Trial Outcomes & Findings for Exercise Capacity Study of LCZ696 vs. Enalapril in Patients With Chronic Heart Failure and Reduced Ejection Fraction. (NCT NCT02768298)
NCT ID: NCT02768298
Last Updated: 2021-10-08
Results Overview
Cardiopulmonary exercise testing (CPET) is an established method to evaluate the exercise tolerance of heart failure patients by evaluating the cardio-pulmonary system using the measurement of respiratory gases during physical (exercise) stress. One of the parameters attained by this test is the peak respiratory oxygen uptake (VO2peak). CPET to assess VO2peak was performed at a cycle ergometer at baseline (Visit 2, 9 days prior randomization) and after 6 weeks and 3 months of treatment (Visit 6 and Visit 7, respectively). The VO2peak adjusted to body weight was calculated based on the corresponding visit's VO2peak (unadjusted) and body weight data by using the following formula: VO2peak (unadjusted)/body weight. Higher values of VO2peak indicate less symptom severity and therefore a positive change from baseline indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
201 participants
Primary outcome timeframe
Baseline, 3 months
Results posted on
2021-10-08
Participant Flow
Participants took part in 34 investigative sites in Germany.
Participants were randomized 1:1 to receive either LCZ696 or enalapril during the double-blind period.
Participant milestones
| Measure |
LCZ696
LCZ696 100 mg oral twice daily (bid) for 2 weeks followed by LCZ696 200 mg oral bid for 10 weeks.
|
Enalapril
Enalapril 5 mg oral twice daily (bid) for 2 weeks followed by enalapril 10 mg oral bid for 10 weeks.
Patients who prior Screening were at a stable daily dose of enalapril above 10 mg per day (or corresponding doses of other ACEI/ARB) started the study at a dose of enalapril 10 mg bid.
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
98
|
|
Overall Study
COMPLETED
|
99
|
91
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
LCZ696
LCZ696 100 mg oral twice daily (bid) for 2 weeks followed by LCZ696 200 mg oral bid for 10 weeks.
|
Enalapril
Enalapril 5 mg oral twice daily (bid) for 2 weeks followed by enalapril 10 mg oral bid for 10 weeks.
Patients who prior Screening were at a stable daily dose of enalapril above 10 mg per day (or corresponding doses of other ACEI/ARB) started the study at a dose of enalapril 10 mg bid.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
4
|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Non-compliance with study treatment
|
0
|
1
|
|
Overall Study
Subject/guardian decision
|
1
|
0
|
|
Overall Study
Withdrawal of informed consent
|
0
|
1
|
Baseline Characteristics
Exercise Capacity Study of LCZ696 vs. Enalapril in Patients With Chronic Heart Failure and Reduced Ejection Fraction.
Baseline characteristics by cohort
| Measure |
LCZ696
n=103 Participants
LCZ696 100 mg oral twice daily (bid) for 2 weeks followed by LCZ696 200 mg oral bid for 10 weeks.
|
Enalapril
n=98 Participants
Enalapril 5 mg oral twice daily (bid) for 2 weeks followed by enalapril 10 mg oral bid for 10 weeks.
Patients who prior Screening were at a stable daily dose of enalapril above 10 mg per day (or corresponding doses of other ACEI/ARB) started the study at a dose of enalapril 10 mg bid.
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.1 Years
STANDARD_DEVIATION 10.792 • n=5 Participants
|
67.6 Years
STANDARD_DEVIATION 9.961 • n=7 Participants
|
66.9 Years
STANDARD_DEVIATION 10.396 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucassian
|
101 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsPopulation: Full Analysis Set including patients with a valid measurements for the outcome measure.
Cardiopulmonary exercise testing (CPET) is an established method to evaluate the exercise tolerance of heart failure patients by evaluating the cardio-pulmonary system using the measurement of respiratory gases during physical (exercise) stress. One of the parameters attained by this test is the peak respiratory oxygen uptake (VO2peak). CPET to assess VO2peak was performed at a cycle ergometer at baseline (Visit 2, 9 days prior randomization) and after 6 weeks and 3 months of treatment (Visit 6 and Visit 7, respectively). The VO2peak adjusted to body weight was calculated based on the corresponding visit's VO2peak (unadjusted) and body weight data by using the following formula: VO2peak (unadjusted)/body weight. Higher values of VO2peak indicate less symptom severity and therefore a positive change from baseline indicates improvement.
Outcome measures
| Measure |
LCZ696
n=98 Participants
LCZ696 100 mg oral twice daily (bid) for 2 weeks followed by LCZ696 200 mg oral bid for 10 weeks.
|
Enalapril
n=90 Participants
Enalapril 5 mg oral twice daily (bid) for 2 weeks followed by enalapril 10 mg oral bid for 10 weeks.
Patients who prior Screening were at a stable daily dose of enalapril above 10 mg per day (or corresponding doses of other ACEI/ARB) started the study at a dose of enalapril 10 mg bid.
|
|---|---|---|
|
Change From Baseline in Peak Respiratory Oxygen Uptake (VO2peak) Adjusted to Body Weight) After 3 Months of Treatment
|
0.51 mL/kg/min
Standard Error 0.180
|
0.19 mL/kg/min
Standard Error 0.188
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: Full Analysis Set including patients with a valid measurements for the outcome measure.
Cardiopulmonary exercise testing (CPET) is an established method to evaluate the exercise tolerance of heart failure patients by evaluating the cardio-pulmonary system using the measurement of respiratory gases during physical (exercise) stress. One of the parameters attained by this test is the peak respiratory oxygen uptake (VO2peak). CPET to assess VO2peak was performed at a cycle ergometer at baseline (Visit 2, 9 days prior randomization) and after 6 weeks and 3 months of treatment (Visit 6 and Visit 7, respectively). The VO2peak adjusted to body weight was calculated based on the corresponding visit's VO2peak (unadjusted) and body weight data by using the following formula: VO2peak (unadjusted)/body weight. A positive change from baseline indicates less symptom severity.
Outcome measures
| Measure |
LCZ696
n=97 Participants
LCZ696 100 mg oral twice daily (bid) for 2 weeks followed by LCZ696 200 mg oral bid for 10 weeks.
|
Enalapril
n=88 Participants
Enalapril 5 mg oral twice daily (bid) for 2 weeks followed by enalapril 10 mg oral bid for 10 weeks.
Patients who prior Screening were at a stable daily dose of enalapril above 10 mg per day (or corresponding doses of other ACEI/ARB) started the study at a dose of enalapril 10 mg bid.
|
|---|---|---|
|
Change From Baseline in Peak Respiratory Oxygen Uptake (VO2peak) Adjusted to Body Weight) After 6 Weeks of Treatment
|
0.28 mL/kg/min
Standard Error 0.185
|
0.42 mL/kg/min
Standard Error 0.195
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 3 monthsPopulation: Full Analysis Set including patients with a valid measurements for the outcome measure.
Cardiopulmonary exercise testing (CPET) is an established method to evaluate the exercise tolerance of heart failure patients by evaluating the cardio-pulmonary system using the measurement of respiratory gases during physical (exercise) stress. One of the parameters attained by this test is the minute ventilation (VE) to carbon dioxide output slope (VE/VCO2 slope). High values of VE/VCO2 slope resembles the inability to eliminate CO2 by respiration (inefficient ventilation). A negative change from baseline indicates less symptom severity.
Outcome measures
| Measure |
LCZ696
n=103 Participants
LCZ696 100 mg oral twice daily (bid) for 2 weeks followed by LCZ696 200 mg oral bid for 10 weeks.
|
Enalapril
n=98 Participants
Enalapril 5 mg oral twice daily (bid) for 2 weeks followed by enalapril 10 mg oral bid for 10 weeks.
Patients who prior Screening were at a stable daily dose of enalapril above 10 mg per day (or corresponding doses of other ACEI/ARB) started the study at a dose of enalapril 10 mg bid.
|
|---|---|---|
|
Change From Baseline in the Minute Ventilation (VE) to Carbon Dioxide Output Slope (VE/VCO2 Slope)
6 weeks
|
-1.05 no units
Standard Error 0.597
|
0.18 no units
Standard Error 0.629
|
|
Change From Baseline in the Minute Ventilation (VE) to Carbon Dioxide Output Slope (VE/VCO2 Slope)
3 months
|
0.76 no units
Standard Error 0.542
|
-0.07 no units
Standard Error 0.575
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 3 monthsPopulation: Full Analysis Set including patients with a valid measurements for the outcome measure.
Cardiopulmonary exercise testing (CPET) is an established method to evaluate the exercise tolerance of heart failure patients by evaluating the cardio-pulmonary system using the measurement of respiratory gases during physical (exercise) stress. CPET was performed at a cycle ergometer with a workload that started at 10 watts (W) and then increased by 10W for each 1-minute stage. Exercise capacity assessed as workload in watts was determined at the ventilatory anaerobic threshold (VAT) which represents the transition from aerobic to partially anaerobic glucose metabolism in muscle, leading to increasing carbon dioxide exhalation in comparison to oxygen uptake. A positive change from baseline in exercise capacity (watt) indicates improvement.
Outcome measures
| Measure |
LCZ696
n=103 Participants
LCZ696 100 mg oral twice daily (bid) for 2 weeks followed by LCZ696 200 mg oral bid for 10 weeks.
|
Enalapril
n=98 Participants
Enalapril 5 mg oral twice daily (bid) for 2 weeks followed by enalapril 10 mg oral bid for 10 weeks.
Patients who prior Screening were at a stable daily dose of enalapril above 10 mg per day (or corresponding doses of other ACEI/ARB) started the study at a dose of enalapril 10 mg bid.
|
|---|---|---|
|
Change From Baseline in Exercise Capacity (Watt) at Ventilatory Anaerobic Threshold (VAT)
6 weeks
|
1.71 Watt
Standard Error 1.168
|
0.83 Watt
Standard Error 1.234
|
|
Change From Baseline in Exercise Capacity (Watt) at Ventilatory Anaerobic Threshold (VAT)
3 months
|
2.45 Watt
Standard Error 1.436
|
-0.83 Watt
Standard Error 1.483
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Full Analysis Set including patients with a valid measurements for the outcome measure.
The individually perceived exertion, in terms of perceived dyspnea and perceived fatigue, during cardiopulmonary exercise testing (CPET) was assessed by Borg scale which is a 15 point scale, starting from 6 which indicates "No exertion at all" to 20 which means "Maximal exertion". Change in Borg scale for both perceived dyspnea and perceived fatigue were measured at different time points at Baseline (Visit 2, 9 days prior randomization) and 3 months of treatment (Visit 7). Maximum value among the time points at every visit was used for the analysis. A negative change from baseline in Borg value of perceived dyspnea and perceived fatigue indicates improvement.
Outcome measures
| Measure |
LCZ696
n=103 Participants
LCZ696 100 mg oral twice daily (bid) for 2 weeks followed by LCZ696 200 mg oral bid for 10 weeks.
|
Enalapril
n=98 Participants
Enalapril 5 mg oral twice daily (bid) for 2 weeks followed by enalapril 10 mg oral bid for 10 weeks.
Patients who prior Screening were at a stable daily dose of enalapril above 10 mg per day (or corresponding doses of other ACEI/ARB) started the study at a dose of enalapril 10 mg bid.
|
|---|---|---|
|
Change From Baseline in Rate of Perceived Exertion (Perceived Dyspnea and Perceived Fatigue) During Exercise Assessed by Borg Scale
Borg value perceived dyspnea
|
-0.19 Score on scale
Standard Error 0.212
|
0.11 Score on scale
Standard Error 0.223
|
|
Change From Baseline in Rate of Perceived Exertion (Perceived Dyspnea and Perceived Fatigue) During Exercise Assessed by Borg Scale
Borg value perceived fatigue
|
-0.04 Score on scale
Standard Error 0.167
|
-0.20 Score on scale
Standard Error 0.178
|
Adverse Events
LCZ696
Serious events: 12 serious events
Other events: 52 other events
Deaths: 2 deaths
Enalapril
Serious events: 14 serious events
Other events: 36 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
LCZ696
n=103 participants at risk
LCZ696 100 mg oral twice daily (bid) for 2 weeks followed by LCZ696 200 mg oral bid for 10 weeks.
|
Enalapril
n=98 participants at risk
Enalapril 5 mg oral twice daily (bid) for 2 weeks followed by enalapril 10 mg oral bid for 10 weeks.
Patients who prior Screening were at a stable daily dose of enalapril above 10 mg per day (or corresponding doses of other ACEI/ARB) started the study at a dose of enalapril 10 mg bid.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.97%
1/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.97%
1/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.97%
1/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
2/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.0%
1/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.0%
1/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.0%
1/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.0%
1/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.0%
1/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.97%
1/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.0%
2/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.0%
1/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.97%
1/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Tachycardia
|
0.97%
1/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
1.9%
2/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.0%
1/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.0%
1/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
General disorders
Vascular stent occlusion
|
0.00%
0/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.0%
1/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Appendicitis
|
0.97%
1/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.97%
1/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Pneumonia
|
1.9%
2/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Septic shock
|
0.97%
1/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.0%
1/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Investigations
Angiocardiogram
|
0.00%
0/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.0%
1/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Investigations
International normalised ratio abnormal
|
0.97%
1/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.0%
1/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Seizure
|
0.00%
0/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.0%
1/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
2.0%
2/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.0%
1/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.97%
1/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.0%
1/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
1.0%
1/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Hypotension
|
0.97%
1/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
Other adverse events
| Measure |
LCZ696
n=103 participants at risk
LCZ696 100 mg oral twice daily (bid) for 2 weeks followed by LCZ696 200 mg oral bid for 10 weeks.
|
Enalapril
n=98 participants at risk
Enalapril 5 mg oral twice daily (bid) for 2 weeks followed by enalapril 10 mg oral bid for 10 weeks.
Patients who prior Screening were at a stable daily dose of enalapril above 10 mg per day (or corresponding doses of other ACEI/ARB) started the study at a dose of enalapril 10 mg bid.
|
|---|---|---|
|
General disorders
Fatigue
|
1.9%
2/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
7.1%
7/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Infections and infestations
Nasopharyngitis
|
8.7%
9/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
3.1%
3/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.7%
9/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
3.1%
3/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Dizziness
|
13.6%
14/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
6.1%
6/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
3/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
9.2%
9/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
2/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
6.1%
6/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Hypotension
|
26.2%
27/103 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
11.2%
11/98 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days (16 weeks on average).
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. 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