Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction (PARAGON-HF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01920711
First received: August 8, 2013
Last updated: October 14, 2015
Last verified: October 2015
  Purpose
The purpose of this study is to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.

Condition Intervention Phase
Heart Failure With Preserved Ejection Fraction
Drug: LCZ696
Drug: Valsartan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Cumulative number of primary composite events of cardiovascular (CV) death and total (first and recurrent) HF hospitalizations. [ Time Frame: Total follow up time (up to 57 months) ] [ Designated as safety issue: No ]
    The primary objective of this study is to compare LCZ696 to valsartan in reducing the rate of the composite endpoint of CV death and total (first and recurrent) HF hospitalizations, in HF patients (New York Heart Association [NYHA] Class II-IV) with preserved ejection fraction (left ventricular ejection fraction [LVEF] ≥45%). The treatment arm with the lower rate of events will be deemed as having a successful response.


Secondary Outcome Measures:
  • Cumulative number of events of the extended composite endpoint of CV death, total HF hospitalizations, total non-fatal strokes, and total non-fatal myocardial infarctions (MIs). [ Time Frame: Total follow up time (up to 57 months) ] [ Designated as safety issue: No ]
    Evaluation of the composite endpoint of CV death, total HF hospitalizations, total strokes, and total MIs. The treatment arm with the lower rate of events will be deemed a successful response.

  • Change from baseline to Month 8 in New York Heart Association (NYHA) functional class [ Time Frame: Baseline, 8 months ] [ Designated as safety issue: No ]
    Evaluation of change from baseline to Month 8 in NYHA functional class, a well established grading scale used to classify a HF patients' level of functionality based on the signs and symptoms of HF exhibited by the patient

  • Time to new onset of atrial fibrillation (AF) [ Time Frame: Total follow up time (up to 57 months) ] [ Designated as safety issue: No ]
    Evaluation of the time to onset of atrial fibrillation (AF) in patients wtihout prior AF (no prior history of AF and no AF at baseline).

  • Time to all-cause mortality [ Time Frame: Total follow up time (up to 57 months) ] [ Designated as safety issue: No ]
    Evaluation of the time to all cause death.


Estimated Enrollment: 4300
Study Start Date: July 2014
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LCZ696
Single Blind Run-in Period (3-8 weeks): Patients will start on Valsartan 80 mg b.i.d. for 1-2 weeks followed by LCZ696 100 mg b.i.d. for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients can only be randomized from the run-in period if they meet all of the run-in safety criteria.
Drug: LCZ696
LCZ696 50mg, 100mg and 200 mg dosage strengths will be available for dose adjustments.
Active Comparator: Valsartan
Single Blind Run-in Period (3-8 weeks): Patients will start on Valsartan 80 mg b.i.d. for 1-2 weeks followed by LCZ696 100 mg b.i.d. for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients can only be randomized from the run-in period if they meet all of the run-in safety criteria.
Drug: Valsartan
Valsartan 40mg, 80mg and 160mg dosage strengths will be available for dose adjustments.
Other Name: Diovan

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Left ventricular ejection fraction (LVEF) ≥45% prior to study entry.
  • Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF ≥30 days prior to study entry
  • Current symptom(s) of HF
  • Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram
  • At least one of the following: a HF hospitalization within 9 months prior to study entry and/or an elevated NT-proBNP.

Exclusion Criteria:

  • Any prior measurement of LVEF < 45%.
  • Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention (PCI) within 30 days of entry.
  • Patients who have had an MI, coronary artery bypass graft (CABG) or other event within the 6 months prior to entry unless an echo measurement performed after the event confirms a LVEF ≥45%.
  • Current acute decompensated HF requiring therapy.
  • Patients who require treatment with 2 or more of the following: an angiotensin converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB) or a renin inhibitor
  • Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dl, or body mass index (BMI) > 40 kg/m2.
  • Systolic blood pressure (SBP) ≥ 180 mmHg at entry, or SBP >150 mmHg and <180 mmHg at entry unless the patient is receiving 3 or more antihypertensive drugs.

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01920711

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Hide Study Locations
Locations
United States, Alabama
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Birmingham, Alabama, United States, 35209
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Huntsville, Alabama, United States, 35801
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Mobile, Alabama, United States, 36604
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Mobile, Alabama, United States, 36608
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Mobile, Alabama, United States, 36617-2293
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Muscle Shoals, Alabama, United States, 35662
United States, Arkansas
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Little Rock, Arkansas, United States, 72204
United States, California
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Anaheim, California, United States, 92801
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Beverly Hills, California, United States, 90211
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Carmichael, California, United States, 95608
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Fresno, California, United States, 93720
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La Jolla, California, United States, 92037
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Los Angeles, California, United States, 90073
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Los Angeles, California, United States, 90033
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Northridge, California, United States, 91325
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Oceanside, California, United States, 92056
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Orange, California, United States, 92868
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Palm Springs, California, United States, 92262
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Pomona, California, United States, 91767
