 3 |
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The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dutasteride 0.5 mg | Oral dutasteride 0.5 milligrams (mg) once a day for 6 months | 0 | 126 | 27 | 126 | ||
| EG001 | Placebo | Matching oral placebo once a day for 6 months | 1 | 127 | 25 | 127 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glaucoma | Eye disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA | Systematic Assessment |
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| Keratitis | Eye disorders | MedDRA | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Dysgeusia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Pharyngitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Throat irritation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA | Systematic Assessment |
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| Alanine aminotransferase increased | Infections and infestations | MedDRA | Systematic Assessment |
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| Aspartate aminotransferase increased | Infections and infestations | MedDRA | Systematic Assessment |
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| Blood glucose increased | Infections and infestations | MedDRA | Systematic Assessment |
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| Prostatic specific antigen increased | Infections and infestations | MedDRA | Systematic Assessment |
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| White blood cell count decreased | Infections and infestations | MedDRA | Systematic Assessment |
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| Red blood cells urine | Infections and infestations | MedDRA | Systematic Assessment |
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| Transaminases increased | Infections and infestations | MedDRA | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Contusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Tinnitus | Nervous system disorders | MedDRA | Systematic Assessment |
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| Vertigo | Nervous system disorders | MedDRA | Systematic Assessment |
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| Poor quality sleep | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Calculus bladder | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Urethral pain | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Libido decreased | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Erectile dysfunction | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068538 | Dutasteride |
| ID | Term |
|---|---|
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Male |
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