Trial Outcomes & Findings for Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function (NCT NCT01569828)
NCT ID: NCT01569828
Last Updated: 2015-09-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
1 and 5 days
Results posted on
2015-09-29
Participant Flow
Participant milestones
| Measure |
Severe Renal Impaired Subjects
Subjects with severe (CrCl from \<30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
|
Matched Healthy Volunteers
All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of \>80 mL/min.Once daily administration of 400 mg LCZ696 p.o. for 5 days
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function
Baseline characteristics by cohort
| Measure |
Severe Renal Impaired Subjects
n=6 Participants
Subjects with severe (CrCl from \<30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement.
Once daily administration of 400 mg LCZ696 p.o. for 5 days
|
Matched Healthy Volunteers
n=6 Participants
All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of \>80 mL/min.
Once daily administration of 400 mg LCZ696 p.o. for 5 days
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 7.76 • n=5 Participants
|
52.5 years
STANDARD_DEVIATION 6.98 • n=7 Participants
|
53.2 years
STANDARD_DEVIATION 7.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 and 5 daysPopulation: Pharmacokinetic analysis set
Outcome measures
| Measure |
Renal Impaired Subjects
n=6 Participants
Subjects with severe (CrCl from \<30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
|
Healthy Volunteers
n=6 Participants
All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of \>80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
|
|---|---|---|
|
Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
AHU377 (Sacubitril) on day 1
|
0.5 hour
Interval 0.5 to 1.0
|
0.5 hour
Interval 0.5 to 1.0
|
|
Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
AHU377 (Sacubitril) on day 5
|
0.5 hour
Interval 0.5 to 1.0
|
0.5 hour
Interval 0.5 to 0.5
|
|
Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
LBQ657(Sacubitril pro-drug) on day 1
|
3 hour
Interval 2.0 to 4.0
|
3 hour
Interval 2.0 to 4.0
|
|
Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
LBQ657(Sacubitril pro-drug) on day 5
|
2 hour
Interval 2.0 to 4.0
|
2.5 hour
Interval 2.0 to 4.0
|
|
Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
VAL489 (valsartan) on day 1
|
2 hour
Interval 1.0 to 3.0
|
2 hour
Interval 2.0 to 2.0
|
|
Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
VAL489 (valsartan) on day 5
|
2 hour
Interval 1.0 to 3.0
|
2 hour
Interval 1.0 to 2.0
|
PRIMARY outcome
Timeframe: 1 and 5 daysPopulation: Pharmacokinetic analysis set
Outcome measures
| Measure |
Renal Impaired Subjects
n=6 Participants
Subjects with severe (CrCl from \<30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
|
Healthy Volunteers
n=6 Participants
All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of \>80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
|
|---|---|---|
|
(Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
VAL489 (valsartan) on day 1
|
5935 ng/mL
Standard Deviation 2191
|
4988 ng/mL
Standard Deviation 1093
|
|
(Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
AHU377 (Sacubitril)on day 1
|
5215 ng/mL
Standard Deviation 3220
|
2810 ng/mL
Standard Deviation 862
|
|
(Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
AHU377(Sacubitril) on day 5
|
4960 ng/mL
Standard Deviation 3430
|
2407 ng/mL
Standard Deviation 1780
|
|
(Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
LBQ657 (Sacubitril prodrug)on day 1
|
15967 ng/mL
Standard Deviation 3380
|
14633 ng/mL
Standard Deviation 2233
|
|
(Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
LBQ657 ( Sacubitril prodrug) on day 5
|
30650 ng/mL
Standard Deviation 11462
|
18233 ng/mL
Standard Deviation 1975
|
|
(Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
VAL489 (valsartan) on day 5
|
5852 ng/mL
Standard Deviation 3306
|
5672 ng/mL
Standard Deviation 1314
|
PRIMARY outcome
Timeframe: 1 and 5 daysPopulation: Pharmacokinetic analysis set
Outcome measures
| Measure |
Renal Impaired Subjects
n=6 Participants
Subjects with severe (CrCl from \<30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
|
Healthy Volunteers
n=6 Participants
All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of \>80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
|
|---|---|---|
|
AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
AHU377 (Sacubitril) on day 1
|
5918 (hr*ng/mL)
Standard Deviation 3430.4
|
4101 (hr*ng/mL)
Standard Deviation 815.36
|
|
AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
AHU377(Sacubitril) on day 5
|
5495 (hr*ng/mL)
Standard Deviation 2890.2
|
4336 (hr*ng/mL)
Standard Deviation 745.88
|
|
AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
LBQ657(Sacubitril prodrug) on day 1
|
254000 (hr*ng/mL)
Standard Deviation 72562
|
146100 (hr*ng/mL)
Standard Deviation 17346
|
|
AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
LBQ657 (Sacubitril prodrug) on day 5
|
538300 (hr*ng/mL)
Standard Deviation 268650
|
185500 (hr*ng/mL)
Standard Deviation 29759
|
|
AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
VAL489 (valsartan) on day 1
|
40560 (hr*ng/mL)
Standard Deviation 11344
|
29870 (hr*ng/mL)
Standard Deviation 8756.9
|
|
AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
VAL489 (valsartan) on day 5
|
51080 (hr*ng/mL)
Standard Deviation 33780
|
32470 (hr*ng/mL)
Standard Deviation 8687.1
|
PRIMARY outcome
Timeframe: 5 daysPopulation: Pharmacokinetic analysis set
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
Outcome measures
| Measure |
Renal Impaired Subjects
n=6 Participants
Subjects with severe (CrCl from \<30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
|
Healthy Volunteers
n=6 Participants
All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of \>80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
|
|---|---|---|
|
T1/2 After Multiple Dose Administration (Day 5)
AHU377 (Sacubitril)on day 5
|
2.030 (hr)
Standard Deviation 1.2793
|
1.916 (hr)
Standard Deviation 0.69234
|
|
T1/2 After Multiple Dose Administration (Day 5)
LBQ657(Sacubitril prodrug) on day 5
|
38.55 (hr)
Standard Deviation 17.301
|
13.16 (hr)
Standard Deviation 2.6829
|
|
T1/2 After Multiple Dose Administration (Day 5)
VAL489 (valsartan) on day 5
|
26.40 (hr)
Standard Deviation 9.1992
|
12.98 (hr)
Standard Deviation 2.9882
|
PRIMARY outcome
Timeframe: 5 daysPopulation: Pharmacokinetic analysis set
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
Outcome measures
| Measure |
Renal Impaired Subjects
n=6 Participants
Subjects with severe (CrCl from \<30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
|
Healthy Volunteers
n=6 Participants
All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of \>80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
|
|---|---|---|
|
CL/F After Multiple Dose Administration (Day 5)
LBQ657( Sacubitril prodrug) on day 5
|
NA (ml/hr)
Standard Deviation NA
LBQ657 is a metabolite of AHU377, and hence LBQ657 CL/F values are not relevant.
|
NA (ml/hr)
Standard Deviation NA
LBQ657 is a metabolite of AHU377, and hence LBQ657 CL/F values are not relevant.
|
|
CL/F After Multiple Dose Administration (Day 5)
AHU377(Sacubitril) on day 5
|
45100 (ml/hr)
Standard Deviation 24523
|
45900 (ml/hr)
Standard Deviation 8168.0
|
|
CL/F After Multiple Dose Administration (Day 5)
VAL489 (valsartan) on day 5
|
7370 (ml/hr)
Standard Deviation 8063.0
|
6792 (ml/hr)
Standard Deviation 2051.1
|
PRIMARY outcome
Timeframe: 5 daysPopulation: Pharmacokinetic analysis set
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
Outcome measures
| Measure |
Renal Impaired Subjects
n=6 Participants
Subjects with severe (CrCl from \<30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
|
Healthy Volunteers
n=6 Participants
All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of \>80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
|
|---|---|---|
|
CLr After Multiple Dose Administration (Day 5)
AHU377 (Sacubitril) on day 5
|
24.18 (ml/hr)
Standard Deviation 28.781
|
111.8 (ml/hr)
Standard Deviation 82.310
|
|
CLr After Multiple Dose Administration (Day 5)
LBQ657 (Sacubitril prodrug) on day 5
|
47.39 (ml/hr)
Standard Deviation 38.392
|
436.9 (ml/hr)
Standard Deviation 72.388
|
|
CLr After Multiple Dose Administration (Day 5)
VAL489 (valsartan) on day 5
|
28.89 (ml/hr)
Standard Deviation 20.781
|
299.4 (ml/hr)
Standard Deviation 97.887
|
SECONDARY outcome
Timeframe: 5 daysOutcome measures
| Measure |
Renal Impaired Subjects
n=6 Participants
Subjects with severe (CrCl from \<30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
|
Healthy Volunteers
n=6 Participants
All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of \>80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
|
|---|---|---|
|
24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers
baseline
|
172.658 mmol/day
Standard Deviation 79.9239
|
177.833 mmol/day
Standard Deviation 39.5533
|
|
24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers
Day 1
|
133.000 mmol/day
Standard Deviation 35.5564
|
187.000 mmol/day
Standard Deviation 42.8392
|
|
24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers
Day 2
|
89.333 mmol/day
Standard Deviation 34.5714
|
156.833 mmol/day
Standard Deviation 26.4607
|
|
24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers
Day 3
|
106.050 mmol/day
Standard Deviation 39.6424
|
145.500 mmol/day
Standard Deviation 31.5325
|
|
24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers
Day 4
|
94.683 mmol/day
Standard Deviation 21.3792
|
140.500 mmol/day
Standard Deviation 30.9629
|
|
24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers
Day 5
|
93.500 mmol/day
Standard Deviation 36.2171
|
156.667 mmol/day
Standard Deviation 32.1165
|
|
24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers
Day 6
|
88.400 mmol/day
Standard Deviation 23.1383
|
96.167 mmol/day
Standard Deviation 28.6316
|
|
24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers
Day 7
|
107.150 mmol/day
Standard Deviation 36.1899
|
107.667 mmol/day
Standard Deviation 57.4514
|
Adverse Events
Severe Renal Impaired Patients
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Matched Healthy Volunteers
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Severe Renal Impaired Patients
n=6 participants at risk
|
Matched Healthy Volunteers
n=6 participants at risk
|
|---|---|---|
|
Vascular disorders
Diastolic hypertension
|
16.7%
1/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
0.00%
0/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
|
Vascular disorders
Orthostatic hypertension
|
50.0%
3/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
0.00%
0/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
|
Vascular disorders
Orthostatic hypotension
|
50.0%
3/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
0.00%
0/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
|
General disorders
Fatigue
|
0.00%
0/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
16.7%
1/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
50.0%
3/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
0.00%
0/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
|
Cardiac disorders
Sinus bradycardia
|
16.7%
1/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
0.00%
0/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
16.7%
1/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
16.7%
1/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
33.3%
2/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
16.7%
1/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
16.7%
1/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
|
Vascular disorders
Systolic hypertension
|
16.7%
1/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
0.00%
0/6 • Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment (FSFT) until Last Subject Last Visit (LSLV).
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial
- Publication restrictions are in place
Restriction type: OTHER