Trial Outcomes & Findings for Efficacy and Safety of Ambrisentan in Children 8-18yrs (NCT NCT01332331)
NCT ID: NCT01332331
Last Updated: 2019-10-08
Results Overview
AEs defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs 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 or incapacity, or is a congenital anomaly or birth defect, medical events that may not immediately life threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention as per medical or scientific judgement and events of drug-induced liver injury with hyperbilirubinaemia. Safety population comprised of all randomized participants who received at least 1 dose of study drug.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Up to 24 Weeks
Results posted on
2019-10-08
Participant Flow
This study investigated the safety and efficacy of a high and low dose ambrisentan (adjusted as per participants body weight) administered orally in participants aged 8 to 18 years with pulmonary arterial hypertension (PAH).
A total of 41 participants were enrolled and randomized.
Participant milestones
| Measure |
Low Dose Ambrisentan
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Low Dose Ambrisentan
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Ambrisentan in Children 8-18yrs
Baseline characteristics by cohort
| Measure |
Low Dose Ambrisentan
n=21 Participants
Participants received ambrisentan low dose tablet either 2.5 mg or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=20 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.8 Years
STANDARD_DEVIATION 2.70 • n=5 Participants
|
12.3 Years
STANDARD_DEVIATION 2.85 • n=7 Participants
|
12.0 Years
STANDARD_DEVIATION 2.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
2 Count of participants
n=5 Participants
|
0 Count of participants
n=7 Participants
|
2 Count of participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 Count of participants
n=5 Participants
|
0 Count of participants
n=7 Participants
|
1 Count of participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
1 Count of participants
n=5 Participants
|
0 Count of participants
n=7 Participants
|
1 Count of participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
1 Count of participants
n=5 Participants
|
0 Count of participants
n=7 Participants
|
1 Count of participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
5 Count of participants
n=5 Participants
|
0 Count of participants
n=7 Participants
|
5 Count of participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
0 Count of participants
n=5 Participants
|
1 Count of participants
n=7 Participants
|
1 Count of participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
11 Count of participants
n=5 Participants
|
19 Count of participants
n=7 Participants
|
30 Count of participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 WeeksPopulation: Safety Population
AEs defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs 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 or incapacity, or is a congenital anomaly or birth defect, medical events that may not immediately life threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention as per medical or scientific judgement and events of drug-induced liver injury with hyperbilirubinaemia. Safety population comprised of all randomized participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=21 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=20 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Treatment-emergent Adverse Events (SAEs)
Any AEs
|
16 Participants
|
16 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Treatment-emergent Adverse Events (SAEs)
Any SAEs
|
6 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 24 WeeksPopulation: Safety Population
Blood samples were collected from participants for analysis of following clinical chemistry parameters: ALT, AST, GGT, total bilirubin and creatinine. PCI ranges were \<3 times the upper limit of normal (ULN), \<34.2 Micromoles per liter (UMOL/L) for total bilirubin and \<176.8 (UMOL/L) for creatinine. Only those parameters having any time post-Baseline PCI values were presented. Day 1 was considered as Baseline.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=21 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=20 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With Post Baseline Potential Clinical Importance (PCI) Value for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT), Total Bilirubin and Creatinine
ALT
|
0 Participants
|
0 Participants
|
|
Number of Participants With Post Baseline Potential Clinical Importance (PCI) Value for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT), Total Bilirubin and Creatinine
AST
|
0 Participants
|
0 Participants
|
|
Number of Participants With Post Baseline Potential Clinical Importance (PCI) Value for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT), Total Bilirubin and Creatinine
GGT
|
0 Participants
|
0 Participants
|
|
Number of Participants With Post Baseline Potential Clinical Importance (PCI) Value for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT), Total Bilirubin and Creatinine
Total bilirubin
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post Baseline Potential Clinical Importance (PCI) Value for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT), Total Bilirubin and Creatinine
Creatinine
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 24 WeeksPopulation: Safety population
