Trial Outcomes & Findings for A Study to Evaluate the Effect of LCZ696 on Aortic Stiffness in Subjects With Hypertension (NCT NCT01870739)
NCT ID: NCT01870739
Last Updated: 2021-01-05
Results Overview
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Ascending aorta distensibility was one of the 3 components for measuring local arota distensibility.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
115 participants
Primary outcome timeframe
Baseline, 52 weeks
Results posted on
2021-01-05
Participant Flow
A total of 115 patients were enrolled. One patient was discontinued after randomization before receiving any dose of study randomized medication. A total of 114 patients received study randomized medication
Participant milestones
| Measure |
Sacubitril/Valsartan (LCZ696)
LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Olmesartan
Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
|---|---|---|
|
Single Drug Treatment (12 Weeks)
STARTED
|
57
|
57
|
|
Single Drug Treatment (12 Weeks)
Initiation Dose Completed
|
57
|
56
|
|
Single Drug Treatment (12 Weeks)
Maintenance Dose Started
|
57
|
56
|
|
Single Drug Treatment (12 Weeks)
COMPLETED
|
54
|
53
|
|
Single Drug Treatment (12 Weeks)
NOT COMPLETED
|
3
|
4
|
|
Add-on Period (40 Weeks)
STARTED
|
54
|
53
|
|
Add-on Period (40 Weeks)
COMPLETED
|
51
|
51
|
|
Add-on Period (40 Weeks)
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Sacubitril/Valsartan (LCZ696)
LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Olmesartan
Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
|---|---|---|
|
Single Drug Treatment (12 Weeks)
Protocol deviation
|
0
|
1
|
|
Single Drug Treatment (12 Weeks)
Adverse Event
|
0
|
1
|
|
Single Drug Treatment (12 Weeks)
Administrative problems
|
3
|
2
|
|
Add-on Period (40 Weeks)
Adverse Event
|
0
|
1
|
|
Add-on Period (40 Weeks)
Unsatisfactory therapeutic effect
|
1
|
0
|
|
Add-on Period (40 Weeks)
Protocol deviation
|
1
|
1
|
|
Add-on Period (40 Weeks)
Patient withdrew consent
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Effect of LCZ696 on Aortic Stiffness in Subjects With Hypertension
Baseline characteristics by cohort
| Measure |
Sacubitril/Valsartan (LCZ696)
n=57 Participants
LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Olmesartan
n=57 Participants
Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.5 Years
STANDARD_DEVIATION 7.8 • n=93 Participants
|
59.2 Years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
59.8 Years
STANDARD_DEVIATION 10.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
77 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 52 weeksPopulation: Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Ascending aorta distensibility was one of the 3 components for measuring local arota distensibility.
Outcome measures
| Measure |
Sacubitril/Valsartan (LCZ696)
n=49 Participants
LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Olmesartan
n=53 Participants
Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
|
Maintenance Dose: Olmesartan 40 mg
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
|
Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
Olmesartan 40mg +/- Amlodipine
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Ascending Aorta Distensibility at 52 Week
|
0.269 10^(-3) x mmHg^(-1)
Standard Error 0.1283
|
0.330 10^(-3) x mmHg^(-1)
Standard Error 0.1233
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 52 weeksPopulation: Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Proximal descending aorta distensibility was one of the 3 components for measuring local arota distensibility.
Outcome measures
| Measure |
Sacubitril/Valsartan (LCZ696)
n=49 Participants
LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Olmesartan
n=53 Participants
Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
|
Maintenance Dose: Olmesartan 40 mg
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
|
Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
Olmesartan 40mg +/- Amlodipine
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks
|
0.510 10^(-3) x mmHg^(-1)
Standard Error 0.1528
|
0.547 10^(-3) x mmHg^(-1)
Standard Error 0.1469
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 52 weeksPopulation: Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Distal descending aorta distensibility was one of the 3 components for measuring local arota distensibility.
Outcome measures
| Measure |
Sacubitril/Valsartan (LCZ696)
n=49 Participants
LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Olmesartan
n=53 Participants
Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
|
Maintenance Dose: Olmesartan 40 mg
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
|
Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
Olmesartan 40mg +/- Amlodipine
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks
|
0.417 10^(-3) x mmHg^(-1)
Standard Error 0.2242
|
0.498 10^(-3) x mmHg^(-1)
Standard Error 0.2156
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic strain. Local aortic strain was measured by assessing ascending aorta strain, proximal descending aorta strain and distal descending aorta strain.
Outcome measures
| Measure |
Sacubitril/Valsartan (LCZ696)
n=49 Participants
LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Olmesartan
n=53 Participants
Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
|
Maintenance Dose: Olmesartan 40 mg
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
|
Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
Olmesartan 40mg +/- Amlodipine
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Local Aortic Strain at 52 Weeks
Ascending Aorta Strain
|
-0.830 percent
Standard Error 0.7903
|
0.453 percent
Standard Error 0.7598
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Local Aortic Strain at 52 Weeks
Proximal Descending Aorta Strain
|
-0.284 percent
Standard Error 0.8940
|
-0.066 percent
Standard Error 0.8596
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Local Aortic Strain at 52 Weeks
Distal Descending Aorta Strain
|
-1.092 percent
Standard Error 1.0956
|
0.225 percent
Standard Error 1.0533
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.
Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of regional aortic pulse wave velocity.
Outcome measures
| Measure |
Sacubitril/Valsartan (LCZ696)
n=49 Participants
LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Olmesartan
n=53 Participants
Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
|
Maintenance Dose: Olmesartan 40 mg
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
|
Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
Olmesartan 40mg +/- Amlodipine
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Regional Aortic Pulse Wave Velocity at 52 Weeks
|
-2.086 meters per second (m/s)
Standard Error 0.5029
|
-1.085 meters per second (m/s)
Standard Error 0.4835
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.
Central blood pressure was determined by measuring central systolic blood pressure , diastolic blood pressure and pulse pressure.
Outcome measures
| Measure |
Sacubitril/Valsartan (LCZ696)
n=50 Participants
LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Olmesartan
n=50 Participants
Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
|
Maintenance Dose: Olmesartan 40 mg
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
|
Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
Olmesartan 40mg +/- Amlodipine
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Central Blood Pressure at 52 Weeks
Central systolic blood pressure
|
-16.655 mmHg
Standard Error 1.4968
|
-13.625 mmHg
Standard Error 1.4968
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Central Blood Pressure at 52 Weeks
Central diastolic blood pressure
|
-10.318 mmHg
Standard Error 1.0578
|
-10.432 mmHg
Standard Error 1.0578
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Central Blood Pressure at 52 Weeks
Central pulse pressure
|
-6.539 mmHg
Standard Error 0.9428
|
-3.041 mmHg
Standard Error 0.9428
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.
Augmentation pressure is the added pressure during systole due to wave reflection.
Outcome measures
| Measure |
Sacubitril/Valsartan (LCZ696)
n=50 Participants
LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Olmesartan
n=50 Participants
Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
|
Maintenance Dose: Olmesartan 40 mg
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
|
Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
Olmesartan 40mg +/- Amlodipine
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Augmentation Pressure at 52 Weeks
|
-2.443 mmHg
Standard Error 0.5950
|
-1.437 mmHg
Standard Error 0.5950
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis
Augmentation index (Alx) is the percentage of the central pulse pressure due to wave reflection.
Outcome measures
| Measure |
Sacubitril/Valsartan (LCZ696)
n=50 Participants
LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Olmesartan
n=50 Participants
Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
|
Maintenance Dose: Olmesartan 40 mg
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
|
Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
Olmesartan 40mg +/- Amlodipine
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Augmentation Index at 52 Weeks
|
-2.385 percent
Standard Error 1.1805
|
-1.515 percent
Standard Error 1.1805
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis
For pulse wave velocity calculation, the pressure waveform at the femoral site (using a partially inflated custom blood pressure cuff) and the carotid site (using hand -held applanation tonometry) were measured simultaneously. Pulse wave analysis was performed on the central aortic pressure waveform as derived from the brachial pressure waveform recorded in a partially-inflated blood pressure cuff around the upper arm.
Outcome measures
| Measure |
Sacubitril/Valsartan (LCZ696)
n=50 Participants
LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Olmesartan
n=50 Participants
Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
|
Maintenance Dose: Olmesartan 40 mg
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
|
Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
Olmesartan 40mg +/- Amlodipine
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Carotid-femoral Pulse Wave Velocity at 52 Weeks
|
-0.428 meters per second (m/s)
Standard Error 0.1663
|
-0.434 meters per second (m/s)
Standard Error 0.1663
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Safety analysis set: All patients that received study drug
This outcome measure summarizes patients with any adverse events, serious adverse events and death.
Outcome measures
| Measure |
Sacubitril/Valsartan (LCZ696)
n=57 Participants
LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Olmesartan
n=57 Participants
Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
|
Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)
n=57 Participants
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
|
Maintenance Dose: Olmesartan 40 mg
n=56 Participants
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
|
Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine
n=54 Participants
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
Olmesartan 40mg +/- Amlodipine
n=53 Participants
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
|---|---|---|---|---|---|---|
|
Number of Patients With Reported Adverse Events, Serious Adverse Events and Death
Death
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
0 Patients
|
|
Number of Patients With Reported Adverse Events, Serious Adverse Events and Death
Any Adverse events
|
13 Patients
|
16 Patients
|
21 Patients
|
28 Patients
|
31 Patients
|
38 Patients
|
|
Number of Patients With Reported Adverse Events, Serious Adverse Events and Death
Serious Adverse Events
|
0 Patients
|
2 Patients
|
0 Patients
|
2 Patients
|
6 Patients
|
5 Patients
|
Adverse Events
Initiation Dose : Sacubitril/Valsartan (LCZ696 200mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Initiation Dose: Olmesartan 20mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Maintenance Dose: Olmesartan 40 mg
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine
Serious events: 6 serious events
Other events: 16 other events
Deaths: 0 deaths
Olmesartan 40mg +/- Amlodipine
Serious events: 5 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Initiation Dose : Sacubitril/Valsartan (LCZ696 200mg)
n=57 participants at risk
Patients received LCZ696 200 mg for 2 weeks as initiation dose for 2 weeks
|
Initiation Dose: Olmesartan 20mg
n=57 participants at risk
Patients received olmesartan 20 mg for 2 weeks as initiation dose for 2 weeks
|
Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)
n=57 participants at risk
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
|
Maintenance Dose: Olmesartan 40 mg
n=56 participants at risk
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
|
Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine
n=54 participants at risk
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
Olmesartan 40mg +/- Amlodipine
n=53 participants at risk
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/56
|
1.9%
1/54
|
0.00%
0/53
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/56
|
1.9%
1/54
|
0.00%
0/53
|
|
General disorders
Fat necrosis
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
1.8%
1/56
|
0.00%
0/54
|
0.00%
0/53
|
|
General disorders
Nodule
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
1.8%
1/56
|
0.00%
0/54
|
0.00%
0/53
|
|
Infections and infestations
Appendicitis
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
1.8%
1/56
|
0.00%
0/54
|
0.00%
0/53
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/56
|
1.9%
1/54
|
1.9%
1/53
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/56
|
1.9%
1/54
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/56
|
1.9%
1/54
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
1.9%
1/53
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
3.8%
2/53
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/56
|
1.9%
1/54
|
0.00%
0/53
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/56
|
1.9%
1/54
|
0.00%
0/53
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/56
|
1.9%
1/54
|
0.00%
0/53
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/57
|
1.8%
1/57
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
0.00%
0/53
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/57
|
1.8%
1/57
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
0.00%
0/53
|
|
Nervous system disorders
Syncope
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/56
|
1.9%
1/54
|
0.00%
0/53
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
1.9%
1/53
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
1.9%
1/53
|
|
Vascular disorders
Hypertension
|
0.00%
0/57
|
1.8%
1/57
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
0.00%
0/53
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
1.9%
1/53
|
Other adverse events
| Measure |
Initiation Dose : Sacubitril/Valsartan (LCZ696 200mg)
n=57 participants at risk
Patients received LCZ696 200 mg for 2 weeks as initiation dose for 2 weeks
|
Initiation Dose: Olmesartan 20mg
n=57 participants at risk
Patients received olmesartan 20 mg for 2 weeks as initiation dose for 2 weeks
|
Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)
n=57 participants at risk
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
|
Maintenance Dose: Olmesartan 40 mg
n=56 participants at risk
After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
|
Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine
n=54 participants at risk
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
Olmesartan 40mg +/- Amlodipine
n=53 participants at risk
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
|
|---|---|---|---|---|---|---|
|
General disorders
Oedema peripheral
|
0.00%
0/57
|
0.00%
0/57
|
1.8%
1/57
|
0.00%
0/56
|
1.9%
1/54
|
7.5%
4/53
|
|
Infections and infestations
Influenza
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/56
|
1.9%
1/54
|
5.7%
3/53
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/57
|
3.5%
2/57
|
7.0%
4/57
|
8.9%
5/56
|
20.4%
11/54
|
18.9%
10/53
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
5.7%
3/53
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/57
|
0.00%
0/56
|
1.9%
1/54
|
5.7%
3/53
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
1/57
|
0.00%
0/57
|
0.00%
0/57
|
8.9%
5/56
|
1.9%
1/54
|
9.4%
5/53
|
|
Nervous system disorders
Dizziness
|
1.8%
1/57
|
3.5%
2/57
|
7.0%
4/57
|
1.8%
1/56
|
1.9%
1/54
|
0.00%
0/53
|
|
Nervous system disorders
Headache
|
0.00%
0/57
|
3.5%
2/57
|
3.5%
2/57
|
10.7%
6/56
|
3.7%
2/54
|
3.8%
2/53
|
|
Renal and urinary disorders
Haematuria
|
1.8%
1/57
|
0.00%
0/57
|
0.00%
0/57
|
3.6%
2/56
|
5.6%
3/54
|
0.00%
0/53
|
Additional Information
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