Trial Outcomes & Findings for Safety and Tolerability and Efficacy of LCZ696 in Japanese Severe Hypertensive Patients (NCT NCT01646671)
NCT ID: NCT01646671
Last Updated: 2015-10-23
Results Overview
Adverse events, serious adverse events deaths were monitored from screening to week 8.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
35 participants
Primary outcome timeframe
Week 8
Results posted on
2015-10-23
Participant Flow
Participant milestones
| Measure |
LCZ696 200 mg
All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
|
LCZ696 400 mg
All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
|
LCZ696 400 mg Plus Other Hypertension (HTN) Medications
All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
11
|
21
|
|
Overall Study
COMPLETED
|
3
|
11
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Tolerability and Efficacy of LCZ696 in Japanese Severe Hypertensive Patients
Baseline characteristics by cohort
| Measure |
LCZ696 200 mg
n=3 Participants
All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
|
LCZ696 400 mg
n=11 Participants
All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
|
LCZ696 400 mg Plus Other Hypertension (HTN) Medications
n=21 Participants
All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.0 Years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
56.0 Years
STANDARD_DEVIATION 12.24 • n=7 Participants
|
49.3 Years
STANDARD_DEVIATION 7.57 • n=5 Participants
|
51.3 Years
STANDARD_DEVIATION 9.45 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: AE analysis was determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category. Other safety analysis was determined by the maximum treatment.
Adverse events, serious adverse events deaths were monitored from screening to week 8.
Outcome measures
| Measure |
LCZ696 200 mg
n=35 Participants
All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
|
LCZ696 400 mg
n=32 Participants
All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
|
LCZ696 400 mg Plus Other Hypertension (HTN) Medications
n=21 Participants
All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
|
Total Participants
n=35 Participants
All participants who were treated
|
|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events and Deaths
Adverse Events (serious and non-serious)
|
20.0 Percentage of participants
|
12.5 Percentage of participants
|
33.3 Percentage of participants
|
48.6 Percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events and Deaths
Serious Adverse Events
|
2.9 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.9 Percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events and Deaths
Deaths
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.
Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP measurements were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline value.
Outcome measures
| Measure |
LCZ696 200 mg
n=3 Participants
All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
|
LCZ696 400 mg
n=11 Participants
All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
|
LCZ696 400 mg Plus Other Hypertension (HTN) Medications
n=21 Participants
All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
|
Total Participants
n=35 Participants
All participants who were treated
|
|---|---|---|---|---|
|
Change From Baseline in msSBP and msDBP at Week 8
msSBP
|
-48.83 mmHg
Standard Deviation 11.730
|
-30.34 mmHg
Standard Deviation 15.054
|
-35.98 mmHg
Standard Deviation 15.229
|
-35.31 mmHg
Standard Deviation 15.348
|
|
Change From Baseline in msSBP and msDBP at Week 8
msDBP
|
-34.25 mmHg
Standard Deviation 7.378
|
-16.98 mmHg
Standard Deviation 7.394
|
-23.08 mmHg
Standard Deviation 8.514
|
-22.12 mmHg
Standard Deviation 9.167
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.
Successful BP control in patients with severe hypertension at the end of study treatment was defined as follows: msSBP/msDBP\< 140/90 mmHg.
Outcome measures
| Measure |
LCZ696 200 mg
n=3 Participants
All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
|
LCZ696 400 mg
n=11 Participants
All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
|
LCZ696 400 mg Plus Other Hypertension (HTN) Medications
n=21 Participants
All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
|
Total Participants
n=35 Participants
All participants who were treated
|
|---|---|---|---|---|
|
Percentage of Participants With Successful Blood Pressure (BP) Control in msSBP/msDBP at End of Study
|
66.7 Percentage of Participants
|
18.2 Percentage of Participants
|
47.6 Percentage of Participants
|
40.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.
Successful msSBP control in patients with severe hypertension at the end of study treatment was defined as msSBP \<140 mmHg.
Outcome measures
| Measure |
LCZ696 200 mg
n=3 Participants
All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
|
LCZ696 400 mg
n=11 Participants
All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
|
LCZ696 400 mg Plus Other Hypertension (HTN) Medications
n=21 Participants
All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
|
Total Participants
n=35 Participants
All participants who were treated
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Successful msSBP Control at End of Study
|
100 Percentage of Participants
|
45.5 Percentage of Participants
|
66.7 Percentage of Participants
|
62.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.