Blood samples were collected from participants for analysis of following hematology parameters: hemoglobin. PCI ranges were Males: 98 to180 grams per liter (G/L), Females: 91 to 161 (G/L) for hemoglobin. Only those parameters having any time post-Baseline PCI values were presented. Day 1 was considered as Baseline.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=21 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=20 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With Post Baseline PCI Value for Hematology Parameter: Hemoglobin
Reference high range
|
0 Participants
|
2 Participants
|
|
Number of Participants With Post Baseline PCI Value for Hematology Parameter: Hemoglobin
Reference low range
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 24 WeeksPopulation: Safety population
Blood samples were collected from participants for analysis of following hematology parameter: hematocrit. PCI ranges were males: \<0.32 to \>0.54, females: \<0.29 to \>0.506 proportion of red blood cells in blood for hematocrit. Only those parameters having any time post-Baseline PCI values were presented. Day 1 was considered as Baseline.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=21 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=20 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With Post Baseline PCI Value for Hematology Parameter: Hematocrit
Reference high range
|
0 Participants
|
2 Participants
|
|
Number of Participants With Post Baseline PCI Value for Hematology Parameter: Hematocrit
Reference low range
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 24 WeeksPopulation: Safety population
Blood samples were collected from participants for analysis of following hematology parameter: platelet count. PCI ranges were 100 to 400 for Giga cells per liter platelet count. Only those parameters having any time post-Baseline PCI values were presented. Day 1 was considered as Baseline.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=21 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=20 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With Post Baseline PCI Value for Hematology Parameter: Platelet Count
Reference high range
|
0 Participants
|
0 Participants
|
|
Number of Participants With Post Baseline PCI Value for Hematology Parameter: Platelet Count
Reference low range
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Week 12 and 24Population: Safety population. Only those participants with available data at the specified time points were analyzed.
Physical examination included measurement of liver size. Any abnormal enlargement or reduction in the size of the liver is reported.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=21 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=20 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Liver Size
Week 12, Abnormal: Improved, n=20, 19
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Liver Size
Week 12, Abnormal: Worsened, n=20, 19
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Liver Size
Week 12, Abnormal: Unchanged, n=20, 19
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Liver Size
Week 24, Abnormal: Improved, n=19, 18
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Liver Size
Week 24, Abnormal: Worsened, n=19, 18
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Liver Size
Week 24, Abnormal: Unchanged, n=19, 18
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 12 and 24Population: Safety population. Only those participants with available data at the specified time points were analyzed.
Physical examination of participants jugular venous pressure is measured.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=21 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=20 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Jugular Venous Pressure
Week 12, Abnormal: Improved, n=20, 19
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Jugular Venous Pressure
Week 12, Abnormal: Worsened, n=20, 19
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Jugular Venous Pressure
Week 12, Abnormal: Unchanged, n=20, 19
|
0 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Jugular Venous Pressure
Week 24, Abnormal: Improved, n=19, 18
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Jugular Venous Pressure
Week 24, Abnormal: Worsened, n=19, 18
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Jugular Venous Pressure
Week 24, Abnormal: Unchanged, n=19, 18
|
0 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Week 12 and 24Population: Safety population. Only those participants with available data at the specified time points were analyzed.
Physical examination of paricipants peripheral edema is measured. Day 1 was considered as Baseline.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=21 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=20 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Peripheral Edema
Week 12, Abnormal: Improved, n=20, 19
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Peripheral Edema
Week 12, Abnormal: Worsened, n=20, 19
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Peripheral Edema
Week 12, Abnormal: Unchanged, n=20, 19
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Peripheral Edema
Week 24, Abnormal: Improved, n=19, 18
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Peripheral Edema
Week 24, Abnormal: Worsened, n=19, 18
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Peripheral Edema
Week 24, Abnormal: Unchanged, n=19, 18
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 12 and 24Population: Safety population. Only those participants with available data at the specified time points were analyzed.
Physcial examination of paricipants ascites was measured. Day 1 was considered as Baseline.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=21 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=20 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Ascites
Week 12, Abnormal: Improved, n=20, 19
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Ascites
Week 12, Abnormal: Worsened, n=20, 19
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Ascites
Week 12, Abnormal: Unchanged, n=20, 19
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Ascites
Week 24, Abnormal: Improved, n=19, 18
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Ascites
Week 24, Abnormal: Worsened, n=19, 18
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Value for Physical Examination Parameter: Ascites
Week 24, Abnormal: Unchanged, n=19, 18
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 12 and 24Population: Safety population. Only those participants with available data at the specified time points were analyzed.
Physical examination of participants saturated oxygen level was measured. Day 1 was considered as Baseline.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=21 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=20 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Percentage of Physical Examination Parameter: Saturated Oxygen Level
Week 12, n=20, 18
|
96.9 Percentage of oxygen saturation
Standard Deviation 2.59
|
96.9 Percentage of oxygen saturation
Standard Deviation 6.93
|
|
Percentage of Physical Examination Parameter: Saturated Oxygen Level
Week 24, n=19, 18
|
97.3 Percentage of oxygen saturation
Standard Deviation 1.85
|
97.4 Percentage of oxygen saturation
Standard Deviation 1.92
|
PRIMARY outcome
Timeframe: Up to 24 WeeksPopulation: Safety population
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. PCI ranges were \<80 to \>160 millimeters of mercury (mmHg) for SDP and \<40 to \>110 mmHg for DBP. Only those parameters having any time post-Baseline PCI values were presented. Day 1 was considered as Baseline.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=21 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=20 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With Post Baseline PCI Value for Vital Signs Parameter: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Reference range high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Post Baseline PCI Value for Vital Signs Parameter: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Reference range low
|
1 Participants
|
2 Participants
|
|
Number of Participants With Post Baseline PCI Value for Vital Signs Parameter: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Reference range high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Post Baseline PCI Value for Vital Signs Parameter: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Reference range low
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 24 WeeksPopulation: Safety population
Heart rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. PCI ranges were \<50 to \>120 beats per minute (beats/min). Only those parameters having any time post-Baseline PCI values were presented. Day 1 was considered as Baseline.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=21 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=20 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With Post Baseline PCI Value for Vital Signs Parameter: Heart Rate
Reference range low
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post Baseline PCI Value for Vital Signs Parameter: Heart Rate
Reference range high
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 24 WeeksPopulation: Safety population
Weight of the participants was measured. PCI ranges were \<20 kilogram (kg) for weight. Only those parameters having any time post-Baseline PCI values were presented. Day 1 was considered as Baseline.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=21 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=20 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With Post Baseline PCI Value for Vital Signs Parameter: Weight
Reference range high
|
0 Participants
|
0 Participants
|
|
Number of Participants With Post Baseline PCI Value for Vital Signs Parameter: Weight
Reference range low
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12 and 24Population: Safety population. Only those male participants with available data at the specified time points were analyzed.
Testicular volume was assessed by Prader's orchiodometer and the assessment was performed by a pediatric endocrinologist using the Tanner's criteria. Only those parameters having status - overall were presented. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=9 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=5 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline of Pubertal Development: Men- Testicular Volume (TV) at Weeks 12 and 24
Week 24, Left TV, n=7, 5
|
1.4 Milliliter
Standard Deviation 2.76
|
0.5 Milliliter
Standard Deviation 1.50
|
|
Change From Baseline of Pubertal Development: Men- Testicular Volume (TV) at Weeks 12 and 24
Week 12, Right TV, n=7, 4
|
0.4 Milliliter
Standard Deviation 1.27
|
0.3 Milliliter
Standard Deviation 0.50
|
|
Change From Baseline of Pubertal Development: Men- Testicular Volume (TV) at Weeks 12 and 24
Week 12, Left TV, n=8, 5
|
0.0 Milliliter
Standard Deviation 0.53
|
0.2 Milliliter
Standard Deviation 0.45
|
|
Change From Baseline of Pubertal Development: Men- Testicular Volume (TV) at Weeks 12 and 24
Week 24, Right TV, n=6, 4
|
0.5 Milliliter
Standard Deviation 1.38
|
0.1 Milliliter
Standard Deviation 0.25
|
PRIMARY outcome
Timeframe: Baseline, Week 12 and 24Population: Safety population. Only those female participants with available data at the specified time points were analyzed.
FSH and LH level of participants were measured. Only those parameters having status - overall were presented. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=12 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=15 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Endocrine Parameter - Female : Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) at Weeks 12 and 24
Week 12, FSH, n=11, 13
|
0.586 International unit per Liter
Standard Deviation 1.412
|
-0.023 International unit per Liter
Standard Deviation 2.104
|
|
Change From Baseline in Plasma Endocrine Parameter - Female : Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) at Weeks 12 and 24
Week 24, FSH, n=10, 12
|
0.010 International unit per Liter
Standard Deviation 1.390
|
1.542 International unit per Liter
Standard Deviation 2.518
|
|
Change From Baseline in Plasma Endocrine Parameter - Female : Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) at Weeks 12 and 24
Week 12, LH, n=11, 13
|
0.39 International unit per Liter
Standard Deviation 3.117
|
-0.28 International unit per Liter
Standard Deviation 6.881
|
|
Change From Baseline in Plasma Endocrine Parameter - Female : Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) at Weeks 12 and 24
Week 24, LH, n=11, 13
|
-0.56 International unit per Liter
Standard Deviation 1.192
|
1.15 International unit per Liter
Standard Deviation 6.806
|
PRIMARY outcome
Timeframe: Baseline, Week 12 and 24Population: Safety population. Only those female participants with available data at the specified time points were analyzed.
Inhibin B level of participants were measured. Only those parameters having status - overall were presented. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=12 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=15 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Endocrine Parameter - Female : Inhibin B at Weeks 12 and 24
Week 24, Left TV, n=9, 7
|
-5.2 Nanogram per liter
Standard Deviation 36.44
|
16.0 Nanogram per liter
Standard Deviation 37.96
|
|
Change From Baseline in Plasma Endocrine Parameter - Female : Inhibin B at Weeks 12 and 24
Week 12, Right TV, n=9, 7
|
4.9 Nanogram per liter
Standard Deviation 10.03
|
1.7 Nanogram per liter
Standard Deviation 33.70
|
PRIMARY outcome
Timeframe: Baseline, Week 12 and 24Population: Safety population. Only those female participants with available data at the specified time points were analyzed.
Sex hormone binding globulin level of participants were measured. Only those parameters having status - overall were presented. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=12 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=15 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in Plasma Endocrine Parameter - Female : Sex Hormone Binding Globulin at Weeks 12 and 24
Week 12, Right TV, n=10, 9
|
1.3 Milliliter
Standard Deviation 9.55
|
7.4 Milliliter
Standard Deviation 18.91
|
|
Change From Baseline in Plasma Endocrine Parameter - Female : Sex Hormone Binding Globulin at Weeks 12 and 24
Week 24, Left TV, n=10, 8
|
-9.2 Milliliter
Standard Deviation 13.62
|
3.1 Milliliter
Standard Deviation 14.21
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20 and 24Population: Intent-to-treat population. Only those participants with available data at the specified time points were analyzed.
Participant's 6MWD data has been presented into three categories as overall, with oxygen use and without oxygen use. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. NA indicates that standard deviation could not be calculated for single participant. Intent-to-Treat (ITT) population consist of all randomized participants who received at least one dose of study drug.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=21 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=20 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test
Week 4, Overall, n=21, 18
|
33.10 Meters
Standard Deviation 66.979
|
24.96 Meters
Standard Deviation 71.254
|
|
Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test
Week 4, With oxygen use, n=2, 1
|
-16.00 Meters
Standard Deviation 11.314
|
85.20 Meters
Standard Deviation NA
NA indicated that standard deviation could not be calculated for single participant.
|
|
Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test
Week 4, Without oxygen use, n=19, 17
|
38.27 Meters
Standard Deviation 68.421
|
21.41 Meters
Standard Deviation 71.793
|
|
Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test
Week 8, Overall, n=20, 18
|
23.84 Meters
Standard Deviation 65.154
|
37.70 Meters
Standard Deviation 74.339
|
|
Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test
Week 8, With oxygen use, n=2, 1
|
-16.00 Meters
Standard Deviation 22.627
|
81.10 Meters
Standard Deviation NA
NA indicated that standard deviation could not be calculated for single participant.
|
|
Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test
Week 8, Without oxygen use, n=18, 17
|
28.26 Meters
Standard Deviation 67.133
|
35.15 Meters
Standard Deviation 75.809
|
|
Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test
Week 12, Overall, n=19, 18
|
29.51 Meters
Standard Deviation 79.657
|
40.29 Meters
Standard Deviation 69.137
|
|
Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test
Week 12, With oxygen use, n=2, 1
|
-1.00 Meters
Standard Deviation 65.054
|
75.40 Meters
Standard Deviation NA
NA indicated that standard deviation could not be calculated for single participant.
|
|
Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test
Week 12, Without oxygen use, n=17, 17
|
33.09 Meters
Standard Deviation 82.121
|
38.22 Meters
Standard Deviation 70.690
|
|
Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test
Week 16, Overall, n=19, 18
|
22.31 Meters
Standard Deviation 88.832
|
36.43 Meters
Standard Deviation 78.220
|
|
Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test
Week 16, With oxygen use, n=2, 1
|
-21.00 Meters
Standard Deviation 57.983
|
65.40 Meters
Standard Deviation NA
NA indicated that standard deviation could not be calculated for single participant.
|
|
Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test
Week 16, Without oxygen use, n=17, 17
|
27.41 Meters
Standard Deviation 91.681
|
34.73 Meters
Standard Deviation 80.282
|
|
Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test
Week 20, Overall, n=19, 18
|
48.49 Meters
Standard Deviation 90.645
|
31.19 Meters
Standard Deviation 71.209
|
|
Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test
Week 20, With oxygen use, n=3, 1
|
-0.33 Meters
Standard Deviation 43.753
|
73.20 Meters
Standard Deviation NA
NA indicated that standard deviation could not be calculated for single participant.
|
|
Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test
Week 20, Without oxygen use, n=16, 17
|
57.64 Meters
Standard Deviation 95.070
|
28.72 Meters
Standard Deviation 72.600
|
|
Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test
Week 24, Overall, n=18, 18
|
55.14 Meters
Standard Deviation 102.182
|
26.25 Meters
Standard Deviation 62.011
|
|
Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test
Week 24, With oxygen use, n=3, 1
|
43.00 Meters
Standard Deviation 53.395
|
65.90 Meters
Standard Deviation NA
NA indicated that standard deviation could not be calculated for single participant.
|
|
Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test
Week 24, Without oxygen use, n=15, 17
|
57.57 Meters
Standard Deviation 110.605
|
23.92 Meters
Standard Deviation 63.100
|
SECONDARY outcome
Timeframe: Up to Week 24Population: Intent-to-treat population. Only those participants with available data at the specified time points were analyzed.
Time to clinical worsening of PAH is defined as the time from randomization to the first occurrence of death or placed for lung transplant, hospitalization due to PAH deterioration, addition or increased dose of other targeted PAH therapeutic agents like prostanoids and PDE-5 inhibitors) and/or atrial septostomy, other PAH related deterioration identified by increase in WHO functional class, deterioration in exercise testing and clinical signs or symptoms of right sided heart failure.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=3 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=3 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Time to the First Clinical Worsening of Pulmonary Arterial Hypertension (PAH)
|
77.3 Days
Standard Deviation 62.56
|
71.7 Days
Standard Deviation 29.26
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Intent-to-treat population. Only those participants with available data at the specified time points were analyzed.
Short-form 10 (SF-10) Health Survey for Children is a 10-item parent-completed health assessment that measures physical and psychosocial functioning for children ages five and over. Each item has either 4, 5 or 6 response choices with associated point systems. Two summary scores were calculated: a Physical Summary Score (PHS) and a Psychosocial Summary Score (PSS) with a range of 5 to 30 points for each 5-item score. This aggregated point score was then standardized and transformed to a norm-based scoring metric in accordance with the developer's algorithms using associated mean and standard deviation derived from 2006 sample data. This generated the final standardized norm-based scores for PHS (range -10.90 to 57.21) and for PSS (range 8.81 to 62.28), respectively. A higher value on each summary score indicates better functioning. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=21 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=20 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in Subject Global Assessment to Week 24 Using the SF-10 Health Survey for Children
Physical health summary, n=16, 15
|
0.194 Scores on a scale
Standard Deviation 11.7733
|
2.811 Scores on a scale
Standard Deviation 13.1172
|
|
Change From Baseline in Subject Global Assessment to Week 24 Using the SF-10 Health Survey for Children
Psychosocial summary, n=16, 15
|
0.725 Scores on a scale
Standard Deviation 8.6431
|
0.412 Scores on a scale
Standard Deviation 10.1331
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 12, 16, 20 and 24Population: Intent-to-treat population. Only those participants with available data at the specified time points were analyzed.
PAH was classified by WHO functional class (FC) at specific time points. There were four WHO FC grades based on severity of PAH symptoms (Class I=none, Class IV=most severe). Grades were then mapped to numeric scale, for which scores ranged from 1 to 4 (Class I=1 and Class IV=4). Score at Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=21 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=20 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in World Health Organization (WHO) Functional Class to Week 24
Week 4, n=21, 19
|
-0.1 Scores on a scale
Standard Deviation 0.36
|
-0.1 Scores on a scale
Standard Deviation 0.23
|
|
Change From Baseline in World Health Organization (WHO) Functional Class to Week 24
Week 8, n=20, 19
|
-0.1 Scores on a scale
Standard Deviation 0.45
|
-0.1 Scores on a scale
Standard Deviation 0.40
|
|
Change From Baseline in World Health Organization (WHO) Functional Class to Week 24
Week 12, n=20, 19
|
-0.1 Scores on a scale
Standard Deviation 0.45
|
0.0 Scores on a scale
Standard Deviation 0.58
|
|
Change From Baseline in World Health Organization (WHO) Functional Class to Week 24
Week 16, n=20, 18
|
-0.2 Scores on a scale
Standard Deviation 0.49
|
-0.2 Scores on a scale
Standard Deviation 0.38
|
|
Change From Baseline in World Health Organization (WHO) Functional Class to Week 24
Week 20, n=19, 18
|
-0.2 Scores on a scale
Standard Deviation 0.50
|
-0.2 Scores on a scale
Standard Deviation 0.38
|
|
Change From Baseline in World Health Organization (WHO) Functional Class to Week 24
Week 24, n=19, 18
|
-0.3 Scores on a scale
Standard Deviation 0.56
|
-0.2 Scores on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and 24Population: Intent-to-treat population. Only those participants with available data at the specified time points were analyzed.
NT-Pro BNP plasma concentrations were determined at specific time points. Geometric mean and SD logs has been presented. Day 1 was considered as Baseline. Ratio to Baseline is expressed as percentage change from Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Low Dose Ambrisentan
n=21 Participants
Participants received ambrisentan low dose tablet either 2.5 milligram (mg) or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=20 Participants
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Ratio to Baseline in Plasma N-terminal Pro-B Type Natriuretic Peptide (NT-Pro BNP) Concentration at Week 24
Week 12, n=19, 17
|
-15.93 Percentage Change
Standard Deviation 0.895
|
-12.43 Percentage Change
Standard Deviation 0.862
|
|
Ratio to Baseline in Plasma N-terminal Pro-B Type Natriuretic Peptide (NT-Pro BNP) Concentration at Week 24
Week 24, n=18, 17
|
-30.91 Percentage Change
Standard Deviation 0.851
|
-28.25 Percentage Change
Standard Deviation 1.179
|
Adverse Events
Low Dose Ambrisentan
Serious events: 6 serious events
Other events: 16 other events
Deaths: 1 deaths
High Dose Ambrisentan
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose Ambrisentan
n=21 participants at risk
Participants received ambrisentan low dose tablet either 2.5 mg or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=20 participants at risk
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
General disorders
General physical health deterioration
|
4.8%
1/21 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
0.00%
0/20 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Infections and infestations
Device related infection
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Infections and infestations
Pharyngitis
|
4.8%
1/21 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
0.00%
0/20 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Infections and infestations
Pneumonia
|
4.8%
1/21 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
0.00%
0/20 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Nervous system disorders
Syncope
|
4.8%
1/21 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
0.00%
0/20 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Product Issues
Device breakage
|
4.8%
1/21 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
0.00%
0/20 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
4.8%
1/21 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
0.00%
0/20 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
Other adverse events
| Measure |
Low Dose Ambrisentan
n=21 participants at risk
Participants received ambrisentan low dose tablet either 2.5 mg or 5 mg orally once daily for 24 weeks.
|
High Dose Ambrisentan
n=20 participants at risk
Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.8%
1/21 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Cardiac disorders
Palpitations
|
4.8%
1/21 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
19.0%
4/21 • Number of events 4 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 2 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
3/21 • Number of events 3 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
10.0%
2/20 • Number of events 4 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
9.5%
2/21 • Number of events 3 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
0.00%
0/20 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Gastrointestinal disorders
Gastritis
|
4.8%
1/21 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Gastrointestinal disorders
Nausea
|
19.0%
4/21 • Number of events 5 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
15.0%
3/20 • Number of events 3 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
2/21 • Number of events 2 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
0.00%
0/20 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
General disorders
Asthenia
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
General disorders
Face oedema
|
4.8%
1/21 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
10.0%
2/20 • Number of events 2 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
General disorders
Fatigue
|
4.8%
1/21 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
General disorders
Pyrexia
|
9.5%
2/21 • Number of events 2 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 2 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
General disorders
Oedema peripheral
|
9.5%
2/21 • Number of events 2 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Infections and infestations
Ear infection
|
4.8%
1/21 • Number of events 2 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Infections and infestations
Gastroenteritis
|
9.5%
2/21 • Number of events 3 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Infections and infestations
Laryngitis
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
10.0%
2/20 • Number of events 2 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
3/21 • Number of events 4 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
10.0%
2/20 • Number of events 2 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Infections and infestations
Pharyngitis
|
9.5%
2/21 • Number of events 3 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Infections and infestations
Pneumonia
|
9.5%
2/21 • Number of events 3 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
0.00%
0/20 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Infections and infestations
Respiratory tract infection
|
4.8%
1/21 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
3/21 • Number of events 4 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Investigations
International normalised ratio increased
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
10.0%
2/20 • Number of events 2 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.5%
2/21 • Number of events 3 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Nervous system disorders
Headache
|
19.0%
4/21 • Number of events 5 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
30.0%
6/20 • Number of events 9 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.8%
1/21 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.5%
2/21 • Number of events 2 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
10.0%
2/20 • Number of events 3 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.8%
1/21 • Number of events 2 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/21 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
5.0%
1/20 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.8%
1/21 • Number of events 1 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
10.0%
2/20 • Number of events 2 • On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Safety Population was used. Safety Population comprised of all randomized participants who received at least one dose of a study drug
|
Additional Information
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