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Trial record 13 of 117 for:    DUTASTERIDE

A Long-term Study to Determine Safety and Efficacy of Dutasteride in Male Subjects With Androgenetic Alopecia

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: NCT01831791
Recruitment Status : Completed
First Posted : April 15, 2013
Results First Posted : March 12, 2015
Last Update Posted : June 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 Alopecia
Intervention Drug: Dutasteride 0.5 mg
Enrollment 120
Recruitment Details Male participants with androgenetic alopecia types III vertex IV and V per Norwood Hamilton classification were enrolled into study.
Pre-assignment Details This outpatient study consisted of a Screening Phase (3 weeks prior to Baseline) and a Treatment Phase (52 weeks).
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Period Title: Overall Study
Started 120
Completed 110
Not Completed 10
Reason Not Completed
Withdrawal by Subject             10
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Baseline Participants 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants
42.2  (5.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants
Female
0
   0.0%
Male
120
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian - Japanese Heritage Number Analyzed 120 participants
120
1.Primary Outcome
Title Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)
Hide Description An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, 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. A 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, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, drug-induced liver injury, breast cancer in male participants, prostate cancer, spontaneous abortion in female partner of male participants
Time Frame From Baseline (Week 0) until Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: comprised of all participants who received a randomization number, regardless of whether or not treatment was administered
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 120
Measure Type: Number
Unit of Measure: Participants
Any AE 64
Any SAE 2
2.Primary Outcome
Title Number of Participants With Drug-related, Treatment-emergent AEs and AE Leading to Premature Study Drug Discontinuation and Possible Suicidality-related Adverse Event (PSRAE)
Hide Description An AE is considered drug-related if the relationship variable indicates so, or if the variable value is missing. Any AE with a start date on or after the treatment start date and on or before the last dose of treatment is considered on-treatment (treatment-emergent). This includes an AE with a missing onset date. Any AE which occurred, in the investigator’s judgement and is possibly related to suicidality, is defined as possible suicidality-related adverse event (PSRAE). Suicidality was assessed by using the columbia-suicide severity rating scale (C-SSRS) as determined by the investigator. The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors.
Time Frame From Baseline (Week 0) until Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 120
Measure Type: Number
Unit of Measure: Participants
Any drug related AEs 20
Any treatment-emergent AEs 64
Any AE leading to study drug discontinuation 0
Any PSRAE 3
3.Primary Outcome
Title Number of Participants With Change From Baseline in Breast Examination Results Any Time Post-Baseline Visit
Hide Description A qualitative breast examination was performed at Baseline (Week 0), at the Week 26 Visit and at the Week 52 Visit (and at the early withdrawal visit, if applicable). Participants were assessed for presence (reported as yes) and absence (reported as no) of palpable breast tissue (PBT) or nipple tenderness (NT) and/or clinically significant (CS) PBT or NT at Baseline (BL), at each scheduled Post-BL assessment. Change from BL in breast examination results included the number of participants with change from ‘no (N)’ at BL to ‘yes (Y)’ at any Post-BL assessment for the presence of PBT or NT, and the number of participants with change from N at BL in CS to Y at any Post-BL assessment in CS for PBT and for NT. BL value of an assessment is defined as the latest assessment on or before the BL date (latest non-missing value of either the treatment start date or the randomization date).
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 120
Measure Type: Number
Unit of Measure: Participants
PBT, Change from N at BL to Y, n=120 0
PBT, CS, Y (among change from N at BL to Y), n=0 0
PBT, CS, N (among change from N at BL to Y), n=0 0
NT, Change from N at BL to Y, n=120 1
NT, CS, Y (among change from N at BL to Y), n=1 1
NT, CS, N (among change from N at BL to Y), n=0 0
4.Primary Outcome
Title Mean Change From Baseline in Hemoglobin, Albumin and Total Protein at the Indicated Time Points
Hide Description Blood samples were collected for the measurement of hemoglobin, albumin and total protein at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the hemoglobin, albumin and total protein values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).
Time Frame Baseline, Week 26 and 52 visits and/or early withdrawal visit
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: Grams per liter (g/L)
Hemoglobin, Week 26, n=114 0.61  (5.891)
Hemoglobin, Week 52, n=111 -0.94  (5.657)
Hemoglobin, Final value, n=118 -0.69  (5.792)
Albumin, Week 26, n=114 -0.64  (2.014)
Albumin, Week 52, n=111 -1.42  (1.928)
Albumin, Final value, n=118 -1.31  (1.969)
Total protein, Week 26, n=114 -0.17  (3.741)
Total protein, Week 52, n=111 -0.55  (3.389)
Total protein, Final value, n=118 -0.40  (3.415)
5.Primary Outcome
Title Mean Change From Baseline in Hematocrit at the Indicated Time Points
Hide Description Blood samples were collected for the measurement of hematocrit at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the hematocrit value is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).
Time Frame Baseline, Week 26 and 52 visits and/or early withdrawal visit
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: Proportion of red blood cells in blood
Week 26, n=114 -0.01  (0.018)
Week 52, n=111 0.00  (0.019)
Final value, n=118 -0.00  (0.019)
6.Primary Outcome
Title Mean Change From Baseline in Platelet Count and White Blood Cell Count at the Indicated Time Points
Hide Description Blood samples were collected for the measurement of platelet count and white blood cell count at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the platelet count and white blood cell count values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).
Time Frame Baseline, Week 26 and 52 visits and/or early withdrawal visit
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/Liter (GI/L)
Platelet count, Week 26, n=114 3.41  (22.172)
Platelet count,Week 52, n=109 -1.48  (22.327)
Platelet count,Final value, n=118 -1.12  (22.758)
White blood cells count, Week 26, n=114 0.05  (1.309)
White blood cells count, Week 52, n=111 0.17  (1.269)
White blood cells count, Final value, n=118 0.13  (1.197)
7.Primary Outcome
Title Mean Change From Baseline in Red Blood Cells Count at the Indicated Time Points
Hide Description Blood samples were collected for the measurement of the red blood cell count at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the red blood cell count value is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).
Time Frame Baseline, Week 26 and 52 visits and/or early withdrawal visit
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: 10^12 cells per liter (TI/L)
Week 26, n=114 -0.01  (0.200)
Week 52, n=111 0.01  (0.192)
Final value, n=118 0.01  (0.198)
8.Primary Outcome
Title Mean Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) at the Indicated Time Points
Hide Description Blood samples were collected for the measurement of ALT, ALP and AST at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the ALT, ALP and AST values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).
Time Frame Baseline, Week 26 and 52 visits and/or early withdrawal visit
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: Units per liter (U/L)
ALT, Week 26, n=114 5.58  (13.697)
ALT, Week 52, n=111 1.51  (8.516)
ALT, Final value, n=118 1.14  (7.982)
ALP, Week 26, n=114 0.30  (10.124)
ALP, Week 52, n=111 0.24  (9.077)
ALP, Final value, n=118 0.24  (9.320)
AST, Week 26, n=113 4.81  (12.164)
AST, Week 52, n=108 1.85  (5.263)
AST, Final value, n=118 1.71  (4.982)
9.Primary Outcome
Title Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points
Hide Description Blood samples were collected for the measurement of total bilirubin and creatinine at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the total bilirubin and creatinine values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).
Time Frame Baseline, Week 26 and 52 visits and/or early withdrawal visit
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter (µmol/L)
Total bilirubin, Week 26, n=114 -0.99  (4.495)
Total bilirubin,, Week 52, n=111 -0.23  (5.189)
Total bilirubin, Final value, n=118 -0.26  (5.302)
Creatinine, Week 26, n=114 -1.14  (5.525)
Creatinine, Week 52, n=111 1.73  (6.514)
Creatinine, Final value, n=118 1.29  (6.525)
10.Primary Outcome
Title Mean Change From Baseline in Potassium, Sodium, Glucose and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points
Hide Description Blood samples were collected for the measurement of potassium, sodium, glucose and urea/BUN at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the potassium, sodium, glucose and urea/BUN values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).
