A Study to Evaluate the Effect of LCZ696 on Aortic Stiffn... | NCT01870739 | Trialant
NCT01870739
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Jan 5, 2021Actual
Enrollment
115Actual
Phase
Phase 2
Conditions
Hypertension
Interventions
sacubitril/valsartan (LCZ696)
olmesartan
placebo to sacubitril/valsartan (LCZ696)
placebo to olmesartan
Amlodipine (Optional)
Countries
Germany
Switzerland
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01870739
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CLCZ696A2224
Secondary IDs
ID
Type
Description
Link
2012-005720-15
EudraCT Number
Brief Title
A Study to Evaluate the Effect of LCZ696 on Aortic Stiffness in Subjects With Hypertension
Official Title
A Randomized, Double-blind, Active-controlled, Parallel Group, 52-week Study to Evaluate the Effect of LCZ696 Compared to Olmesartan on Regional Aortic Stiffness in Subjects With Essential Hypertension
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Mar 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2013
Primary Completion Date
Jun 2015Actual
Completion Date
Jun 2015Actual
First Submitted Date
Jun 3, 2013
First Submission Date that Met QC Criteria
Jun 3, 2013
First Posted Date
Jun 6, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
May 31, 2016
Results First Submitted that Met QC Criteria
Jul 20, 2016
Results First Posted Date
Sep 1, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 9, 2020
Last Update Posted Date
Jan 5, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This was the first evaluation of the effects of LCZ696 on local and regional measures of aortic stiffness in subjects with mild to moderate hypertension and widened pulse pressure. The results of this exploratory study will help to understand the mechanism of action of LCZ696 and used to inform the design of future clinical studies with LCZ696 in subjects with cardiovascular diseases.
Detailed Description
Not provided
Conditions Module
Conditions
Hypertension
Keywords
LCZ696,
Hypertension,
Aortic stiffness,
Central blood pressure,
Cardiovascular MRI
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
115Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
sacubitril/valsartan (LCZ696)
Experimental
Single drug treatment period: Patients received LCZ696 200mg once daily (q.d.) + placebo to 20 mg olmesartan q.d for 2 weeks. After 2 weeks, patients were dosed at the maintenance dose level (400 mg qd LCZ696 + placebo to 40 mg qd olmesartan) for 10 weeks.
Add-on Period: After 12 weeks on single-drug treatment, patients continued in the study on the blinded maintenance dose and if required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to the treatment regimen and titrated according to the investigator's discretion to achieve target blood pressure.
Drug: sacubitril/valsartan (LCZ696)
Other: placebo to olmesartan
Drug: Amlodipine (Optional)
olmesartan
Active Comparator
Single drug treatment period: Patients received 20 mg olmesartan q.d + placebo to LCZ696 200mg once daily (q.d.) for 2 weeks. After 2 weeks, patients were dosed at the maintenance dose level (40 mg olmesartan q.d + placebo to 400 mg qd LCZ696) for 10 weeks.
Add-on Period: After 12 weeks on single-drug treatment, patients continued in the study on the blinded maintenance dose and if required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to the treatment regimen and titrated according to the investigator's discretion to achieve target blood pressure.
Drug: olmesartan
Other: placebo to sacubitril/valsartan (LCZ696)
Drug: Amlodipine (Optional)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
sacubitril/valsartan (LCZ696)
Drug
200 mg tablets
sacubitril/valsartan (LCZ696)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Ascending Aorta Distensibility at 52 Week
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.
Baseline, 52 weeks
Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks
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.
Baseline, 52 weeks
Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks
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.
Baseline, 52 weeks
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Local Aortic Strain at 52 Weeks
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.
Baseline, 52 weeks
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Subjects with essential hypertension, untreated or currently taking antihypertensive therapy
Key exclusion Criteria:
women of child bearing potential (WOCBP) if not on highly effective contraception
Malignant or severe hypertension (grade 3 of WHO classification)
History or evidence of a secondary form of hypertension
Transient ischemic cerebral attack (TIA) during the 12 months prior to screening or any history of stroke.
Previous or current diagnosis of heart failure (New York Heart Association Class II-IV).
Hrabak-Paar M, Kircher A, Al Sayari S, Kopp S, Santini F, Schmieder RE, Kachenoura N, Yates D, Langenickel T, Bremerich J, Heye T. Variability of MRI Aortic Stiffness Measurements in a Multicenter Clinical Trial Setting: Intraobserver, Interobserver, and Intracenter Variability of Pulse Wave Velocity and Aortic Strain Measurement. Radiol Cardiothorac Imaging. 2020 Apr 30;2(2):e190090. doi: 10.1148/ryct.2020190090. eCollection 2020 Apr.
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
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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)
If required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to treatment regimen
olmesartan
sacubitril/valsartan (LCZ696)
Change From Baseline in Regional Aortic Pulse Wave Velocity at 52 Weeks
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.
Baseline, 52 weeks
Change From Baseline in Central Blood Pressure at 52 Weeks
Central blood pressure was determined by measuring central systolic blood pressure , diastolic blood pressure and pulse pressure.
Baseline, 52 weeks
Change From Baseline in Augmentation Pressure at 52 Weeks
Augmentation pressure is the added pressure during systole due to wave reflection.
Baseline, 52 weeks
Change From Baseline in Augmentation Index at 52 Weeks
Augmentation index (Alx) is the percentage of the central pulse pressure due to wave reflection.
Baseline, 52 weeks
Change From Baseline in Carotid-femoral Pulse Wave Velocity at 52 Weeks
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.
Baseline, 52 weeks
Number of Patients With Reported Adverse Events, Serious Adverse Events and Death
This outcome measure summarizes patients with any adverse events, serious adverse events and death.
12 weeks
Erlangen
91054
Germany
Novartis Investigative Site
Basel
4031
Switzerland
Novartis Investigative Site
Glasgow
Scotland
G12 8TA
United Kingdom
Derived
Santini F, Pansini M, Hrabak-Paar M, Yates D, Langenickel TH, Bremerich J, Bieri O, Schubert T. On the optimal temporal resolution for phase contrast cardiovascular magnetic resonance imaging: establishment of baseline values. J Cardiovasc Magn Reson. 2020 Oct 5;22(1):72. doi: 10.1186/s12968-020-00669-1.
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)
FG00057 subjects"Start" = Safety/Pharmacokinetic/Pharmacodynamic analysis set
Safety analysis set: All patients that received study drug
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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)
BG001
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)
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00057
BG00157
BG002114
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00060.5± 7.8
BG00159.2± 13.1
BG00259.8± 10.7
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00020
BG00117
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Ascending Aorta Distensibility at 52 Week
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.
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.
Posted
Least Squares Mean
Standard Error
10^(-3) x mmHg^(-1)
Baseline, 52 weeks
ID
Title
Description
OG000
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)
OG001
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)
Units
Counts
Participants
OG00049
OG00153
Title
Denominators
Categories
Title
Measurements
OG0000.269± 0.1283
OG0010.330± 0.1233
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Linear Model
Treatment as fixed effect and corresponding baseline as covariate.
0.7324
Mean Difference (Net)
-0.0616
2-Sided
95
-0.4178
0.2947
Superiority or Other (legacy)
Primary
Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks
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.
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.
Posted
Least Squares Mean
Standard Error
10^(-3) x mmHg^(-1)
Baseline, 52 weeks
ID
Title
Description
OG000
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)
OG001
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)
Primary
Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks
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.
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.
Posted
Least Squares Mean
Standard Error
10^(-3) x mmHg^(-1)
Baseline, 52 weeks
ID
Title
Description
OG000
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)
OG001
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)
Secondary
Change From Baseline in Local Aortic Strain at 52 Weeks
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.
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.
Posted
Least Squares Mean
Standard Error
percent
Baseline, 52 weeks
ID
Title
Description
OG000
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)
OG001
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)
Secondary
Change From Baseline in Regional Aortic Pulse Wave Velocity at 52 Weeks
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.
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.
Posted
Least Squares Mean
Standard Error
meters per second (m/s)
Baseline, 52 weeks
ID
Title
Description
OG000
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)
OG001
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)
Units
Counts
Secondary
Change From Baseline in Central Blood Pressure at 52 Weeks
Central blood pressure was determined by measuring central systolic blood pressure , diastolic blood pressure and pulse pressure.
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.
Posted
Least Squares Mean
Standard Error
mmHg
Baseline, 52 weeks
ID
Title
Description
OG000
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)
OG001
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)
Units
Counts
Participants
Secondary
Change From Baseline in Augmentation Pressure at 52 Weeks
Augmentation pressure is the added pressure during systole due to wave reflection.
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.
Posted
Least Squares Mean
Standard Error
mmHg
Baseline, 52 weeks
ID
Title
Description
OG000
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)
OG001
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)
Units
Counts
Participants
Secondary
Change From Baseline in Augmentation Index at 52 Weeks
Augmentation index (Alx) is the percentage of the central pulse pressure due to wave reflection.
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
Posted
Least Squares Mean
Standard Error
percent
Baseline, 52 weeks
ID
Title
Description
OG000
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)
OG001
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)
Units
Counts
Participants
Secondary
Change From Baseline in Carotid-femoral Pulse Wave Velocity at 52 Weeks
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.
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
Posted
Least Squares Mean
Standard Error
meters per second (m/s)
Baseline, 52 weeks
ID
Title
Description
OG000
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)
OG001
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)
Secondary
Number of Patients With Reported Adverse Events, Serious Adverse Events and Death
This outcome measure summarizes patients with any adverse events, serious adverse events and death.
Safety analysis set: All patients that received study drug
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
6
54
16
54
EG005
Olmesartan 40mg +/- Amlodipine
Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
5
53
24
53
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Enterocolitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG0030 affected56 at risk
EG0041 affected54 at risk
EG0050 affected53 at risk
Inguinal hernia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Fat necrosis
General disorders
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Nodule
General disorders
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Appendicitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Abdominal injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Intraductal proliferative breast lesion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Prostate cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Syncope
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0011 affected57 at risk
EG0020 affected57 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Oedema peripheral
General disorders
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0021 affected57 at risk
EG0030 affected56 at risk
EG0041 affected54 at risk
EG0054 affected53 at risk
Influenza
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0012 affected57 at risk
EG0024 affected57 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected57 at risk
EG0012 affected57 at risk
EG0024 affected57 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected57 at risk
EG0012 affected57 at risk
EG0022 affected57 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0001 affected57 at risk
EG0010 affected57 at risk
EG0020 affected57 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis Pharmaceuticals
862-778-8300
trialandresults.registries@novartis.com
ID
Term
D006973
Hypertension
Ancestor Terms
ID
Term
D014652
Vascular Diseases
D002318
Cardiovascular Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000717211
sacubitril
D000068756
Valsartan
C549068
sacubitril and valsartan sodium hydrate drug combination
C437965
olmesartan
D017311
Amlodipine
Ancestor Terms
ID
Term
D013777
Tetrazoles
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D014633
Valine
D000597
Amino Acids, Branched-Chain
D000596
Amino Acids
D000602
Amino Acids, Peptides, and Proteins
D000601
Amino Acids, Essential
D004095
Dihydropyridines
D011725
Pyridines
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
Protocol deviation
FG0001 subjects
FG0011 subjects
Patient withdrew consent
FG0001 subjects
FG0010 subjects
37
Male
BG00037
BG00140
BG00277
Units
Counts
Participants
OG00049
OG00153
Title
Denominators
Categories
Title
Measurements
OG0000.510± 0.1528
OG0010.547± 0.1469
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Linear Model
Treatment as a fixed effect and corresponding baseline as a covariate
0.8614
Mean Difference (Net)
-0.0371
2-Sided
95
-0.4582
0.3839
Superiority or Other (legacy)
Units
Counts
Participants
OG00049
OG00153
Title
Denominators
Categories
Title
Measurements
OG0000.417± 0.2242
OG0010.498± 0.2156
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Linear Model
Treatment as a fixed effect and corresponding baseline as a covariate