Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)

A Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group, Active Controlled Study to Evaluate the Effect of Sacubitril/Valsartan (LCZ696) Versus Valsartan on Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)

ClinicalTrials.gov Identifier: NCT03988634

Novartis Reference Number: CLCZ696DUS01

Last Update: Mar 24, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The effect of sacubitril/valsartan vs. valsartan on changes in NT-proBNP, safety, and tolerability in HFpEF patients with a WHF event (HFpEF decompensation) who have been stabilized and initiated at the time of or within 30 days post-decompensation.

Condition 
Heart Failure With Preserved Ejection Fraction (HFpEF)
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Jun 27, 2019
Completion date 
Oct 29, 2022
Gender 
All
Age(s)
18 Years - 99 Years (Adult, Older Adult)

Interventions

Drug
sacubitril/valsartan
Sacubitril/valsartan (LCZ696) is available as 24/26 mg, 49/51 mg, and 97/103 mg in tablet form to be taken orally, twice daily, for the double-blind period. Valsartan matching placebo is available as 40 mg, 80 mg, and 160 mg in tablet form to be taken orally, twice daily, for the double-blind period.
Drug
valsartan
Valsartan is available as 40 mg, 80 mg, and 160 mg in tablet form to be taken orally, twice daily, for the double-blind period. Sacubitril/valsartan (LCZ696) matching placebo is available as 24/26 mg, 49/51 mg, and 97/103 mg in tablet form to be taken orally, twice daily, for the double-blind period.
Drug
sacubitril/valsartan
Sacubitril/valsartan (LCZ696) is available as 24/26 mg, 49/51 mg, and 97/103 mg in tablet form to be taken orally, twice daily, for the double-blind period. Valsartan matching placebo is available as 40 mg, 80 mg, and 160 mg in tablet form to be taken orally, twice daily, for the double-blind period.
Drug
valsartan
Valsartan is available as 40 mg, 80 mg, and 160 mg in tablet form to be taken orally, twice daily, for the double-blind period. Sacubitril/valsartan (LCZ696) matching placebo is available as 24/26 mg, 49/51 mg, and 97/103 mg in tablet form to be taken orally, twice daily, for the double-blind period.

Eligibility Criteria

INCLUSION CRITERIA:

Signed informed consent must be obtained prior to participation in the study
Patients >=18 years of age, male or female

Current hospitalization for Worsening Heart Failure (WHF) (HFpEF decompensation), or within 30 days of discharge following a WHF event (defined as hospitalization, emergency department (ED) visit or out-of-hospital urgent HF visit, all requiring IV diuretics). Patients with a diagnosis of acute heart failure had to have symptoms and signs of fluid overload (i.e. jugular venous distention, edema or rales on auscultation or pulmonary congestion on chest x-ray). Eligible patients will be randomized after IV diuresis for HFpEF is given (and no earlier than 36 hours from their last ACEi dose if applicable) and within 30 days post-decompensation after presentation with acute HFpEF decompensation and meeting the following definitions of hemodynamic stability:

Randomized patients will have been hemodynamically stable defined in this study as:

SBP >=100mmHg for the preceding 6 hours prior to randomization; no symptomatic hypotension
No increase (intensification) in IV diuretic dose within last 6 hours prior to randomization
No IV inotropic drugs for 24 hours prior to randomization
No IV vasodilators including nitrates within last 6 hours prior to randomization
HFpEF with most recent LVEF > 40% (within past 3 months)

Elevated NT-proBNP or BNP at the time of acute HFpEF decompensation or post-decompensation screening (and within 72 hours for out-of-hospital randomization, if applicable):

a. Patients not in Atrial Fibrillation(AF) at the time of biomarker assessment: NT-proBNP >= 500pg/mL or BNP >= 150 pg/mL; patients in AF at the time of biomarker assessment: NT-proBNP >= 1000pg/mL or BNP >= 300 pg/mL b. Patients recruited in-hospital will be randomized based on the qualifying local lab value in-hospital NT-proBNP or BNP value. c. Patients enrolled post-decompensation can be randomized based on their NT-proBNP or BNP value in the following way: i. if enrolling in post-decompensation setting then need eligible screening/local NTproBNP/BNP within 72 hours of randomization. The test value could be from recent hospitalization if within 72 hours or ii. would require (re)drawing NT-proBNP or BNP labs in post-decompensation setting if the lab value is not already available within the last 72 hours).

6) Has not taken an ACEi for 36 hours prior to randomization

EXCLUSION CRITERIA:

Any clinical event within the 90 days prior to randomization that could have reduced the LVEF (i.e., myocardial infarction (MI), coronary artery bypass graft (CABG), unless an echo measurement was performed after the event confirming the LVEF to be > 40%
Entresto™ (sacubitril/valsartan) usage within the past 60 days
eGFR < 20ml/min/1.73 m2 as measured by the simplified Modification of Diet in Renal Disease (MDRD) formula at most recent assessment prior to randomization and within 24 hours prior to inpatient randomization or 72 hours prior to outpatient randomization
Serum potassium > 5.2 mEq/L at most recent assessment prior to randomization and within 24 hours prior to inpatient randomization or 72 hours prior to outpatient randomization
Acute coronary syndrome, stroke, transient ischemic attack; cardiac, carotid or other major CV surgery; percutaneous coronary intervention (PCI) or carotid angioplasty, within 30 days prior to randomization
Probable alternative diagnoses that in the opinion of the investigator could account for the patient's HF symptoms (i.e. dyspnea, fatigue) such as significant pulmonary disease (including primary pulmonary HTN), anemia or obesity.
Isolated right HF in the absence of left-sided structural heart disease
History of hypersensitivity (i.e. including angioedema), known or suspected contraindications, or intolerance to any of the study drugs including ARNIs (i.e. sacubitril/valsartan), and/or ARBs
Patients with a known history of angioedema due to any etiology
Patients with a history of heart transplant or LVAD, currently on the transplant list, or with planned intent to implant LVAD or CRT device within the initial three months of enrollment during the trial
A cardiac or non-cardiac medical condition other than HF with an estimated life expectancy of < 6 months
Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including suspected or confirmed amyloid heart disease (amyloidosis)
Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter with a resting ventricular rate > 110 bpm
Clinically significant congenital heart disease felt to be the cause of the patient's symptoms and signs of HF
Coronary or carotid artery disease or valvular heart disease likely to require surgical or percutaneous intervention within the duration of the trial
Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study
Known hepatic impairment (as evidenced by total bilirubin > 3 mg/dL, or increased ammonia levels, if performed), or history of cirrhosis with evidence of portal hypertension such as varices
Participation in any other clinical trial involving investigational agents or devices within the past 30 days
Current confirmed COVID19 infection
Past COVID19 infection with persistent symptom burden suspected due to COVID19 (further defined in Section 5.2).
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of investigational drug and for 7 days off of study drug. Highly effective contraception methods are defined in protocol.

Study Locations

United States
Novartis Investigative Site
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Little Rock, 72205
Arkansas
United States
Novartis Investigative Site
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Fresno, 93701
California
United States
Novartis Investigative Site
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Long Beach, 90806
California
United States
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Los Angeles, 90033-4605
California
United States
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Orange, 92868
California
United States
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San Diego, 92123
California
United States
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San Pablo, 94806
California
United States
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Santa Ana, 92704
California
United States
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Littleton, 80120
Colorado
United States
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West Hartford, 06109
Connecticut
United States
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West Haven, 06516
Connecticut
United States
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Newark, 19713
Delaware
United States
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Washington, 20010-2975
District of Columbia
United States
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Fort Lauderdale, 33308
Florida
United States
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Gainesville, 32610
Florida
United States
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Hialeah, 33016
Florida
United States
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Jacksonville, 32209
Florida
United States
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Sarasota, 34239
Florida
United States
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Atlanta, 30322
Georgia
United States
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Augusta, 30901
Georgia
United States
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Macon, 31201
Georgia
United States
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Boise, 83702
Idaho
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Aurora, 60504
Illinois
United States
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Oakbrook Terrace, 60181
Illinois
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Park Ridge, 60068
Illinois
United States
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Peoria, 61606
Illinois
United States
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Peoria, 61614
Illinois
United States
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Winfield, 60190
Illinois
United States
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Elkhart, 46514
Indiana
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Indianapolis, 46202
Indiana
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Muncie, 47303
Indiana
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Richmond, 47374
Indiana
United States
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Des Moines, 50314
Iowa
United States
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Kansas City, 66160
Kansas
United States
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Lexington, 40504
Kentucky
United States
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Louisville, 40205
Kentucky
United States
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Alexandria, 71301
Louisiana
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Baton Rouge, 70808
Louisiana
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Slidell, 70458
Louisiana
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Bangor, 04401
Maine
United States
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Annapolis, 21401
Maryland
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Baltimore, 21287
Maryland
United States
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Salisbury, 21804
Maryland
United States
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Boston, 02114
Massachusetts
United States
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Boston, 02215
Massachusetts
United States
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Ann Arbor, 48109
Michigan
United States
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Detroit, 48201
Michigan
United States
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Detroit, 48202
Michigan
United States
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Petoskey, 49770
Michigan
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Ypsilanti, 48197
Michigan
United States
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Saint Paul, 55101
Minnesota
United States
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Saint Paul, 55103
Minnesota
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Jackson, 39216
Mississippi
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Saint Louis, 63104
Missouri
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Lincoln, 68506
Nebraska
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Omaha, 68198
Nebraska
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Reno, 89502
Nevada
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Camden, 08103-3117
New Jersey
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Elmer, 08318
New Jersey
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Haddon Heights, 08035
New Jersey
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Newark, 07102
New Jersey
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Bronx, 10461
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Johnson City, 13790
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Manhasset, 11030
New York
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New York, 10016
New York
United States
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Poughkeepsie, 12601
New York
United States
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Roslyn, 11576
New York
United States
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Staten Island, 10310
New York
United States
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Stony Brook, 11794
New York
United States
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Chapel Hill, 27599-7075
North Carolina
United States
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Greenville, 27835
North Carolina
United States
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Grand Forks, 58201
North Dakota
United States
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Cincinnati, 45220
Ohio
United States
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Cleveland, 44106-5028
Ohio
United States
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Cleveland, 44109-1998
Ohio
United States
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Cleveland, 44195
Ohio
United States
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Toledo, 43608
Ohio
United States
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Bartlesville, 74006
Oklahoma
United States
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Oklahoma City, 73112
Oklahoma
United States
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Tulsa, 74104
Oklahoma
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Abington, 19001
Pennsylvania
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Camp Hill, 17011
Pennsylvania
United States
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Philadelphia, 19107
Pennsylvania
United States
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Rapid City, 57701
South Dakota
United States
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Sioux Falls, 57105
South Dakota
United States
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Nashville, 37212
Tennessee
United States
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Dallas, 75246
Texas
United States
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Galveston, 77555-1062
Texas
United States
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San Antonio, 78229
Texas
United States
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Burlington, 05401
Vermont
United States
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White River Junction, 05009
Vermont
United States
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Fairfax, 22046
Virginia
United States
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Lynchburg, 24501
Virginia
United States
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Richmond, 23226
Virginia
United States
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Richmond, 23298
Virginia
United States
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Seattle, 98122
Washington
United States
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Seattle, 98195
Washington
United States
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Tacoma, 98405
Washington
United States
Novartis Investigative Site
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Madison, 53792-1615
Wisconsin
United States
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Little Rock, 72205
Arkansas
United States
Novartis Investigative Site
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Fresno, 93701
California
United States
Novartis Investigative Site
Recruiting
Long Beach, 90806
California
United States
Novartis Investigative Site
Recruiting
Los Angeles, 90033-4605
California
United States
Novartis Investigative Site
Recruiting
Orange, 92868
California
United States
Novartis Investigative Site
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San Diego, 92123
California
United States
Novartis Investigative Site
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San Pablo, 94806
California
United States
Novartis Investigative Site
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Santa Ana, 92704
California
United States
Novartis Investigative Site
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Littleton, 80120
Colorado
United States
Novartis Investigative Site
Recruiting
West Hartford, 06109
Connecticut
United States
Novartis Investigative Site
Recruiting
West Haven, 06516
Connecticut
United States
Novartis Investigative Site
Recruiting
Newark, 19713
Delaware
United States
Novartis Investigative Site
Recruiting
Washington, 20010-2975
District of Columbia
United States
Novartis Investigative Site
Recruiting
Fort Lauderdale, 33308
Florida
United States
Novartis Investigative Site
Recruiting
Gainesville, 32610
Florida
United States
Novartis Investigative Site
Recruiting
Hialeah, 33016
Florida
United States
Novartis Investigative Site
Recruiting
Jacksonville, 32209
Florida
United States
Novartis Investigative Site
Recruiting
Sarasota, 34239
Florida
United States
Novartis Investigative Site
Recruiting
Atlanta, 30322
Georgia
United States
Novartis Investigative Site
Recruiting
Augusta, 30901
Georgia
United States
Novartis Investigative Site
Recruiting
Macon, 31201
Georgia
United States
Novartis Investigative Site
Recruiting
Boise, 83702
Idaho
United States
Novartis Investigative Site
Recruiting
Aurora, 60504
Illinois
United States
Novartis Investigative Site
Recruiting
Oakbrook Terrace, 60181
Illinois
United States
Novartis Investigative Site
Recruiting
Park Ridge, 60068
Illinois
United States
Novartis Investigative Site
Recruiting
Peoria, 61606
Illinois
United States
Novartis Investigative Site
Recruiting
Peoria, 61614
Illinois
United States
Novartis Investigative Site
Recruiting
Winfield, 60190
Illinois
United States
Novartis Investigative Site
Recruiting
Elkhart, 46514
Indiana
United States
Novartis Investigative Site
Recruiting
Indianapolis, 46202
Indiana
United States
Novartis Investigative Site
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Muncie, 47303
Indiana
United States
Novartis Investigative Site
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Richmond, 47374
Indiana
United States
Novartis Investigative Site
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Des Moines, 50314
Iowa
United States
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Kansas City, 66160
Kansas
United States
Novartis Investigative Site
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Lexington, 40504
Kentucky
United States
Novartis Investigative Site
Recruiting
Louisville, 40205
Kentucky
United States
Novartis Investigative Site
Recruiting
Alexandria, 71301
Louisiana
United States
Novartis Investigative Site
Recruiting
Baton Rouge, 70808
Louisiana
United States
Novartis Investigative Site
Recruiting
Slidell, 70458
Louisiana
United States
Novartis Investigative Site
Recruiting
Bangor, 04401
Maine
United States
Novartis Investigative Site
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Annapolis, 21401
Maryland
United States
Novartis Investigative Site
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Baltimore, 21287
Maryland
United States
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Salisbury, 21804
Maryland
United States
Novartis Investigative Site
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Boston, 02114
Massachusetts
United States
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Boston, 02215
Massachusetts
United States
Novartis Investigative Site
Recruiting
Ann Arbor, 48109
Michigan
United States
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Detroit, 48201
Michigan
United States
Novartis Investigative Site
Recruiting
Detroit, 48202
Michigan
United States
Novartis Investigative Site
Recruiting
Petoskey, 49770
Michigan
United States
Novartis Investigative Site
Recruiting
Ypsilanti, 48197
Michigan
United States
Novartis Investigative Site
Recruiting
Saint Paul, 55101
Minnesota
United States
Novartis Investigative Site
Recruiting
Saint Paul, 55103
Minnesota
United States
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Recruiting
Jackson, 39216
Mississippi
United States
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Recruiting
Saint Louis, 63104
Missouri
United States
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Recruiting
Lincoln, 68506
Nebraska
United States
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Omaha, 68198
Nebraska
United States
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Reno, 89502
Nevada
United States
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Camden, 08103-3117
New Jersey
United States
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Elmer, 08318
New Jersey
United States
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Haddon Heights, 08035
New Jersey
United States
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Newark, 07102
New Jersey
United States
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Bronx, 10461
New York
United States
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Johnson City, 13790
New York
United States
Novartis Investigative Site
Recruiting
Manhasset, 11030
New York
United States
Novartis Investigative Site
Recruiting
New York, 10016
New York
United States
Novartis Investigative Site
Recruiting
Poughkeepsie, 12601
New York
United States
Novartis Investigative Site
Recruiting
Roslyn, 11576
New York
United States
Novartis Investigative Site
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Staten Island, 10310
New York
United States
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Stony Brook, 11794
New York
United States
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Chapel Hill, 27599-7075
North Carolina
United States
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Greenville, 27835
North Carolina
United States
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Grand Forks, 58201
North Dakota
United States
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Cincinnati, 45220
Ohio
United States
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Cleveland, 44106-5028
Ohio
United States
Novartis Investigative Site
Recruiting
Cleveland, 44109-1998
Ohio
United States
Novartis Investigative Site
Recruiting
Cleveland, 44195
Ohio
United States
Novartis Investigative Site
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Toledo, 43608
Ohio
United States
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Bartlesville, 74006
Oklahoma
United States
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Oklahoma City, 73112
Oklahoma
United States
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Tulsa, 74104
Oklahoma
United States
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Abington, 19001
Pennsylvania
United States
Novartis Investigative Site
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Camp Hill, 17011
Pennsylvania
United States
Novartis Investigative Site
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Philadelphia, 19107
Pennsylvania
United States
Novartis Investigative Site
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Rapid City, 57701
South Dakota
United States
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Sioux Falls, 57105
South Dakota
United States
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Nashville, 37212
Tennessee
United States
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Dallas, 75246
Texas
United States
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Galveston, 77555-1062
Texas
United States
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San Antonio, 78229
Texas
United States
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Burlington, 05401
Vermont
United States
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White River Junction, 05009
Vermont
United States
Novartis Investigative Site
Recruiting
Fairfax, 22046
Virginia
United States
Novartis Investigative Site
Recruiting
Lynchburg, 24501
Virginia
United States
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Richmond, 23226
Virginia
United States
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Richmond, 23298
Virginia
United States
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Seattle, 98122
Washington
United States
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Seattle, 98195
Washington
United States
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Tacoma, 98405
Washington
United States
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Madison, 53792-1615
Wisconsin
United States
Canada
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Winnipeg, R2H 2A6
Manitoba
Canada
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Montreal, H3G 1A4
Quebec
Canada
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Saguenay, G7H 5H6
Quebec
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Sainte Foy, G1V 4G5
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Canada
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Sherbrooke, J1H 5N4
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Canada
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Terrebonne, J6V 2H2
Quebec
Canada
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Quebec, G1R 2J6
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Canada
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Winnipeg, R2H 2A6
Manitoba
Canada
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Montreal, H3G 1A4
Quebec
Canada
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Saguenay, G7H 5H6
Quebec
Canada
Novartis Investigative Site
Recruiting
Sainte Foy, G1V 4G5
Quebec
Canada
Novartis Investigative Site
Recruiting
Sherbrooke, J1H 5N4
Quebec
Canada
Novartis Investigative Site
Recruiting
Terrebonne, J6V 2H2
Quebec
Canada
Novartis Investigative Site
Recruiting
Quebec, G1R 2J6
-
Canada

Contacts

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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Call 1-888-669-6682 or email [email protected]