Time Frame Baseline, Week 26 and 52 visits and/or early withdrawal visit
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter (mmol/L)
Potassium, Week 26, n=113 0.08  (0.289)
Potassium,, Week 52, n=108 0.02  (0.308)
Potassium, Final value, n=118 0.02  (0.309)
Sodium, Week 26, n=114 1.22  (1.857)
Sodium, Week 52, n=111 1.01  (2.143)
Sodium, Final value, n=118 1.02  (2.152)
Glucose, Week 26, n=114 0.48  (0.867)
Glucose, Week 52, n=111 0.44  (0.822)
Glucose, Final value, n=118 0.45  (0.822)
Urea/BUN , Week 26, n=114 0.05  (1.175)
Urea/BUN , Week 52, n=111 0.02  (1.056)
Urea/BUN , Final value, n=118 0.00  (1.106)
11.Primary Outcome
Title Mean Change From Baseline in Prostate-specific Antigen at the Indicated Time Points
Hide Description Blood samples were collected for the measurement of prostate-specific antigen at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the prostate-specific antigen value is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).
Time Frame Baseline, Week 26 and 52 visits and/or early withdrawal visit
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: Microgram per liter (µg/L)
Week 26, n=116 -0.29  (0.550)
Week 52, n=111 -0.32  (0.582)
Final value, n=118 -0.32  (0.556)
12.Primary Outcome
Title Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline
Hide Description Blood samples for the assessment of the indicated laboratory parameters were taken at the Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. The laboratory parameters included ALP, ALT, AST, total bilirubin, total protein, sodium, potassium, albumin, glucose, creatinine, urea/BUN, hemoglobin, hematocrit, red blood cell (RBC) count, platelet count, white blood cell (WBC) count, and prostate-specific antigen (PSA). A laboratory value (LV) that is within the normal range is considered normal. A LV that is above the upper limit of the normal range is considered high abnormal. A LV that is below the lower limit of the normal range is considered low abnormal. Number of participants with any LV shifts from BL at any time post-BL are presented for, normal at BL to abnormal; normal at BL to high; normal at BL to low; normal or low at BL to high; normal or high at BL to low.
Time Frame Baseline, Week 26 and 52 visits and/or early withdrawal visit
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants with a normal BL and at least one post-BL LV are analysed. ITT Population (represented by n=X in the category titles).
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 118
Measure Type: Number
Unit of Measure: Participants
Hemoglobin, normal at BL to abnormal, n=98 8
Hematocrit, normal at BL to abnormal, n=95 8
Platelet count, normal at BL to abnormal, n=118 0
RBC count, normal at BL to abnormal, n=99 11
WBC count, normal at BL to abnormal, n=117 3
Albumin, normal at BL to abnormal, n=116 0
ALP, normal at BL to abnormal, n=118 1
ALT, normal at BL to abnormal, n=116 7
AST, normal at BL to abnormal, n=118 6
Total Bilirubin, normal at BL to abnormal, n=104 5
Creatinine, normal at BL to abnormal, n=99 10
Glucose, normal at BL to abnormal, n=116 14
Potassium, normal at BL to abnormal, n=118 0
Total Protein, normal at BL to abnormal, n=118 2
Sodium, normal at BL to abnormal, n=118 1
Urea/BUN, normal at BL to abnormal, n=116 0
PSA, normal at BL to abnormal, n=118 1
Hemoglobin, normal at BL to high, n=98 0
Hematocrit, normal at BL to high, n=95 0
Platelet count, normal at BL to high, n=118 0
RBC count, normal at BL to high, n=99 0
WBC count, normal at BL to high, n=117 3
Albumin, normal at BL to high, n=116 0
ALP, normal at BL to high, n=118 1
ALT, normal at BL to high, n=116 7
AST, normal at BL to high, n=118 6
Total Bilirubin, normal at BL to high, n=104 5
Creatinine, normal at BL to high, n=99 0
Glucose, normal at BL to high, n=116 14
Potassium, normal at BL to high, n=118 0
Total Protein, normal at BL to high, n=118 0
Sodium, normal at BL to high, n=118 1
Urea/BUN, normal at BL to high, n=116 0
PSA, normal at BL to high, n=118 1
Hemoglobin, normal at BL to low, n=98 8
Hematocrit, normal at BL to low, n=95 8
Platelet count, normal at BL to low, n=118 0
RBC count, normal at BL to low, n=99 11
WBC count, normal at BL to low, n=117 0
Albumin, normal at BL to low, n=116 0
ALP, normal at BL to low, n=118 0
ALT, normal at BL to low, n=116 0
AST, normal at BL to low, n=118 0
Total Bilirubin, normal at BL to low, n=104 0
Creatinine, normal at BL to low, n=99 10
Glucose, normal at BL to low, n=116 0
Potassium, normal at BL to low, n=118 0
Total Protein, normal at BL to low, n=118 2
Sodium, normal at BL to low, n=118 0
Urea/BUN, normal at BL to low, n=116 0
PSA, normal at BL to low, n=118 0
Hemoglobin, normal or low at BL to high, n=118 0
Hematocrit, normal or low at BL to high, n=106 0
Platelet count, normal or low at BL to high, n=118 0
RBC count, normal or low at BL to high, n=118 0
WBC count, normal or low at BL to high, n=118 3
Albumin, normal or low at BL to high, n=116 0
ALP, normal or low at BL to high, n=118 1
ALT, normal or low at BL to high, n=116 7
AST, normal or low at BL to high, n=118 6
Total Bilirubin, normal or low at BL to high n=104 5
Creatinine, normal or low at BL to high, n=118 0
Glucose, normal or low at BL to high, n=117 14
Potassium, normal or low at BL to high, n=118 0
Total Protein, normal or low at BL to high, n=118 0
Sodium, normal or low at BL to high, n=118 1
Urea/BUN, normal or low at BL to high, n=117 0
PSA, normal or low at BL to high, n=118 1
Hemoglobin, normal or high at BL to low, n=98 8
Hematocrit, normal or high at BL to low, n=107 8
Platelet count, normal or high at BL to low, n=118 0
RBC count, normal or high at BL to low, n=99 11
WBC count, normal or high at BL to low, n=117 0
Albumin, normal or high at BL to low, n=118 0
ALP, normal or high at BL to low, n=118 0
ALT, normal or high at BL to low, n=118 0
AST, normal or high at BL to low, n=118 0
Total Bilirubin, normal or high at BL to low,n=118 0
Creatinine, normal or high at BL to low, n=99 10
Glucose, normal or high at BL to low, n=117 0
Potassium, normal or high at BL to low, n=118 0
Total Protein, normal or high at BL to low, n=118 2
Sodium, normal or high at BL to low, n=118 0
Urea/BUN, normal or high at BL to low, n=117 0
PSA, normal or high at BL to low, n=118 0
13.Primary Outcome
Title Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points
Hide Description Blood pressure measurements were taken to observe vital signs and included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the Screening visit, Baseline visit, Weeks 13, 26, 39, and 52 visits and the early withdrawal visit if applicable. Change from Baseline in SBP and DBP is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).
Time Frame Baseline, Weeks 13, 26, 39, and 52 visits and or early withdrawal visit
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
SBP, Week 13, n=120 -0.3  (8.80)
SBP, Week 26, n=116 0.9  (9.30)
SBP, Week 39, n=112 0.9  (8.70)
SBP, Week 52, n=111 -1.3  (9.36)
SBP, Final value, n=120 -1.0  (9.47)
DBP, Week 13, n=120 -1.3  (7.78)
DBP, Week 26, n=116 1.9  (7.35)
DBP, Week 39, n=112 0.4  (7.61)
DBP, Week 52, n=111 -0.3  (7.44)
DBP, Final value, n=120 -0.6  (7.50)
14.Primary Outcome
Title Mean Change From Baseline in Heart Rate at the Indicated Time Points
Hide Description Vital sign monitoring included heart rate measurement at the Screening visit, Baseline visit, Weeks 13, 26, 39, and 52 visits and the early withdrawal visit if applicable. Change from Baseline in heart rate is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).
Time Frame Baseline visit, Weeks 13, 26, 39, and 52 visits and or early withdrawal visit
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Week 13, n=120 0.3  (8.27)
Week 26, n=116 0.6  (8.30)
Week 39, n=112 2.7  (9.33)
Week 52, n=111 -0.3  (7.84)
Final value, n=120 -0.6  (7.87)
15.Primary Outcome
Title Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. The number of participants answering yes/no responses to questions about suicidal ideation (Question [Que] 1 and Que 2) at Baseline and post-Baseline (since last visit) and suicidal behaviors (Que 6 – Que 10) at post-Baseline (since last visit) are presented. Questions included the presence (yes) or absence (no) of the following: Que 1 - a wish to be dead; Que 2 - nonspecific (NS) active suicidal thoughts; Que 6 - preparatory acts or behavior; Que 7 - aborted attempt; Que 8 - interrupted attempt (int. att.); Que 9 - non-fatal actual suicide attempt; Que 10 - completed suicide and non-suicidal self-injurious behavior. Final assessment (FA) is the last post-Baseline measurement during the study.
Time Frame Baseline, Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 120
Measure Type: Number
Unit of Measure: Participants
BL, wish to be dead, n=103 2
BL, NS active suicidal thoughts, n=103 0
Week 26, wish to be dead, n=116 2
Week 26, NS active suicidal thoughts, n=116 1
Week 26 preparatory acts or behavior, n=116 0
Week 26, aborted attempt, n=116 0
Week 26, int. att., n=116 0
Week 26, non-fatal actual suicide attempt, n=116 0
Week 26, completed suicide, n=116 0
Week 26, non-suicidal self-injurious, n=116 0
Week 52, wish to be dead, n=111 1
Week 52, NS active suicidal thoughts, n=111 0
Week 52 preparatory acts or behavior, n=111 0
Week 52, aborted attempt, n=111 0
Week 52, interrupted attempt n=111 0
Week 52, non-fatal actual suicide attempt, n=111 0
Week 52, completed suicide, n=111 0
Week 52, non-suicidal self-injurious, n=111 0
FA, wish to be dead, n=118 3
FA, NS active suicidal thoughts, n=118 1
FA preparatory acts or behavior, n=118 0
FA, aborted attempt, n=118 0
FA, int. att., n=118 0
FA, non-fatal actual suicide attempt, n=118 0
FA, completed suicide, n=118 0
FA, non-suicidal self-injurious, n=118 0
16.Secondary Outcome
Title Mean Change From Baseline (BL) in Target Area Hair Count Within a 2.54 Centimeter (cm) Diameter Circle at Week 26 and Week 52
Hide Description Target area hair count is based on the nonvellus hair(>= 30 micrometer[μm] in width) count within a target 2.54cm(1 inch) diameter circle at the vertex and was assessed by macrophotographic technique. A cosmetic ink dot was placed by means of a tattoo at BL on the scalp in the center of the circle as a marker to guide the placement of the hair count area at subsequent time points. If the ink dot faded between study visits, it was redone. For the macrophotography, hair was clipped before each photograph. Change from BL is defined as post-BL value minus BL value. The BL value is defined as the latest assessment on or before the BL date(latest non-missing value of either treatment start date or randomization date). The last observation carried forward(LOCF) method for missing data was used by carrying forward the last non-missing post-BL assessment value for participants with missing data and/or for participants who discontinued from the study.
Time Frame Baseline, Week 26, and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants avilable at the specified time were analysed.
