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Multiple Patient Program to Ensure Access to LCZ696 Treatment to Patients Diagnosed With Heart Failure With Reduced Ejection Fraction (HF-rEF)

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
No longer available
CT.gov ID
NCT02389933
Collaborator
(none)
289
Locations

Study Details

Study Description

Brief Summary

Novartis has set up this global Multiple Patient Program (MPP) treatment plan to provide access to life-saving treatment with LCZ696 for patients that were not previously exposed to LCZ696 but have no other option to receive LCZ696 in their country prior to market authorization OR commercial availability, based on local regulatory and legal requirements.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Expanded Access
Official Title:
Multiple Patient Program to Ensure Access to LCZ696 Treatment to Patients Diagnosed With Heart Failure With Reduced Ejection Fraction (HF-rEF)

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion criteria

    The patient(s) for whom the MPP is sought meets all of the following:

    • Is suffering from a serious or life-threatening disease or condition

    • Does not have access to a comparable or satisfactory alternative treatment (i.e., comparable or satisfactory treatment is not available or does not exist)

    • Patient should be on optimized standard of care treatment, including treatment with ARBs or ACEI, beta-blockers and MRA;

    • Intolerance to evidence-based target doses should be documented by the treating physician

    • Meets any other relevant medical criteria for compassionate use of the investigational product

    Patients eligible for inclusion in this program have to fulfill all of the following criteria:

    1. Adult patients (but not younger than 18 year old) will be included, upon completion of written informed consent before any assessment is performed.

    2. Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction:

    • LVEF ≤ 35% at the time of screening for participation in the program (any local measurement, made within the past 6 months using echocardiography, MUGA, CT scanning, MRI or ventricular angiography is acceptable, provided there are no subsequent measurement above 35%)

    1. Patient had a hospitalization for HF within the last 12 months

    2. Patients must be on an ACEI or an ARB at a stable dose for at least 4 weeks prior to starting treatment with LCZ696

    3. Patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to starting treatment with LCZ696 (reason should be documented for patients not on CHF target doses per local guidelines, or in absence of that medication).

    4. An aldosterone antagonist should also be considered in all patients, taking account of renal function, serum potassium and tolerability. If given, the dose of aldosterone antagonist should be optimized according to guideline recommendations and patient tolerability, and should be stable for at least 4 weeks prior to starting treatment with LCZ696

    Exclusion criteria

    Patients fulfilling any of the following criteria are not eligible for inclusion in this program:

    1. The patient is eligible for participation in any of the IMP's ongoing clinical trials

    2. The patient has recently completed a clinical trial that has been terminated and other options (e.g., trial extensions, amendments, etc.) are available to continue a similar treatment.

    3. The patient is being transferred from an ongoing clinical trial for which the patient is still eligible for participation

    4. History of hypersensitivity or allergy to LCZ696 or to any of its metabolites; to drugs of similar chemical classes, ARBs, or NEP inhibitors; as well as known or suspected contraindications to LCZ696

    5. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer

    6. Previous history of intolerance to recommended target doses of ARBs

    7. Known history of angioedema

    8. Requirement of concomitant treatment with both ACEIs and ARBs

    9. Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)

    10. Symptomatic hypotension and/or a SBP less than 100 mm Hg over the last 4 weeks prior to starting treatment with LCZ696

    11. Estimated GFR below 30 mL/min/1.73m2 as measured by the simplified MDRD formula

    12. Presence of bilateral renal artery stenosis

    13. Serum potassium above 5.2 mmol/L during the week prior to starting treatment with LCZ696

    14. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within the 3 months prior to starting treatment with LCZ696

    15. Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after the schedule date to start treatment with LCZ696

    16. Implantation of a cardiac resynchronization therapy pacemaker (CRT-P) or a cardiac resynchronization therapy defibrillator (CRT-D) or upgrading of an existing conventional pacemaker or an implantable cardioverter defibrillator (ICD) to CRT device within 3 months prior to starting treatment with LCZ696, or intent to implant such a device.

    Also, patients who had implantation of a conventional pacemaker or an ICD or had a revision of a pacemaker or other device leads within 1 month before starting treatment with LCZ696 are excluded.

    1. Heart transplant or ventricular assistance device (VAD) or intent to transplant (on transplant list) or implant a VAD

    2. History of severe pulmonary disease

    3. Diagnosis of peripartum or chemotherapy induced cardiomyopathy within the 12 months prior to starting treatment with LCZ696

    4. Documented untreated ventricular arrhythmia with syncopal episodes within the 3 months prior to starting treatment with LCZ696

    5. Symptomatic bradycardia or second or third degree heart block without a pacemaker

    6. Presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation

    7. Presence of other hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis

    8. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs, including but not limited to any of the following:

    • History of active inflammatory bowel disease during the 12 months before starting treatment with LCZ696.

    • Current duodenal or gastric ulcers during the 3 months prior to starting treatment with LCZ696

    • Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 2 x ULN prior to starting treatment with LCZ696, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt

    • Active treatment with cholestyramine or colestipol resins

    1. Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 3 x ULN prior to starting treatment with LCZ696, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt

    2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (above 5 mIU/mL)

    3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method (if accepted by the local regulatory authority and ethics committee) or a barrier method plus a hormonal method

    • Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progesterone agent.

    • Reliable contraception should be maintained throughout the treatment and for 7 days after LCZ696 treatment discontinuation

    • Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea, or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.

    1. Presence of any other disease with a life expectancy of < 3 years

    2. Any condition, not identified in the protocol that in the opinion of the treating physician is likely to prevent the patient from safely tolerating LCZ696 or complying with the requirements of the therapy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Vero Beach Florida United States 32960
    2 Novartis Investigative Site Darlinghurst New South Wales Australia 2010
    3 Novartis Investigative Site North Ryde New South Wales Australia 2109
    4 Novartis Investigative Site Perth Western Australia Australia 6000
    5 Novartis Investigative Site Krems Austria A-3500
    6 Novartis Investigative Site Salzburg Austria
    7 Novartis Investigative Site St. Poelten Austria 3100
    8 Novartis Investigative Site Vienna Austria 1130
    9 Novartis Investigative Site Wien Austria A-1090
    10 Novartis Investigative Site Salvador BA Brazil 41180-780
    11 Novartis Investigative Site Fortaleza CE Brazil 60864-190
    12 Novartis Investigative Site Belo Horizonte MG Brazil 30170-040
    13 Novartis Investigative Site Porto Alegre Rio Grande Do Sul Brazil 90610-000
    14 Novartis Investigative Site Porto Alegre RS Brazil 90620 001
    15 Novartis Investigative Site Varazdin HRV Croatia 42000
    16 Novartis Investigative Site Limassol Cyprus 3021
    17 Novartis Investigative Site Nicosia Cyprus 1086
    18 Novartis Investigative Site Nicosia Cyprus 2024
    19 Novartis Investigative Site Nicosia Cyprus 2029
    20 Novartis Investigative Site Nicosia Cyprus 2042
    21 Novartis Investigative Site Nicosia Cyprus 2047
    22 Novartis Investigative Site Marseille cedex 20 Bouches Du Rhone France 13915
    23 Novartis Investigative Site Bron Cedex France 69677
    24 Novartis Investigative Site Caen Cedex France 14033
    25 Novartis Investigative Site Saint Denis France / La Reunion France 97405
    26 Novartis Investigative Site Amiens cedex 1 France 80054
    27 Novartis Investigative Site Amilly France 45200
    28 Novartis Investigative Site Angers Cedex 9 France 49933
    29 Novartis Investigative Site Antibes France 06600
    30 Novartis Investigative Site Aressy France 64320
    31 Novartis Investigative Site Avignon Cedex 2 France 84082
    32 Novartis Investigative Site Avignon France 84000
    33 Novartis Investigative Site Bayeux France 14401
    34 Novartis Investigative Site Beziers Cedex France 34525
    35 Novartis Investigative Site Bobigny France 93009
    36 Novartis Investigative Site Brest Armees France 29240
    37 Novartis Investigative Site Brest France 29609
    38 Novartis Investigative Site Bron Cedex France 69677
    39 Novartis Investigative Site Bron France 69677
    40 Novartis Investigative Site Caen Cedex France 14033
    41 Novartis Investigative Site Caen France 14000
    42 Novartis Investigative Site Cambrai Cedex France 59507
    43 Novartis Investigative Site Cannes Cedex France 06414
    44 Novartis Investigative Site Chambéry cedex France 73011
    45 Novartis Investigative Site Chaumont Cedex France 52014
    46 Novartis Investigative Site Cherbourg Octeville France 50102
    47 Novartis Investigative Site Clamart France 92140
    48 Novartis Investigative Site Clermont-Ferrand cedex 1 France 63003
    49 Novartis Investigative Site Compiègne cedex France 60321
    50 Novartis Investigative Site Contamine Sur Arve France 74130
    51 Novartis Investigative Site Corbeil Essonnes France 91100
    52 Novartis Investigative Site Cornebarrieu France 31700
    53 Novartis Investigative Site Dijon France 21000
    54 Novartis Investigative Site Eaubonne France 95600
    55 Novartis Investigative Site Honfleur Cedex France 14601
    56 Novartis Investigative Site Hyeres France 83418
    57 Novartis Investigative Site La Roche sur Yon Cedex France 85295
    58 Novartis Investigative Site La Seyne sur mer France 83500
    59 Novartis Investigative Site La Tronche France 38700
    60 Novartis Investigative Site Lille Cedex France 59003
    61 Novartis Investigative Site Lille Cedex France 59037
    62 Novartis Investigative Site Limoges France
    63 Novartis Investigative Site Lyon CEDEX 04 France 69317
    64 Novartis Investigative Site Lyon France 69394
    65 Novartis Investigative Site Lyon France F-69001
    66 Novartis Investigative Site Marseille Cedex 05 France 13385
    67 Novartis Investigative Site Marseille Cedex 20 France 13915
    68 Novartis Investigative Site Marseille France 13008
    69 Novartis Investigative Site Marseille France 13385
    70 Novartis Investigative Site Metz Cedex France F-57038
    71 Novartis Investigative Site Metz-Tessy France 74370
    72 Novartis Investigative Site Monaco France 98000
    73 Novartis Investigative Site Montbeliard Cedex France 25209
    74 Novartis Investigative Site Montpellier Cedex France 34960
    75 Novartis Investigative Site Montpellier France 34295
    76 Novartis Investigative Site Morlaix Cedex France 29672
    77 Novartis Investigative Site Moulins Cedex France 03006
    78 Novartis Investigative Site Mulhouse Cedex France 68051
    79 Novartis Investigative Site Mâcon Cedex France 71018
    80 Novartis Investigative Site Nantes Cedex 1 France 44093
    81 Novartis Investigative Site Neuilly-sur-seine France 92200
    82 Novartis Investigative Site Nice Cedex 1 France 06003
    83 Novartis Investigative Site Nice Cedex 2 France 06105
    84 Novartis Investigative Site Nimes France 30029
    85 Novartis Investigative Site Paris Cedex 10 France 75475
    86 Novartis Investigative Site Paris Cedex 13 France 75651
    87 Novartis Investigative Site Paris Cedex 14 France 75679
    88 Novartis Investigative Site Pau Cedex France 64046
    89 Novartis Investigative Site Perpignan France 66000
    90 Novartis Investigative Site Pessac Cedex France 33604
    91 Novartis Investigative Site Poitiers France 86021
    92 Novartis Investigative Site Pont L'Abbe France 29123
    93 Novartis Investigative Site Pontarlier Cedex France 25304
    94 Novartis Investigative Site Pontoise France F-95300
    95 Novartis Investigative Site Rennes Cedex 9 France 35033
    96 Novartis Investigative Site Rouen Cedex France 76031
    97 Novartis Investigative Site Rumilly France 74150
    98 Novartis Investigative Site Saint Denis France 97400
    99 Novartis Investigative Site Saint Denis France 97490
    100 Novartis Investigative Site Saint Etienne Cedex 2 France 42055
    101 Novartis Investigative Site Saint Palais France 64120
    102 Novartis Investigative Site Saint-Germain-en-Laye France 78105
    103 Novartis Investigative Site St Jean France 31240
    104 Novartis Investigative Site St. Etienne France 42100
    105 Novartis Investigative Site Strasbourg France 67091
    106 Novartis Investigative Site Thonon Les Bains Cedex France 74203
    107 Novartis Investigative Site Toulouse Cedex France 31059
    108 Novartis Investigative Site Toulouse France 31054
    109 Novartis Investigative Site Tours France 37044
    110 Novartis Investigative Site Valence Cedex 9 France 26953
    111 Novartis Investigative Site Valenciennes Cedex France 59322
    112 Novartis Investigative Site Vandoeuvre Les Nancy France 54511
    113 Novartis Investigative Site Vichy France 03201
    114 Novartis Investigative Site Villefranche sur Saone France 69655
    115 Novartis Investigative Site Wattrelos France 59393
    116 Novartis Investigative Site Suderholz OT Bartmannshagen Germany 18516
    117 Novartis Investigative Site Ahlen Germany 59227
    118 Novartis Investigative Site Augsburg Germany 86199
    119 Novartis Investigative Site Bad Endbach Germany 35080
    120 Novartis Investigative Site Bad Homburg Germany 61348
    121 Novartis Investigative Site Bad Kreuznach Germany 55543
    122 Novartis Investigative Site Bad Krozingen Germany 79189
    123 Novartis Investigative Site Bad Oeynhausen Germany 32545
    124 Novartis Investigative Site Berlin Germany 10789
    125 Novartis Investigative Site Berlin Germany 13353
    126 Novartis Investigative Site Bielefeld Germany 33602
    127 Novartis Investigative Site Bielefeld Germany 33604
    128 Novartis Investigative Site Bonn Germany 53115
    129 Novartis Investigative Site Chemnitz Germany 09117
    130 Novartis Investigative Site Chemnitz Germany 09126
    131 Novartis Investigative Site Chemnitz Germany 09130
    132 Novartis Investigative Site Cologne Germany 51105
    133 Novartis Investigative Site Dessau-Rosslau Germany 06847
    134 Novartis Investigative Site Diepholz Germany 49356
    135 Novartis Investigative Site Dinslaken Germany 46535
    136 Novartis Investigative Site Dortmund Germany 44309
    137 Novartis Investigative Site Dresden Germany 01067
    138 Novartis Investigative Site Dresden Germany 01277
    139 Novartis Investigative Site Dresden Germany 01307
    140 Novartis Investigative Site Dusseldorf Germany 40477
    141 Novartis Investigative Site Eilenburg Germany D 04838
    142 Novartis Investigative Site Eschwege Germany 37269
    143 Novartis Investigative Site Essen Germany 45355
    144 Novartis Investigative Site Frankfurt Germany 60322
    145 Novartis Investigative Site Frankfurt Germany 60431
    146 Novartis Investigative Site Frankfurt Germany 60439
    147 Novartis Investigative Site Frankfurt Germany 60590
    148 Novartis Investigative Site Friedrichroda Germany 99894
    149 Novartis Investigative Site Goettingen Germany 37075
    150 Novartis Investigative Site Gronau Germany 31028
    151 Novartis Investigative Site Guenzburg Germany 89312
    152 Novartis Investigative Site Hamburg Germany 22457
    153 Novartis Investigative Site Hannover Germany 30159
    154 Novartis Investigative Site Hannover Germany 30559
    155 Novartis Investigative Site Hassfurt Germany 97437
    156 Novartis Investigative Site Hassloch Germany 67454
    157 Novartis Investigative Site Hohenstein-Ernstthal Germany 09337
    158 Novartis Investigative Site Jena Germany 07740
    159 Novartis Investigative Site Karlsruhe Germany 76135
    160 Novartis Investigative Site Kassel Germany 34121
    161 Novartis Investigative Site Koeln Germany 50937
    162 Novartis Investigative Site Koeln Germany 51605
    163 Novartis Investigative Site Köthen Germany 06366
    164 Novartis Investigative Site Lauchringen Germany 79787
    165 Novartis Investigative Site Leipzig Germany 04103
    166 Novartis Investigative Site Ludwigshafen Germany 67063
    167 Novartis Investigative Site Magdeburg Germany 39114
    168 Novartis Investigative Site Magdeburg Germany 39120
    169 Novartis Investigative Site Mainz Germany 55131
    170 Novartis Investigative Site Mannheim Germany 68167
    171 Novartis Investigative Site Marl Germany 45768
    172 Novartis Investigative Site Muenchen Germany 80636
    173 Novartis Investigative Site Munchen Germany 80336
    174 Novartis Investigative Site Munster Germany 48153
    175 Novartis Investigative Site Oldenburg Germany 26133
    176 Novartis Investigative Site Pressath Germany 92690
    177 Novartis Investigative Site Rostock Germany 18107
    178 Novartis Investigative Site Ulm Germany 89081
    179 Novartis Investigative Site Weinheim Germany 69469
    180 Novartis Investigative Site Wildeshausen Germany 27793
    181 Novartis Investigative Site Wolfratshausen Germany 82515
    182 Novartis Investigative Site Wuerzburg Germany 97080
    183 Novartis Investigative Site Alexandroupolis Evros Greece 681 00
    184 Novartis Investigative Site Athens GR Greece 115 21
    185 Novartis Investigative Site Athens GR Greece 115 25
    186 Novartis Investigative Site Athens GR Greece 115 27
    187 Novartis Investigative Site Athens GR Greece 14233
    188 Novartis Investigative Site Ioannina GR Greece 451 10
    189 Novartis Investigative Site Larissa GR Greece 411 10
    190 Novartis Investigative Site Thessaloniki GR Greece 546 36
    191 Novartis Investigative Site Thessaloniki GR Greece 56429
    192 Novartis Investigative Site Thessaloniki GR Greece 570 10
    193 Novartis Investigative Site Tripoli GR Greece 221 00
    194 Novartis Investigative Site Voula GR Greece 166 73
    195 Novartis Investigative Site Athens Greece 106 76
    196 Novartis Investigative Site Athens Greece 115 21
    197 Novartis Investigative Site Athens Greece 115 26
    198 Novartis Investigative Site Athens Greece 115 27
    199 Novartis Investigative Site Athens Greece 115 28
    200 Novartis Investigative Site Athens Greece 11521
    201 Novartis Investigative Site Athens Greece 11526
    202 Novartis Investigative Site Athens Greece 11527
    203 Novartis Investigative Site Athens Greece 145 61
    204 Novartis Investigative Site Athens Greece 15127
    205 Novartis Investigative Site Athens Greece 15562
    206 Novartis Investigative Site Athens Greece 176 74
    207 Novartis Investigative Site Athens Greece GR14564
    208 Novartis Investigative Site Chaidari Greece 12461
    209 Novartis Investigative Site Chios Greece 821 00
    210 Novartis Investigative Site Edessa Greece 58200
    211 Novartis Investigative Site Elefsina Greece 19600
    212 Novartis Investigative Site Glyfada Greece 16675
    213 Novartis Investigative Site Heraklion - Crete Greece 711 10
    214 Novartis Investigative Site Heraklion Greece 714 09
    215 Novartis Investigative Site Ioannina Greece 45001
    216 Novartis Investigative Site Kalamata Greece 241 00
    217 Novartis Investigative Site Karditsa Greece 43100
    218 Novartis Investigative Site Katerini Greece 601 00
    219 Novartis Investigative Site Kavala Greece 65 500
    220 Novartis Investigative Site Kerkyra Greece 49100
    221 Novartis Investigative Site Kilkis Greece 611 00
    222 Novartis Investigative Site Kozani Greece 50100
    223 Novartis Investigative Site Maroussi Greece 15125
    224 Novartis Investigative Site Piraeus Greece 18454
    225 Novartis Investigative Site Piraeus Greece 185 36
    226 Novartis Investigative Site Rio Patra Greece 26504
    227 Novartis Investigative Site Thesaloniki Greece 55134
    228 Novartis Investigative Site Thessaloniki Greece 54636
    229 Novartis Investigative Site Thessaloniki Greece 54642
    230 Novartis Investigative Site Thessaloniki Greece 552 36
    231 Novartis Investigative Site Volos Greece GR 38222
    232 Novartis Investigative Site Co Dublin Ireland
    233 Novartis Investigative Site Dublin Ireland 9
    234 Novartis Investigative Site Ashrafieh Lebanon 166830
