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Trial record 20 of 117 for:    DUTASTERIDE

Safety and Efficacy of 0.5mg Dutasteride and 0.4mg Tamsulosin Combination Once Daily for Six Months for Benign Prostatic Hyperplasia (FDC114785)

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ClinicalTrials.gov Identifier: NCT01673490
Recruitment Status : Terminated (The sole investigative site refused to accept the amended protocol and declined to continue the study. There was no safety signal nor any other reason.)
First Posted : August 28, 2012
Results First Posted : December 17, 2015
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostatic Hyperplasia
Intervention Drug: Dutasteride/Tamsulosin
Enrollment 59
Recruitment Details  
Pre-assignment Details Eligible participants with benign prostatic hyperplasia (BPH) entered into a 6-month enrollment period followed by a6-month treatment period and a one-month follow-up period. The total duration of the study was 13 months.
Arm/Group Title Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Hide Arm/Group Description Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
Period Title: Overall Study
Started 59
Completed 52
Not Completed 7
Reason Not Completed
Lost to Follow-up             1
Adverse Event             3
Withdrawal by Subject             3
Arm/Group Title Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Hide Arm/Group Description Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
Overall Number of Baseline Participants 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants
66.5  (8.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
Female
0
   0.0%
Male
59
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian Number Analyzed 59 participants
59
1.Primary Outcome
Title Number of Participants With Any On-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs
Hide Description An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.
Time Frame From start of study medication until follow-up (up to 7 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) Population: all enrolled participants regardless of whether or not study treatment was administered.
Arm/Group Title Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Hide Arm/Group Description:
Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: Participants
Any AE 13
Any SAE 1
Any treatment-related AE 3
2.Primary Outcome
Title Number of Participants With Any Post-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs
Hide Description An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.
Time Frame From start of study medication until follow-up (up to 7 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Hide Arm/Group Description:
Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: Participants
Any AE 2
Any SAE 1
Any treatment-related AE 1
3.Primary Outcome
Title Number of Participants With Abnormal Electrocardiogram (ECG) Findings at the Indicated Time Points
Hide Description A 12 lead ECG was measured at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5).
Time Frame Screening, Month 1, Month 3 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Arm/Group Title Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Hide Arm/Group Description:
Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: Participants
Screening, n=59 49
Month 1, n=56 47
Month 3, n=53 50
Month 6, n=52 44
4.Primary Outcome
Title Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Hide Description Blood samples were collected at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5) for chemistry laboratory assessments. Clinical chemistry parameters included alanine aminotrasferase (ALT), aspartate aminotrasferase (AST), creatinine, glucose, potassium, protein, sodium and urea. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for a clinical chemistry parameter are summarized.
Time Frame Screening, Month 1, Month 3 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Arm/Group Title Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Hide Arm/Group Description:
Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: Participants
ALT, n=48 9
AST, n=49 6
Creatinine, n=51 9
Glucose, n=47 8
Potassium, n=52 1
Protein, n=56 4
Sodium, n=53 0
Urea, n=54 7
5.Primary Outcome
Title Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Hide Description Blood samples were collected at Screening, Month 3 (Visit 3) and Month 6 (Visit 5) for hematology laboratory assessments. Hematology parameters included basophils, leukocytes, hemoglobin (HGB), eosinophils, erythrocytes (ery), ery mean Corpuscular HGB concentration, ery mean corpuscular HGB, ery distribution width, lymphocytes, hematocrit, monocytes, neutrophils and platelets. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for hematology parameters are summarized.
Time Frame Screening, Month 3 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Arm/Group Title Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Hide Arm/Group Description:
Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: Participants
Basophils/Leukocytes, n=54 0
Eosinophils/Leukocytes, n=46 5
Ery Mean Corpuscular HGB Concentration, n=44 22
Ery Mean Corpuscular Hemoglobin, n=36 6
Ery Mean Corpuscular Volume, n=42 4
Erythrocytes, n=49 3
Erythrocytes Distribution Width, n=4 3
Hematocrit, n=48 7
Hemoglobin, n=49 2
Leukocytes, n=47 7
Lymphocytes/Leukocytes, n=53 1
Monocytes/Leukocytes, n=52 1
Neutrophils/Leukocytes, n=41 5
Platelets, n=53 1
6.Primary Outcome
Title Number Participants With a Negative or Positive Response at the Indicated Time Points
Hide Description Urine samples were collected at Screening (SC), Month 3 (3M) and Month 6 (6M) for urinalysis laboratory assesment. Final value (FV) is defined as the latest post-Baseline value available in the study for each parameter.Urinalysis parameters included erythrocytes, glucose, ketones, leukocytes and protein. Number of participants with a negative (NEG) or positive (POS) response at the indicated time points are summarized.
Time Frame Screening, Month 3 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Arm/Group Title Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Hide Arm/Group Description:
Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: Participants
Erythrocytes, SC, POS, n=59 4
Erythrocytes, SC, NEG, n=59 55
Erythrocytes, 3M, POS, n=54 6
Erythrocytes, 3M, NEG, n=54 48
Erythrocytes, 6M, POS, n=52 6
Erythrocytes, 6M, NEG, n=52 46
Erythrocytes, FV, POS, n=54 7
Erythrocytes, FV, NEG, n=54 47
Glucose, SC, POS, n=59 3
Glucose, SC, NEG, n=59 56
Glucose, 3M, POS, n=54 1
Glucose, 3M, NEG, n=54 53
Glucose, 6M, POS, n=52 0
Glucose, 6M, NEG, n=52 52
Glucose, FV, POS, n=54 0
Glucose, FV, NEG, n=54 54
Ketones, SC, POS, n=59 0
Ketones, SC, NEG, n=59 59
Ketones, 3M, POS, n=54 2
Ketones, 3M, NEG, n=54 52
Ketones, 6M, POS, n=52 1
Ketones, 6M, NEG, n=52 51
Ketones, FV, POS, n=54 1
Ketones, FV, NEG, n=54 53
Leukocytes, SC, POS, n=59 3
Leukocytes, SC, NEG, n=59 56
Leukocytes, 3M, POS, n=54 0
Leukocytes, 3M, NEG, n=54 54
Leukocytes, 6M, POS, n=52 6
Leukocytes, 6M, NEG, n=52 46
Leukocytes, FV, POS, n=54 6
Leukocytes, FV, NEG, n=54 48
Protein, SC, POS, n=59 9
Protein, SC, NEG, n=59 50
Protein, 3M, POS, n=54 6
Protein, 3M, NEG, n=54 48
Protein, 6M, POS, n=52 7
Protein, 6M, NEG, N=52 45
Protein, FV, POS, n=54 8
Protein, FV, NEG, n=54 46
7.Primary Outcome
Title Change From Baseline in Total Prostate -Specific Antigen (PSA) at the Indicated Time Points
Hide Description Serum sample was collected at Baseline, Month 3 and Month 6 for assesment of total PSA. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Change from Baseline in total PSA at Month 3 and Month 6 was calculated as value at specified visist minus Baseline value.
Time Frame Baseline, Month 3 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Arm/Group Title Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Hide Arm/Group Description:
Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: Microgram per liter (ug/L)
Month 3, n=54 -1.499  (1.2263)
Month 6, n=52 -1.824  (1.2413)
8.Primary Outcome
Title Free to Total PSA Ratio at the Indicated Time Points
Hide Description Serum sample was collected at Screening (Baseline for participants with Free to Total PSA ratio at Month 6), and Month 6 for assessment of free to total PSA ratio. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Free to total PSA ratio at Baseline for participants with free to total PSA Ratio at Month 6 and free to total PSA ratio at month 6 are presented.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Arm/Group Title Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Hide Arm/Group Description:
Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
Overall Number of Participants Analyzed 57
Mean (Standard Deviation)
Unit of Measure: Ratio
Baseline, n=50 28.207  (10.5868)
Month 6, n=52 24.887  (8.1112)
9.Secondary Outcome
Title Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 6
Hide Description The IPSS is a screening tool used to assess the symptoms of prostate related disease. The IPSS questionnaire consists of seven symptoms questions including feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 (no symptoms to almost always symptoms) for a total of maximum 35 points. IPSS total is the sum of the scores of seven questions; therefore, the possible total score ranges from 0 to 35 (0-7: Mildly symptomatic; 8-19: Moderately symptomatic; 20-35: Severely symptomatic). IPSS was assessed at Baseline and Month 6. Change from Baseline was calculated as Month 6 IPSS score- minus Baseline IPSS score.
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Arm/Group Title Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Hide Arm/Group Description:
Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-8.3  (3.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Maximum Rate of Urinary Flow (Qmax) at the Indicated Time Points
Hide Description The Qmax is used as an indicator for the diagnosis of enlarged prostate. A lower Qmax may indicate that the enlarged prostate. Qmax was assessed at Baseline (screening), Month 3 and Month 6. Change from Baseline was calculated as Qmax score at specified timepoint minus the Baseline Qmax score.
Time Frame Baseline, Month 3 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Arm/Group Title Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Hide Arm/Group Description:
Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: Mililiter/seconds
Month 3, n=54 2.77  (4.361)
Month 6, n=52 2.01  (3.684)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments for Month 3
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments for Month 6
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to Month 7).
Adverse Event Reporting Description SAEs and non-serious AEs were collected for the participants of the ITT population, comprised of all enrolled participants regardless of whether or not study treatment was administered.
 
Arm/Group Title Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Hide Arm/Group Description Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
All-Cause Mortality
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Affected / at Risk (%)
Total   1/59 (1.69%) 
Investigations   
Hepatic Enzyme Increased  1  1/59 (1.69%) 
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 5%
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Affected / at Risk (%)
Total   0/59 (0.00%) 
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: NCT01673490     History of Changes
Other Study ID Numbers: 114785
First Submitted: June 28, 2012
First Posted: August 28, 2012
Results First Submitted: October 8, 2015
Results First Posted: December 17, 2015
Last Update Posted: August 20, 2018