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 not yet open for participant recruitment.
Verified November 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01920711
First received: August 8, 2013
Last updated: November 22, 2013
Last verified: November 2013
  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: November 2013
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (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
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
Novartis Investigative Site Not yet recruiting
Birmingham, Alabama, United States, 35209
Novartis Investigative Site Not yet recruiting
Mobile, Alabama, United States, 36608
Novartis Investigative Site Withdrawn
Mobile, Alabama, United States, 36617-2293
Novartis Investigative Site Not yet recruiting
Muscle Shoals, Alabama, United States, 35662
United States, Arizona
Novartis Investigative Site Withdrawn
Gilbert, Arizona, United States, 85297
Novartis Investigative Site Withdrawn
Phoenix, Arizona, United States, 85054
Novartis Investigative Site Not yet recruiting
Tucson, Arizona, United States, 85724
Novartis Investigative Site Withdrawn
Tucson, Arizona, United States, 85723-0001
United States, Arkansas
Novartis Investigative Site Not yet recruiting
Little Rock, Arkansas, United States, 72204
United States, California
Novartis Investigative Site Not yet recruiting
Anaheim, California, United States, 92801
Novartis Investigative Site Not yet recruiting
Beverly Hills, California, United States, 90211
Novartis Investigative Site Not yet recruiting
Carmichael, California, United States, 95608
Novartis Investigative Site Not yet recruiting
Los Angeles, California, United States, 90033
Novartis Investigative Site Withdrawn
Los Angeles, California, United States, 90033
Novartis Investigative Site Not yet recruiting
Los Angeles, California, United States, 90073
Novartis Investigative Site Not yet recruiting
Northridge, California, United States, 91325
Novartis Investigative Site Not yet recruiting
Oceanside, California, United States, 92056
Novartis Investigative Site Not yet recruiting
Palm Springs, California, United States, 92262
Novartis Investigative Site Not yet recruiting
Pomona, California, United States, 91767
Novartis Investigative Site Not yet recruiting
San Diego, California, United States, 92161
Novartis Investigative Site Not yet recruiting
Santa Ana, California, United States, 92704
Novartis Investigative Site Withdrawn
Sylmar, California, United States, 91342
Novartis Investigative Site Withdrawn
Torrance, California, United States, 90502
United States, Colorado
Novartis Investigative Site Withdrawn
Denver, Colorado, United States, 80220
United States, Connecticut
Novartis Investigative Site Withdrawn
Hartford, Connecticut, United States, 06105
United States, Florida
Novartis Investigative Site Not yet recruiting
Davie, Florida, United States, 33324
Novartis Investigative Site Withdrawn
Hollywood, Florida, United States, 33021
Novartis Investigative Site Withdrawn
Jacksonville, Florida, United States, 32209
Novartis Investigative Site Not yet recruiting
Jacksonville, Florida, United States, 32223
Novartis Investigative Site Not yet recruiting
Lady Lake, Florida, United States, 32159
Novartis Investigative Site Not yet recruiting
Miami, Florida, United States, 33126
Novartis Investigative Site Not yet recruiting
Miami, Florida, United States, 33143
Novartis Investigative Site Not yet recruiting
Pembroke Pines, Florida, United States, 33024
Novartis Investigative Site Withdrawn
Rockledge, Florida, United States, 32955
Novartis Investigative Site Withdrawn
South Miami, Florida, United States, 33143
Novartis Investigative Site Not yet recruiting
Tallahassee, Florida, United States, 32308
United States, Georgia
Novartis Investigative Site Not yet recruiting
Atlanta, Georgia, United States, 30322
Novartis Investigative Site Not yet recruiting
Atlanta, Georgia, United States, 30310-1495
Novartis Investigative Site Not yet recruiting
Atlanta, Georgia, United States, 30342
Novartis Investigative Site Not yet recruiting
Covington, Georgia, United States, 30014
Novartis Investigative Site Not yet recruiting
Cumming, Georgia, United States, 30041
Novartis Investigative Site Not yet recruiting
Macon, Georgia, United States, 31201
United States, Illinois
Novartis Investigative Site Not yet recruiting
Chicago, Illinois, United States, 60612
Novartis Investigative Site Not yet recruiting
Chicago, Illinois, United States, 60611
Novartis Investigative Site Not yet recruiting
Lombard, Illinois, United States, 60148
Novartis Investigative Site Not yet recruiting
Maywood, Illinois, United States, 60153
Novartis Investigative Site Not yet recruiting
Melrose Park, Illinois, United States, 60160
Novartis Investigative Site Not yet recruiting
Peoria, Illinois, United States, 61606
Novartis Investigative Site Not yet recruiting
Quincy, Illinois, United States, 62301
United States, Kentucky
Novartis Investigative Site Withdrawn
Louisville, Kentucky, United States, 40207
Novartis Investigative Site Not yet recruiting
Louisville, Kentucky, United States, 40206
United States, Louisiana
Novartis Investigative Site Not yet recruiting
Shreveport, Louisiana, United States, 71101
Novartis Investigative Site Not yet recruiting
Slidell, Louisiana, United States, 70458
United States, Maine
Novartis Investigative Site Not yet recruiting
Biddeford, Maine, United States, 04005
Novartis Investigative Site Not yet recruiting
Westbrook, Maine, United States, 04092
United States, Maryland
Novartis Investigative Site Not yet recruiting
Columbia, Maryland, United States, 21044
United States, Massachusetts
Novartis Investigative Site Not yet recruiting
Boston, Massachusetts, United States
Novartis Investigative Site Not yet recruiting
Boston, Massachusetts, United States, 02118
Novartis Investigative Site Not yet recruiting
Natick, Massachusetts, United States, 01760
United States, Michigan
Novartis Investigative Site Not yet recruiting
Ann Arbor, Michigan, United States, 48109-0356
Novartis Investigative Site Not yet recruiting
Detroit, Michigan, United States, 48202
Novartis Investigative Site Not yet recruiting
Grand Blanc, Michigan, United States, 48439
Novartis Investigative Site Not yet recruiting
Kalamazoo, Michigan, United States, 49048
Novartis Investigative Site Withdrawn
Petoskey, Michigan, United States, 49770
Novartis Investigative Site Not yet recruiting
Saginaw, Michigan, United States, 48601
United States, Minnesota
Novartis Investigative Site Not yet recruiting
Minneapolis, Minnesota, United States, 55417
Novartis Investigative Site Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Novartis Investigative Site Withdrawn
Robbinsdale, Minnesota, United States, 55422
Novartis Investigative Site Not yet recruiting
Rochester, Minnesota, United States, 55905
Novartis Investigative Site Withdrawn
Saint Paul, Minnesota, United States, 55102
Novartis Investigative Site Not yet recruiting
St. Cloud, Minnesota, United States, 56303
United States, Mississippi
Novartis Investigative Site Not yet recruiting
Jackson, Mississippi, United States, 39216
Novartis Investigative Site Not yet recruiting
Picayune, Mississippi, United States, 39466
United States, Missouri
Novartis Investigative Site Not yet recruiting
Saint Louis, Missouri, United States, 63136
Novartis Investigative Site Withdrawn
St. Louis, Missouri, United States, 63110
Novartis Investigative Site Withdrawn
Washington, Missouri, United States, 63090
United States, Montana
Novartis Investigative Site Not yet recruiting
Kalispell, Montana, United States, 59901
United States, Nebraska
Novartis Investigative Site Not yet recruiting
Grand Island, Nebraska, United States, 68803
Novartis Investigative Site Not yet recruiting
Lincoln, Nebraska, United States, 68506
Novartis Investigative Site Withdrawn
Omaha, Nebraska, United States, 68198
Novartis Investigative Site Not yet recruiting
Omaha, Nebraska, United States, 68131
United States, New Jersey
Novartis Investigative Site Not yet recruiting
Elmer, New Jersey, United States, 08318
United States, New Mexico
Novartis Investigative Site Not yet recruiting
Albuquerque, New Mexico, United States, 87102
United States, New York
Novartis Investigative Site Not yet recruiting
Bronx, New York, United States, 10467
Novartis Investigative Site Not yet recruiting
Brooklyn, New York, United States, 11215
Novartis Investigative Site Not yet recruiting
New York, New York, United States, 10032
Novartis Investigative Site Not yet recruiting
Northport, New York, United States, 11768
Novartis Investigative Site Not yet recruiting
Saratoga Springs, New York, United States, 12866
Novartis Investigative Site Not yet recruiting
Syracuse, New York, United States, 13202
United States, North Carolina
Novartis Investigative Site Withdrawn
Asheville, North Carolina, United States, 28803
Novartis Investigative Site Not yet recruiting
Chapel Hill, North Carolina, United States, 27599-7075
Novartis Investigative Site Withdrawn
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Novartis Investigative Site Not yet recruiting
Fargo, North Dakota, United States, 58103
United States, Ohio
Novartis Investigative Site Not yet recruiting
Cincinnati, Ohio, United States, 45219
Novartis Investigative Site Not yet recruiting
Marion, Ohio, United States, 43302
United States, Oklahoma
Novartis Investigative Site Not yet recruiting
Oklahoma City, Oklahoma, United States, 73120
Novartis Investigative Site Not yet recruiting
Tulsa, Oklahoma, United States, 74133
United States, Oregon
Novartis Investigative Site Not yet recruiting
Hillsboro, Oregon, United States, 97123
Novartis Investigative Site Not yet recruiting
Portland, Oregon, United States, 97225
United States, Pennsylvania
Novartis Investigative Site Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Novartis Investigative Site Not yet recruiting
Philadelphia, Pennsylvania, United States, 19102-1192
Novartis Investigative Site Not yet recruiting
Yardley, Pennsylvania, United States, 19067
United States, Rhode Island
Novartis Investigative Site Not yet recruiting
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Novartis Investigative Site Not yet recruiting
Charleston, South Carolina, United States, 29403
United States, South Dakota
Novartis Investigative Site Not yet recruiting
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Novartis Investigative Site Not yet recruiting
Memphis, Tennessee, United States, 38104
Novartis Investigative Site Withdrawn
Oak Ridge, Tennessee, United States, 37830
United States, Texas
Novartis Investigative Site Not yet recruiting
Beaumont, Texas, United States, 77702
Novartis Investigative Site Not yet recruiting
Dallas, Texas, United States, 75216
Novartis Investigative Site Not yet recruiting
Dallas, Texas, United States, 75235
Novartis Investigative Site Not yet recruiting
Dallas, Texas, United States, 75231
Novartis Investigative Site Withdrawn
Houston, Texas, United States, 77030
Novartis Investigative Site Not yet recruiting
Houston, Texas, United States, 77070
Novartis Investigative Site Not yet recruiting
Houston, Texas, United States, 77094
Novartis Investigative Site Not yet recruiting
Houston, Texas, United States, 77064
Novartis Investigative Site Not yet recruiting
Houston, Texas, United States, 77030
Novartis Investigative Site Not yet recruiting
Livingston, Texas, United States, 77351
Novartis Investigative Site Not yet recruiting
Marshall, Texas, United States, 75670
Novartis Investigative Site Not yet recruiting
McKinney, Texas, United States, 75069
Novartis Investigative Site Not yet recruiting
Tomball, Texas, United States, 77375
United States, Utah
Novartis Investigative Site Not yet recruiting
Salt Lake City, Utah, United States, 84124
Novartis Investigative Site Not yet recruiting
Salt Lake City, Utah, United States, 84132
United States, Virginia
Novartis Investigative Site Not yet recruiting
Chesapeake, Virginia, United States, 23320
Novartis Investigative Site Not yet recruiting
Manassas, Virginia, United States, 20110
United States, Washington
Novartis Investigative Site Withdrawn
Kirkland, Washington, United States, 98034
Novartis Investigative Site Withdrawn
Seattle, Washington, United States, 98103
United States, Wisconsin
Novartis Investigative Site Not yet recruiting
Madison, Wisconsin, United States, 53705
Novartis Investigative Site Withdrawn
Madison, Wisconsin, United States, 53792-1615
Novartis Investigative Site Not yet recruiting
Milwaukee, Wisconsin, United States, 53295
Novartis Investigative Site Not yet recruiting
Milwaukee, Wisconsin, United States, 53215
Austria
Novartis Investigative Site Not yet recruiting
Graz, Austria, A-8036
Novartis Investigative Site Not yet recruiting
Großgmain, Austria, 5084
Novartis Investigative Site Not yet recruiting
Innsbruck, Austria, 6020
Novartis Investigative Site Not yet recruiting
Linz, Austria, A-4010
Novartis Investigative Site Not yet recruiting
Linz, Austria, A-4020
Novartis Investigative Site Not yet recruiting
Salzburg, Austria, A-5020
Novartis Investigative Site Not yet recruiting
Wien, Austria, A-1090
Bulgaria
Novartis Investigative Site Not yet recruiting
Burgas, Bulgaria, 8000
Novartis Investigative Site Not yet recruiting
Pazardzhik, Bulgaria, 4400
Novartis Investigative Site Not yet recruiting
Pleven, Bulgaria, 5800
Novartis Investigative Site Not yet recruiting
Russe, Bulgaria, 7002
Novartis Investigative Site Not yet recruiting
Sliven, Bulgaria, 8800
Novartis Investigative Site Not yet recruiting
Sofia, Bulgaria, 1407
Novartis Investigative Site Not yet recruiting
Sofia, Bulgaria, 1309
Novartis Investigative Site Not yet recruiting
Sofia, Bulgaria, 1606
Novartis Investigative Site Not yet recruiting
Sofia, Bulgaria, 1233
Novartis Investigative Site Not yet recruiting
Varna, Bulgaria, 9010
Canada, Alberta
Novartis Investigative Site Not yet recruiting
Calgary, Alberta, Canada, T2N 4Z6
Novartis Investigative Site Not yet recruiting
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Novartis Investigative Site Not yet recruiting
Victoria, British Columbia, Canada, V8R4R2
Canada, New Brunswick
Novartis Investigative Site Not yet recruiting
Moncton, New Brunswick, Canada, E1G 1A7
Canada, Nova Scotia
Novartis Investigative Site Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Novartis Investigative Site Not yet recruiting
Cambridge, Ontario, Canada, N1R 6V6
Novartis Investigative Site Not yet recruiting
Hamilton, Ontario, Canada, L8L 2X2
Novartis Investigative Site Not yet recruiting
Kitchener, Ontario, Canada, N2M 5N4
Canada, Quebec
Novartis Investigative Site Not yet recruiting
Fleurimont, Quebec, Canada, J1H 5N4
Novartis Investigative Site Not yet recruiting
Montreal, Quebec, Canada, H1T 1C8
Novartis Investigative Site Not yet recruiting
Montreal, Quebec, Canada, H3G 1A4
Novartis Investigative Site Not yet recruiting
Montreal, Quebec, Canada, H2X 3J4
Novartis Investigative Site Not yet recruiting
Montreal, Quebec, Canada, H2W 1T8
Novartis Investigative Site Not yet recruiting
Sainte-Foy, Quebec, Canada, G1V 4G5
Novartis Investigative Site Not yet recruiting
Thetford Mines, Quebec, Canada, G6G 2V4
Novartis Investigative Site Not yet recruiting
Trois-Rivières, Quebec, Canada, G8Z 3R9
Germany
Novartis Investigative Site Withdrawn
Berlin, Germany, 14050
Novartis Investigative Site Withdrawn
Berlin-Buch, Germany, 13125
Novartis Investigative Site Withdrawn
Dessau-Roßlau, Germany, 06846
Novartis Investigative Site Withdrawn
Dortmund, Germany, 44137
Novartis Investigative Site Withdrawn
Dresden, Germany, 01309
Novartis Investigative Site Withdrawn
Duisburg, Germany, 47137
Novartis Investigative Site Withdrawn
Essen, Germany, 45355
Novartis Investigative Site Withdrawn
Essen, Germany, 45138
Novartis Investigative Site Withdrawn
Frankfurt, Germany, 65929
Novartis Investigative Site Withdrawn
Frankfurt, Germany, 60594
Novartis Investigative Site Withdrawn
Goettingen, Germany, 37075
Novartis Investigative Site Withdrawn
Koethen, Germany, 06366
Novartis Investigative Site Withdrawn
Köln, Germany, 51605
Novartis Investigative Site Withdrawn
Loehne, Germany, 32584
Novartis Investigative Site Withdrawn
Lüneburg, Germany, 21339
Novartis Investigative Site Withdrawn
Münster, Germany, 48149
Novartis Investigative Site Withdrawn
Reinfeld, Germany, 23858
Novartis Investigative Site Withdrawn
Weyhe, Germany, 28844
Hungary
Novartis Investigative Site Not yet recruiting
Budapest, Hungary, 1042
Novartis Investigative Site Not yet recruiting
Budapest, Hungary, H-1096
Novartis Investigative Site Not yet recruiting
Budapest, Hungary, 1145
Novartis Investigative Site Not yet recruiting
Budapest, Hungary, 1085
Novartis Investigative Site Not yet recruiting
Cegled, Hungary, 2700
Novartis Investigative Site Not yet recruiting
Gyula, Hungary, 5703
Novartis Investigative Site Not yet recruiting
Nyiregyháza, Hungary, 4400
Novartis Investigative Site Not yet recruiting
Pecs, Hungary, 7624
Novartis Investigative Site Not yet recruiting
Sopron, Hungary, 9400
Novartis Investigative Site Not yet recruiting
Szeged, Hungary, H-6720
Novartis Investigative Site Not yet recruiting
Szekesfehervar, Hungary, 8000
Novartis Investigative Site Not yet recruiting
Zalaegerszeg, Hungary, 8900
Italy
Novartis Investigative Site Withdrawn
Ancona, AN, Italy, 60128
Novartis Investigative Site Withdrawn
Cortona, AR, Italy, 52044
Novartis Investigative Site Withdrawn
Bergamo, BG, Italy, 24128
Novartis Investigative Site Withdrawn
Bologna, BO, Italy, 40138
Novartis Investigative Site Withdrawn
Catanzaro, CZ, Italy, 88100
Novartis Investigative Site Withdrawn
Cona, FE, Italy, 44100
Novartis Investigative Site Withdrawn
Genova, GE, Italy, 16128
Novartis Investigative Site Withdrawn
Pozzilli, IS, Italy, 86077
Novartis Investigative Site Withdrawn
Monza, MB, Italy, 20900
Novartis Investigative Site Withdrawn
Milano, MI, Italy, 20132
Novartis Investigative Site Withdrawn
Milano, MI, Italy, 20162
Novartis Investigative Site Withdrawn
Piacenza, PC, Italy, 29100
Novartis Investigative Site Withdrawn
Perugia, PG, Italy, 06100
Novartis Investigative Site Withdrawn
Casorate Primo, PV, Italy, 27022
Novartis Investigative Site Withdrawn
Scandiano, RE, Italy, 42019
Novartis Investigative Site Withdrawn
Albano Laziale, RM, Italy, 00041
Novartis Investigative Site Withdrawn
Roma, RM, Italy, 00189
Novartis Investigative Site Withdrawn
Roma, RM, Italy, 00161
Novartis Investigative Site Withdrawn
Roma, RM, Italy, 00163
Novartis Investigative Site Withdrawn
Sassari, SS, Italy, 07100
Novartis Investigative Site Withdrawn
Torino, TO, Italy, 10126
Novartis Investigative Site Withdrawn
Trieste, TS, Italy, 34142
Novartis Investigative Site Withdrawn
Vittorio Veneto, TV, Italy, 31029
Novartis Investigative Site Withdrawn
San Daniele Del Friuli, UD, Italy, 33038
Novartis Investigative Site Withdrawn
Vicenza, VI, Italy, 36100
Novartis Investigative Site Withdrawn
Verona, VR, Italy, 37134
Novartis Investigative Site Withdrawn
Napoli, Italy, 80131
Novartis Investigative Site Withdrawn
Novara, Italy, 28100
Mexico
Novartis Investigative Site Withdrawn
San Luis Potosi, Mexico, 78200
Novartis Investigative Site Withdrawn
San Luis Potosí, Mexico, 78240
Philippines
Novartis Investigative Site Not yet recruiting
Bulacan, Philippines, 3020
Novartis Investigative Site Not yet recruiting
Quezon City, Philippines, 1100
Novartis Investigative Site Not yet recruiting
Quezon City, Philippines, 1102
Portugal
Novartis Investigative Site Not yet recruiting
Carnaxide, Lisboa, Portugal, 2790-134
Novartis Investigative Site Not yet recruiting
Lisboa, Portugal, 1169-024
Novartis Investigative Site Not yet recruiting
Lisboa, Portugal, 1500-650
Novartis Investigative Site Not yet recruiting
Lisbon, Portugal, 1449-005
Novartis Investigative Site Not yet recruiting
Porto, Portugal, 4200-319
Novartis Investigative Site Not yet recruiting
Porto, Portugal, 4099-001
Novartis Investigative Site Not yet recruiting
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
Tg-Mures, jud Mures, Romania
Novartis Investigative Site Not yet recruiting
Craiova, Jud. Dolj, Romania, 200147
Novartis Investigative Site Not yet recruiting
Iasi, Jud. Iasi, Romania, 700005
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
Oradea, Romania, 410042
Novartis Investigative Site Not yet recruiting
Timisoara, Romania, 300079
Novartis Investigative Site Not yet recruiting
Timisoara, Romania, 300041
Slovakia
Novartis Investigative Site Not yet recruiting
Bratislava, Slovakia, 833 48
Novartis Investigative Site Not yet recruiting
Bratislava, Slovakia, 821 07
Novartis Investigative Site Not yet recruiting
Kosice, Slovakia, 040 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
Presov, Slovakia, 080 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, 7505
Novartis Investigative Site Not yet recruiting
Cape Town, South Africa
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
Cordoba, Andalucia, Spain, 14004
Novartis Investigative Site Not yet recruiting
Sevilla, Andalucia, Spain, 41013
Novartis Investigative Site Not yet recruiting
Sevilla, Andalucia, Spain, 41014
Novartis Investigative Site Not yet recruiting
Sant Joan Despí, Barcelona, Spain, 08970
Novartis Investigative Site Not yet recruiting
Barcelona, Cataluña, Spain, 08003
Novartis Investigative Site Not yet recruiting
Alzira, Comunidad Valenciana, Spain, 46600
Novartis Investigative Site Not yet recruiting
Valencia, Comunidad Valenciana, Spain, 46026
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
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
El Palmar, Murcia, Spain, 30120
Novartis Investigative Site Not yet recruiting
Pamplona, Navarra, Spain, 31008
Novartis Investigative Site Not yet recruiting
Madrid, Spain, 28034
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, 28046
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: November 22, 2013
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
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014