    235 Novartis Investigative Site Beirut Lebanon 11-2555
    236 Novartis Investigative Site Beirut Lebanon 1107 2020
    237 Novartis Investigative Site Beirut Lebanon 166378
    238 Novartis Investigative Site Beirut Lebanon 5544
    239 Novartis Investigative Site Beirut Lebanon 6301
    240 Novartis Investigative Site Beirut Lebanon
    241 Novartis Investigative Site Saida Lebanon 652
    242 Novartis Investigative Site Tripoli Lebanon
    243 Novartis Investigative Site Msida Malta MSD 2090
    244 Novartis Investigative Site Panama City Panama
    245 Novartis Investigative Site Panama Panama
    246 Novartis Investigative Site Manila Metro Manila Philippines 1000
    247 Novartis Investigative Site Makati City Philippines 1229
    248 Novartis Investigative Site Manila Philippines 1000
    249 Novartis Investigative Site Ljubljana Slovenia 1000
    250 Novartis Investigative Site Cordoba Andalucia Spain 14004
    251 Novartis Investigative Site Garanada Andalucia Spain 18004
    252 Novartis Investigative Site Jerez de la Frontera Andalucia Spain 11407
    253 Novartis Investigative Site Sevilla Andalucia Spain 41014
    254 Novartis Investigative Site Utrera Andalucia Spain 41710
    255 Novartis Investigative Site Hospitalet de Llobregat Barcelona Spain 08907
    256 Novartis Investigative Site Villamartin Cadiz Spain 11650
    257 Novartis Investigative Site Santander Cantabria Spain 39008
    258 Novartis Investigative Site Torrelavega Cantabria Spain 39300
    259 Novartis Investigative Site Lleida Cataluna Spain 25198
    260 Novartis Investigative Site Barcelona Catalunya Spain 08035
    261 Novartis Investigative Site Salt Cataluña Spain 17190
    262 Novartis Investigative Site Badajoz Extremadura Spain 6011
    263 Novartis Investigative Site Pontevedra Galicia Spain 36001
    264 Novartis Investigative Site Logrono La Rioja Spain 26006
    265 Novartis Investigative Site Las Palmas de Gran Canaria Las Palmas De G.C Spain 35010
    266 Novartis Investigative Site Majadahonda Madrid Spain 28222
    267 Novartis Investigative Site San Sebastian de los Reyes Madrid Spain 28702
    268 Novartis Investigative Site San Sebastian de los Reyes Madrid Spain 28703
    269 Novartis Investigative Site Marbella Malaga Spain 29603
    270 Novartis Investigative Site Pamplona Navarra Spain 31008
    271 Novartis Investigative Site Bilbao Pais Vasco Spain 48013
    272 Novartis Investigative Site Galdakano Pais Vasco Spain 48960
    273 Novartis Investigative Site Badalona Spain 08911
    274 Novartis Investigative Site Baleares Spain 7014
    275 Novartis Investigative Site El Palmar (Murcia) Spain 30120
    276 Novartis Investigative Site Las Palmas de Gran Canaria Spain 35010
    277 Novartis Investigative Site Las Palmas de Gran Canaria Spain 35016
    278 Novartis Investigative Site Madrid Spain 28023
    279 Novartis Investigative Site Madrid Spain 28031
    280 Novartis Investigative Site Madrid Spain 28040
    281 Novartis Investigative Site Madrid Spain 28046
    282 Novartis Investigative Site Salamanca Spain 37007
    283 Novartis Investigative Site Sevilla Spain 41009
    284 Novartis Investigative Site Sevilla Spain 41010
    285 Novartis Investigative Site Zaragoza Spain 50009
    286 Novartis Investigative Site Zaragoza Spain 50015
    287 Novartis Investigative Site Luzern LU Switzerland 6004
    288 Novartis Investigative Site Abu Dhabi United Arab Emirates 51900
    289 Novartis Investigative Site Ras Al Khaimah United Arab Emirates 4727

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02389933
    Other Study ID Numbers:
    • CLCZ696B2318M
    First Posted:
    Mar 17, 2015
    Last Update Posted:
    Feb 15, 2021
    Last Verified:
    Feb 1, 2021
    Keywords provided by Novartis Pharmaceuticals
    Multiple Patient Program, LCZ696, heart failure, heart failure with reduced ejection fraction, HF-rEF
    Additional relevant MeSH terms:
    Heart Failure
    Sacubitril and valsartan sodium hydrate drug combination

    Study Results

    No Results Posted as of Feb 15, 2021