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 July 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01920711
First received: August 8, 2013
Last updated: July 22, 2014
Last verified: July 2014
  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:   55 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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Mobile, Alabama, United States, 36608
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Mobile, Alabama, United States, 36617-2293
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Mobile, Alabama, United States, 36604
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Muscle Shoals, Alabama, United States, 35662
United States, Arizona
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Gilbert, Arizona, United States, 85297
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Phoenix, Arizona, United States, 85054
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Tucson, Arizona, United States, 85724
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Tucson, Arizona, United States, 85723-0001
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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Los Angeles, California, United States, 90033
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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
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Sylmar, California, United States, 91342
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Torrance, California, United States, 90502
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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Stamford, Connecticut, United States, 06905
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West Haven, Connecticut, United States, 06516
United States, Florida
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Davie, Florida, United States, 33324
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Defuniak Springs, Florida, United States, 32435
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Hollywood, Florida, United States, 33021
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Jacksonville, Florida, United States, 32223
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Jacksonville, Florida, United States, 32209
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Lady Lake, Florida, United States, 32159
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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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Rockledge, Florida, United States, 32955
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South Miami, Florida, United States, 33143
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Tallahassee, Florida, United States, 32308
United States, Georgia
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Atlanta, Georgia, United States, 30322
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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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Macon, Georgia, United States, 31201
United States, Illinois
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Chicago, Illinois, United States, 60612
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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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Melrose Park, Illinois, United States, 60160
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Peoria, Illinois, United States, 61602
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Quincy, Illinois, United States, 62301
United States, Iowa
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Iowa City, Iowa, United States, 52242
United States, Kentucky
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Louisville, Kentucky, United States, 40207
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Louisville, Kentucky, United States, 40206
United States, Louisiana
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Opelousas, Louisiana, United States, 70570
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Shreveport, Louisiana, United States, 71101
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Shreveport, Louisiana, United States, 71105
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Slidell, Louisiana, United States, 70458
United States, Maine
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Biddeford, Maine, United States, 04005
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Westbrook, Maine, United States, 04092
United States, Maryland
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Columbia, Maryland, United States, 21044
United States, Massachusetts
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States, 02118
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Boston, Massachusetts, United States, 02114
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Natick, Massachusetts, United States, 01760
United States, Michigan
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Ann Arbor, Michigan, United States, 48109-0356
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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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Petoskey, Michigan, United States, 49770
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Saginaw, Michigan, United States, 48601
United States, Minnesota
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Minneapolis, Minnesota, United States, 55417
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Minneapolis, Minnesota, United States, 55455
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Minneapolis, Minnesota, United States, 55433
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Robbinsdale, Minnesota, United States, 55422
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Rochester, Minnesota, United States, 55905
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Saint Paul, Minnesota, United States, 55102
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St. Cloud, Minnesota, United States, 56303
United States, Mississippi
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Belzoni, Mississippi, United States, 39038
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Jackson, Mississippi, United States, 39216
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Jackson, Mississippi, United States, 39209
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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
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Washington, Missouri, United States, 63090
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
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Omaha, Nebraska, United States, 68131
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Omaha, Nebraska, United States, 68198
United States, New Jersey
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Elmer, New Jersey, United States, 08318
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Ridgewood, New Jersey, United States, 07450
United States, New Mexico
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Albuquerque, New Mexico, United States, 87102
United States, New York
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Bronx, New York, United States, 10467
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Brooklyn, New York, United States, 11215-9008
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Fluhing, New York, United States, 11355
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New York, New York, United States, 10032
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Northport, New York, United States, 11768
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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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Asheville, North Carolina, United States, 28803
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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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Fargo, North Dakota, United States, 58103
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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Marion, Ohio, United States, 43302
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73120
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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, 19107
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Philadelphia, Pennsylvania, United States, 19102-1192
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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
United States, Tennessee
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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
Novartis Investigative Site Withdrawn
Oak Ridge, Tennessee, United States, 37830
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
Novartis Investigative Site Withdrawn
Houston, Texas, United States, 77064
Novartis Investigative Site Withdrawn
Houston, Texas, United States, 77070
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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, Virginia
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Chesapeake, Virginia, United States, 23320
Novartis Investigative Site Withdrawn
Manassas, Virginia, United States, 20110
United States, Washington
Novartis Investigative Site Withdrawn
Kirkland, Washington, United States, 98034
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Seattle, Washington, United States, 98103
United States, Wisconsin
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Madison, Wisconsin, United States, 53705
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Madison, Wisconsin, United States, 53792-1615
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Milwaukee, Wisconsin, United States, 53295
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Milwaukee, Wisconsin, United States, 53215
Austria
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Graz, Austria, A-8036
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Großgmain, Austria, 5084
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Innsbruck, Austria, 6020
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Linz, Austria, A-4010
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Linz, Austria, A-4020
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Salzburg, Austria, A-5020
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Wien, Austria, A-1090
Bulgaria
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Burgas, Bulgaria, 8000
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Pazardzhik, Bulgaria, 4400
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Pleven, Bulgaria, 5800
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Russe, Bulgaria, 7002
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Sliven, Bulgaria, 8800
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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, 1606
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Varna, Bulgaria, 9010
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4Z6
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Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
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Victoria, British Columbia, Canada, V8R4R2
Canada, New Brunswick
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Moncton, New Brunswick, Canada, E1G 1A7
Canada, Newfoundland and Labrador
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St. John, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
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
Canada, Quebec
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Fleurimont, Quebec, Canada, J1H 5N4
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Montreal, Quebec, Canada, H3G 1A4
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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, H1T 1C8
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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
Croatia
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Krapinske Toplice, Croatia, 49217
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Varazdin, Croatia, 42000
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Zadar, Croatia, 23000
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Zagreb, Croatia, 10000
Czech Republic
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Praha 2, CZE, Czech Republic, 128 08
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Louny, Czech Republic
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Uherske Hradiste, Czech Republic, 68601
Germany
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Berlin, Germany, 14050
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Berlin-Buch, Germany, 13125
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Dessau-Roßlau, Germany, 06846
Novartis Investigative Site Withdrawn
Dortmund, Germany, 44137
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Dresden, Germany, 01309
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Duisburg, Germany, 47137
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Essen, Germany, 45138
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Essen, Germany, 45355
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Frankfurt, Germany, 65929
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Frankfurt, Germany, 60594
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Goettingen, Germany, 37075
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Koethen, Germany, 06366
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Köln, Germany, 51605
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Loehne, Germany, 32584
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Lüneburg, Germany, 21339
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Münster, Germany, 48149
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Reinfeld, Germany, 23858
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Weyhe, Germany, 28844
Greece
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Athens, GR, Greece, 124 62
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Heraklion, Crete, GR, Greece, 700 13
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Larissa, GR, Greece, 41110
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Athens, Greece, 15562
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Athens, Greece
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Thessaloniki, Greece, 54636
Hungary
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Budapest, Hungary, H-1096
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Budapest, Hungary, 1085
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Budapest, Hungary, 1042
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Budapest, Hungary, 1145
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Cegled, Hungary, 2700
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Gyula, Hungary, 5703
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Nyiregyháza, Hungary, 4400
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Pecs, Hungary, 7624
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Sopron, Hungary, 9400
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Szeged, Hungary, H-6720
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Szekesfehervar, Hungary, 8000
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Zalaegerszeg, Hungary, 8900
Italy
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Ancona, AN, Italy, 60128
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Cortona, AR, Italy, 52044
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Bergamo, BG, Italy, 24128
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Bologna, BO, Italy, 40138
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Catanzaro, CZ, Italy, 88100
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Cona, FE, Italy, 44100
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Genova, GE, Italy, 16128
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Pozzilli, IS, Italy, 86077
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Monza, MB, Italy, 20900
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Milano, MI, Italy, 20132
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Milano, MI, Italy, 20162
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Piacenza, PC, Italy, 29100
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Perugia, PG, Italy, 06100
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Casorate Primo, PV, Italy, 27022
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Scandiano, RE, Italy, 42019
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Albano Laziale, RM, Italy, 00041
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Roma, RM, Italy, 00161
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Roma, RM, Italy, 00189
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Roma, RM, Italy, 00163
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Sassari, SS, Italy, 07100
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Torino, TO, Italy, 10126
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Trieste, TS, Italy, 34142
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Vittorio Veneto, TV, Italy, 31029
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San Daniele Del Friuli, UD, Italy, 33038
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Vicenza, VI, Italy, 36100
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Verona, VR, Italy, 37134
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Napoli, Italy, 80131
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Novara, Italy, 28100
Mexico
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San Luis Potosi, Mexico, 78200
Novartis Investigative Site Withdrawn
San Luis Potosí, Mexico, 78240
Philippines
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Bulacan, Philippines, 3020
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Quezon City, Philippines, 1102
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Quezon City, Philippines, 1100
Portugal
Novartis Investigative Site Withdrawn
Carnaxide, Lisboa, Portugal, 2790-134
Novartis Investigative Site Withdrawn
Lisboa, Portugal, 1169-024
Novartis Investigative Site Withdrawn
Lisboa, Portugal, 1500-650
Novartis Investigative Site Withdrawn
Lisbon, Portugal, 1449-005
Novartis Investigative Site Withdrawn
Porto, Portugal, 4200-319
Novartis Investigative Site Withdrawn
Porto, Portugal, 4099-001
Novartis Investigative Site Withdrawn
Vila Nova de Gaia, Portugal, 4434-502
Romania
Novartis Investigative Site Not yet recruiting
Pitesti, Arges, Romania
Novartis Investigative Site Not yet recruiting
Bucuresti, District 1, Romania, 014461
Novartis Investigative Site Not yet recruiting
Craiova, Jud. Dolj, Romania, 200147
Novartis Investigative Site Not yet recruiting
Sibiu, Jud. Iasi, Romania, 550371
Novartis Investigative Site Not yet recruiting
Timisoara, jud. Timis, Romania, 300359
Novartis Investigative Site Not yet recruiting
Timisoara, Timis, Romania, 300125
Novartis Investigative Site Not yet recruiting
Arad, Romania, 310158
Novartis Investigative Site Not yet recruiting
Braila, Romania, 810249
Novartis Investigative Site Not yet recruiting
Bucharest, Romania, 050098
Novartis Investigative Site Withdrawn
Oradea, Romania, 410042
Novartis Investigative Site Not yet recruiting
Targu Mures, Romania, 540143
Novartis Investigative Site Not yet recruiting
Targu-Mures, Romania, 540142
Novartis Investigative Site Not yet recruiting
Timisoara, Romania, 300361
Novartis Investigative Site Not yet recruiting
Timisoara, Romania, 300041
Slovakia
Novartis Investigative Site Not yet recruiting
Brezno, Slovak Republic, Slovakia, 977 42
Novartis Investigative Site Not yet recruiting
Komarno, Slovak Republic, Slovakia, 94575
Novartis Investigative Site Not yet recruiting
Levice, Slovak Republic, Slovakia, 93401
Novartis Investigative Site Not yet recruiting
Presov, Slovak Republic, Slovakia, 08001
Novartis Investigative Site Not yet recruiting
Velky Krtis, Slovak Republic, Slovakia, 990 01
Novartis Investigative Site Not yet recruiting
Banska Bystrica, Slovakia, 97401
Novartis Investigative Site Not yet recruiting
Bardejov, Slovakia, 085 01
Novartis Investigative Site Not yet recruiting
Bratislava, Slovakia, 841 04
Novartis Investigative Site Not yet recruiting
Bratislava, Slovakia, 821 07
Novartis Investigative Site Not yet recruiting
Bratislava, Slovakia, 833 48
Novartis Investigative Site Not yet recruiting
Bratislava, Slovakia, 831 01
Novartis Investigative Site Not yet recruiting
Bratislava, Slovakia, 851 01
Novartis Investigative Site Not yet recruiting
Kosice, Slovakia, 040 01
Novartis Investigative Site Not yet recruiting
Levice, Slovakia, 934 01
Novartis Investigative Site Not yet recruiting
Lucenec, Slovakia, 984 01
Novartis Investigative Site Not yet recruiting
Nitra, Slovakia, 949 88
Novartis Investigative Site Not yet recruiting
Nitra, Slovakia, 949 01
Novartis Investigative Site Not yet recruiting
Nove Zamky, Slovakia, 940 01
Novartis Investigative Site Not yet recruiting
Nové Zámky, Slovakia, 940 01
Novartis Investigative Site Not yet recruiting
Presov, Slovakia, 080 01
Novartis Investigative Site Not yet recruiting
Svidnik, Slovakia, 089 01
Novartis Investigative Site Not yet recruiting
Trebisov, Slovakia, 075 01
Novartis Investigative Site Not yet recruiting
Zilina, Slovakia, 012 07
South Africa
Novartis Investigative Site Not yet recruiting
Mthatha, Eastern Cape, South Africa
Novartis Investigative Site Not yet recruiting
Cape Town, Western Cape, South Africa, 7500
Novartis Investigative Site Not yet recruiting
Observatory, Western Cape, South Africa, 7925
Novartis Investigative Site Not yet recruiting
Alberton, South Africa, 1449
Novartis Investigative Site Not yet recruiting
Cape Town, South Africa
Novartis Investigative Site Not yet recruiting
Cape Town, South Africa, 7505
Novartis Investigative Site Not yet recruiting
Durban, South Africa, 4001
Novartis Investigative Site Not yet recruiting
Durban, South Africa, 4052
Novartis Investigative Site Not yet recruiting
Johannesburg, South Africa, 2157
Novartis Investigative Site Not yet recruiting
Johannesburg, South Africa, 2193
Spain
Novartis Investigative Site Not yet recruiting
Almeria, Andalucia, Spain, 04120
Novartis Investigative Site Not yet recruiting
Cordoba, Andalucia, Spain, 14004
Novartis Investigative Site Not yet recruiting
Malaga, Andalucia, Spain, 29010
Novartis Investigative Site Not yet recruiting
Marbella, Andalucia, Spain, 29600
Novartis Investigative Site Not yet recruiting
Sevilla, Andalucia, Spain, 41014
Novartis Investigative Site Not yet recruiting
Sevilla, Andalucia, Spain, 41013
Novartis Investigative Site Not yet recruiting
Sant Joan Despí, Barcelona, Spain, 08970
Novartis Investigative Site Not yet recruiting
Santander, Cantabria, Spain, 39008
Novartis Investigative Site Not yet recruiting
Barcelona, Catalunya, Spain, 08003
Novartis Investigative Site Not yet recruiting
Alzira, Comunidad Valenciana, Spain, 46600
Novartis Investigative Site Not yet recruiting
Valencia, Comunidad Valenciana, Spain, 46014
Novartis Investigative Site Not yet recruiting
Valencia, Comunidad Valenciana, Spain, 46010
Novartis Investigative Site Not yet recruiting
Valencia, Comunidad Valenciana, Spain, 46026
Novartis Investigative Site Not yet recruiting
A Coruña, Galicia, Spain, 15006
Novartis Investigative Site Not yet recruiting
Santiago de Compostela, Galicia, Spain, 15706
Novartis Investigative Site Not yet recruiting
Olot, Girona, Spain, 17800
Novartis Investigative Site Not yet recruiting
Alcala de Henares, Madrid, Spain, 28805
Novartis Investigative Site Not yet recruiting
Ciudad Real, Madrid, Spain, 13005
Novartis Investigative Site Not yet recruiting
El Palmar, Murcia, Spain, 30120
Novartis Investigative Site Not yet recruiting
Pamplona, Navarra, Spain, 31008
Novartis Investigative Site Not yet recruiting
Madrid, Spain, 28046
Novartis Investigative Site Not yet recruiting
Madrid, Spain, 28935
Novartis Investigative Site Not yet recruiting
Madrid, Spain, 28009
Novartis Investigative Site Not yet recruiting
Madrid, Spain, 28034
Novartis Investigative Site Not yet recruiting
Oviedo (Asturias), Spain, 33006
United Kingdom
Novartis Investigative Site Not yet recruiting
Dorchester, Dorset, United Kingdom, DT1 2JY
Novartis Investigative Site Not yet recruiting
Basingstoke, Hampshire, United Kingdom, RG24 9NA
Novartis Investigative Site Not yet recruiting
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Novartis Investigative Site Not yet recruiting
Oldham, Lancashire, United Kingdom, OL1 2JH
Novartis Investigative Site Not yet recruiting
Harrow, Middlesex, United Kingdom, HA1 3UJ
Novartis Investigative Site Not yet recruiting
Taunton, Somerset, United Kingdom, TA1 5DA
Novartis Investigative Site Not yet recruiting
Gateshead, Tyne and Wear, United Kingdom, NE9 6SX
Novartis Investigative Site Not yet recruiting
Cheshire, United Kingdom, CW1 4QJ
Novartis Investigative Site Not yet recruiting
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

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: July 22, 2014
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
Heart Diseases
Cardiovascular Diseases
Valsartan
3-(1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-3'-methyl-2'-(pentanoyl(2'-(tetrazol-5-ylate)biphenyl-4'-ylmethyl)amino)butyrate
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014