Successful msDBP control in patients with severe hypertension at the end of study treatment was defined as msDBP \< 90 mmHg.
Outcome measures
| Measure |
LCZ696 200 mg
n=3 Participants
All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
|
LCZ696 400 mg
n=11 Participants
All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
|
LCZ696 400 mg Plus Other Hypertension (HTN) Medications
n=21 Participants
All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
|
Total Participants
n=35 Participants
All participants who were treated
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Successful msDBP Control at End of Study
|
66.7 Percentage of Participants
|
36.4 Percentage of Participants
|
52.4 Percentage of Participants
|
48.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.
SBP response was defined as \<140 mmHg or a reduction ≥ 20 mmHg from baseline.
Outcome measures
| Measure |
LCZ696 200 mg
n=3 Participants
All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
|
LCZ696 400 mg
n=11 Participants
All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
|
LCZ696 400 mg Plus Other Hypertension (HTN) Medications
n=21 Participants
All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
|
Total Participants
n=35 Participants
All participants who were treated
|
|---|---|---|---|---|
|
Percentage of Participants With SBP Response at End of Study
|
100 Percentage of Participants
|
81.8 Percentage of Participants
|
85.7 Percentage of Participants
|
85.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.
DBP response was defined as \<90 mmHg or a reduction ≥ 10 mmHg from baseline.
Outcome measures
| Measure |
LCZ696 200 mg
n=3 Participants
All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
|
LCZ696 400 mg
n=11 Participants
All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
|
LCZ696 400 mg Plus Other Hypertension (HTN) Medications
n=21 Participants
All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
|
Total Participants
n=35 Participants
All participants who were treated
|
|---|---|---|---|---|
|
Percentage of Participants With DBP Response at End of Study
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
Adverse Events
LCZ 200 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
LCZ 400 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LCZ 400 mg + Other HTN Medications
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Total Participants
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LCZ 200 mg
n=35 participants at risk
LCZ 200 mg
|
LCZ 400 mg
n=32 participants at risk
LCZ 400 mg
|
LCZ 400 mg + Other HTN Medications
n=21 participants at risk
LCZ 400 mg + other HTN medications
|
Total Participants
n=35 participants at risk
All participants who were treated
|
|---|---|---|---|---|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
2.9%
1/35
SAE and other AE analyses were determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category.
|
0.00%
0/32
SAE and other AE analyses were determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category.
|
0.00%
0/21
SAE and other AE analyses were determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category.
|
2.9%
1/35
SAE and other AE analyses were determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
2.9%
1/35
SAE and other AE analyses were determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category.
|
0.00%
0/32
SAE and other AE analyses were determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category.
|
0.00%
0/21
SAE and other AE analyses were determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category.
|
2.9%
1/35
SAE and other AE analyses were determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category.
|
Other adverse events
| Measure |
LCZ 200 mg
n=35 participants at risk
LCZ 200 mg
|
LCZ 400 mg
n=32 participants at risk
LCZ 400 mg
|
LCZ 400 mg + Other HTN Medications
n=21 participants at risk
LCZ 400 mg + other HTN medications
|
Total Participants
n=35 participants at risk
All participants who were treated
|
|---|---|---|---|---|
|
Infections and infestations
NASOPHARYNGITIS
|
2.9%
1/35
SAE and other AE analyses were determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category.
|
6.2%
2/32
SAE and other AE analyses were determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category.
|
14.3%
3/21
SAE and other AE analyses were determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category.
|
17.1%
6/35
SAE and other AE analyses were determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
5.7%
2/35
SAE and other AE analyses were determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category.
|
0.00%
0/32
SAE and other AE analyses were determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category.
|
4.8%
1/21
SAE and other AE analyses were determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category.
|
8.6%
3/35
SAE and other AE analyses were determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category.
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
2.9%
1/35
SAE and other AE analyses were determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category.
|
0.00%
0/32
SAE and other AE analyses were determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category.
|
4.8%
1/21
SAE and other AE analyses were determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category.
|
5.7%
2/35
SAE and other AE analyses were determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: +1-862-778-8300
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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER