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Trial record 46 of 117 for:    DUTASTERIDE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00527605
Recruitment Status : Completed
First Posted : September 11, 2007
Results First Posted : March 11, 2010
Last Update Posted : March 21, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Benign Prostatic Hyperplasia
Prostatic Hyperplasia
Interventions Drug: Dutasteride 0.5mg capsule
Drug: Dutasteride matched placebo
Enrollment 253
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dutasteride 0.5 mg Placebo
Hide Arm/Group Description Oral dutasteride 0.5 milligrams (mg) once a day for 6 months Matching oral placebo once a day for 6 months
Period Title: Overall Study
Started 126 127
Completed 113 116
Not Completed 13 11
Reason Not Completed
Adverse Event             3             0
Withdrawal by Subject             3             7
Lost to Follow-up             6             2
Protocol Violation             1             2
Arm/Group Title Dutasteride 0.5 mg Placebo Total
Hide Arm/Group Description Oral dutasteride 0.5 milligrams (mg) once a day for 6 months Matching oral placebo once a day for 6 months Total of all reporting groups
Overall Number of Baseline Participants 126 127 253
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 126 participants 127 participants 253 participants
65.8  (7.7) 66.9  (8.2) 66.4  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 127 participants 253 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
126
 100.0%
127
 100.0%
253
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Chinese Number Analyzed 126 participants 127 participants 253 participants
126 127 253
1.Primary Outcome
Title Percent Change From Baseline in the Prostate Volume at Month 6
Hide Description 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.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dutasteride 0.5 mg Placebo
Hide Arm/Group Description:
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
Matching oral placebo once a day for 6 months
Overall Number of Participants Analyzed 114 120
Mean (Standard Deviation)
Unit of Measure: percent change in volume
-17.00  (21.41) -2.77  (24.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dutasteride 0.5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -14.23
Confidence Interval 95%
-20.23 to -8.22
Estimation Comments Dutasteride arm minus placebo arm.
2.Secondary Outcome
Title Percent Change From Baseline in the Prostate Volume at Month 3
Hide Description 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.
Time Frame Baseline and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants were missing Month 3 measurements.
Arm/Group Title Dutasteride 0.5 mg Placebo
Hide Arm/Group Description:
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
Matching oral placebo once a day for 6 months
Overall Number of Participants Analyzed 112 118
Mean (Standard Deviation)
Unit of Measure: percent change in volume
-12.02  (23.22) -1.02  (25.79)
3.Secondary Outcome
Title Change From Baseline in the Prostate Volume at Month 6
Hide Description Change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline. Prostate volume was measured by transrectal ultrasound.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants were missing Month 6 measurements.
Arm/Group Title Dutasteride 0.5 mg Placebo
Hide Arm/Group Description:
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
Matching oral placebo once a day for 6 months
Overall Number of Participants Analyzed 114 120
Mean (Standard Deviation)
Unit of Measure: cubic centimeters
-9.16  (12.74) -1.20  (12.77)
4.Secondary Outcome
Title Change From Baseline in the Prostate Volume at Month 3
Hide Description Change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline. Prostate volume is measured by transrectal ultrasound.
Time Frame Baseline and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants were missing Month 3 measurements.
Arm/Group Title Dutasteride 0.5 mg Placebo
Hide Arm/Group Description:
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
Matching oral placebo once a day for 6 months
Overall Number of Participants Analyzed 112 118
Mean (Standard Deviation)
Unit of Measure: cubic centimeters
-7.11  (13.02) -1.06  (11.48)
5.Secondary Outcome
Title Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6
Hide Description 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.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants were missing Month 6 measurements.
Arm/Group Title Dutasteride 0.5 mg Placebo
Hide Arm/Group Description:
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
Matching oral placebo once a day for 6 months
Overall Number of Participants Analyzed 114 121
Mean (Standard Deviation)
Unit of Measure: percent change
-52.53  (44.42) 26.78  (149.07)
6.Secondary Outcome
Title Percent Change From Baseline in the Serum DHT at Month 3
Hide Description 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.
Time Frame Baseline and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants were missing Month 3 measurements.
Arm/Group Title Dutasteride 0.5 mg Placebo
Hide Arm/Group Description:
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
Matching oral placebo once a day for 6 months
Overall Number of Participants Analyzed 114 120
Mean (Standard Deviation)
Unit of Measure: percent change
-59.15  (37.90) 28.33  (133.71)
7.Secondary Outcome
Title Change From Baseline in the Serum DHT at Month 6
Hide Description Change from baseline was calculated as the value of DHT at Month 6 minus the baseline value.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants were missing Month 6 measurements.
Arm/Group Title Dutasteride 0.5 mg Placebo
Hide Arm/Group Description:
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
Matching oral placebo once a day for 6 months
Overall Number of Participants Analyzed 114 121
Mean (Standard Deviation)
Unit of Measure: picograms/milliliter (pg/ml)
-289.175  (270.610) -46.099  (399.806)
8.Secondary Outcome
Title Change From Baseline in the Serum DHT at Month 3
Hide Description Change from baseline was calculated as the value of DHT at Month 3 minus the baseline value.
Time Frame Baseline and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants were missing Month 3 measurements.
Arm/Group Title Dutasteride 0.5 mg Placebo
Hide Arm/Group Description:
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
Matching oral placebo once a day for 6 months
Overall Number of Participants Analyzed 114 120
Mean (Standard Deviation)
Unit of Measure: pg/ml
-319.605  (256.058) -34.400  (399.633)
9.Secondary Outcome
Title Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6
Hide Description 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.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants were missing Month 6 measurements.
Arm/Group Title Dutasteride 0.5 mg Placebo
Hide Arm/Group Description:
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
Matching oral placebo once a day for 6 months
Overall Number of Participants Analyzed 113 121
Mean (Standard Deviation)
Unit of Measure: percent change
-26.48  (26.01) -20.79  (30.18)
10.Secondary Outcome
Title Percent Change From Baseline in the AUA-SI Score at Month 3
Hide Description 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.
Time Frame Baseline and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants were missing Month 3 measurements.
Arm/Group Title Dutasteride 0.5 mg Placebo
Hide Arm/Group Description:
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
Matching oral placebo once a day for 6 months
Overall Number of Participants Analyzed 113 121
Mean (Standard Deviation)
Unit of Measure: percent change
-15.64  (24.59) -11.91  (21.55)
11.Secondary Outcome
Title Change From Baseline in the AUA-SI Score at Month 6
Hide Description 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.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants were missing Month 6 measurements.
Arm/Group Title Dutasteride 0.5 mg Placebo
Hide Arm/Group Description:
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
Matching oral placebo once a day for 6 months
Overall Number of Participants Analyzed 113 121
Mean (Standard Deviation)
Unit of Measure: points on a scale
-4.9  (4.8) -4.1  (5.4)
12.Secondary Outcome
Title Change From Baseline in the AUA-SI Score at Month 3
Hide Description 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.
Time Frame Baseline and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants were missing Month 3 measurements.
Arm/Group Title Dutasteride 0.5 mg Placebo
Hide Arm/Group Description:
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
Matching oral placebo once a day for 6 months
Overall Number of Participants Analyzed 113 121
Mean (Standard Deviation)
Unit of Measure: points on a scale
-2.9  (3.9) -2.4  (3.9)
13.Secondary Outcome
Title Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6
Hide Description 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.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants were missing Month 6 measurements.
Arm/Group Title Dutasteride 0.5 mg Placebo
Hide Arm/Group Description:
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
Matching oral placebo once a day for 6 months
Overall Number of Participants Analyzed 113 119
Mean (Standard Deviation)
Unit of Measure: percent change
16.14  (57.43) 6.31  (47.55)
14.Secondary Outcome
Title Percent Change From Baseline in Qmax at Month 3
Hide Description 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.
Time Frame Baseline and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants were missing Month 3 measurements.
Arm/Group Title Dutasteride 0.5 mg Placebo
Hide Arm/Group Description:
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
Matching oral placebo once a day for 6 months
Overall Number of Participants Analyzed 111 117
Mean (Standard Deviation)
Unit of Measure: percent change
14.34  (42.86) 5.85  (34.69)
15.Secondary Outcome
Title Change From Baseline in Qmax at Month 6
Hide Description 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.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants were missing Month 6 measurements.
Arm/Group Title Dutasteride 0.5 mg Placebo
Hide Arm/Group Description:
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
Matching oral placebo once a day for 6 months
Overall Number of Participants Analyzed 113 119
Mean (Standard Deviation)
Unit of Measure: milliliters/second (ml/s)
0.75  (5.61) 0.03  (5.35)
16.Secondary Outcome
Title Change From Baseline in Qmax at Month 3
Hide Description 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.
Time Frame Baseline and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Some participants were missing Month 3 measurements.
Arm/Group Title Dutasteride 0.5 mg Placebo
Hide Arm/Group Description:
Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
Matching oral placebo once a day for 6 months
Overall Number of Participants Analyzed 111 117
Mean (Standard Deviation)
Unit of Measure: ml/s
0.93  (4.74) 0.17  (4.56)
Time Frame The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dutasteride 0.5 mg Placebo
Hide Arm/Group Description Oral dutasteride 0.5 milligrams (mg) once a day for 6 months Matching oral placebo once a day for 6 months
All-Cause Mortality
Dutasteride 0.5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dutasteride 0.5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/126 (0.00%)   1/127 (0.79%) 
Eye disorders     
Glaucoma  1  0/126 (0.00%)  1/127 (0.79%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dutasteride 0.5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   27/126 (21.43%)   25/127 (19.69%) 
Cardiac disorders     
Palpitations  1  0/126 (0.00%)  1/127 (0.79%) 
Eye disorders     
Dry eye  1  1/126 (0.79%)  0/127 (0.00%) 
Keratitis  1  1/126 (0.79%)  0/127 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  1  1/126 (0.79%)  0/127 (0.00%) 
Abdominal pain  1  1/126 (0.79%)  0/127 (0.00%) 
Abdominal pain upper  1  0/126 (0.00%)  1/127 (0.79%) 
Diarrhoea  1  0/126 (0.00%)  2/127 (1.57%) 
Dry mouth  1  1/126 (0.79%)  0/127 (0.00%) 
Dysgeusia  1  1/126 (0.79%)  0/127 (0.00%) 
Pharyngitis  1  0/126 (0.00%)  1/127 (0.79%) 
Stomach discomfort  1  3/126 (2.38%)  3/127 (2.36%) 
Throat irritation  1  1/126 (0.79%)  0/127 (0.00%) 
Vomiting  1  0/126 (0.00%)  1/127 (0.79%) 
Infections and infestations     
Erysipelas  1  1/126 (0.79%)  0/127 (0.00%) 
Alanine aminotransferase increased  1  0/126 (0.00%)  1/127 (0.79%) 
Aspartate aminotransferase increased  1  0/126 (0.00%)  1/127 (0.79%) 
Blood glucose increased  1  2/126 (1.59%)  0/127 (0.00%) 
Prostatic specific antigen increased  1  1/126 (0.79%)  0/127 (0.00%) 
White blood cell count decreased  1  1/126 (0.79%)  0/127 (0.00%) 
Red blood cells urine  1  1/126 (0.79%)  1/127 (0.79%) 
Transaminases increased  1  1/126 (0.79%)  0/127 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/126 (0.79%)  0/127 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/126 (0.00%)  1/127 (0.79%) 
Arthritis  1  0/126 (0.00%)  1/127 (0.79%) 
Back pain  1  2/126 (1.59%)  2/127 (1.57%) 
Musculoskeletal pain  1  1/126 (0.79%)  0/127 (0.00%) 
Contusion  1  0/126 (0.00%)  1/127 (0.79%) 
Nervous system disorders     
Tinnitus  1  1/126 (0.79%)  0/127 (0.00%) 
Vertigo  1  0/126 (0.00%)  1/127 (0.79%) 
Psychiatric disorders     
Poor quality sleep  1  0/126 (0.00%)  1/127 (0.79%) 
Renal and urinary disorders     
Calculus bladder  1  0/126 (0.00%)  1/127 (0.79%) 
Urethral pain  1  0/126 (0.00%)  1/127 (0.79%) 
Urinary incontinence  1  0/126 (0.00%)  1/127 (0.79%) 
Urinary retention  1  1/126 (0.79%)  0/127 (0.00%) 
Urinary tract infection  1  0/126 (0.00%)  1/127 (0.79%) 
Reproductive system and breast disorders     
Breast pain  1  1/126 (0.79%)  0/127 (0.00%) 
Libido decreased  1  3/126 (2.38%)  0/127 (0.00%) 
Erectile dysfunction  1  0/126 (0.00%)  1/127 (0.79%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/126 (0.00%)  1/127 (0.79%) 
Dyspnoea  1  1/126 (0.79%)  0/127 (0.00%) 
Nasopharyngitis  1  2/126 (1.59%)  3/127 (2.36%) 
Pharyngolaryngeal pain  1  2/126 (1.59%)  0/127 (0.00%) 
Upper respiratory tract infection  1  3/126 (2.38%)  5/127 (3.94%) 
Respiratory tract infection  1  1/126 (0.79%)  0/127 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  0/126 (0.00%)  1/127 (0.79%) 
Pigmentation disorder  1  1/126 (0.79%)  0/127 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00527605     History of Changes
Other Study ID Numbers: ARI108898
First Submitted: September 10, 2007
First Posted: September 11, 2007
Results First Submitted: February 22, 2010
Results First Posted: March 11, 2010
Last Update Posted: March 21, 2012