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Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction (PERSPECTIVE)

Primary Purpose

Chronic Heart Failure (CHF)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
LCZ696
Valsartan
Placebo of LCZ696
Placebo of Valsartan
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure (CHF) focused on measuring heart failure, cognition, positron emission tomography, magnetic resonance imaging, LCZ696, valsartan, Chronic heart failure, CHF

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Chronic heart failure with current symptoms NYHA class II-IV
  • Left ventricular ejection fraction > 40%
  • NT-proBNP >= 125 pg/mL at screening visit
  • Patient with evidence of adequate functioning to complete study assessments

Key Exclusion Criteria:

  • Patients with acute decompensated heart failure requiring augmented therapy with diuretics, vasodilators and/or inotropic drugs
  • Acute coronary syndrome (including myocardial infarction (MI)), cardiac surgery, other major CV surgery, or urgent percutaneous coronary intervention (PCI), carotid surgery or carotid angioplasty, history of stroke or transient ischemic attack within the 3 months prior to Screening visit or an elective PCI within 30 days prior to Screening visit
  • Patients with history of hereditary or idiopathic angioedema or angioedema related to previous ACEi or ARB therapies
  • Patients who require treatment with 2 or more of the following: an ACEi, an ARB or a renin inhibitor

  • Patients with one of the following:

    1. Patients with serum potassium >5.2 mmol/L (mEq/L) at Screening visit
    2. Patients with serum potassium >5.4 mmol/L (mEq/L) at any visit during run-in treatment period or at randomization visit
    3. Systolic blood pressure (SBP) ≥180 mmHg at Screening visit, or
    4. SBP <110 mmHg at Screening visit, or
    5. SBP <100 mmHg or symptomatic hypotension as determined by the investigator at Visit 103 or at randomization visit
    6. Body mass index (BMI) >45 kg/m^2

  • Patients with

    1. known pericardial constriction, genetic hypertrophic cardiomyopathy, infiltrative cardiomyopathy
    2. hemodynamically significant obstructive valvular disease
  • Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter with a resting ventricular rate >110 beats per minute
  • Inability to perform cognitive battery or other study evaluations based on significant motor (e.g. hemiplegia, muscular-skeletal injury) or sensory (blindness, decreased or uncorrected visual or auditory acuity) skill
  • Clinically significant cerebral pathology for example large cerebral aneurysm or space occupying lesion that may impact cognition as assessed by central MRI reader
  • Mini mental state examination score less than 24 at screening
  • Patients with a clinical diagnosis of Alzheimer's disease or other dementia syndromes or any indication for or current treatment with cholinesterase inhibitors and/or another prescription AD treatment (e.g. memantine).

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
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  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LCZ696

Valsartan

Arm Description

Patients will receive LCZ696 at 100 mg twice daily during a single-blind treatment run-in period to ensure patients tolerate this medication before they are randomized. Down-titration is not allowed during this period. Patients who are able to tolerate LCZ696 100 mg twice daily are eligible to enter the randomized treatment period. Patients randomized to receive LCZ696 will be given LCZ696 at 200 mg twice daily. Patients will receive randomized study drug for three years.

Patients will receive valsartan at 40mg and/or 80mg twice daily during a single-blind treatment run-in period. Following the run-in period, patients randomized to receive valsartan will be given valsartan at 160 mg twice daily for three years.

Outcomes

Primary Outcome Measures

Change from baseline in the CogState Global Cognitive Composite Score (GCCS)
Change in cognition is assessed as a change in a Global Cognitive Composite Z score. The cognitive composite comprises cognitive domains including attention, memory, and executive function. A negative change from baseline will indicate worsening performance.

Secondary Outcome Measures

Change from baseline in cortical composite standardized uptake value ratio (SUVr)
Changes in amyloid plaque deposition over time will be assessed using florbetapir-18F. The longitudinal change in the standardized uptake value ratio will be determined.
Change from baseline in individual cognitive domains (memory, executive function, and attention)
Specific cognitive domains to be assessed include memory, executive function, and attention. A negative change from baseline will indicate worsening performance.
Change from baseline in the summary score of the instrumental activities of daily living (IADL)
Instrumental activities of daily living will be assessed using the functional activities questionnaire. The functional activities questionnaire will be used as a standardized assessment of activities of daily living. This questionnaire is typically used to distinguish normal subjects from subjects with mild to moderate cognitive impairment. The test is made up of 10 questions that reflect a subject's ability to perform activities of daily living and to function independently. Test scores range from 0 to 30, a score of 0 is completely normal where as a higher score denotes impairment. Each of 10 questions is scored from 0, representing normal to 3, dependent on someone else to perform the activity. A negative change from baseline denotes improvement.

Full Information

First Posted
August 25, 2016
Last Updated
November 2, 2022
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02884206
Brief Title
Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction
Acronym
PERSPECTIVE
Official Title
A Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 23, 2016 (Actual)
Primary Completion Date
May 16, 2022 (Actual)
Study Completion Date
May 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of LCZ696 compared to valsartan on cognitive function in patients with chronic heart failure and preserved ejection fraction. Cognitive function will be assessed using a comprehensive battery of tests with an evaluation of longitudinal change of cognitive domains including memory, executive function, and attention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure (CHF)
Keywords
heart failure, cognition, positron emission tomography, magnetic resonance imaging, LCZ696, valsartan, Chronic heart failure, CHF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
592 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LCZ696
Arm Type
Experimental
Arm Description
Patients will receive LCZ696 at 100 mg twice daily during a single-blind treatment run-in period to ensure patients tolerate this medication before they are randomized. Down-titration is not allowed during this period. Patients who are able to tolerate LCZ696 100 mg twice daily are eligible to enter the randomized treatment period. Patients randomized to receive LCZ696 will be given LCZ696 at 200 mg twice daily. Patients will receive randomized study drug for three years.
Arm Title
Valsartan
Arm Type
Active Comparator
Arm Description
Patients will receive valsartan at 40mg and/or 80mg twice daily during a single-blind treatment run-in period. Following the run-in period, patients randomized to receive valsartan will be given valsartan at 160 mg twice daily for three years.
Intervention Type
Drug
Intervention Name(s)
LCZ696
Intervention Description
LCZ696 50, 100, and 200 mg tablets taken orally twice daily with matching placebo for valsartan
Intervention Type
Drug
Intervention Name(s)
Valsartan
Intervention Description
Valsartan 40, 80, and 160 mg tablets taken orally twice daily with matching placebo for LCZ696
Intervention Type
Drug
Intervention Name(s)
Placebo of LCZ696
Intervention Description
Placebo to match LCZ696 50 mg, 100 mg, and 200 mg tablets
Intervention Type
Drug
Intervention Name(s)
Placebo of Valsartan
Intervention Description
Placebo to match valsartan 40 mg, 80 mg, and 160 mg tablets
Primary Outcome Measure Information:
Title
Change from baseline in the CogState Global Cognitive Composite Score (GCCS)
Description
Change in cognition is assessed as a change in a Global Cognitive Composite Z score. The cognitive composite comprises cognitive domains including attention, memory, and executive function. A negative change from baseline will indicate worsening performance.
Time Frame
Baseline, week 156
Secondary Outcome Measure Information:
Title
Change from baseline in cortical composite standardized uptake value ratio (SUVr)
Description
Changes in amyloid plaque deposition over time will be assessed using florbetapir-18F. The longitudinal change in the standardized uptake value ratio will be determined.
Time Frame
Baseline, week 156
Title
Change from baseline in individual cognitive domains (memory, executive function, and attention)
Description
Specific cognitive domains to be assessed include memory, executive function, and attention. A negative change from baseline will indicate worsening performance.
Time Frame
Baseline, week 156
Title
Change from baseline in the summary score of the instrumental activities of daily living (IADL)
Description
Instrumental activities of daily living will be assessed using the functional activities questionnaire. The functional activities questionnaire will be used as a standardized assessment of activities of daily living. This questionnaire is typically used to distinguish normal subjects from subjects with mild to moderate cognitive impairment. The test is made up of 10 questions that reflect a subject's ability to perform activities of daily living and to function independently. Test scores range from 0 to 30, a score of 0 is completely normal where as a higher score denotes impairment. Each of 10 questions is scored from 0, representing normal to 3, dependent on someone else to perform the activity. A negative change from baseline denotes improvement.
Time Frame
Baseline, week 156

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Chronic heart failure with current symptoms NYHA class II-IV Left ventricular ejection fraction > 40% NT-proBNP >= 125 pg/mL at screening visit Patient with evidence of adequate functioning to complete study assessments Key Exclusion Criteria: Patients with acute decompensated heart failure requiring augmented therapy with diuretics, vasodilators and/or inotropic drugs Acute coronary syndrome (including myocardial infarction (MI)), cardiac surgery, other major CV surgery, or urgent percutaneous coronary intervention (PCI), carotid surgery or carotid angioplasty, history of stroke or transient ischemic attack within the 3 months prior to Screening visit or an elective PCI within 30 days prior to Screening visit Patients with history of hereditary or idiopathic angioedema or angioedema related to previous ACEi or ARB therapies Patients who require treatment with 2 or more of the following: an ACEi, an ARB or a renin inhibitor Patients with one of the following: Patients with serum potassium >5.2 mmol/L (mEq/L) at Screening visit Patients with serum potassium >5.4 mmol/L (mEq/L) at any visit during run-in treatment period or at randomization visit Systolic blood pressure (SBP) ≥180 mmHg at Screening visit, or SBP <110 mmHg at Screening visit, or SBP <100 mmHg or symptomatic hypotension as determined by the investigator at Visit 103 or at randomization visit Body mass index (BMI) >45 kg/m^2 Patients with known pericardial constriction, genetic hypertrophic cardiomyopathy, infiltrative cardiomyopathy hemodynamically significant obstructive valvular disease Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter with a resting ventricular rate >110 beats per minute Inability to perform cognitive battery or other study evaluations based on significant motor (e.g. hemiplegia, muscular-skeletal injury) or sensory (blindness, decreased or uncorrected visual or auditory acuity) skill Clinically significant cerebral pathology for example large cerebral aneurysm or space occupying lesion that may impact cognition as assessed by central MRI reader Mini mental state examination score less than 24 at screening Patients with a clinical diagnosis of Alzheimer's disease or other dementia syndromes or any indication for or current treatment with cholinesterase inhibitors and/or another prescription AD treatment (e.g. memantine).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Andalusia
State/Province
Alabama
ZIP/Postal Code
36420
Country
United States
Facility Name
Novartis Investigative Site
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Novartis Investigative Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Novartis Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
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United States
Facility Name
Novartis Investigative Site
City
Sun City West
State/Province
Arizona
ZIP/Postal Code
85375
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United States
Facility Name
Novartis Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
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United States
Facility Name
Novartis Investigative Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Novartis Investigative Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
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United States
Facility Name
Novartis Investigative Site
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
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United States
Facility Name
Novartis Investigative Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
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United States
Facility Name
Novartis Investigative Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
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United States
Facility Name
Novartis Investigative Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
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United States
Facility Name
Novartis Investigative Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
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United States
Facility Name
Novartis Investigative Site
City
Torrance
State/Province
California
ZIP/Postal Code
90503
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United States
Facility Name
Novartis Investigative Site
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
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United States
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Novartis Investigative Site
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Clearwater
State/Province
Florida
ZIP/Postal Code
33756
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United States
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Novartis Investigative Site
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Edgewater
State/Province
Florida
ZIP/Postal Code
32132
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United States
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Novartis Investigative Site
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Hollywood
State/Province
Florida
ZIP/Postal Code
33312
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United States
Facility Name
Novartis Investigative Site
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Homestead
State/Province
Florida
ZIP/Postal Code
33030
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United States
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Novartis Investigative Site
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Inverness
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Florida
ZIP/Postal Code
34452
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United States
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Novartis Investigative Site
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Jacksonville Beach
State/Province
Florida
ZIP/Postal Code
32050
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United States
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Novartis Investigative Site
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Miami
State/Province
Florida
ZIP/Postal Code
33133
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United States
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
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United States
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
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United States
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Novartis Investigative Site
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
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United States
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Novartis Investigative Site
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Port Orange
State/Province
Florida
ZIP/Postal Code
32127
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United States
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Novartis Investigative Site
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Tampa
State/Province
Florida
ZIP/Postal Code
33612
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United States
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Novartis Investigative Site
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
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United States
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Novartis Investigative Site
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Springfield
State/Province
Illinois
ZIP/Postal Code
62701
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United States
Facility Name
Novartis Investigative Site
City
Topeka
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Kansas
ZIP/Postal Code
66606
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United States
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Eunice
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Louisiana
ZIP/Postal Code
70535
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United States
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Baltimore
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Maryland
ZIP/Postal Code
21229
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United States
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Novartis Investigative Site
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Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
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United States
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Novartis Investigative Site
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Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
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United States
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Novartis Investigative Site
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Kalispell
State/Province
Montana
ZIP/Postal Code
59901 3158
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United States
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Novartis Investigative Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
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United States
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Novartis Investigative Site
City
Elmer
State/Province
New Jersey
ZIP/Postal Code
08318
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United States
Facility Name
Novartis Investigative Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
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United States
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Novartis Investigative Site
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Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
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United States
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Novartis Investigative Site
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Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
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United States
Facility Name
Novartis Investigative Site
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Oregon City
State/Province
Oregon
ZIP/Postal Code
97045
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United States
Facility Name
Novartis Investigative Site
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Springfield
State/Province
Oregon
ZIP/Postal Code
97477
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United States
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Novartis Investigative Site
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Fort Mill
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South Carolina
ZIP/Postal Code
29707
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United States
Facility Name
Novartis Investigative Site
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Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
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United States
Facility Name
Novartis Investigative Site
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Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
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United States
Facility Name
Novartis Investigative Site
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Dallas
State/Province
Texas
ZIP/Postal Code
75226
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United States
Facility Name
Novartis Investigative Site
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Dallas
State/Province
Texas
ZIP/Postal Code
75235
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United States
Facility Name
Novartis Investigative Site
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Gonzales
State/Province
Texas
ZIP/Postal Code
78629
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United States
Facility Name
Novartis Investigative Site
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Houston
State/Province
Texas
ZIP/Postal Code
77030
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United States
Facility Name
Novartis Investigative Site
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Lufkin
State/Province
Texas
ZIP/Postal Code
75904
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United States
Facility Name
Novartis Investigative Site
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San Antonio
State/Province
Texas