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: Hair count
Week 26 LOCF 87.3  (81.14)
Week 52 LOCF 68.1  (82.14)
17.Secondary Outcome
Title Mean Change From Baseline (BL) in Target Area Hair Width Within a 2.54 cm Diameter Circle at Week 26 and Week 52
Hide Description Target area hair width was based on the total width of the nonvellus hairs(>=30μm in width) within a target 2.54cm(1 inch) diameter circle at the vertex and was assessed by macrophotographic technique. A cosmetic ink dot was placed by means of a tattoo at BL on the scalp in the center of the circle as a marker to guide the placement of the hair count area at subsequent time points. If the ink dot faded between study visits, it was redone. For the macrophotography, hair was clipped before each photograph. Change from BL is defined as the post-BL value minus the BL value. The BL value of an assessment is defined as the latest assessment on or before the BL date(latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-BL assessment value for participants with missing data and/or for participants who discontinued from the study.
Time Frame Baseline, Week 26, and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants avilable at the specified time were analysed.
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: microns x 10^-3
Week 26 LOCF 6.7  (4.80)
Week 52 LOCF 6.5  (5.29)
18.Secondary Outcome
Title Mean Change From Baseline (BL) in Terminal Hair Count Within a 2.54 cm Diameter Circle at Week 26 and Week 52
Hide Description Terminal hair count was based on the terminal hair(>=60 μm in width) count within a target 2.54cm(1 inch) diameter circle at the vertex and was assessed by macrophotographic technique. A cosmetic ink dot was placed by means of a tattoo at BL on the scalp in the center of the circle as a marker to guide the placement of the hair count area at subsequent time points. If the ink dot faded between study visits, it was redone. For the macrophotography, hair was clipped before each photograph. Change from BL is defined as the post-BL value minus the BL value. BL value of an assessment is defined as the latest assessment on or before the BL date(latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-BL assessment for participants with missing data and/or for participants who discontinued from the study.
Time Frame Baseline, Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants avilable at the specified time were analysed.
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: Hair count
Week 26 LOCF 60.8  (70.22)
Week 52 LOCF 76.9  (86.19)
19.Secondary Outcome
Title Mean of Median Score for Panel Global Assessment of Improvement From Baseline to 26 Weeks and 52 Weeks for Vertex and Frontal Views
Hide Description A central panel of 3 dermatologists independently assessed change in hair growth from Baseline to Week 26 and Week 52 using a 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3). The median score, across the 3 panel members, is summarized. This assessment was performed by comparing the global photographs obtained at Baseline (Screening) with those subsequently obtained at Week 26 and Week 52. This assessment was made separately based on the global photography of the vertex and frontal views. The LOCF method for missing data was used for the assessment, if a participants was missing the Week 26 global photograph, but has a global photograph from an earlier assessment (i.e., a withdrawal visit), then that photograph was assessed during the panel review.
Time Frame Baseline, Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants avilable at the specified time were analysed.
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 117
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 26 LOCF, vertex view 1.34  (0.921)
Week 26 LOCF, frontal view 1.21  (0.963)
Week 52 LOCF, vertex view 1.50  (0.897)
Week 52 LOCF, frontal view 1.40  (0.974)
20.Secondary Outcome
Title Number of Participants With the Indicated Change From Baseline (BL) in the Stage of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at 26 Weeks and 52 Weeks
Hide Description The investigator/designee assessed the stage (Stage I to Stage VII) of AGA (i.e., male pattern baldness [MPB]) by utilizing the Norwood-Hamilton scale, used to measure the progression of MPB. Stage VII indicates worse balding than Stage I. Assessment was made by direct visual examination (aided by pictures) of the participant at Screening (Baseline), Week 26, and Week 52. "v," vertex; most of the hair loss (commonly seen with advancing age) is on the vertex. "a," type a variant; major features are (1) the entire anterior hairline border recedes in unison; (2) there is no simultaneous balding of the vertex. The number of participants with stage changes from Baseline are summarized. The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing data and/or for participants who discontinued from the study.
Time Frame Baseline, Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 120
Measure Type: Number
Unit of Measure: Participants
Baseline BL Stage IIIv to W26 Stage I, n=53 0
BL Stage IIIv to W26 Stage II, n=53 0
BL Stage IIIv to W26 Stage IIa, n=53 2
BL Stage IIIv to W26 Stage III, n=53 4
BL Stage IIIv to W26 Stage IIIa, n=53 0
BL Stage IIIv to W26 Stage IIIv, n=53 45
BL Stage IIIv to W26 Stage IV, n=53 2
BL Stage IIIv to W26 Stage IVa, n=53 0
BL Stage IIIv to W26 Stage V, n=53 0
BL Stage IIIv to W26 Stage Va, n=53 0
BL Stage IIIv to W26 Stage VI, n=53 0
BL Stage IV to W26 Stage I, n=46 0
BL Stage IV to W26 Stage II, n=46 0
BL Stage IV to W26 Stage IIa, n=46 0
BL Stage IV to W26 Stage III, n=46 1
BL Stage IV to W26 Stage IIIa, n=46 0
BL Stage IV to W26 Stage IIIv, n=46 15
BL Stage IV to W26 Stage IV, n=46 29
BL Stage IV to W26 Stage IVa, n=46 0
BL Stage IV to W26 Stage V, n=46 0
BL Stage IV to W26 Stage Va, n=46 0
BL Stage IV to W26 Stage VI, n=46 1
BL Stage V to W26 Stage I, n=19 0
BL Stage V to W26 Stage II, n=19 0
BL Stage V to W26 Stage IIa, n=19 0
BL Stage V to W26 Stage III, n=19 1
BL Stage V to W26 Stage IIIa, n=19 0
BL Stage V to W26 Stage IIIv, n=19 3
BL Stage V to W26 Stage IV, n=19 10
BL Stage V to W26 Stage IVa, n=19 0
BL Stage V to W26 Stage V, n=19 5
BL Stage V to W26 Stage Va, n=19 0
BL Stage V to W26 Stage VI, n=19 0
BL Stage IIIv to W52 Stage I, n=53 1
BL Stage IIIv to W52 Stage II, n=53 2
BL Stage IIIv to W52 Stage IIa, n=53 4
BL Stage IIIv to W52 Stage III, n=53 14
BL Stage IIIv to W52 Stage IIIa, n=53 0
BL Stage IIIv to W52 Stage IIIv, n=53 28
BL Stage IIIv to W52 Stage IV, n=53 4
BL Stage IIIv to W52 Stage IVa, n=53 0
BL Stage IIIv to W52 Stage V, n=53 0
BL Stage IIIv to W52 Stage Va, n=53 0
BL Stage IIIv to W52 Stage VI, n=53 0
BL Stage IV to W52 Stage I, n=46 0
BL Stage IV to W52 Stage II, n=46 1
BL Stage IV to W52 Stage IIa, n=46 0
BL Stage IV to W52 Stage III, n=46 0
BL Stage IV to W52 Stage IIIa, n=46 0
BL Stage IV to W52 Stage IIIv, n=46 19
BL Stage IV to W52 Stage IV, n=46 26
BL Stage IV to W52 Stage IVa, n=46 0
BL Stage IV to W52 Stage V, n=46 0
BL Stage IV to W52 Stage Va, n=46 0
BL Stage IV to W52 Stage VI, n=46 0
BL Stage V to W52 Stage I, n=19 0
BL Stage V to W52 Stage II, n=19 0
BL Stage V to W52 Stage IIa, n=19 0
BL Stage V to W52 Stage III, n=19 2
BL Stage V to W52 Stage IIIa, n=19 0
BL Stage V to W52 Stage IIIv, n=19 4
BL Stage V to W52 Stage IV, n=19 10
BL Stage V to W52 Stage IVa, n=19 0
BL Stage V to W52 Stage V, n=19 3
BL Stage V to W52 Stage Va, n=19 0
BL Stage V to W52 Stage VI, n=19 0
21.Secondary Outcome
Title Change From Baseline in Sexual Problems as Assessed by the Problem Assessment Scale of the Sexual Function Inventory (PAS SFI) at Week 13, Week 26, Week 39, and Week 52
Hide Description The Problem Assessment Scale of the Sexual Function Inventory (PAS SFI) questionnaire was used to assess participant-perceived problems in sexual function using 3 questions assessing problems with sex drive, erections and ejaculation. They are scored on a 5-point scale of 0 to 4 (0=big problem, 1= medium problem, 2=small problem, 3=very small problem, 4=no problem). Total scores range from 0-12. Change from Baseline in PAS SFI scores is defined as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing data and/or for participants who discontinued from the study.
Time Frame Baseline, Week 13, Week 26, Week 39 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 13 LOCF -0.6  (2.30)
Week 26 LOCF -0.7  (2.36)
Week 39 LOCF -0.3  (1.97)
Week 52 LOCF -0.3  (1.90)
22.Secondary Outcome
Title Change From Baseline in Quality of Life as Assessed by Dermatology Life Quality Index (DLQI) at Week 13, Week 26, Week 39, and Week 52
Hide Description The DLQI is a 10-item validated measure developed specifically to assess quality of life (QoL) in participants with dermatological conditions. It assesses six domains: symptoms and feelings, daily activities, leisure, work ⁄school, personal relationships, and treatment. The DLQI total is the sum of 10 questions, each ranging from 0 (unanswered/not relevant,not at all) to 3 (very much). The higher the score, the greater the impairment of (QoL). Change from Baseline in DLQI scores is defined as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing data and/or for participants who discontinued from the study.
Time Frame Baseline, Week 13, Week 26, Week 39, and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 13 LOCF -0.15  (1.281)
Week 26 LOCF -0.25  (1.367)
Week 39 LOCF -0.27  (1.465)
Week 52 LOCF -0.23  (1.393)
23.Secondary Outcome
Title Serum Concentrations of Dihydrotestosterone (DHT) at Baseline, and After 26 Weeks and 52 Weeks
Hide Description Blood samples for DHT analysis was collected at Baseline, Week 26 and Week 52. DHT values at a lower limit of quantification (LLQ) were imputed using 1/2 LLQ. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing visit data and/or for participants who discontinued from the study.
Time Frame Baseline, Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: nanomole per liter (nmol/L)
Baseline, n=120 1.55  (0.714)
Week 26 LOCF, n=118 0.19  (0.518)
Week 52 LOCF, n=118 0.17  (0.267)
Time Frame Serious adverse events (SAE) and non-serious adverse events (AE) are reported from the start of treatment until the last dose of treatment.
Adverse Event Reporting Description SAEs and non-serious AEs are summarized for members of the ITT Population, comprised of all participants who received a randomization number, regardless of whether or not treatment was administered. This also includes AEs with missing onset date.
 
Arm/Group Title Dutasteride 0.5 mg
Hide Arm/Group Description Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
All-Cause Mortality
Dutasteride 0.5 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dutasteride 0.5 mg
Affected / at Risk (%)
Total   2/120 (1.67%) 
Injury, poisoning and procedural complications   
Stress fracture  1  1/120 (0.83%) 
Post-traumatic neck syndrome  1  1/120 (0.83%) 
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
Affected / at Risk (%)
Total   31/120 (25.83%) 
Infections and infestations   
Nasopharyngitis  1  18/120 (15.00%) 
Psychiatric disorders   
Libido decreased  1  10/120 (8.33%) 
Reproductive system and breast disorders   
Erectile dysfunction  1  14/120 (11.67%) 
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: NCT01831791     History of Changes
Other Study ID Numbers: 114264
First Submitted: April 11, 2013
First Posted: April 15, 2013
Results First Submitted: February 26, 2015
Results First Posted: March 12, 2015
Last Update Posted: June 20, 2018