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San Diego, California, United States, 92161
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Santa Ana, California, United States, 92704
United States, Colorado
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Denver, Colorado, United States, 80220
United States, Connecticut
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Hartford, Connecticut, United States, 06105
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Hartford, Connecticut, United States, 06105-2000
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Stamford, Connecticut, United States, 06905
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West Haven, Connecticut, United States, 06516
United States, Florida
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Atlantis, Florida, United States, 33462
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Bradenton, Florida, United States, 34209
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Defuniak Springs, Florida, United States, 32435
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Gainesville, Florida, United States, 32608
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Hallandale, Florida, United States, 33009-3770
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Jacksonville, Florida, United States, 32223
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Miami, Florida, United States, 33126
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Miami, Florida, United States, 33143
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Pembroke Pines, Florida, United States, 33024
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Tallahassee, Florida, United States, 32308
United States, Georgia
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Atlanta, Georgia, United States, 30310-1495
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Atlanta, Georgia, United States, 30342
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Covington, Georgia, United States, 30014
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Cumming, Georgia, United States, 30041
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Cumming, Georgia, United States, 30041
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Macon, Georgia, United States, 31201
United States, Illinois
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Chicago, Illinois, United States, 60611
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Lombard, Illinois, United States, 60148
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Maywood, Illinois, United States, 60153
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Oakbrook Terrace, Illinois, United States, 60181
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Peoria, Illinois, United States, 61602
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Quincy, Illinois, United States, 62301
United States, Kentucky
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Louisville, Kentucky, United States, 40206
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Owensboro, Kentucky, United States, 42303
United States, Louisiana
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Baton Rouge, Louisiana, United States, 70808
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Hammond, Louisiana, United States, 70403
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Lafayette, Louisiana, United States, 70508
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Opelousas, Louisiana, United States, 70570
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Shreveport, Louisiana, United States, 71105
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Shreveport, Louisiana, United States, 71101
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Slidell, Louisiana, United States, 70458
United States, Maine
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Biddeford, Maine, United States, 04005
United States, Maryland
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Baltimore, Maryland, United States, 21229
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Baltimore, Maryland, United States, 21287
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Columbia, Maryland, United States, 21044
United States, Massachusetts
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Boston, Massachusetts, United States, 02114
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Boston, Massachusetts, United States, 02118
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Boston, Massachusetts, United States, 02215
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Boston, Massachusetts, United States
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Haverhill, Massachusetts, United States, 01830
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Natick, Massachusetts, United States, 01760
United States, Michigan
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Ann Arbor, Michigan, United States, 48105
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Detroit, Michigan, United States, 48202
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Grand Blanc, Michigan, United States, 48439
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Kalamazoo, Michigan, United States, 49048
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Midland, Michigan, United States, 48640
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Saginaw, Michigan, United States, 48601
United States, Minnesota
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Minneapolis, Minnesota, United States, 55455
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Minneapolis, Minnesota, United States, 55433
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Minneapolis, Minnesota, United States, 55417
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Robbinsdale, Minnesota, United States, 55422
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St. Cloud, Minnesota, United States, 56303
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St. Paul, Minnesota, United States, 55102
United States, Mississippi
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Belzoni, Mississippi, United States, 39038
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Jackson, Mississippi, United States, 39209
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Jackson, Mississippi, United States, 39216
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Picayune, Mississippi, United States, 39466
United States, Missouri
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Saint Louis, Missouri, United States, 63136
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St. Louis, Missouri, United States, 63110
United States, Montana
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Kalispell, Montana, United States, 59901
United States, Nebraska
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Grand Island, Nebraska, United States, 68803
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Lincoln, Nebraska, United States, 68506
United States, New Jersey
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Hackensack, New Jersey, United States, 07601
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Morristown, New Jersey, United States, 07960
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New Brunswick, New Jersey, United States, 08901
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Oakland, New Jersey, United States, 07436
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Bronx, New York, United States, 10467
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Buffalo, New York, United States, 14203
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Buffalo, New York, United States, 14215
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Fluhing, New York, United States, 11355
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Kingston, New York, United States, 12401
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Northport, New York, United States, 11768
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Rochester, New York, United States, 14642
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Saratoga Springs, New York, United States, 12866
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Syracuse, New York, United States, 13202
United States, North Carolina
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Chapel Hill, North Carolina, United States, 27599-7075
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Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
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Grand Forks, North Dakota, United States, 58201
United States, Ohio
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Canton, Ohio, United States, 44710
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Cincinnati, Ohio, United States, 45219
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Dayton, Ohio, United States, 45414
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Marion, Ohio, United States, 43302
United States, Oklahoma
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Bartlesville, Oklahoma, United States, 74006
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Tulsa, Oklahoma, United States, 74133
United States, Oregon
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Hillsboro, Oregon, United States, 97123
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Portland, Oregon, United States, 97225
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19102-1192
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Philadelphia, Pennsylvania, United States, 19107
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Yardley, Pennsylvania, United States, 19067
United States, Rhode Island
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Warwick, Rhode Island, United States, 02886
United States, South Carolina
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Charleston, South Carolina, United States, 29403
United States, South Dakota
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Rapid City, South Dakota, United States, 57701
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Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
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Germantown, Tennessee, United States, 38138
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Knoxville, Tennessee, United States, 37917
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Knoxville, Tennessee, United States, 37920
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Memphis, Tennessee, United States, 38104
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Nashville, Tennessee, United States, 37203
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Nashville, Tennessee, United States, 37212
United States, Texas
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Beaumont, Texas, United States, 77702
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Dallas, Texas, United States, 75235
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Dallas, Texas, United States, 75231
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Dallas, Texas, United States, 75216
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77094
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Livingston, Texas, United States, 77351
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Marshall, Texas, United States, 75670
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McKinney, Texas, United States, 75069
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San Antonio, Texas, United States, 78234
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Tomball, Texas, United States, 77375
United States, Utah
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Salt Lake City, Utah, United States, 84124
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Salt Lake City, Utah, United States, 84132
United States, Vermont
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White River Junction, Vermont, United States, 05009
United States, Washington
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Seattle, Washington, United States, 98103
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Seattle, Washington, United States, 98195
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Spokane, Washington, United States, 99204
United States, Wisconsin
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Madison, Wisconsin, United States, 53792-1615
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Madison, Wisconsin, United States, 53705
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Milwaukee, Wisconsin, United States, 53215
Argentina
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Caba, Capital Federal, Argentina, C1179AAB
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Rosario, Santa Fe, Argentina, 2000
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Rosario, Santa Fe, Argentina, S2000DSV
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Buenos Aires, Argentina, C1405CNF
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Buenos Aires, Argentina, C1428DCO
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Caba, Argentina, C1119ACN
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Cordoba, Argentina, X5000AAX
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San Luis, Argentina, D5702JRS
Australia, New South Wales
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Gosford, New South Wales, Australia, 2250
Australia, Queensland
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Auchenflower, Queensland, Australia, 4066
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Southport, Queensland, Australia, 4215
Australia, Victoria
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Bundoora, Victoria, Australia, 3083
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Epping, Victoria, Australia, 3076
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Geelong, Victoria, Australia, 3220
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Heidelberg, Victoria, Australia, 3084
Austria
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Innsbruck, Tyrol, Austria, 6020
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Braunau, Austria, 5280
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Graz, Austria, A-8036
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Großgmain, Austria, 5084
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Linz, Austria, 4010
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Linz, Austria, A-4010
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Wien, Austria, A-1090
Belgium
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Aalst, Belgium, 9300
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Antwerpen, Belgium, 2060
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Brasschaat, Belgium, 2930
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Brussel, Belgium, 1000
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Genk, Belgium, 3600
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Gent, Belgium, 9000
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Huy, Belgium, 4500
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Kortrijk, Belgium, 8500
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Leuven, Belgium, 3000
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Ottignies, Belgium, 1340
Brazil
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Goiania, GO, Brazil, 74605-020
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Belo Horizonte, MG, Brazil, 30150-221
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Curitiba, PR, Brazil, 80730-150
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Porto Alegre, RS, Brazil, 90035-003
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Campinas, SP, Brazil, 13060-904
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Ribeirao Preto, SP, Brazil, 14055-370
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São Paulo, SP, Brazil, 08270-070
Bulgaria
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Burgas, Bulgaria, 8127
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Pazardzhik, Bulgaria, 4400
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Pleven, Bulgaria, 5800
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Plovdiv, Bulgaria, 4000
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Plovdiv, Bulgaria, 4002
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Russe, Bulgaria, 7002
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Shumen, Bulgaria, 9700
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Silistra, Bulgaria, 7500
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Sliven, Bulgaria, 8800
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Sofia, Bulgaria, 1202
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Sofia, Bulgaria, 1233
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Sofia, Bulgaria, 1309
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Sofia, Bulgaria, 1407
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Sofia, Bulgaria, 1527
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Sofia, Bulgaria, 1606
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Varna, Bulgaria, 9010
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
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Victoria, British Columbia, Canada, V8R4R2
Canada, Newfoundland and Labrador
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St. John, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
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Cambridge, Ontario, Canada, N1R 6V6
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Hamilton, Ontario, Canada, L8L 2X2
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Kitchener, Ontario, Canada, N2M 5N4
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Toronto, Ontario, Canada, M5G 1X5
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Toronto, Ontario, Canada, M5S 1B2
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Weston, Ontario, Canada, M9N 1W4
Canada, Quebec
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Fleurimont, Quebec, Canada, J1H 5N4
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Montreal, Quebec, Canada, H1T 1C8
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Montreal, Quebec, Canada, H2W 1T8
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Montreal, Quebec, Canada, H2X 3J4
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Montreal, Quebec, Canada, H3G 1A4
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Sainte-Foy, Quebec, Canada, G1V 4G5
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Thetford Mines, Quebec, Canada, G6G 2V4
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Trois-Rivières, Quebec, Canada, G8Z 3R9
China, Beijing
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Beijing, Beijing, China, 100037
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Beijing, Beijing, China, 100730
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Beijing, Beijing, China
China, Chongqing
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Chongqing, Chongqing, China, 400010
China, Guangdong
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Guangzhou, Guangdong, China, 510080
China, Guangxi
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Nanning, Guangxi, China, 530021
China, Hunan
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Changsha, Hunan, China, 410003
China, Jiangsu
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Nanjing, Jiangsu, China, 210009
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Nanjing, Jiangsu, China, 210029
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Suzhou, Jiangsu, China, 215006
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Wuxi, Jiangsu, China
China, Jiangxi
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Nanchang, Jiangxi, China, 330006
China, Jilin
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Changchun, Jilin, China, 130022
China, Liaoning
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Shenyang, Liaoning, China, 110016
China, Shanghai
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Shanghai, Shanghai, China, 200120
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Shanghai, Shanghai, China
China, Shanxi
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Xi'an, Shanxi, China, 710032
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Xi'an, Shanxi, China, 710061
China, Sichuan
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Chengdu, Sichuan, China, 610041
China, Tianjin
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Tianjin, Tianjin, China, 300121
China, Zhejiang
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Hangzhou, Zhejiang, China, 310009
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Hangzhou, Zhejiang, China, 310013
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Hangzhou, Zhejiang, China, 310016
China
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Beijing, China, 100029
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Beijing, China, 100034
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Chongqing, China, 400037
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Jinan, China, 250012
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Shanghai, China, 200025
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Shanghai, China, 200031
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Shanghai, China, 200032
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Shanghai, China, 200080
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Urumqi, China, 830054
Croatia
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Varazdin, HRV, Croatia, 42000
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Krapinske Toplice, Croatia, 49217
Novartis Investigative Site Recruiting
Rijeka, Croatia, 51000
Novartis Investigative Site Recruiting
Zadar, Croatia, 23000
Novartis Investigative Site Recruiting
Zagreb, Croatia, 10000
Novartis Investigative Site Active, not recruiting
Zagreb, Croatia, 10000
Czech Republic
Novartis Investigative Site Active, not recruiting
Praha 2, CZE, Czech Republic, 128 08
Novartis Investigative Site Recruiting
Praha 2, CZE, Czech Republic, 128 08
Novartis Investigative Site Recruiting
Brandys nad Labem, Czech Republic, 250 01
Novartis Investigative Site Recruiting
Brno, Czech Republic, 60200
Novartis Investigative Site Recruiting
Chomutov, Czech Republic, 43002
Novartis Investigative Site Recruiting
Ivancice, Czech Republic, 66491
Novartis Investigative Site Recruiting
Kladno, Czech Republic, 272 80
Novartis Investigative Site Recruiting
Kolin, Czech Republic, 280 20
Novartis Investigative Site Recruiting
Liberec, Czech Republic, 460 05
Novartis Investigative Site Recruiting
Louny, Czech Republic
Novartis Investigative Site Recruiting
Ostrava, Czech Republic, 70200
Novartis Investigative Site Recruiting
Plzen, Czech Republic, 30100
Novartis Investigative Site Recruiting
Praha 11, Czech Republic, 148 00
Novartis Investigative Site Recruiting
Praha 4, Czech Republic, 140 21
Novartis Investigative Site Recruiting
Roznov pod Radhostem, Czech Republic, 756 61
Novartis Investigative Site Recruiting
Trebic, Czech Republic, 674 01
Novartis Investigative Site Recruiting
Uherske Hradiste, Czech Republic, 68601
Novartis Investigative Site Recruiting
Usti nad Labem, Czech Republic, 400 01
Novartis Investigative Site Recruiting
Znojmo, Czech Republic, 66902
Denmark
Novartis Investigative Site Recruiting
Copenhagen, Denmark, 2100
Novartis Investigative Site Recruiting
Esbjerg, Denmark, DK-6700
Novartis Investigative Site Recruiting
Herlev, Denmark, 2730
Novartis Investigative Site Recruiting
Hvidovre, Denmark, DK-2650
Novartis Investigative Site Recruiting
Randers NØ, Denmark, DK-8930
Novartis Investigative Site Withdrawn
Slagelse, Denmark, DK-4200
Novartis Investigative Site Recruiting
Svendborg, Denmark, DK-5700
Novartis Investigative Site Recruiting
Viborg, Denmark, DK-8800
Finland
Novartis Investigative Site Recruiting
Jyvaskyla, Finland, 40620
Novartis Investigative Site Recruiting
Oulu, Finland, 90220
Novartis Investigative Site Recruiting
Tampere, Finland, 33520
France
Novartis Investigative Site Recruiting
Beziers Cedex, France, 34525
Novartis Investigative Site Recruiting
Bordeaux Cedex, France, 33075
Novartis Investigative Site Recruiting
Grenoble, France, 38043
Novartis Investigative Site Recruiting
Lyon, France, F-69001
Novartis Investigative Site Recruiting
Montpellier, France, 34059
Novartis Investigative Site Recruiting
Paris, France, 75012
Novartis Investigative Site Recruiting
Paris cedex 10, France, 75010
Novartis Investigative Site Recruiting
Poitiers, France, 86000
Novartis Investigative Site Recruiting
Rennes Cedex 9, France, 35033
Novartis Investigative Site Recruiting
Toulouse Cedex, France, 31059
Novartis Investigative Site Recruiting
Vandoeuvre Les Nancy, France, 54511
Germany
Novartis Investigative Site Recruiting
Bad Krozingen, Germany, 79189
Novartis Investigative Site Recruiting
Berlin, Germany, 13405
Novartis Investigative Site Recruiting
Berlin, Germany, 13353
Novartis Investigative Site Recruiting
Berlin, Germany, 10789
Novartis Investigative Site Recruiting
Berlin, Germany, 10967
Novartis Investigative Site Recruiting
Berlin, Germany, 13055
Novartis Investigative Site Recruiting
Berlin, Germany, 13347
Novartis Investigative Site Recruiting
Berlin, Germany, 10249
Novartis Investigative Site Recruiting
Berlin-Buch, Germany, 13125
Novartis Investigative Site Recruiting
Chemnitz, Germany, 09126
Novartis Investigative Site Active, not recruiting
Dessau-Roßlau, Germany, 06846
Novartis Investigative Site Recruiting
Dietzenbach, Germany, 63128
Novartis Investigative Site Recruiting
Dinkelsbühl, Germany, 91550
Novartis Investigative Site Recruiting
Dresden, Germany, 01099
Novartis Investigative Site Recruiting
Dresden, Germany, 01307
Novartis Investigative Site Recruiting
Dresden, Germany, 01309
Novartis Investigative Site Recruiting
Duisburg, Germany, 47137
Novartis Investigative Site Recruiting
Eilenburg, Germany, 04838
Novartis Investigative Site Recruiting
Elsterwerda, Germany, 04910
Novartis Investigative Site Recruiting
Essen, Germany, 45355
Novartis Investigative Site Recruiting
Frankfurt, Germany, 60594
Novartis Investigative Site Recruiting
Frankfurt, Germany, 65929
Novartis Investigative Site Completed
Freiburg, Germany, 79106
Novartis Investigative Site Recruiting
Goettingen, Germany, 37075
Novartis Investigative Site Recruiting
Hamburg, Germany, 22765
Novartis Investigative Site Recruiting
Hamburg, Germany, 20099
Novartis Investigative Site Recruiting
Hassloch, Germany, 67454
Novartis Investigative Site Recruiting
Heide, Germany, 25746
Novartis Investigative Site Recruiting
Heppenheim, Germany, 64646
Novartis Investigative Site Recruiting
Homburg, Germany, 66421
Novartis Investigative Site Recruiting
Huy / OT Anderbeck, Germany, 38836
Novartis Investigative Site Recruiting
Ingelheim, Germany, 55218
Novartis Investigative Site Recruiting
Jena, Germany, 07740
Novartis Investigative Site Recruiting
Kleve, Germany, 47533
Novartis Investigative Site Recruiting
Koblenz, Germany, 56068
Novartis Investigative Site Recruiting
Köln, Germany, 51605
Novartis Investigative Site Recruiting
Leipzig, Germany, 04103
Novartis Investigative Site Completed
Leipzig, Germany, 04315
Novartis Investigative Site Recruiting
Loehne, Germany, 32584
Novartis Investigative Site Recruiting
Lüneburg, Germany, 21339
Novartis Investigative Site Recruiting
Mainz, Germany, 55116
Novartis Investigative Site Recruiting
Markkleeberg, Germany, 04416
Novartis Investigative Site Recruiting
Meißen, Germany, 01662
Novartis Investigative Site Recruiting
Muehldorf am Inn, Germany, 84453
Novartis Investigative Site Recruiting
Muenster, Germany, 48149
Novartis Investigative Site Recruiting
Mönchengladbach, Germany, 41063
Novartis Investigative Site Recruiting
Mühldorf, Germany, 84453
Novartis Investigative Site Recruiting
Mühlheim, Germany, 45468
Novartis Investigative Site Recruiting
Münster, Germany, 48149
Novartis Investigative Site Recruiting
Nienburg, Germany, 31582
Novartis Investigative Site Recruiting
Oschatz, Germany, 04758
Novartis Investigative Site Recruiting
Reinfeld, Germany, 23858
Novartis Investigative Site Recruiting
Riesa, Germany, 01589
Novartis Investigative Site Recruiting
Siegen, Germany, 57072
Novartis Investigative Site Recruiting
Vilshofen, Germany, 94474
Novartis Investigative Site Recruiting
Wermsdorf, Germany, 04779
Novartis Investigative Site Recruiting
Weyhe, Germany, 28844
Novartis Investigative Site Recruiting
Witten, Germany, 58455
Greece
Novartis Investigative Site Recruiting
Athens, GR, Greece, 124 62
Novartis Investigative Site Withdrawn
Heraklion, Crete, GR, Greece, 71110
Novartis Investigative Site Recruiting
Ioannina, GR, Greece, 45110
Novartis Investigative Site Recruiting
Larissa, GR, Greece, 411 10
Novartis Investigative Site Recruiting
Athens, Greece, 15562
Novartis Investigative Site Recruiting
Athens, Greece
Novartis Investigative Site Recruiting
Thessaloniki, Greece, 54636
Guatemala
Novartis Investigative Site Recruiting
Guatemala City, Guatemala, 01011
Novartis Investigative Site Recruiting
Guatemala City, Guatemala, 01010
Novartis Investigative Site Recruiting
Guatemala City, Guatemala, 01009
Novartis Investigative Site Recruiting
Guatemala City, Guatemala, 01015
Hungary
Novartis Investigative Site Recruiting
Budapest, Hungary, 1042
Novartis Investigative Site Recruiting
Budapest, Hungary, 1085
Novartis Investigative Site Recruiting
Budapest, Hungary, 1134
Novartis Investigative Site Recruiting
Budapest, Hungary, 1145
Novartis Investigative Site Recruiting
Budapest, Hungary, H-1096
Novartis Investigative Site Recruiting
Cegled, Hungary, 2700
Novartis Investigative Site Recruiting
Gyula, Hungary, 5700
Novartis Investigative Site Recruiting
Kistarcsa, Hungary, 2143
Novartis Investigative Site Recruiting
Nyiregyháza, Hungary, 4400
Novartis Investigative Site Recruiting
Pecs, Hungary, 7624
Novartis Investigative Site Recruiting
Pécs, Hungary, 7623
Novartis Investigative Site Recruiting
Szeged, Hungary, H-6720
Novartis Investigative Site Recruiting
Szekesfehervar, Hungary, 8000
Novartis Investigative Site Recruiting
Zalaegerszeg, Hungary, 8900
Israel
Novartis Investigative Site Recruiting
Hadera, Israel, 38100
Novartis Investigative Site Recruiting
Haifa, Israel, 31096
Novartis Investigative Site Recruiting
Haifa, Israel, 3339419
Novartis Investigative Site Recruiting
Nahariya, Israel, 22100
Novartis Investigative Site Recruiting
Petach Tikva, Israel, 49100
Novartis Investigative Site Recruiting
Ramat Gan, Israel, 5266202
Novartis Investigative Site Recruiting
Rehovot, Israel, 76100
Novartis Investigative Site Recruiting
Tel Giborim, Holon, Israel, 58100
Italy
Novartis Investigative Site Recruiting
Aosta, AO, Italy, 11100
Novartis Investigative Site Recruiting
Cortona, AR, Italy, 52044
Novartis Investigative Site Recruiting
Bergamo, BG, Italy, 24128
Novartis Investigative Site Recruiting
Bologna, BO, Italy, 40138
Novartis Investigative Site Recruiting
Brescia, BS, Italy, 25123
Novartis Investigative Site Recruiting
San Fermo della Battaglia, CO, Italy, 22020
Novartis Investigative Site Recruiting
Cona, FE, Italy, 44100
Novartis Investigative Site Recruiting
Pozzilli, IS, Italy, 86077
Novartis Investigative Site Recruiting
Monza, MB, Italy, 20900
Novartis Investigative Site Recruiting
Messina, ME, Italy, 98125
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20162
Novartis Investigative Site Recruiting
Vimercate, MI, Italy, 200059
Novartis Investigative Site Recruiting
Palermo, PA, Italy, 90146
Novartis Investigative Site Recruiting
Piacenza, PC, Italy, 29100
Novartis Investigative Site Recruiting
Padova, PD, Italy, 35100
Novartis Investigative Site Recruiting
Padova, PD, Italy, 35128
Novartis Investigative Site Recruiting
Perugia, PG, Italy, 06129
Novartis Investigative Site Recruiting
Perugia, PG, Italy, 06100
Novartis Investigative Site Recruiting
Pisa, PI, Italy, 56126
Novartis Investigative Site Recruiting
Pavia, PV, Italy, 27100
Novartis Investigative Site Recruiting
Albano Laziale, RM, Italy, 00041
Novartis Investigative Site Recruiting
Roma, RM, Italy, 00163
Novartis Investigative Site Recruiting
Roma, RM, Italy, 00184
Novartis Investigative Site Recruiting
Roma, RM, Italy, 00189
Novartis Investigative Site Recruiting
Sassari, SS, Italy, 07100
Novartis Investigative Site Recruiting
Torino, TO, Italy, 10126
Novartis Investigative Site Recruiting
Trieste, TS, Italy, 34142
Novartis Investigative Site Recruiting
Vittorio Veneto, TV, Italy, 31029
Novartis Investigative Site Recruiting
Saronno, Va, Italy, 21047
Novartis Investigative Site Recruiting
Venezia, VE, Italy, 30174
Novartis Investigative Site Recruiting
Napoli, Italy, 80131
Novartis Investigative Site Active, not recruiting
Novara, Italy, 28100
Korea, Republic of
Novartis Investigative Site Recruiting
Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 361 711
Novartis Investigative Site Recruiting
Wonju, Gangwon, Korea, Republic of, 220-701
Novartis Investigative Site Recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 442-723
Novartis Investigative Site Recruiting
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Novartis Investigative Site Recruiting
Seoul, Korea, Korea, Republic of, 137-701
Novartis Investigative Site Recruiting
Seoul, Korea, Korea, Republic of, 06351
Novartis Investigative Site Recruiting
Seoul, Korea, Korea, Republic of, 110 744
Novartis Investigative Site Recruiting
Seoul, Korea, Korea, Republic of, 05505
Novartis Investigative Site Recruiting
Daegu, Korea, Republic of, 705-718
Novartis Investigative Site Recruiting
Incheon, Korea, Republic of, 22332
Novartis Investigative Site Recruiting
Seoul, Korea, Republic of, 120-752
Novartis Investigative Site Recruiting
Seoul, Korea, Republic of, 134-701
Mexico
Novartis Investigative Site Recruiting
Zapopan, Jalisco, Mexico, 45200
Novartis Investigative Site Recruiting
San Juan del Rio, Queretaro, Mexico, 76800
Novartis Investigative Site Recruiting
Aguascalientes, Mexico, 20230
Novartis Investigative Site Recruiting
Queretaro, Mexico, 76000
Novartis Investigative Site Recruiting
San Luis Potosi, Mexico, 78200
Novartis Investigative Site Recruiting
San Luis Potosí, Mexico, 78200
Novartis Investigative Site Recruiting
San Luis Potosí, Mexico, 78240
Netherlands
Novartis Investigative Site Recruiting
Den Haag, NL, Netherlands, 2597 AX
Novartis Investigative Site Recruiting
Almelo, PP, Netherlands, 7609
Novartis Investigative Site Recruiting
Apeldoorn, Netherlands, 7334 DZ
Novartis Investigative Site Recruiting
Arnhem, Netherlands, 6815 AD
Novartis Investigative Site Recruiting
Blaricum, Netherlands, 1261 AN
Novartis Investigative Site Recruiting
Den Haag, Netherlands, 2512 VA
Novartis Investigative Site Recruiting
Ede, Netherlands, 6716 RP
Novartis Investigative Site Recruiting
Gouda, Netherlands, 2800 BB
Novartis Investigative Site Recruiting
Groningen, Netherlands, 9713 GZ
Novartis Investigative Site Recruiting
Hardenberg, Netherlands, 7770 AA
Novartis Investigative Site Recruiting
Harderwijk, Netherlands, 3840 AC
Novartis Investigative Site Recruiting
Nijmegen, Netherlands, 6525 GA
Novartis Investigative Site Recruiting
Sneek, Netherlands, 8601 ZK
Novartis Investigative Site Recruiting
Tilburg, Netherlands, 5022 GC
Norway
Novartis Investigative Site Recruiting
Lørenskog, Norway, NO-1478
Novartis Investigative Site Recruiting
Oslo, Norway, 0407
Novartis Investigative Site Recruiting
Stavanger, Norway, 4068
Philippines
Novartis Investigative Site Recruiting
Quezon City, Manila, Philippines, 1100
Novartis Investigative Site Recruiting
Quezon City, Philippines, 1100
Novartis Investigative Site Recruiting
Quezon City, Philippines, 1102
Poland
Novartis Investigative Site Recruiting
Gdanska, Poland, 80-141
Novartis Investigative Site Recruiting
Gdynia, Poland, 81-157
Novartis Investigative Site Recruiting
Gdynia, Poland, 81-472
Novartis Investigative Site Recruiting
Gdynia, Poland, 81-548
Novartis Investigative Site Recruiting
Grodzisk Mazowiecki, Poland, 05-825
Novartis Investigative Site Recruiting
Katowice, Poland, 40-645
Novartis Investigative Site Recruiting
Krakow, Poland, 30-015
Novartis Investigative Site Recruiting
Lodz, Poland, 92-231
Novartis Investigative Site Recruiting
Lublin, Poland, 20-363
Novartis Investigative Site Recruiting
Sandomierz, Poland, 27-600
Novartis Investigative Site Recruiting
Staszów, Poland, 28-200
Novartis Investigative Site Recruiting
Torun, Poland, 87-100
Novartis Investigative Site Recruiting
Warszawa, Poland, 04-154
Novartis Investigative Site Recruiting
Warszawa/Anin, Poland, 04-761
Novartis Investigative Site Recruiting
Zabrze, Poland, 41-800
Novartis Investigative Site Recruiting
Zamosc, Poland, 22-400
Romania
Novartis Investigative Site Recruiting
Pitesti, Arges, Romania
Novartis Investigative Site Recruiting
Bucuresti, District 1, Romania, 014461
Novartis Investigative Site Recruiting
Craiova, Jud. Dolj, Romania, 200147
Novartis Investigative Site Recruiting
Sibiu, Jud. Iasi, Romania, 550371
Novartis Investigative Site Recruiting
Timisoara, jud. Timis, Romania, 300359
Novartis Investigative Site Recruiting
Timisoara, Timis, Romania, 300125
Novartis Investigative Site Recruiting
Arad, Romania, 310158
Novartis Investigative Site Recruiting
Braila, Romania, 810249
Novartis Investigative Site Recruiting
Bucharest, Romania, 050098
Novartis Investigative Site Recruiting
Bucuresti, Romania, 062272
Novartis Investigative Site Recruiting
Oradea, Romania, 410042
Novartis Investigative Site Recruiting
Targu Mures, Romania, 540143
Novartis Investigative Site Recruiting
Targu-Mures, Romania, 540142
Novartis Investigative Site Recruiting
Timisoara, Romania, 300041
Russian Federation
Novartis Investigative Site Recruiting
Ekaterinburg, Russian Federation, 620028
Novartis Investigative Site Recruiting
Ekaterinburg, Russian Federation, 620137
Novartis Investigative Site Recruiting
Ivanovo, Russian Federation, 153012
Novartis Investigative Site Recruiting
Izhevsk, Russian Federation, 426009
Novartis Investigative Site Recruiting
Izhevsk, Russian Federation, 426063
Novartis Investigative Site Recruiting
Kemerovo, Russian Federation, 650029
Novartis Investigative Site Recruiting
Kirov, Russian Federation, 610014
Novartis Investigative Site Recruiting
Moscow, Russian Federation, 101990
Novartis Investigative Site Recruiting
Moscow, Russian Federation, 109469
Novartis Investigative Site Recruiting
Moscow, Russian Federation, 117198
Novartis Investigative Site Recruiting
N.Novgorod, Russian Federation, 603005
Novartis Investigative Site Recruiting
Perm, Russian Federation, 614990
Novartis Investigative Site Recruiting
Rostov-on-Don, Russian Federation, 344022
Novartis Investigative Site Recruiting
Saint Petersburg, Russian Federation, 199106
Novartis Investigative Site Recruiting
Saint-Petersburg, Russian Federation, 194044
Novartis Investigative Site Recruiting
Saint-Petersburg, Russian Federation, 197341
Novartis Investigative Site Recruiting
Sankt-Peterburg, Russian Federation, 197022
Novartis Investigative Site Recruiting
Saratov, Russian Federation, 410012
Novartis Investigative Site Recruiting
Smolensk, Russian Federation, 214018
Novartis Investigative Site Recruiting
St-Petersburg, Russian Federation, 194295
Novartis Investigative Site Recruiting
St. Petersburg, Russian Federation, 197706
Novartis Investigative Site Recruiting
St.- Petersburg, Russian Federation, 197110
Novartis Investigative Site Withdrawn
Syktyvkar, Russian Federation, 167981
Singapore
Novartis Investigative Site Recruiting
Singapore, Singapore, 768825
Novartis Investigative Site Recruiting
Singapore, Singapore, 169609
Novartis Investigative Site Recruiting
Singapore, Singapore, 308433
Novartis Investigative Site Recruiting
Singapore, Singapore, 529889
Novartis Investigative Site Recruiting
Singapore, Singapore, 119074
Slovakia
Novartis Investigative Site Recruiting
Brezno, Slovak Republic, Slovakia, 977 42
Novartis Investigative Site Recruiting
Komarno, Slovak Republic, Slovakia, 94575
Novartis Investigative Site Recruiting
Levice, Slovak Republic, Slovakia, 93401
Novartis Investigative Site Recruiting
Povazska Bystrica, Slovak republic, Slovakia, 01701
Novartis Investigative Site Recruiting
Presov, Slovak Republic, Slovakia, 08001
Novartis Investigative Site Recruiting
Velky Krtis, Slovak Republic, Slovakia, 990 01
Novartis Investigative Site Recruiting
Banska Bystrica, Slovakia, 97401
Novartis Investigative Site Recruiting
Bardejov, Slovakia, 085 01
Novartis Investigative Site Recruiting
Bratislava, Slovakia, 851 01
Novartis Investigative Site Recruiting
Bratislava, Slovakia, 831 01
Novartis Investigative Site Recruiting
Bratislava, Slovakia, 833 48
Novartis Investigative Site Recruiting
Bratislava, Slovakia, 841 04
Novartis Investigative Site Recruiting
Bratislava, Slovakia, 821 07
Novartis Investigative Site Recruiting
Kosice, Slovakia, 040 01
Novartis Investigative Site Recruiting
Levice, Slovakia, 934 01
Novartis Investigative Site Recruiting
Lucenec, Slovakia, 984 01
Novartis Investigative Site Recruiting
Nitra, Slovakia, 949 88
Novartis Investigative Site Recruiting
Nitra, Slovakia, 949 01
Novartis Investigative Site Recruiting
Nove Zamky, Slovakia, 940 01
Novartis Investigative Site Recruiting
Nové Zámky, Slovakia, 940 01
Novartis Investigative Site Recruiting
Presov, Slovakia, 080 01
Novartis Investigative Site Recruiting
Svidnik, Slovakia, 089 01
Novartis Investigative Site Recruiting
Trebisov, Slovakia, 075 01
Novartis Investigative Site Recruiting
Zilina, Slovakia, 012 07
South Africa
Novartis Investigative Site Recruiting
Bloemfontein, Free State, South Africa, 9301
Novartis Investigative Site Recruiting
Alberton, South Africa, 1449
Novartis Investigative Site Recruiting
Bloemfontein, South Africa, 9301
Novartis Investigative Site Recruiting
Cape Town, South Africa, 7505
Novartis Investigative Site Recruiting
Cape Town, South Africa
Novartis Investigative Site Recruiting
Durban, South Africa, 4052
Novartis Investigative Site Recruiting
Durban, South Africa, 4001
Novartis Investigative Site Recruiting
Johannesburg, South Africa, 2193
Spain
Novartis Investigative Site Recruiting
Cordoba, Andalucia, Spain, 14004
Novartis Investigative Site Recruiting
Malaga, Andalucia, Spain, 29010
Novartis Investigative Site Recruiting
Marbella, Andalucia, Spain, 29600
Novartis Investigative Site Recruiting
Sanlúcar de Barrameda, Andalucia, Spain, 11540
Novartis Investigative Site Recruiting
Sevilla, Andalucia, Spain, 41013
Novartis Investigative Site Recruiting
Sevilla, Andalucia, Spain, 41014
Novartis Investigative Site Recruiting
Oviedo, Asturias, Spain, 33011
Novartis Investigative Site Recruiting
Sant Joan Despi, Barcelona, Spain, 08970
Novartis Investigative Site Recruiting
Santander, Cantabria, Spain, 39008
Novartis Investigative Site Recruiting
Leon, Castilla y Leon, Spain, 24071
Novartis Investigative Site Recruiting
Badalona, Catalunya, Spain, 08916
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08003
Novartis Investigative Site Recruiting
Alzira, Comunidad Valenciana, Spain, 46600
Novartis Investigative Site Recruiting
Valencia, Comunidad Valenciana, Spain, 46010
Novartis Investigative Site Recruiting
Valencia, Comunidad Valenciana, Spain, 46014
Novartis Investigative Site Recruiting
Valencia, Comunidad Valenciana, Spain, 46026
Novartis Investigative Site Recruiting
Mérida, Extremadura, Spain, 06800
Novartis Investigative Site Recruiting
A Coruna, Galicia, Spain, 15006
Novartis Investigative Site Recruiting
Santiago de Compostela, Galicia, Spain, 15706
Novartis Investigative Site Recruiting
Olot, Girona, Spain, 17800
Novartis Investigative Site Recruiting
Mostoles, Madrid, Spain, 28935
Novartis Investigative Site Recruiting
El Palmar, Murcia, Spain, 30120
Novartis Investigative Site Recruiting
Ciudad Real, Spain, 13005
Novartis Investigative Site Recruiting
Madrid, Spain, 28046
Novartis Investigative Site Recruiting
Madrid, Spain, 28034
Novartis Investigative Site Recruiting
Madrid, Spain, 28040
Novartis Investigative Site Recruiting
Madrid, Spain, 28007
Sweden
Novartis Investigative Site Recruiting
Falun, Sweden, 791 82
Switzerland
Novartis Investigative Site Recruiting
Bern, Switzerland, 3010
Novartis Investigative Site Recruiting
Lausanne, Switzerland, 1011
Novartis Investigative Site Recruiting
Zurich, Switzerland, 8091
Taiwan
Novartis Investigative Site Recruiting
Yungkang, Tainan, Taiwan, 710
Novartis Investigative Site Recruiting
Tainan 704, Taiwan ROC, Taiwan, 33305
Novartis Investigative Site Recruiting
Changhua, Taiwan, 500
Novartis Investigative Site Recruiting
Kaohsiung, Taiwan, 807
Novartis Investigative Site Recruiting
Taichung, Taiwan, 40447
Novartis Investigative Site Recruiting
Taipei, Taiwan, 10002
Novartis Investigative Site Recruiting
Taipei, Taiwan, 112
United Kingdom
Novartis Investigative Site Recruiting
Torquay, Devon,, United Kingdom, TQ2 7AA
Novartis Investigative Site Recruiting
Dorchester, Dorset, United Kingdom, DT1 2JY
Novartis Investigative Site Recruiting
Basingstoke, Hampshire, United Kingdom, RG24 9NA
Novartis Investigative Site Recruiting
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Novartis Investigative Site Recruiting
Oldham, Lancashire, United Kingdom, OL1 2JH
Novartis Investigative Site Recruiting
Harrow, Middlesex, United Kingdom, HA1 3UJ
Novartis Investigative Site Recruiting
Portadown, Nothern Ireland, United Kingdom, BT63 5QQ
Novartis Investigative Site Recruiting
Wansford, Peterborough, United Kingdom, PE8 6PL
Novartis Investigative Site Recruiting
Glasgow, Scotland, United Kingdom, G12 8TA
Novartis Investigative Site Recruiting
Taunton, Somerset, United Kingdom, TA1 5DA
Novartis Investigative Site Recruiting
Gateshead, Tyne and Wear, United Kingdom, NE9 6SX
Novartis Investigative Site Recruiting
Cheshire, United Kingdom, CW1 4QJ
Novartis Investigative Site Recruiting
Doncaster, United Kingdom, DN2 5LT
Novartis Investigative Site Recruiting
Dundee, United Kingdom, DD1 9SY
Novartis Investigative Site Recruiting
Glasgow, United Kingdom, G20 0XA
Novartis Investigative Site Recruiting
Hull, United Kingdom, HU16 5JQ
Novartis Investigative Site Recruiting
Leicester, United Kingdom, LE3 9QP
Novartis Investigative Site Recruiting
London, United Kingdom, SE5 9RS
Novartis Investigative Site Recruiting
Newport, United Kingdom, NP20 2UB
Novartis Investigative Site Recruiting
Sheffield, United Kingdom, S5 7AU
Novartis Investigative Site Recruiting
Swindon, United Kingdom, SN3 6BB
Novartis Investigative Site Recruiting
Wrexham, United Kingdom, LL13 7TD
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01920711     History of Changes
Other Study ID Numbers: CLCZ696D2301  2013-001747-31 
Study First Received: August 8, 2013
Last Updated: October 14, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Heart failure, preserved ejection fraction, diastolic heart failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016