Trial Outcomes & Findings for Safety and Efficacy of 0.5mg Dutasteride and 0.4mg Tamsulosin Combination Once Daily for Six Months for Benign Prostatic Hyperplasia (NCT NCT01673490)
NCT ID: NCT01673490
Last Updated: 2018-08-20
Results Overview
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.
TERMINATED
PHASE4
59 participants
From start of study medication until follow-up (up to 7 months)
2018-08-20
Participant Flow
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.
Participant milestones
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
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 Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
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.
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|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Safety and Efficacy of 0.5mg Dutasteride and 0.4mg Tamsulosin Combination Once Daily for Six Months for Benign Prostatic Hyperplasia
Baseline characteristics by cohort
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=59 Participants
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.
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|---|---|
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Age, Continuous
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66.5 Years
STANDARD_DEVIATION 8.37 • n=5 Participants
|
|
Sex: Female, Male
Female
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0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
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59 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of study medication until follow-up (up to 7 months)Population: Intention-to-Treat (ITT) Population: all enrolled participants regardless of whether or not study treatment was administered.
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.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=59 Participants
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.
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|---|---|
|
Number of Participants With Any On-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs
Any AE
|
13 Participants
|
|
Number of Participants With Any On-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs
Any SAE
|
1 Participants
|
|
Number of Participants With Any On-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs
Any treatment-related AE
|
3 Participants
|
PRIMARY outcome
Timeframe: From start of study medication until follow-up (up to 7 months)Population: ITT Population
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.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=59 Participants
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.
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|---|---|
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Number of Participants With Any Post-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs
Any AE
|
2 Participants
|
|
Number of Participants With Any Post-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs
Any SAE
|
1 Participants
|
|
Number of Participants With Any Post-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs
Any treatment-related AE
|
1 Participants
|
PRIMARY outcome
Timeframe: Screening, Month 1, Month 3 and Month 6Population: ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
A 12 lead ECG was measured at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5).
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=59 Participants
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.
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|---|---|
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Number of Participants With Abnormal Electrocardiogram (ECG) Findings at the Indicated Time Points
Screening, n=59
|
49 Participants
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|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings at the Indicated Time Points
Month 1, n=56
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47 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings at the Indicated Time Points
Month 3, n=53
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50 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings at the Indicated Time Points
Month 6, n=52
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44 Participants
|
PRIMARY outcome
Timeframe: Screening, Month 1, Month 3 and Month 6Population: ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
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.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=56 Participants
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.
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|---|---|
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Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
ALT, n=48
|
9 Participants
|
|
Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
AST, n=49
|
6 Participants
|
|
Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Creatinine, n=51
|
9 Participants
|
|
Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Glucose, n=47
|
8 Participants
|
|
Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Potassium, n=52
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Protein, n=56
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4 Participants
|
|
Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Sodium, n=53
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Urea, n=54
|
7 Participants
|
PRIMARY outcome
Timeframe: Screening, Month 3 and Month 6Population: ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
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.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=56 Participants
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.
|
|---|---|
|
Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Basophils/Leukocytes, n=54
|
0 Participants
|
|
Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Eosinophils/Leukocytes, n=46
|
5 Participants
|
|
Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Ery Mean Corpuscular HGB Concentration, n=44
|
22 Participants
|
|
Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Ery Mean Corpuscular Hemoglobin, n=36
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6 Participants
|
|
Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Ery Mean Corpuscular Volume, n=42
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4 Participants
|
|
Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Erythrocytes, n=49
|
3 Participants
|
|
Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Erythrocytes Distribution Width, n=4
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3 Participants
|
|
Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Hematocrit, n=48
|
7 Participants
|
|
Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Hemoglobin, n=49
|
2 Participants
|
|
Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Leukocytes, n=47
|
7 Participants
|
|
Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Lymphocytes/Leukocytes, n=53
|
1 Participants
|
|
Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Monocytes/Leukocytes, n=52
|
1 Participants
|
|
Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Neutrophils/Leukocytes, n=41
|
5 Participants
|
|
Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Platelets, n=53
|
1 Participants
|
PRIMARY outcome
Timeframe: Screening, Month 3 and Month 6Population: ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
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.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=59 Participants
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.
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|---|---|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Erythrocytes, SC, POS, n=59
|
4 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Erythrocytes, SC, NEG, n=59
|
55 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Erythrocytes, 3M, POS, n=54
|
6 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Erythrocytes, 3M, NEG, n=54
|
48 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Erythrocytes, 6M, POS, n=52
|
6 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Erythrocytes, 6M, NEG, n=52
|
46 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Erythrocytes, FV, POS, n=54
|
7 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Erythrocytes, FV, NEG, n=54
|
47 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Glucose, SC, POS, n=59
|
3 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Glucose, SC, NEG, n=59
|
56 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Glucose, 3M, POS, n=54
|
1 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Glucose, 3M, NEG, n=54
|
53 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Glucose, 6M, POS, n=52
|
0 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Glucose, 6M, NEG, n=52
|
52 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Glucose, FV, POS, n=54
|
0 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Glucose, FV, NEG, n=54
|
54 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Ketones, SC, POS, n=59
|
0 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Ketones, SC, NEG, n=59
|
59 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Ketones, 3M, POS, n=54
|
2 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Ketones, 3M, NEG, n=54
|
52 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Ketones, 6M, POS, n=52
|
1 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Ketones, 6M, NEG, n=52
|
51 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Ketones, FV, POS, n=54
|
1 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Ketones, FV, NEG, n=54
|
53 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Leukocytes, SC, POS, n=59
|
3 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Leukocytes, SC, NEG, n=59
|
56 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Leukocytes, 3M, POS, n=54
|
0 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Leukocytes, 3M, NEG, n=54
|
54 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Leukocytes, 6M, POS, n=52
|
6 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Leukocytes, 6M, NEG, n=52
|
46 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Leukocytes, FV, POS, n=54
|
6 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Leukocytes, FV, NEG, n=54
|
48 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Protein, SC, POS, n=59
|
9 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Protein, SC, NEG, n=59
|
50 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Protein, 3M, POS, n=54
|
6 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Protein, 3M, NEG, n=54
|
48 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Protein, 6M, POS, n=52
|
7 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Protein, 6M, NEG, N=52
|
45 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Protein, FV, POS, n=54
|
8 Participants
|
|
Number Participants With a Negative or Positive Response at the Indicated Time Points
Protein, FV, NEG, n=54
|
46 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3 and Month 6Population: ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
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.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=54 Participants
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.
|
|---|---|
|
Change From Baseline in Total Prostate -Specific Antigen (PSA) at the Indicated Time Points
Month 3, n=54
|
-1.499 Microgram per liter (ug/L)
Standard Deviation 1.2263
|
|
Change From Baseline in Total Prostate -Specific Antigen (PSA) at the Indicated Time Points
Month 6, n=52
|
-1.824 Microgram per liter (ug/L)
Standard Deviation 1.2413
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
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.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=57 Participants
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.
|
|---|---|
|
Free to Total PSA Ratio at the Indicated Time Points
Baseline, n=50
|
28.207 Ratio
Standard Deviation 10.5868
|
|
Free to Total PSA Ratio at the Indicated Time Points
Month 6, n=52
|
24.887 Ratio
Standard Deviation 8.1112
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
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.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=52 Participants
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.
|
|---|---|
|
Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 6
|
-8.3 Scores on a scale
Standard Deviation 3.92
|
SECONDARY outcome
Timeframe: Baseline, Month 3 and Month 6Population: ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
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.
Outcome measures
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=54 Participants
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.
|
|---|---|
|
Change From Baseline in Maximum Rate of Urinary Flow (Qmax) at the Indicated Time Points
Month 3, n=54
|
2.77 Mililiter/seconds
Standard Deviation 4.361
|
|
Change From Baseline in Maximum Rate of Urinary Flow (Qmax) at the Indicated Time Points
Month 6, n=52
|
2.01 Mililiter/seconds
Standard Deviation 3.684
|
Adverse Events
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
Serious adverse events
| Measure |
Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg
n=59 participants at risk
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.
|
|---|---|
|
Investigations
Hepatic Enzyme Increased
|
1.7%
1/59 • 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).
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.
|
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER