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A Phase 2a Pharmacodynamic Study of TAK-448 in Participants With Hypogonadotropic Hypogonadism

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: NCT02369796
Recruitment Status : Terminated (Sponsor decision to terminate the study because the study did not achieve the primary efficacy objective.)
First Posted : February 24, 2015
Results First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypogonadotropic Hypogonadism
Intervention Drug: TAK-448
Enrollment 15
Recruitment Details Participants took part in the study at 1 investigative site in the United Kingdom from 10 February 2015 to 3 November 2015.
Pre-assignment Details Overweight/obese male participants with a diagnosis of hypogonadotropic hypogonadism were enrolled in 1 of 5 treatment groups: once weekly TAK-448 3 µg, 1 µg or 0.3 µg or twice weekly TAK-448 0.3 µg or 0.1 µg.
Arm/Group Title TAK-448 3 µg Once Weekly TAK-448 1 µg Once Weekly TAK-448 0.3 µg Once Weekly TAK-448 0.3 µg Twice Weekly TAK-448 0.1 µg Twice Weekly
Hide Arm/Group Description TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22. TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22. TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22. TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25. TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
Period Title: Overall Study
Started 3 3 3 3 3
Completed 3 3 3 3 3
Not Completed 0 0 0 0 0
Arm/Group Title TAK-448 3 µg Once Weekly TAK-448 1 µg Once Weekly TAK-448 0.3 µg Once Weekly TAK-448 0.3 µg Twice Weekly TAK-448 0.1 µg Twice Weekly Total
Hide Arm/Group Description TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22. TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22. TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22. TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25. TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25. Total of all reporting groups
Overall Number of Baseline Participants 3 3 3 3 3 15
Hide Baseline Analysis Population Description
Safety analysis set included all participants who were enrolled and received at least 1 dose of study drug, including participants who did not complete all scheduled study visits.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 3 participants 3 participants 3 participants 15 participants
50.7  (8.02) 50.7  (4.62) 51.7  (3.79) 56.0  (3.61) 45.0  (19.16) 50.8  (9.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 3 participants 15 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
15
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 3 participants 15 participants
Asian 2 0 0 0 0 2
White 1 3 3 3 3 13
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 3 participants 3 participants 3 participants 3 participants 3 participants 15 participants
3 3 3 3 3 15
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 3 participants 3 participants 3 participants 3 participants 3 participants 15 participants
168  (7) 174  (6) 181  (18) 178  (6) 178  (12) 176  (10)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 3 participants 3 participants 3 participants 3 participants 3 participants 15 participants
104  (30) 113  (10) 119  (26) 115  (7) 110  (26) 112  (19)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 3 participants 3 participants 3 participants 3 participants 3 participants 15 participants
36  (8) 37  (1) 36  (2) 36  (2) 34  (4) 36  (4)
Smoking Classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 3 participants 15 participants
Has never smoked 3 0 0 1 1 5
Is current smoker 0 0 1 0 0 1
Is an ex-smoker 0 3 2 2 2 9
Alcohol Classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 3 participants 15 participants
Has never drunk 0 0 1 0 0 1
Is current drinker 3 2 1 2 2 10
Is an ex-drinker 0 1 1 1 1 4
Caffeine Consumption  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 3 participants 15 participants
Yes 3 3 3 2 3 14
No 0 0 0 1 0 1
1.Primary Outcome
Title Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Once Weekly Dosing Groups
Hide Description Area under the pharmacodynamic (PD) total serum testosterone (ST) concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Time Frame Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dose
Hide Outcome Measure Data
Hide Analysis Population Description
PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.
Arm/Group Title TAK-448 3 µg Once Weekly TAK-448 1 µg Once Weekly TAK-448 0.3 µg Once Weekly
Hide Arm/Group Description:
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
Overall Number of Participants Analyzed 3 3 3
Mean (Standard Deviation)
Unit of Measure: percent change
1.9  (11.3) 13.5  (24.9) 14.9  (16.3)
2.Primary Outcome
Title Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Twice Weekly Dosing Groups
Hide Description Area under the PD total ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Time Frame Baseline and Day 25 pre-dose and multiple time points (up to 72 hours) post dose
Hide Outcome Measure Data
Hide Analysis Population Description
PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.
Arm/Group Title TAK-448 0.3 µg Twice Weekly TAK-448 0.1 µg Twice Weekly
Hide Arm/Group Description:
TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: percent change
-2.8  (3.7) 6.0  (12.3)
3.Primary Outcome
Title Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Free Serum Testosterone for Once Weekly Dosing Groups
Hide Description Area under the PD free ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Time Frame Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dose
Hide Outcome Measure Data
Hide Analysis Population Description
PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.
Arm/Group Title TAK-448 3 µg Once Weekly TAK-448 1 µg Once Weekly TAK-448 0.3 µg Once Weekly
Hide Arm/Group Description:
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
Overall Number of Participants Analyzed 3 3 3
Mean (Standard Deviation)
Unit of Measure: percent change
3.55  (9.08) 11.1  (28.0) 7.92  (8.88)
4.Primary Outcome
Title Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Free Serum Testosterone for Twice Weekly Dosing Groups
Hide Description Area under the PD free ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Time Frame Baseline and Day 25 pre-dose and multiple time points (up to 72 hours) post dose
Hide Outcome Measure Data
Hide Analysis Population Description
PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.
Arm/Group Title TAK-448 0.3 µg Twice Weekly TAK-448 0.1 µg Twice Weekly
Hide Arm/Group Description:
TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: percent change
-9.00  (4.23) 20.5  (5.33)
5.Primary Outcome
Title Trough Serum Concentration (Ctrough) of Total Serum Testosterone for Once Weekly Dosing Groups
Hide Description Trough serum concentration of total ST, defined as lowest baseline concentration compared to pre-dose of the last dose.
Time Frame Day 22 pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.
Arm/Group Title TAK-448 3 µg Once Weekly TAK-448 1 µg Once Weekly TAK-448 0.3 µg Once Weekly
Hide Arm/Group Description:
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
Overall Number of Participants Analyzed 3 3 3
Mean (Standard Deviation)
Unit of Measure: nmol/L
5.4  (1.3) 4.4  (3.1) 8.7  (1.3)
6.Primary Outcome
Title Trough Serum Concentration (Ctrough) of Total Serum Testosterone for Twice Weekly Dosing Group
Hide Description Trough serum concentration of total ST, defined as lowest baseline concentration compared to pre-dose of the last dose.
Time Frame Day 25 pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.
Arm/Group Title TAK-448 0.3 µg Twice Weekly TAK-448 0.1 µg Twice Weekly
Hide Arm/Group Description:
TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: nmol/L
4.7  (2.8) 6.9  (2.1)
7.Primary Outcome
Title Trough Serum Concentration (Ctrough) of Free Serum Testosterone for Once Weekly Dosing Groups
Hide Description Trough serum concentration of free ST, defined as lowest baseline concentration compared to pre-dose of the last dose.
Time Frame Day 22 pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure. Number of participants analyzed is number of participants evaluated for this outcome measure.
Arm/Group Title TAK-448 3 µg Once Weekly TAK-448 1 µg Once Weekly TAK-448 0.3 µg Once Weekly
Hide Arm/Group Description:
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
Overall Number of Participants Analyzed 3 3 2
Mean (Standard Deviation)
Unit of Measure: nmol/L
0.16  (0.03) 0.12  (0.07) 0.21  (0.004)
8.Primary Outcome
Title Trough Serum Concentration (Ctrough) of Free Serum Testosterone for Twice Weekly Dosing Groups
Hide Description Trough serum concentration of free ST, defined as lowest baseline concentration compared to pre-dose of the last dose.
Time Frame Day 25 pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.
Arm/Group Title TAK-448 0.3 µg Twice Weekly TAK-448 0.1 µg Twice Weekly
Hide Arm/Group Description:
TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: nmol/L
0.12  (0.09) 0.20  (0.06)
9.Secondary Outcome
Title Cmax: Mean Maximum Observed Plasma Concentration for TAK-448 Free Base Form (TAK-448F)
Hide Description Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time Frame Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all participants who received at least one dose of study drug and had at least 1 measurable concentration of TAK-448F.
Arm/Group Title TAK-448 3 µg Once Weekly TAK-448 1 µg Once Weekly TAK-448 0.3 µg Once Weekly
Hide Arm/Group Description:
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
Overall Number of Participants Analyzed 3 3 1
Mean (Standard Deviation)
Unit of Measure: pg/mL
Day 1 39.50  (4.943) 10.46  (1.484) NA [1]   (NA)
Day 22 40.10  (6.344) 12.27  (3.618) NA [2]   (NA)
[1]
Data was not estimable as plasma concentration was below the lower level of quantification (LLOQ).
[2]
Data was not estimable as plasma concentration was below LLOQ.
10.Secondary Outcome
Title AUC(0-∞): Mean Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-448F
Hide Description AUC(0-∞) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Time Frame Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK set included all participants who received at least one dose of study drug and had at least 1 measurable concentration of TAK-448F. Here, 'n' is the participants who were analyzed at specific time point.
Arm/Group Title TAK-448 3 µg Once Weekly TAK-448 1 µg Once Weekly TAK-448 0.3 µg Once Weekly
Hide Arm/Group Description:
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
Overall Number of Participants Analyzed 3 1 1
Mean (Standard Deviation)
Unit of Measure: pg*hr/mL
Day 1 (n=3, 0 1) 112.00  (5.686) NA [1]   (NA) NA [2]   (NA)
Day 22 (n=3, 1, 1) 122.33  (10.477) 33.30 [3]   (NA) NA [2]   (NA)
[1]
No participant was analyzed at this time point.
[2]
Data was not estimable as plasma concentration was below LLOQ.
[3]
Only 1 participant was analyzed at this time point.
11.Secondary Outcome
Title AUC(0-tlqc): Mean Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-448F
Hide Description AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).
Time Frame Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK set included all participants who received at least one dose of study drug and had at least 1 measurable concentration of TAK-448F.
Arm/Group Title TAK-448 3 µg Once Weekly TAK-448 1 µg Once Weekly TAK-448 0.3 µg Once Weekly
Hide Arm/Group Description:
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
Overall Number of Participants Analyzed 3 3 1
Mean (Standard Deviation)
Unit of Measure: pg*hr/mL
Day 1 92.23  (6.732) 19.00  (3.470) NA [1]   (NA)
Day 22 95.20  (11.914) 18.37  (3.069) NA [1]   (NA)
[1]
Data was not estimable as plasma concentration was below LLOQ.
12.Secondary Outcome
Title Mean Terminal Phase Elimination Half-life (T1/2) for TAK-448F
Hide Description Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Time Frame Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all participants who received at least one dose of study drug and had at least 1 measurable concentration of TAK-448F. Here, 'n' is the participants who were analyzed at specific time point.
Arm/Group Title TAK-448 3 µg Once Weekly TAK-448 1 µg Once Weekly TAK-448 0.3 µg Once Weekly
Hide Arm/Group Description:
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
Overall Number of Participants Analyzed 3 1 1
Mean (Standard Deviation)
Unit of Measure: hr
Day 1 (n=3, 0, 1) 1.800  (0.0751) NA [1]   (NA) NA [2]   (NA)
Day 22 (n=3, 1, 1) 2.073  (0.1920) 1.150 [3]   (NA) NA [2]   (NA)
[1]
No participant was analyzed at this time point.
[2]
Data was not estimable as plasma concentration was below LLOQ.
[3]
Only 1 participant was analyzed at this time point.
Time Frame Day 1 up to Day 39
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title TAK-448 3 µg Once Weekly TAK-448 1 µg Once Weekly TAK-448 0.3 µg Once Weekly TAK-448 0.3 µg Twice Weekly TAK-448 0.1 µg Twice Weekly
Hide Arm/Group Description TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22. TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22. TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22. TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25. TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
All-Cause Mortality
TAK-448 3 µg Once Weekly TAK-448 1 µg Once Weekly TAK-448 0.3 µg Once Weekly TAK-448 0.3 µg Twice Weekly TAK-448 0.1 µg Twice Weekly
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TAK-448 3 µg Once Weekly TAK-448 1 µg Once Weekly TAK-448 0.3 µg Once Weekly TAK-448 0.3 µg Twice Weekly TAK-448 0.1 µg Twice Weekly
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TAK-448 3 µg Once Weekly TAK-448 1 µg Once Weekly TAK-448 0.3 µg Once Weekly TAK-448 0.3 µg Twice Weekly TAK-448 0.1 µg Twice Weekly
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/3 (33.33%)   1/3 (33.33%)   1/3 (33.33%)   3/3 (100.00%)   1/3 (33.33%) 
Eye disorders           
Eye haemorrhage  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Gastrointestinal disorders           
Diarrhoea  1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders           
Musculoskeletal pain  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Nervous system disorders           
Headache  1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Dizziness  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Hypoaesthesia  1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Skin and subcutaneous tissue disorders           
Acne  1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  2/3 (66.67%)  0/3 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v 18.0
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.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02369796     History of Changes
Other Study ID Numbers: TAK-448-2001
U1111-1162-4892 ( Registry Identifier: WHO )
2014-002155-25 ( EudraCT Number )
14/LO/1950 ( Registry Identifier: NRES )
First Submitted: February 17, 2015
First Posted: February 24, 2015
Results First Submitted: November 1, 2016
Results First Posted: March 31, 2017
Last Update Posted: March 31, 2017