ZIP/Postal Code
78229
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United States
Facility Name
Novartis Investigative Site
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Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Novartis Investigative Site
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Buenos Aires
State/Province
ARG
ZIP/Postal Code
C1405BCK
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1407
Country
Argentina
Facility Name
Novartis Investigative Site
City
Ciudad Autonoma de Bs As
State/Province
Buenos Aires
ZIP/Postal Code
C1119ACN
Country
Argentina
Facility Name
Novartis Investigative Site
City
Ramos Mejia
State/Province
Buenos Aires
ZIP/Postal Code
B1704ETD
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Capital Federal
ZIP/Postal Code
C1179AAB
Country
Argentina
Facility Name
Novartis Investigative Site
City
Chemside
State/Province
Queensland
ZIP/Postal Code
4032
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Australia
Facility Name
Novartis Investigative Site
City
Milton
State/Province
Queensland
ZIP/Postal Code
4064
Country
Australia
Facility Name
Novartis Investigative Site
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Novartis Investigative Site
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Novartis Investigative Site
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Novartis Investigative Site
City
Sofia
State/Province
BGR
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Novartis Investigative Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2G8
Country
Canada
Facility Name
Novartis Investigative Site
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Novartis Investigative Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Novartis Investigative Site
City
Tourcoing
ZIP/Postal Code
59208
Country
France
Facility Name
Novartis Investigative Site
City
Regensburg
State/Province
Bavaria
ZIP/Postal Code
93053
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01099
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin Buch
ZIP/Postal Code
13125
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novartis Investigative Site
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
Facility Name
Novartis Investigative Site
City
Bitburg
ZIP/Postal Code
54634
Country
Germany
Facility Name
Novartis Investigative Site
City
Dessau-Roßlau
ZIP/Postal Code
06846
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01277
Country
Germany
Facility Name
Novartis Investigative Site
City
Elsterwerda
ZIP/Postal Code
04910
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60594
Country
Germany
Facility Name
Novartis Investigative Site
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Novartis Investigative Site
City
Koeln
ZIP/Postal Code
51065
Country
Germany
Facility Name
Novartis Investigative Site
City
Ulm
ZIP/Postal Code
89077
Country
Germany
Facility Name
Novartis Investigative Site
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Novartis Investigative Site
City
Wuppertal
ZIP/Postal Code
42109
Country
Germany
Facility Name
Novartis Investigative Site
City
Ancona
State/Province
AN
ZIP/Postal Code
60128
Country
Italy
Facility Name
Novartis Investigative Site
City
Bergamo
State/Province
BG
ZIP/Postal Code
24127
Country
Italy
Facility Name
Novartis Investigative Site
City
Cona
State/Province
FE
ZIP/Postal Code
44100
Country
Italy
Facility Name
Novartis Investigative Site
City
Firenze
State/Province
FI
ZIP/Postal Code
50134
Country
Italy
Facility Name
Novartis Investigative Site
City
Pozzilli
State/Province
IS
ZIP/Postal Code
86077
Country
Italy
Facility Name
Novartis Investigative Site
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
Facility Name
Novartis Investigative Site
City
Modena
State/Province
MO
ZIP/Postal Code
41100
Country
Italy
Facility Name
Novartis Investigative Site
City
Pisa
State/Province
PI
ZIP/Postal Code
56124
Country
Italy
Facility Name
Novartis Investigative Site
City
Wonju
State/Province
Gangwon-Do
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seongnam Si
State/Province
Gyeonggi Do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Kaunas
State/Province
LTU
ZIP/Postal Code
LT 50161
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Hertogenbosch
ZIP/Postal Code
5200
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90 549
Country
Poland
Facility Name
Novartis Investigative Site
City
Tarnow
State/Province
Malopolskie
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Novartis Investigative Site
City
Krakow
State/Province
Maloposkie
ZIP/Postal Code
31271
Country
Poland
Facility Name
Novartis Investigative Site
City
Bialystok
ZIP/Postal Code
15 276
Country
Poland
Facility Name
Novartis Investigative Site
City
Katowice
ZIP/Postal Code
40-645
Country
Poland
Facility Name
Novartis Investigative Site
City
Krakow
ZIP/Postal Code
31 202
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
127644
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saint Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St Petersburg
ZIP/Postal Code
196601
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46010
Country
Spain
Facility Name
Novartis Investigative Site
City
San Sebastian de los Reyes
State/Province
Madrid
ZIP/Postal Code
28702
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Novartis Investigative Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Novartis Investigative Site
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Meselik
State/Province
Eskisehir
ZIP/Postal Code
26480
Country
Turkey
Facility Name
Novartis Investigative Site
City
Sivas
ZIP/Postal Code
58140
Country
Turkey
Facility Name
Novartis Investigative Site
City
Axbridge
State/Province
Somerset
ZIP/Postal Code
BS26 2BJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF5 4AD
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Birmingham
ZIP/Postal Code
B16 8QQ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
East Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Newport
ZIP/Postal Code
NP20 2UB
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Stevenage
ZIP/Postal Code
SG1 4AB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Learn more about this trial

Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction

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