Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction (PARAGON-HF)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01920711 |
Recruitment Status :
Completed
First Posted : August 12, 2013
Results First Posted : September 29, 2020
Last Update Posted : September 29, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure With Preserved Ejection Fraction | Drug: LCZ696 Drug: Valsartan | Phase 3 |
This was a multicenter, randomized, double-blind, parallel group, active-controlled, study to evaluate the efficacy and safety of sacubitril/valsartan compared to valsartan, on morbidity and mortality in heart failure patients (NYHA Class II-IV) with preserved ejection fraction. Specifically, the study evaluated the effect of sacubitril/valsartan compared to the active comparator valsartan in the reduction of the rate of CV death and total HF hospitalizations in patients with HFpEF. The trial consisted of two periods: (1) a single-blind treatment run-in epoch that lasted from 3 to 8 weeks, in which patients received valsartan 80 mg bid, followed by sacubitril/valsartan 100 mg bid and (2) a double-blind randomized treatment epoch (sacubitril/valsartan 200 mg bid or valsartan 160 mg bid). In this study, investigators were responsible for assessing and submitting all events which could potentially fulfill the criteria for the primary, secondary, or other clinical endpoints to a Clinical Endpoint Committee (CEC). Investigator reported events were assessed by the CEC for adjudication.
For angioedema or angioedema-like events, investigators completed an Adjudication Questionnaire for an Angioedema-like Event form. All angioedema reports were forwarded to an Angioedema Adjudication Committee (AAC) by Novartis for assessment.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4822 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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 (PARAGON-HF) |
Actual Study Start Date : | July 18, 2014 |
Actual Primary Completion Date : | June 7, 2019 |
Actual Study Completion Date : | June 7, 2019 |

Arm | Intervention/treatment |
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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. Target dose of LCZ696 during the double blind period is 200 mg b.i.d.
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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. Target dose of Valsartan during the double blind period is 160 mg b.i.d.
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Drug: Valsartan
Valsartan 40mg, 80mg and 160mg dosage strengths will be available for dose adjustments. |
- 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) ]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.
- Change in the Clinical Summary Score From Baseline to Month 8 by Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Baseline, 8 months ]The KCCQ is a validated instrument for self-assessment of quality of life and health status in heart failure (HF) patients. The clinical summary score, which is derived from the physical limitations and heart failure (HF) symptoms domains of the KCCQ is a valid measure for assessing the patient's health aspects that may be influenced by CV medications. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. Evaluation of change from baseline to month 8 in KCCQ a most sensitive, specific, and responsive health-related quality of life measure for heart failure symptoms and physical limitations.
- Change From Baseline to Month 8 in New York Heart Association (NYHA) Functional Class [ Time Frame: Baseline, 8 months ]Evaluation of change from baseline to Month 8 in NYHA functional class, a well established grading scale used to classify a heart failure's (HF) patients' level of functionality based on the signs and symptoms of HF exhibited by the patient.
- Participants With First Occurrence of a Composite Renal Endpoint [ Time Frame: Randomization to total follow-up time (up to 57 months) ]Analyis of composite renal endpoint defined as renal death, or reaching ESRD, or ≥50% decline in eGFR relative to baseline, using Cox's proportional hazards model.
- All-cause Mortality [ Time Frame: Randomization to total follow up time (up to 57 months) ]Analysis for all-cause mortality using Cox's proportional hazards model.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Left ventricular ejection fraction (LVEF) ≥45% by echo during screening epoch or within 6 months prior to study entry.
- Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF at least 30 days prior to study entry.
- Current symptom(s) of HF (NYHA class II-IV)
- Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
- Elevated NT-proBNP
Exclusion Criteria:
- Any prior measurement of LVEF < 40%.
- Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention within 3 months or and elective PCI within 30 days prior to entry.
- Any clinical event within the 6 months prior to entry could have reduced the LVEF (e.g., MI, CABG), 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, or SBP < 110 mmHg at entry.
Other protocol-defined inclusion/exclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920711


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China, Jiangxi | |
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Nanchang, Jiangxi, China, 330006 | |
China, Jilin | |
Novartis Investigative Site | |
Changchun, Jilin, China, 130022 | |
Novartis Investigative Site | |
Jilin, Jilin, China, 132000 | |
China, Liaoning | |
Novartis Investigative Site | |
Shenyang, Liaoning, China, 110003 | |
Novartis Investigative Site | |
Shenyang, Liaoning, China, 110016 | |
China, Shanghai | |
Novartis Investigative Site | |
Shanghai, Shanghai, China, 200032 | |
Novartis Investigative Site | |
Shanghai, Shanghai, China, 200120 | |
Novartis Investigative Site | |
Shanghai, Shanghai, China | |
China, Shanxi | |
Novartis Investigative Site | |
Xi'an, Shanxi, China, 710032 | |
Novartis Investigative Site | |
Xian, Shanxi, China, 710061 | |
China, Sichuan | |
Novartis Investigative Site | |
Chengdu, Sichuan, China, 610041 | |
China, Tianjin | |
Novartis Investigative Site | |
Tianjin, Tianjin, China, 300121 | |
China, Xinjiang | |
Novartis Investigative Site | |
Wulumuqi, Xinjiang, China, 830054 | |
China, Zhejiang | |
Novartis Investigative Site | |
Hangzhou, Zhejiang, China, 310009 | |
Novartis Investigative Site | |
Hangzhou, Zhejiang, China, 310013 | |
Novartis Investigative Site | |
Hangzhou, Zhejiang, China, 310016 | |
China | |
Novartis Investigative Site | |
Beijing, China, 100029 | |
Novartis Investigative Site | |
Beijing, China, 100034 | |
Novartis Investigative Site | |
Chongqing, China, 400037 | |
Novartis Investigative Site | |
Jinan, China, 250012 | |
Novartis Investigative Site | |
Nanjing, China, 210036 | |
Novartis Investigative Site | |
Shanghai, China, 200025 | |
Novartis Investigative Site | |
Shanghai, China, 200031 | |
Novartis Investigative Site | |
Shanghai, China, 200080 | |
Colombia | |
Novartis Investigative Site | |
Medellin, Antioquia, Colombia, 050036 | |
Novartis Investigative Site | |
Barranquilla, Atlantico, Colombia | |
Novartis Investigative Site | |
Barranquilla, Colombia, 080020 | |
Novartis Investigative Site | |
Barranquilla, Colombia | |
Novartis Investigative Site | |
Florida Blanca, Colombia | |
Croatia | |
Novartis Investigative Site | |
Varazdin, HRV, Croatia, 42000 | |
Novartis Investigative Site | |
Rijeka, Croatia, 51000 | |
Novartis Investigative Site | |
Zadar, Croatia, 23000 | |
Novartis Investigative Site | |
Zagreb, Croatia, 10000 | |
Czechia | |
Novartis Investigative Site | |
Brandys nad Labem, Czech Republic, Czechia, 250 01 | |
Novartis Investigative Site | |
Brno, Czech Republic, Czechia, 60200 | |
Novartis Investigative Site | |
Ivancice, Czech Republic, Czechia, 66491 | |
Novartis Investigative Site | |
Kladno, Czech Republic, Czechia, 272 80 | |
Novartis Investigative Site | |
Liberec, Czech Republic, Czechia, 460 05 | |
Novartis Investigative Site | |
Louny, Czech Republic, Czechia | |
Novartis Investigative Site | |
Ostrava, Czech Republic, Czechia, 70200 | |
Novartis Investigative Site | |
Plzen, Czech Republic, Czechia, 30100 | |
Novartis Investigative Site | |
Praha 4, Czech Republic, Czechia, 140 21 | |
Novartis Investigative Site | |
Roznov pod Radhostem, Czech Republic, Czechia, 756 61 | |
Novartis Investigative Site | |
Svitavy, Czech Republic, Czechia, 568 25 | |
Novartis Investigative Site | |
Trebic, Czech Republic, Czechia, 674 01 | |
Novartis Investigative Site | |
Usti nad Labem, Czech Republic, Czechia, 400 01 | |
Novartis Investigative Site | |
Znojmo, Czech Republic, Czechia, 66902 | |
Novartis Investigative Site | |
Policska, CZE, Czechia, 57201 | |
Novartis Investigative Site | |
Praha 2, CZE, Czechia, 128 08 | |
Novartis Investigative Site | |
Usti nad Labem, CZE, Czechia, 400 01 | |
Novartis Investigative Site | |
CZE, Czechia, 11000 | |
Novartis Investigative Site | |
Kolin, Czechia, 280 20 | |
Novartis Investigative Site | |
Marianske lazne, Czechia, 353 01 | |
Novartis Investigative Site | |
Uherske Hradiste, Czechia, 68601 | |
Denmark | |
Novartis Investigative Site | |
Esbjerg, Denmark, DK-6700 | |
Novartis Investigative Site | |
Glostrup, Denmark, 2600 | |
Novartis Investigative Site | |
Herlev, Denmark, 2730 | |
Novartis Investigative Site | |
Hvidovre, Denmark, 2650 | |
Novartis Investigative Site | |
Randers, Denmark, 8930 | |
Novartis Investigative Site | |
Svendborg, Denmark, 5700 | |
Novartis Investigative Site | |
Viborg, Denmark, DK-8800 | |
Finland | |
Novartis Investigative Site | |
Jyvaskyla, Finland, 40620 | |
Novartis Investigative Site | |
Oulu, Finland, 90220 | |
Novartis Investigative Site | |
Tampere, Finland, 33520 | |
France | |
Novartis Investigative Site | |
Bayonne, Bayonne Cedex, France, 64109 | |
Novartis Investigative Site | |
Montpellier cedex 5, Herault, France, 34059 | |
Novartis Investigative Site | |
Besancon Cedex, France, 25030 | |
Novartis Investigative Site | |
Beziers Cedex, France, 34525 | |
Novartis Investigative Site | |
Bordeaux Cedex, France, 33075 | |
Novartis Investigative Site | |
Grenoble, France, 38043 | |
Novartis Investigative Site | |
Lyon, France, F-69001 | |
Novartis Investigative Site | |
Paris cedex 10, France, 75010 | |
Novartis Investigative Site | |
Poitiers, France, 86000 | |
Novartis Investigative Site | |
Pontoise, France, F-95300 | |
Novartis Investigative Site | |
Rennes Cedex 9, France, 35033 | |
Novartis Investigative Site | |
Toulouse Cedex, France, 31059 | |
Novartis Investigative Site | |
Tourcoing, France, 59208 | |
Novartis Investigative Site | |
Vandoeuvre Les Nancy, France, 54511 | |
Germany | |
Novartis Investigative Site | |
Dresden, Sachsen, Germany, 01099 | |
Novartis Investigative Site | |
Aachen, Germany, 52074 | |
Novartis Investigative Site | |
Bad Homburg, Germany, 61348 | |
Novartis Investigative Site | |
Bad Krozingen, Germany, 79189 | |
Novartis Investigative Site | |
Bamberg, Germany, 96049 | |
Novartis Investigative Site | |
Berlin Buch, Germany, 13125 | |
Novartis Investigative Site | |
Berlin, Germany, 10789 | |
Novartis Investigative Site | |
Berlin, Germany, 12157 | |
Novartis Investigative Site | |
Berlin, Germany, 12683 | |
Novartis Investigative Site | |
Berlin, Germany, 13086 | |
Novartis Investigative Site | |
Berlin, Germany, 13353 | |
Novartis Investigative Site | |
Berlin, Germany, 13405 | |
Novartis Investigative Site | |
Chemnitz, Germany, 09126 | |
Novartis Investigative Site | |
Chemnitz, Germany, 09130 | |
Novartis Investigative Site | |
Dessau-Roßlau, Germany, 06846 | |
Novartis Investigative Site | |
Dresden, Germany, 01277 | |
Novartis Investigative Site | |
Dresden, Germany, 01307 | |
Novartis Investigative Site | |
Dresden, Germany, 01309 | |
Novartis Investigative Site | |
Duisburg, Germany, 47137 | |
Novartis Investigative Site | |
Eilenburg, Germany, D 04838 | |
Novartis Investigative Site | |
Elsterwerda, Germany, 04910 | |
Novartis Investigative Site | |
Essen, Germany, 45355 | |
Novartis Investigative Site | |
Frankfurt, Germany, 60594 | |
Novartis Investigative Site | |
Frankfurt, Germany, 65929 | |
Novartis Investigative Site | |
Hamburg, Germany, 20099 | |
Novartis Investigative Site | |
Hamburg, Germany, 20246 | |
Novartis Investigative Site | |
Hamburg, Germany, 22041 | |
Novartis Investigative Site | |
Hamburg, Germany, 22765 | |
Novartis Investigative Site | |
Hassloch, Germany, 67454 | |
Novartis Investigative Site | |
Heidenau, Germany, 01809 | |
Novartis Investigative Site | |
Heppenheim, Germany, 64646 | |
Novartis Investigative Site | |
Homburg, Germany, 66421 | |
Novartis Investigative Site | |
Ingelheim, Germany, 55218 | |
Novartis Investigative Site | |
Jena, Germany, 07740 | |
Novartis Investigative Site | |
Kassel, Germany, 34121 | |
Novartis Investigative Site | |
Kleve, Germany, 47533 | |
Novartis Investigative Site | |
Koblenz, Germany, 56068 | |
Novartis Investigative Site | |
Koeln, Germany, 51065 | |
Novartis Investigative Site | |
Leipzig, Germany, 04103 | |
Novartis Investigative Site | |
Loehne, Germany, 32584 | |
Novartis Investigative Site | |
Ludwigshafen, Germany, 67071 | |
Novartis Investigative Site | |
Lutherstadt Wittenberg, Germany, 06886 | |
Novartis Investigative Site | |
Lüneburg, Germany, 21339 | |
Novartis Investigative Site | |
Mainz, Germany, 55116 | |
Novartis Investigative Site | |
Meißen, Germany, 01662 | |
Novartis Investigative Site | |
Memmingen, Germany, 87700 | |
Novartis Investigative Site | |
Muehldorf Am Inn, Germany, 84453 | |
Novartis Investigative Site | |
Muehldorf, Germany, 84453 | |
Novartis Investigative Site | |
Muenster, Germany, 48149 | |
Novartis Investigative Site | |
Munchen, Germany, 81675 | |
Novartis Investigative Site | |
Munich, Germany, 80638 | |
Novartis Investigative Site | |
Nienburg, Germany, 31582 | |
Novartis Investigative Site | |
Northeim, Germany, 37154 | |
Novartis Investigative Site | |
Oschatz, Germany, 04758 | |
Novartis Investigative Site | |
Papenburg, Germany, 26871 | |
Novartis Investigative Site | |
Reinfeld, Germany, 23858 | |
Novartis Investigative Site | |
Riesa, Germany, 01589 | |
Novartis Investigative Site | |
Rodgau, Germany, 63110 | |
Novartis Investigative Site | |
Siegen, Germany, 57072 | |
Novartis Investigative Site | |
Ulm, Germany, 89077 | |
Novartis Investigative Site | |
Wermsdorf, Germany, 04779 | |
Novartis Investigative Site | |
Weyhe, Germany, 28844 | |
Novartis Investigative Site | |
Witten, Germany, 58455 | |
Novartis Investigative Site | |
Wuerzburg, Germany, 97080 | |
Greece | |
Novartis Investigative Site | |
Athens, Attica, Greece, 15562 | |
Novartis Investigative Site | |
Athens, GR, Greece, 14233 | |
Novartis Investigative Site | |
Ioannina, GR, Greece, 455 00 | |
Novartis Investigative Site | |
Larissa, GR, Greece, 411 10 | |
Novartis Investigative Site | |
Athens, Greece, 115 27 | |
Novartis Investigative Site | |
Athens, Greece, 12462 | |
Novartis Investigative Site | |
Thessaloniki, Greece, 54642 | |
Novartis Investigative Site | |
Thessaloniki, Greece, GR 54636 | |
Guatemala | |
Novartis Investigative Site | |
Guatemala City, Guatemala, 01010 | |
Novartis Investigative Site | |
Guatemala City, Guatemala, 01011 | |
Novartis Investigative Site | |
Guatemala City, Guatemala, 01015 | |
Novartis Investigative Site | |
Guatemala City, Guatemala, 10110 | |
Hungary | |
Novartis Investigative Site | |
Zalaegerszeg, Zala, Hungary, 8900 | |
Novartis Investigative Site | |
Budapest, Hungary, 1042 | |
Novartis Investigative Site | |
Budapest, Hungary, 1085 | |
Novartis Investigative Site | |
Budapest, Hungary, 1134 | |
Novartis Investigative Site | |
Budapest, Hungary, 1145 | |
Novartis Investigative Site | |
Budapest, Hungary, H 1096 | |
Novartis Investigative Site | |
Cegled, Hungary, 2700 | |
Novartis Investigative Site | |
Kistarcsa, Hungary, 2143 | |
Novartis Investigative Site | |
Mako, Hungary, 6900 | |
Novartis Investigative Site | |
Nyiregyháza, Hungary, 4400 | |
Novartis Investigative Site | |
Pecs, Hungary, 7623 | |
Novartis Investigative Site | |
Pecs, Hungary, 7635 | |
Novartis Investigative Site | |
Pécs, Hungary, 7623 | |
Novartis Investigative Site | |
Szeged, Hungary, H 6725 | |
Novartis Investigative Site | |
Szekesfehervar, Hungary, H-8000 | |
India | |
Novartis Investigative Site | |
Guntur, Andhra Pradesh, India, 522001 | |
Novartis Investigative Site | |
Vishakhapatnam, Andhra Pradesh, India, 532 002 | |
Novartis Investigative Site | |
New Delhi, Delhi, India, 110 060 | |
Novartis Investigative Site | |
Ahmedabad, Gujarat, India, 380054 | |
Novartis Investigative Site | |
Surat, Gujarat, India, 395 002 | |
Novartis Investigative Site | |
Chandigarh, Haryana, India, 160 030 | |
Novartis Investigative Site | |
Gurgaon, Haryana, India, 122001 | |
Novartis Investigative Site | |
Kochi, Kerala, India, 683 594 | |
Novartis Investigative Site | |
Pune, Maharashtra, India, 411 030 | |
Novartis Investigative Site | |
Ludhiana, Punjab, India, 141002 | |
Novartis Investigative Site | |
Bikaner, Rajasthan, India, 334003 | |
Novartis Investigative Site | |
Chennai, Tamil NADU, India, 600037 | |
Novartis Investigative Site | |
Chennai, Tamil Nadu, India, 600081 | |
Novartis Investigative Site | |
Madurai, Tamil NADU, India, 625107 | |
Novartis Investigative Site | |
Kolkata, West Bengal, India, 700 020 | |
Novartis Investigative Site | |
New Delhi, India, 110025 | |
Israel | |
Novartis Investigative Site | |
Hadera, Israel, 38100 | |
Novartis Investigative Site | |
Hadera, Israel | |
Novartis Investigative Site | |
Haifa, Israel, 3339419 | |
Novartis Investigative Site | |
Haifa, Israel, 3525408 | |
Novartis Investigative Site | |
Lower Galilee, Israel, 15208 | |
Novartis Investigative Site | |
Nahariya, Israel, 22100 | |
Novartis Investigative Site | |
Petach Tikva, Israel, 49100 | |
Novartis Investigative Site | |
Ramat Gan, Israel, 52621 | |
Novartis Investigative Site | |
Rehovot, Israel, 76100 | |
Novartis Investigative Site | |
Tel Giborim, Holon, Israel, 58100 | |
Italy | |
Novartis Investigative Site | |
Aosta, AO, Italy, 11100 | |
Novartis Investigative Site | |
Cortona, AR, Italy, 52044 | |
Novartis Investigative Site | |
Bergamo, BG, Italy, 24127 | |
Novartis Investigative Site | |
Treviglio, BG, Italy, 24047 | |
Novartis Investigative Site | |
Bologna, BO, Italy, 40138 | |
Novartis Investigative Site | |
Brescia, BS, Italy, 25123 | |
Novartis Investigative Site | |
Cona, FE, Italy, 44100 | |
Novartis Investigative Site | |
Pozzilli, IS, Italy, 86077 | |
Novartis Investigative Site | |
Monza, MB, Italy, 20900 | |
Novartis Investigative Site | |
Messina, ME, Italy, 98125 | |
Novartis Investigative Site | |
Milano, MI, Italy, 20162 | |
Novartis Investigative Site | |
Vimercate, MI, Italy, 200059 | |
Novartis Investigative Site | |
Padova, PD, Italy, 35128 | |
Novartis Investigative Site | |
Perugia, PG, Italy, 06100 | |
Novartis Investigative Site | |
Perugia, PG, Italy, 06129 | |
Novartis Investigative Site | |
Pavia, PV, Italy, 27100 | |
Novartis Investigative Site | |
Ariccia, RM, Italy, 00041 | |
Novartis Investigative Site | |
Roma, RM, Italy, 00163 | |
Novartis Investigative Site | |
Roma, RM, Italy, 00189 | |
Novartis Investigative Site | |
Sassari, SS, Italy, 07100 | |
Novartis Investigative Site | |
Trieste, TS, Italy, 34142 | |
Novartis Investigative Site | |
Trieste, TS, Italy, 34149 | |
Novartis Investigative Site | |
Palmanova, UD, Italy, 33057 | |
Novartis Investigative Site | |
San Daniele Del Friuli, UD, Italy, 33038 | |
Novartis Investigative Site | |
Saronno, Va, Italy, 21047 | |
Novartis Investigative Site | |
Venezia, VE, Italy, 30174 | |
Novartis Investigative Site | |
Milano, Italy, 20149 | |
Novartis Investigative Site | |
Napoli, Italy, 80131 | |
Japan | |
Novartis Investigative Site | |
Seto-city, Aichi, Japan, 489-8642 | |
Novartis Investigative Site | |
Chikushino-city, Fukuka, Japan, 818-8516 | |
Novartis Investigative Site | |
Ogaki-city, Gifu, Japan, 503-8502 | |
Novartis Investigative Site | |
Maebashi city, Gunma, Japan, 371 8511 | |
Novartis Investigative Site | |
Amagasaki city, Hyogo, Japan, 660 8550 | |
Novartis Investigative Site | |
Kanazawa, Ishikawa, Japan, 920 8650 | |
Novartis Investigative Site | |
Morioka, Iwate, Japan, 020 0066 | |
Novartis Investigative Site | |
Kanonji-city, Kagawa, Japan, 769-1695 | |
Novartis Investigative Site | |
Takamatsu city, Kagawa, Japan, 760 8557 | |
Novartis Investigative Site | |
Yokohama-city, Kanagawa, Japan, 227-8501 | |
Novartis Investigative Site | |
Yokohama-city, Kanagawa, Japan, 236 0051 | |
Novartis Investigative Site | |
Sendai city, Miyagi, Japan, 980 8574 | |
Novartis Investigative Site | |
Kashihara city, Nara, Japan, 634 8522 | |
Novartis Investigative Site | |
Sayama-city, Saitama, Japan, 350-1305 | |
Novartis Investigative Site | |
Kusatsu city, Shiga, Japan, 525 8585 | |
Novartis Investigative Site | |
Chiyoda-ku, Tokyo, Japan, 101-8309 | |
Novartis Investigative Site | |
Hachioji-city, Tokyo, Japan, 192-0918 | |
Novartis Investigative Site | |
Itabashi-ku, Tokyo, Japan, 173-8610 | |
Novartis Investigative Site | |
Shinagawa-ku, Tokyo, Japan, 142-8666 | |
Korea, Republic of | |
Novartis Investigative Site | |
Gyeonggi do, Bucheon Si, Korea, Republic of, 422-711 | |
Novartis Investigative Site | |
Cheongju si, Chungcheongbuk Do, Korea, Republic of, 28644 | |
Novartis Investigative Site | |
Wonju, Gangwon-do, Korea, Republic of, 26427 | |
Novartis Investigative Site | |
Bundang Gu, Gyeonggi Do, Korea, Republic of, 13620 | |
Novartis Investigative Site | |
Seoul, Korea, Korea, Republic of, 05505 | |
Novartis Investigative Site | |
Incheon, KOR, Korea, Republic of, 22332 | |
Novartis Investigative Site | |
Seoul, KOR, Korea, Republic of, 08308 | |
Novartis Investigative Site | |
Daegu, Korea, Republic of, 705 718 | |
Novartis Investigative Site | |
Seoul, Korea, Republic of, 02841 | |
Novartis Investigative Site | |
Seoul, Korea, Republic of, 03080 | |
Novartis Investigative Site | |
Seoul, Korea, Republic of, 03722 | |
Novartis Investigative Site | |
Seoul, Korea, Republic of, 06351 | |
Mexico | |
Novartis Investigative Site | |
Torreon, Coahulia, Mexico, 27000 | |
Novartis Investigative Site | |
Mexico, Distrito Federal, Mexico, 14080 | |
Novartis Investigative Site | |
Leon, Guanajuato, Mexico, 37530 | |
Novartis Investigative Site | |
Zapopan, Jalisco, Mexico, 45200 | |
Novartis Investigative Site | |
San Juan del Rio, Queretaro, Mexico, 76800 | |
Novartis Investigative Site | |
San Luis Potosi, San Luis Potosí, Mexico, 78240 | |
Novartis Investigative Site | |
Culiacan, Sinaloa, Mexico, 80230 | |
Novartis Investigative Site | |
Aguascalientes, Mexico, 20230 | |
Novartis Investigative Site | |
Queretaro, Mexico, 76000 | |
Novartis Investigative Site | |
San Luis Potosi, Mexico, 78200 | |
Novartis Investigative Site | |
San Luis Potosí, Mexico, 78200 | |
Netherlands | |
Novartis Investigative Site | |
Apeldoorn, DZ, Netherlands, 7334 | |
Novartis Investigative Site | |
Den Haag, NL, Netherlands, 2597 AX | |
Novartis Investigative Site | |
Almelo, PP, Netherlands, 7609 | |
Novartis Investigative Site | |
Arnhem, Netherlands, 6815 AD | |
Novartis Investigative Site | |
Blaricum, Netherlands, 1261 AN | |
Novartis Investigative Site | |
Den Haag, Netherlands, 2512 VA | |
Novartis Investigative Site | |
Ede, Netherlands, 6716 RP | |
Novartis Investigative Site | |
Gouda, Netherlands, 2803 HH | |
Novartis Investigative Site | |
Groningen, Netherlands, 9713 GZ | |
Novartis Investigative Site | |
Hardenberg, Netherlands, 7770 AA | |
Novartis Investigative Site | |
Harderwijk, Netherlands, 3840 AC | |
Novartis Investigative Site | |
Nijmegen, Netherlands, 6500 HB | |
Novartis Investigative Site | |
Rotterdam, Netherlands, 3015 CE | |
Novartis Investigative Site | |
Sneek, Netherlands, 8601 ZK | |
Novartis Investigative Site | |
Tilburg, Netherlands, 5022 GC | |
Norway | |
Novartis Investigative Site | |
Loerenskog, Norway, NO 1478 | |
Novartis Investigative Site | |
Oslo, Norway, 0450 | |
Novartis Investigative Site | |
Stavanger, Norway, 4068 | |
Novartis Investigative Site | |
Tromsoe, Norway, NO-9038 | |
Peru | |
Novartis Investigative Site | |
Bellavista, Lima, Peru, CALLAO 02 | |
Novartis Investigative Site | |
Cercado De Lima, Lima, Peru, 01 | |
Novartis Investigative Site | |
Jesus Maria, Lima, Peru, 11 | |
Novartis Investigative Site | |
Miraflores, Lima, Peru, 18 | |
Novartis Investigative Site | |
San Isidro, Lima, Peru, 27 | |
Philippines | |
Novartis Investigative Site | |
Lipa City, Batangas, Philippines, 4217 | |
Novartis Investigative Site | |
Quezon City, Manila, Philippines, 1100 | |
Novartis Investigative Site | |
Quezon City, Philippines, 1100 | |
Novartis Investigative Site | |
Quezon City, Philippines, 1102 | |
Poland | |
Novartis Investigative Site | |
Lodz, Lodzkie, Poland, 90 549 | |
Novartis Investigative Site | |
Gdynia, Poland, 81-157 | |
Novartis Investigative Site | |
Gdynia, Poland, 81-548 | |
Novartis Investigative Site | |
Grodzisk Mazowiecki, Poland, 05 825 | |
Novartis Investigative Site | |
Katowice, Poland, 40-645 | |
Novartis Investigative Site | |
Krakow, Poland, 30-015 | |
Novartis Investigative Site | |
Krakow, Poland, 31 501 | |
Novartis Investigative Site | |
Lublin, Poland, 20-363 | |
Novartis Investigative Site | |
Sandomierz, Poland, 27 600 | |
Novartis Investigative Site | |
Staszów, Poland, 28-200 | |
Novartis Investigative Site | |
Torun, Poland, 87-100 | |
Novartis Investigative Site | |
Warszawa/Anin, Poland, 04-761 | |
Novartis Investigative Site | |
Warszawa, Poland, 02-097 | |
Novartis Investigative Site | |
Warszawa, Poland, 04-154 | |
Novartis Investigative Site | |
Zabrze, Poland, 41 800 | |
Novartis Investigative Site | |
Zamosc, Poland, 22-400 | |
Romania | |
Novartis Investigative Site | |
Pitesti, Arges, Romania, 110438 | |
Novartis Investigative Site | |
Bucuresti, District 1, Romania, 014461 | |
Novartis Investigative Site | |
Craiova, Jud. Dolj, Romania, 200497 | |
Novartis Investigative Site | |
Sibiu, Jud. Iasi, Romania, 550371 | |
Novartis Investigative Site | |
Timisoara, Timis, Romania, 300125 | |
Novartis Investigative Site | |
Timisoara, Timis, Romania, 300362 | |
Novartis Investigative Site | |
Arad, Romania, 310158 | |
Novartis Investigative Site | |
Baia Mare, Romania, 430222 | |
Novartis Investigative Site | |
Bucharest, Romania, 050098 | |
Novartis Investigative Site | |
Bucuresti, Romania, 062272 | |
Novartis Investigative Site | |
Targu Mures, Romania, 540142 | |
Novartis Investigative Site | |
Targu Mures, Romania, 540143 | |
Novartis Investigative Site | |
Timisoara, Romania, 300041 | |
Russian Federation | |
Novartis Investigative Site | |
Ekaterinburg, Russian Federation, 620028 | |
Novartis Investigative Site | |
Ekaterinburg, Russian Federation, 620137 | |
Novartis Investigative Site | |
Ivanovo, Russian Federation, 153012 | |
Novartis Investigative Site | |
Izhevsk, Russian Federation, 426009 | |
Novartis Investigative Site | |
Izhevsk, Russian Federation, 426063 | |
Novartis Investigative Site | |
Kemerovo, Russian Federation, 650029 | |
Novartis Investigative Site | |
Kemerovo, Russian Federation, 650099 | |
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Kirov, Russian Federation, 610027 | |
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Kirov, Russian Federation, 610035 | |
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Moscow, Russian Federation, 101990 | |
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Moscow, Russian Federation, 117198 | |
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Moscow, Russian Federation, 121309 | |
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Moscow, Russian Federation, 121552 | |
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N.Novgorod, Russian Federation, 603005 | |
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Perm, Russian Federation, 614990 | |
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Rostov on Don, Russian Federation, 344022 | |
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Rostov-on-Don, Russian Federation, 344068 | |
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Saint Petersburg, Russian Federation, 194044 | |
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Saint Petersburg, Russian Federation, 197022 | |
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Saint Petersburg, Russian Federation, 197341 | |
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Saint Petersburg, Russian Federation, 199106 | |
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Saint-Petersburg, Russian Federation, 192257 | |
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Saratov, Russian Federation, 410012 | |
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Sestroretsk, Russian Federation, 197706 | |
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Smolensk, Russian Federation, 214018 | |
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St Petersburg, Russian Federation, 196601 | |
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St-Petersburg, Russian Federation, 194295 | |
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St.- Petersburg, Russian Federation, 197110 | |
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Yaroslavl, Russian Federation, 150003 | |
Serbia | |
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Belgrade, Serbia, 11000 | |
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Beograd, Serbia, 11040 | |
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Niska Banja, Serbia, 18205 | |
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Nis, Serbia, 18000 | |
Singapore | |
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Singapore, Singapore, 119074 | |
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Singapore, Singapore, 169609 | |
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Singapore, Singapore, 308433 | |
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Singapore, Singapore, 529889 | |
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Singapore, Singapore, 768828 | |
Slovakia | |
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Brezno, Slovak Republic, Slovakia, 977 42 | |
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Komarno, Slovak Republic, Slovakia, 94501 | |
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Levice, Slovak Republic, Slovakia, 93401 | |
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Namestovo, Slovak Republic, Slovakia, 02901 | |
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Povazska Bystrica, Slovak Republic, Slovakia, 01701 | |
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Presov, Slovak Republic, Slovakia, 08001 | |
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Bardejov, Slovakia, 085 01 | |
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Bratislava, Slovakia, 821 07 | |
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Bratislava, Slovakia, 831 01 | |
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Bratislava, Slovakia, 833 48 | |
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Bratislava, Slovakia, 841 07 | |
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Bratislava, Slovakia, 842 31 | |
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Bratislava, Slovakia, 851 01 | |
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Kosice, Slovakia, 040 01 | |
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Levice, Slovakia, 934 01 | |
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Lucenec, Slovakia, 984 01 | |
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Lucenec, Slovakia, 98439 | |
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Nitra, Slovakia, 949 01 | |
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Nitra, Slovakia, 949 88 | |
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Nove Zamky, Slovakia, 940 01 | |
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Nove Zamky, Slovakia, 94002 | |
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Piestany, Slovakia, 921 01 | |
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Presov, Slovakia, 080 01 | |
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Svidnik, Slovakia, 089 01 | |
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Trebisov, Slovakia, 075 01 | |
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Zilina, Slovakia, 012 07 | |
Slovenia | |
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Golnik, Slovenia, 4204 | |
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Ljubljana, Slovenia, 1000 | |
South Africa | |
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Bloemfontein, Free State, South Africa, 9301 | |
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Soweto, Gauteng, South Africa, 2013 | |
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Durban, Kwa-Zulu Natal, South Africa, 4052 | |
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Alberton, South Africa, 1449 | |
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Bloemfontein, South Africa, 9301 | |
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Cape Town, South Africa, 7500 | |
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Cape Town, South Africa, 7531 | |
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Cape Town, South Africa, 7925 | |
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Durban, South Africa, 4001 | |
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Tongaat, South Africa, 3300 | |
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Western Cape, South Africa, 7130 | |
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Worcester, South Africa, 6850 | |
Spain | |
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Almeria, Andalucia, Spain, 04120 | |
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Cordoba, Andalucia, Spain, 14004 | |
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Malaga, Andalucia, Spain, 29010 | |
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Marbella, Andalucia, Spain, 29600 | |
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Sanlúcar de Barrameda, Andalucia, Spain, 11540 | |
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Sevilla, Andalucia, Spain, 41013 | |
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Sevilla, Andalucia, Spain, 41014 | |
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Sant Joan Despi, Barcelona, Spain, 08970 | |
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Villamartin, Cadiz, Spain, 11650 | |
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Santander, Cantabria, Spain, 39008 | |
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Aranda de Duero, Castilla Y Leon, Spain, 09400 | |
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Leon, Castilla Y Leon, Spain, 24071 | |
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Lerida, Cataluna, Spain, 25198 | |
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Badalona, Catalunya, Spain, 08916 | |
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Barcelona, Catalunya, Spain, 08003 | |
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Alzira, Comunidad Valenciana, Spain, 46600 | |
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Valencia, Comunidad Valenciana, Spain, 46010 | |
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Valencia, Comunidad Valenciana, Spain, 46014 | |
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Valencia, Comunidad Valenciana, Spain, 46026 | |
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Merida, Extremadura, Spain, 06800 | |
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A Coruna, Galicia, Spain, 15006 | |
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Santiago de Compostela, Galicia, Spain, 15706 | |
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Olot, Girona, Spain, 17800 | |
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Mostoles, Madrid, Spain, 28935 | |
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El Palmar, Murcia, Spain, 30120 | |
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Ciudad Real, Spain, 13005 | |
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Madrid, Spain, 28009 | |
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Madrid, Spain, 28034 | |
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Madrid, Spain, 28040 | |
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Madrid, Spain, 28046 | |
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Madrid, Spain, 28222 | |
Sweden | |
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Danderyd, Sweden, 182 88 | |
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Falun, Sweden, 791 82 | |
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Goteborg, Sweden, 413 45 | |
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Karlstad, Sweden, 652 30 | |
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Lund, Sweden, 222 21 | |
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Orebro, Sweden, 701 85 | |
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Stockholm, Sweden, 17176 | |
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Vasteras, Sweden, 72189 | |
Switzerland | |
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Basel, Switzerland, 4031 | |
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Bern, Switzerland, 3010 | |
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Biel, Switzerland, 2502 | |
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Lausanne, Switzerland, 1011 | |
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Zurich, Switzerland, 8091 | |
Taiwan | |
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Tainan, Taiwan ROC, Taiwan, 70403 | |
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Changhua, Taiwan, 50006 | |
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Kaohsiung, Taiwan, 80756 | |
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New Taipei, Taiwan, 22060 | |
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Taichung, Taiwan, 40447 | |
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Tainan, Taiwan, 71004 | |
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Taipei, Taiwan, 10002 | |
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Taipei, Taiwan, 11217 | |
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Yilan, Taiwan, 26058 | |
Turkey | |
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Istanbul, TUR, Turkey, 34098 | |
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Haydarpasa Istanbul, Turkey, 34668 | |
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Istanbul, Turkey, 34304 | |
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Izmir, Turkey, 35040 | |
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Izmir, Turkey, 35340 | |
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Kocaeli, Turkey, 41380 | |
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Pendik / Istanbul, Turkey, 34899 | |
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Sivas, Turkey, 58140 | |
United Kingdom | |
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High Wycombe, Buckinghamshire, United Kingdom, HP11 2TT | |
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Stockton on Tees, Cleveland, United Kingdom, TS19 8PE | |
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Darlington, Co Durham, United Kingdom, DL3 8SQ | |
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Durham, County Durham, United Kingdom, DH1 5TW | |
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Torquay, Devon, United Kingdom, TQ2 7AA | |
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Dorchester, Dorset, United Kingdom, DT1 2JY | |
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Peterborough, GBR, United Kingdom, PE3 6DA | |
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Basingstoke, Hampshire, United Kingdom, RG24 9NA | |
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Portsmouth, Hampshire, United Kingdom, PO6 3LY | |
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Oldham, Lancashire, United Kingdom, OL1 2JH | |
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Harrow, Middlesex, United Kingdom, HA1 3UJ | |
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Portadown, Nothern Ireland, United Kingdom, BT63 5QQ | |
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Wansford, Peterborough, United Kingdom, PE8 6PL | |
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Glasgow, Scotland, United Kingdom, G12 8TA | |
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Taunton, Somerset, United Kingdom, TA1 5DA | |
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Gateshead, Tyne And Wear, United Kingdom, NE9 6SX | |
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Clydebank, West Dumbartonshire, United Kingdom, G81 4HX | |
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Cheshire, United Kingdom, CW1 4QJ | |
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Coventry, United Kingdom, CV2 2DX | |
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Dundee, United Kingdom, DD1 9SY | |
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Glasgow, United Kingdom, G20 0XA | |
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Hull, United Kingdom, HU16 5JQ | |
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London, United Kingdom, SE5 9RS | |
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London, United Kingdom, SW 6NP | |
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Newport, United Kingdom, NP20 2UB | |
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Nottingham, United Kingdom, NG5 1PB | |
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Sheffield, United Kingdom, S5 7AU | |
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Swindon, United Kingdom, SN3 6BB | |
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Wiltshire, United Kingdom, SN15 2SB | |
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Wrexham, United Kingdom, LL13 7TD |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Documents provided by Novartis ( Novartis Pharmaceuticals ):
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01920711 |
Other Study ID Numbers: |
CLCZ696D2301 2013-001747-31 ( EudraCT Number ) |
First Posted: | August 12, 2013 Key Record Dates |
Results First Posted: | September 29, 2020 |
Last Update Posted: | September 29, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Heart failure preserved ejection fraction diastolic heart failure |
Heart Failure Heart Diseases Cardiovascular Diseases Valsartan LCZ 696 |
Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |