Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction

NCT ID: NCT02226120

Last Updated: 2019-02-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1980 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-16

Study Completion Date

2017-12-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF (NCT01035255) trial was terminated early due to compelling efficacy of LCZ696 in patients with heart failure with reduced ejection fraction (HFrEF) after the final pre-specified interim analysis in March 2014.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Heart Failure With Reduced Ejection Fraction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LCZ696

Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid

Group Type EXPERIMENTAL

LCZ696

Intervention Type DRUG

Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LCZ696

Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Written informed consent for the extension must be obtained before any assessment is performed.
2. Patients who have completed PARADIGM-HF (protocol CLCZ696B2314) and are able to be safely enrolled into the open-label trial as judged by the investigator.

Exclusion Criteria

1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
2. History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to LCZ696
3. Known history of angioedema
4. Requirement of simultaneous treatment with both ACEIs and ARBs
5. Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
6. Symptomatic hypotension and/or a SBP \< 100 mmHg at Visit 1 (screening)
7. Estimated GFR \< 30 mL/min/1.73m\^2 as measured by the simplified MDRD formula at Visit 1 (screening)
8. Presence of bilateral renal artery stenosis
9. Serum potassium \> 5.2 mmol/L at Visit 1 (screening)
10. Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 3 x ULN at Visit 1, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt
11. Pregnant or nursing (lactating) women
12. Women of child-bearing potential
13. Any condition, not identified in the protocol, that in the opinion of the investigator is likely to prevent the patient from safely tolerating LCZ696 or complying with the requirements of the study.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Huntsville, Alabama, United States

Site Status

Novartis Investigative Site

Muscle Shoals, Alabama, United States

Site Status

Novartis Investigative Site

Little Rock, Arkansas, United States

Site Status

Novartis Investigative Site

Oceanside, California, United States

Site Status

Novartis Investigative Site

Palm Springs, California, United States

Site Status

Novartis Investigative Site

San Diego, California, United States

Site Status

Novartis Investigative Site

Santa Rosa, California, United States

Site Status

Novartis Investigative Site

Boynton Beach, Florida, United States

Site Status

Novartis Investigative Site

Des Moines, Iowa, United States

Site Status

Novartis Investigative Site

Covington, Louisiana, United States

Site Status

Novartis Investigative Site

Columbia, Maryland, United States

Site Status

Novartis Investigative Site

Saginaw, Michigan, United States

Site Status

Novartis Investigative Site

Minneapolis, Minnesota, United States

Site Status

Novartis Investigative Site

Fremont, Nebraska, United States

Site Status

Novartis Investigative Site

New York, New York, United States

Site Status

Novartis Investigative Site

Rosedale, New York, United States

Site Status

Novartis Investigative Site

Raleigh, North Carolina, United States

Site Status

Novartis Investigative Site

Marion, Ohio, United States

Site Status

Novartis Investigative Site

Rapid City, South Dakota, United States

Site Status

Novartis Investigative Site

Dallas, Texas, United States

Site Status

Novartis Investigative Site

Dallas, Texas, United States

Site Status

Novartis Investigative Site

Livingston, Texas, United States

Site Status

Novartis Investigative Site

Spokane, Washington, United States

Site Status

Novartis Investigative Site

Waukesha, Wisconsin, United States

Site Status

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Ciudad Autonoma de Bs As, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Mar del Plata, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Quilmes, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

CABA, Buenos Aires F.D., Argentina

Site Status

Novartis Investigative Site

San Salvador de Jujuy, Jujuy Province, Argentina

Site Status

Novartis Investigative Site

Salta, Salta Province, Argentina

Site Status

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Site Status

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Site Status

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Site Status

Novartis Investigative Site

Corrientes, , Argentina

Site Status

Novartis Investigative Site

Córdoba, , Argentina

Site Status

Novartis Investigative Site

Córdoba, , Argentina

Site Status

Novartis Investigative Site

Córdoba, , Argentina

Site Status

Novartis Investigative Site

Formosa, , Argentina

Site Status

Novartis Investigative Site

Formosa, , Argentina

Site Status

Novartis Investigative Site

Mendoza, , Argentina

Site Status

Novartis Investigative Site

San Luis, , Argentina

Site Status

Novartis Investigative Site

Santa Fe, , Argentina

Site Status

Novartis Investigative Site

Santa Fe, , Argentina

Site Status

Novartis Investigative Site

Santiago del Estero, , Argentina

Site Status

Novartis Investigative Site

Brasschaat, , Belgium

Site Status

Novartis Investigative Site

Ghent, , Belgium

Site Status

Novartis Investigative Site

La Louvière, , Belgium

Site Status

Novartis Investigative Site

Leuven, , Belgium

Site Status

Novartis Investigative Site

Ronse, , Belgium

Site Status

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil

Site Status

Novartis Investigative Site

Brasília, Federal District, Brazil

Site Status

Novartis Investigative Site

Goiânia, Goiás, Brazil

Site Status

Novartis Investigative Site

Goiânia, Goiás, Brazil

Site Status

Novartis Investigative Site

Goiânia, Goiás, Brazil

Site Status

Novartis Investigative Site

São Luís, Maranhão, Brazil

Site Status

Novartis Investigative Site

Uberlândia, Mg-cep, Brazil

Site Status

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil

Site Status

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil

Site Status

Novartis Investigative Site

Belém, Pará, Brazil

Site Status

Novartis Investigative Site

Recife, Pernambuco, Brazil

Site Status

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Novartis Investigative Site

Marília, São Paulo, Brazil

Site Status

Novartis Investigative Site

Ribeirão Preto, São Paulo, Brazil

Site Status

Novartis Investigative Site

Santo André, São Paulo, Brazil

Site Status

Novartis Investigative Site

São José do Rio Preto, São Paulo, Brazil

Site Status

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Site Status

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Site Status

Novartis Investigative Site

Votuporanga, São Paulo, Brazil

Site Status

Novartis Investigative Site

Haskovo, , Bulgaria

Site Status

Novartis Investigative Site

Pleven, , Bulgaria

Site Status

Novartis Investigative Site

Plovdiv, , Bulgaria

Site Status

Novartis Investigative Site

Shumen, , Bulgaria

Site Status

Novartis Investigative Site

Sofia, , Bulgaria

Site Status

Novartis Investigative Site

Sofia, , Bulgaria

Site Status

Novartis Investigative Site

Sofia, , Bulgaria

Site Status

Novartis Investigative Site

Sofia, , Bulgaria

Site Status

Novartis Investigative Site

Sofia, , Bulgaria

Site Status

Novartis Investigative Site

Varna, , Bulgaria

Site Status

Novartis Investigative Site

Victoria, British Columbia, Canada

Site Status

Novartis Investigative Site

Halifax, Nova Scotia, Canada

Site Status

Novartis Investigative Site

Kitchener, Ontario, Canada

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Weston, Ontario, Canada

Site Status

Novartis Investigative Site

Lévis, Quebec, Canada

Site Status

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status

Novartis Investigative Site

St-Georges Beauce, Quebec, Canada

Site Status

Novartis Investigative Site

Temuco, Región de la Araucanía, Chile

Site Status

Novartis Investigative Site

Beroun, Czech Republic, Czechia

Site Status

Novartis Investigative Site

Brandýs nad Labem, Czech Republic, Czechia

Site Status

Novartis Investigative Site

Liberec V Kristianova, Czech Republic, Czechia

Site Status

Novartis Investigative Site

Olomouc, Czech Republic, Czechia

Site Status

Novartis Investigative Site

Prague 10, Vrsovice, Czech Republic, Czechia

Site Status

Novartis Investigative Site

Třebíč, Czech Republic, Czechia

Site Status

Novartis Investigative Site

Bílovec, CZE, Czechia

Site Status

Novartis Investigative Site

Kolín, , Czechia

Site Status

Novartis Investigative Site

Prague, , Czechia

Site Status

Novartis Investigative Site

Prague, , Czechia

Site Status

Novartis Investigative Site

Uherské Hradiště, , Czechia

Site Status

Novartis Investigative Site

Copenhagen, , Denmark

Site Status

Novartis Investigative Site

Esbjerg, , Denmark

Site Status

Novartis Investigative Site

Hellerup, , Denmark

Site Status

Novartis Investigative Site

Randers, , Denmark

Site Status

Novartis Investigative Site

Svendborg, , Denmark

Site Status

Novartis Investigative Site

Vejle, , Denmark

Site Status

Novartis Investigative Site

Viborg, , Denmark

Site Status

Novartis Investigative Site

Tallinn, , Estonia

Site Status

Novartis Investigative Site

Tartu, , Estonia

Site Status

Novartis Investigative Site

Tampere, , Finland

Site Status

Novartis Investigative Site

Montpellier, Herault, France

Site Status

Novartis Investigative Site

Paris, , France

Site Status

Novartis Investigative Site

Dresden, Saxony, Germany

Site Status

Novartis Investigative Site

Bad Homburg, , Germany

Site Status

Novartis Investigative Site

Bad Krozingen, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Buch, , Germany

Site Status

Novartis Investigative Site

Dessau, , Germany

Site Status

Novartis Investigative Site

Dresden, , Germany

Site Status

Novartis Investigative Site

Dresden, , Germany

Site Status

Novartis Investigative Site

Elsterwerda, , Germany

Site Status

Novartis Investigative Site

Frankfurt, , Germany

Site Status

Novartis Investigative Site

Frankfurt, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Huy / OT Anderbeck, , Germany

Site Status

Novartis Investigative Site

Ingelheim, , Germany

Site Status

Novartis Investigative Site

Kelkheim, , Germany

Site Status

Novartis Investigative Site

Köthen, , Germany

Site Status

Novartis Investigative Site

Künzelsau, , Germany

Site Status

Novartis Investigative Site

Leipzig, , Germany

Site Status

Novartis Investigative Site

Leipzig, , Germany

Site Status

Novartis Investigative Site

Leipzig, , Germany

Site Status

Novartis Investigative Site

Löhne, , Germany

Site Status

Novartis Investigative Site

Muehlheim An Der Ruhr, , Germany

Site Status

Novartis Investigative Site

Mühldorf, , Germany

Site Status

Novartis Investigative Site

Offenbach, , Germany

Site Status

Novartis Investigative Site

Wermsdorf, , Germany

Site Status

Novartis Investigative Site

Wetzlar-Naunheim, , Germany

Site Status

Novartis Investigative Site

Weyhe, , Germany

Site Status

Novartis Investigative Site

Guatemala City, Ciudad, Guatemala

Site Status

Novartis Investigative Site

Guatemala City, , Guatemala

Site Status

Novartis Investigative Site

Guatemala City, , Guatemala

Site Status

Novartis Investigative Site

Hong Kong, , Hong Kong

Site Status

Novartis Investigative Site

Hong Kong SAR, , Hong Kong

Site Status

Novartis Investigative Site

Budapest, , Hungary

Site Status

Novartis Investigative Site

Budapest, , Hungary

Site Status

Novartis Investigative Site

Budapest, , Hungary

Site Status

Novartis Investigative Site

Budapest, , Hungary

Site Status

Novartis Investigative Site

Budapest, , Hungary

Site Status

Novartis Investigative Site

Debrecen, , Hungary

Site Status

Novartis Investigative Site

Nyiregyháza, , Hungary

Site Status

Novartis Investigative Site

Szekszárd, , Hungary

Site Status

Novartis Investigative Site

Székesfehérvár, , Hungary

Site Status

Novartis Investigative Site

Zalaegerszeg, , Hungary

Site Status

Novartis Investigative Site

Guntur, Andhra Pradesh, India

Site Status

Novartis Investigative Site

Ahmedabad, Gujarat, India

Site Status

Novartis Investigative Site

Ahmedabad, Gujarat, India

Site Status

Novartis Investigative Site

Anand, Gujarat, India

Site Status

Novartis Investigative Site

Surat, Gujarat, India

Site Status

Novartis Investigative Site

Surat, Gujarat, India

Site Status

Novartis Investigative Site

Vadodara, Gujarat, India

Site Status

Novartis Investigative Site

Mumbai, Maharashtra, India

Site Status

Novartis Investigative Site

Nagpur, Maharashtra, India

Site Status

Novartis Investigative Site

Nagpur, Maharashtra, India

Site Status

Novartis Investigative Site

Nashik, Maharashtra, India

Site Status

Novartis Investigative Site

Nashik, Maharashtra, India

Site Status

Novartis Investigative Site

Nashik, Maharashtra, India

Site Status

Novartis Investigative Site

Pune, Maharashtra, India

Site Status

Novartis Investigative Site

Pune, Maharashtra, India

Site Status

Novartis Investigative Site

Delhi, National Capital Territory of Delhi, India

Site Status

Novartis Investigative Site

Ludhiana, Punjab, India

Site Status

Novartis Investigative Site

Bikaner, Rajasthan, India

Site Status

Novartis Investigative Site

Hyderabad, Telangana, India

Site Status

Novartis Investigative Site

Indore, , India

Site Status

Novartis Investigative Site

Ashkelon, , Israel

Site Status

Novartis Investigative Site

Hadera, , Israel

Site Status

Novartis Investigative Site

Haifa, , Israel

Site Status

Novartis Investigative Site

Haifa, , Israel

Site Status

Novartis Investigative Site

Jerusalem, , Israel

Site Status

Novartis Investigative Site

Petah Tikva, , Israel

Site Status

Novartis Investigative Site

Rehovot, , Israel

Site Status

Novartis Investigative Site

Safed, , Israel

Site Status

Novartis Investigative Site

Aosta, AO, Italy

Site Status

Novartis Investigative Site

Cortona, AR, Italy

Site Status

Novartis Investigative Site

Bergamo, BG, Italy

Site Status

Novartis Investigative Site

Treviglio, BG, Italy

Site Status

Novartis Investigative Site

Cosenza, CS, Italy

Site Status

Novartis Investigative Site

Cona, FE, Italy

Site Status

Novartis Investigative Site

Genova, GE, Italy

Site Status

Novartis Investigative Site

Pozzilli, IS, Italy

Site Status

Novartis Investigative Site

Lido di Camaiore, LU, Italy

Site Status

Novartis Investigative Site

Milazzo, ME, Italy

Site Status

Novartis Investigative Site

Pisa, PI, Italy

Site Status

Novartis Investigative Site

Pescia, Point, Italy

Site Status

Novartis Investigative Site

Pavia, PV, Italy

Site Status

Novartis Investigative Site

Ariccia, RM, Italy

Site Status

Novartis Investigative Site

Roma, RM, Italy

Site Status

Novartis Investigative Site

Salerno, SA, Italy

Site Status

Novartis Investigative Site

Sassari, SS, Italy

Site Status

Novartis Investigative Site

Daugavpils, , Latvia

Site Status

Novartis Investigative Site

Ventspils, , Latvia

Site Status

Novartis Investigative Site

Kaunas, , Lithuania

Site Status

Novartis Investigative Site

Kėdainiai, , Lithuania

Site Status

Novartis Investigative Site

Vilnius, , Lithuania

Site Status

Novartis Investigative Site

Kuala Lumpur, , Malaysia

Site Status

Novartis Investigative Site

Kuala Lumpur, , Malaysia

Site Status

Novartis Investigative Site

San Juan del Río, Querétaro, Mexico

Site Status

Novartis Investigative Site

Aguascalientes, , Mexico

Site Status

Novartis Investigative Site

San Luis Potosí City, , Mexico

Site Status

Novartis Investigative Site

Breda, CK, Netherlands

Site Status

Novartis Investigative Site

's-Hertogenbosch, , Netherlands

Site Status

Novartis Investigative Site

Amersfoort, , Netherlands

Site Status

Novartis Investigative Site

Arnhem, , Netherlands

Site Status

Novartis Investigative Site

Blaricum, , Netherlands

Site Status

Novartis Investigative Site

Delft, , Netherlands

Site Status

Novartis Investigative Site

Ede, , Netherlands

Site Status

Novartis Investigative Site

Gorinchem, , Netherlands

Site Status

Novartis Investigative Site

Hardenberg, , Netherlands

Site Status

Novartis Investigative Site

Harderwijk, , Netherlands

Site Status

Novartis Investigative Site

Heerenveen, , Netherlands

Site Status

Novartis Investigative Site

Hengelo, , Netherlands

Site Status

Novartis Investigative Site

Sneek, , Netherlands

Site Status

Novartis Investigative Site

Tilburg, , Netherlands

Site Status

Novartis Investigative Site

Veldhoven, , Netherlands

Site Status

Novartis Investigative Site

Panama City, , Panama

Site Status

Novartis Investigative Site

Panama City, , Panama

Site Status

Novartis Investigative Site

Bellavista, Lima region, Peru

Site Status

Novartis Investigative Site

Jesus Maria, Lima region, Peru

Site Status

Novartis Investigative Site

La Molina, Lima region, Peru

Site Status

Novartis Investigative Site

San Borja, Lima region, Peru

Site Status

Novartis Investigative Site

San Isidro, Lima region, Peru

Site Status

Novartis Investigative Site

San Miguel, Lima region, Peru

Site Status

Novartis Investigative Site

Arequipa, , Peru

Site Status

Novartis Investigative Site

Lipa City, Batangas, Philippines

Site Status

Novartis Investigative Site

Quezon City, Manila, Philippines

Site Status

Novartis Investigative Site

Pasig, , Philippines

Site Status

Novartis Investigative Site

Quezon City, , Philippines

Site Status

Novartis Investigative Site

Quezon City, , Philippines

Site Status

Novartis Investigative Site

Gdynia, , Poland

Site Status

Novartis Investigative Site

Gdynia, , Poland

Site Status

Novartis Investigative Site

Lublin, , Poland

Site Status

Novartis Investigative Site

Vila Real, Portuigal, Portugal

Site Status

Novartis Investigative Site

Covilha, , Portugal

Site Status

Novartis Investigative Site

Guimarães, , Portugal

Site Status

Novartis Investigative Site

Lisbon, , Portugal

Site Status

Novartis Investigative Site

Portalegre, , Portugal

Site Status

Novartis Investigative Site

Porto, , Portugal

Site Status

Novartis Investigative Site

Setúbal, , Portugal

Site Status

Novartis Investigative Site

Bucharest, District 1, Romania

Site Status

Novartis Investigative Site

Bucharest, District 1, Romania

Site Status

Novartis Investigative Site

Craiova, Jud. Dolj, Romania

Site Status

Novartis Investigative Site

Timișoara, Timiș County, Romania

Site Status

Novartis Investigative Site

Bucharest, , Romania

Site Status

Novartis Investigative Site

Bucharest, , Romania

Site Status

Novartis Investigative Site

Craiova, , Romania

Site Status

Novartis Investigative Site

Deva, , Romania

Site Status

Novartis Investigative Site

Timișoara, , Romania

Site Status

Novartis Investigative Site

Timișoara, , Romania

Site Status

Novartis Investigative Site

Ivanovo, , Russia

Site Status

Novartis Investigative Site

Kazan', , Russia

Site Status

Novartis Investigative Site

Kemerovo, , Russia

Site Status

Novartis Investigative Site

Kirov, , Russia

Site Status

Novartis Investigative Site

Krasnodar, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

N.Novgorod, , Russia

Site Status

Novartis Investigative Site

Nizhny Novgorod, , Russia

Site Status

Novartis Investigative Site

Nizhny Novgorod, , Russia

Site Status

Novartis Investigative Site

Novosibirsk-117, , Russia

Site Status

Novartis Investigative Site

Orenburg, , Russia

Site Status

Novartis Investigative Site

Orenburg, , Russia

Site Status

Novartis Investigative Site

Perm, , Russia

Site Status

Novartis Investigative Site

Rostov-on-Don, , Russia

Site Status

Novartis Investigative Site

S-Petersburg, , Russia

Site Status

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status

Novartis Investigative Site

Saratov, , Russia

Site Status

Novartis Investigative Site

Smolensk, , Russia

Site Status

Novartis Investigative Site

Tula, , Russia

Site Status

Novartis Investigative Site

Vladimir, , Russia

Site Status

Novartis Investigative Site

Yekaterinburg, , Russia

Site Status

Novartis Investigative Site

Singapore, , Singapore

Site Status

Novartis Investigative Site

Singapore, , Singapore

Site Status

Novartis Investigative Site

Brezno, Slovak Republic, Slovakia

Site Status

Novartis Investigative Site

Košice, Slovak Republic, Slovakia

Site Status

Novartis Investigative Site

Levice, Slovak Republic, Slovakia

Site Status

Novartis Investigative Site

Prešov, Slovak Republic, Slovakia

Site Status

Novartis Investigative Site

Svidník, Slovak Republic, Slovakia

Site Status

Novartis Investigative Site

Bratislava, , Slovakia

Site Status

Novartis Investigative Site

Bratislava, , Slovakia

Site Status

Novartis Investigative Site

Bratislava, , Slovakia

Site Status

Novartis Investigative Site

Košice, , Slovakia

Site Status

Novartis Investigative Site

Lučenec, , Slovakia

Site Status

Novartis Investigative Site

Martin, , Slovakia

Site Status

Novartis Investigative Site

Bloemfontein, Free State, South Africa

Site Status

Novartis Investigative Site

Soweto, Gauteng, South Africa

Site Status

Novartis Investigative Site

Durban, KwaZulu-Natal, South Africa

Site Status

Novartis Investigative Site

Cape Town, Western Cape, South Africa

Site Status

Novartis Investigative Site

Alberton, , South Africa

Site Status

Novartis Investigative Site

Bloemfontein, , South Africa

Site Status

Novartis Investigative Site

Cape Town, , South Africa

Site Status

Novartis Investigative Site

Cape Town, , South Africa

Site Status

Novartis Investigative Site

Durban, , South Africa

Site Status

Novartis Investigative Site

Johannesburg, , South Africa

Site Status

Novartis Investigative Site

Kempton Park, , South Africa

Site Status

Novartis Investigative Site

Pretoria, , South Africa

Site Status

Novartis Investigative Site

Pretoria, , South Africa

Site Status

Novartis Investigative Site

Worcester, , South Africa

Site Status

Novartis Investigative Site

Wŏnju, Gangwon-do, South Korea

Site Status

Novartis Investigative Site

Suwon, Gyeonggi-do, South Korea

Site Status

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status

Novartis Investigative Site

Seoul, Seocho-gu, South Korea

Site Status

Novartis Investigative Site

Daegu, , South Korea

Site Status

Novartis Investigative Site

Daegu, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Marbella, Andalusia, Spain

Site Status

Novartis Investigative Site

Málaga, Andalusia, Spain

Site Status

Novartis Investigative Site

Seville, Andalusia, Spain

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Sant Joan Despí, Catalonia, Spain

Site Status

Novartis Investigative Site

A Coruña, Galicia, Spain

Site Status

Novartis Investigative Site

Santiago de Compostela, Galicia, Spain

Site Status

Novartis Investigative Site

Vigo, Galicia, Spain

Site Status

Novartis Investigative Site

Alcalá de Henares, Madrid, Spain

Site Status

Novartis Investigative Site

Móstoles, Madrid, Spain

Site Status

Novartis Investigative Site

Valencia, Valencia, Spain

Site Status

Novartis Investigative Site

Valencia, Valencia, Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Stockholm, SE, Sweden

Site Status

Novartis Investigative Site

Gothenburg, , Sweden

Site Status

Novartis Investigative Site

Karlshamn, , Sweden

Site Status

Novartis Investigative Site

Motala, , Sweden

Site Status

Novartis Investigative Site

Changhua, , Taiwan

Site Status

Novartis Investigative Site

Kaohsiung City, , Taiwan

Site Status

Novartis Investigative Site

Taichung, , Taiwan

Site Status

Novartis Investigative Site

Taipei, , Taiwan

Site Status

Novartis Investigative Site

Taipei, , Taiwan

Site Status

Novartis Investigative Site

Taipei, , Taiwan

Site Status

Novartis Investigative Site

Yilan, , Taiwan

Site Status

Novartis Investigative Site

Taladkwan, Changwat Nonthaburi, Thailand

Site Status

Novartis Investigative Site

Muang, Thailand, Thailand

Site Status

Novartis Investigative Site

Khon Kaen, THA, Thailand

Site Status

Novartis Investigative Site

Istanbul, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Istanbul, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Izmir, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Izmir, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Kocaeli, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Sivas, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Durham, County Durham, United Kingdom

Site Status

Novartis Investigative Site

Dorchester, Dorset, United Kingdom

Site Status

Novartis Investigative Site

Basingstoke, Hampshire, United Kingdom

Site Status

Novartis Investigative Site

Portsmouth, Hampshire, United Kingdom

Site Status

Novartis Investigative Site

Inverness, Invernesshire, United Kingdom

Site Status

Novartis Investigative Site

Oldham, Lancashire, United Kingdom

Site Status

Novartis Investigative Site

Leicester, Leicestershire, United Kingdom

Site Status

Novartis Investigative Site

Craigavon, Northern Ireland, United Kingdom

Site Status

Novartis Investigative Site

Dundee, Perthshire, United Kingdom

Site Status

Novartis Investigative Site

Taunton, Somerset, United Kingdom

Site Status

Novartis Investigative Site

Yeovil, Somerset, United Kingdom

Site Status

Novartis Investigative Site

Sheffield, South Yorkshire, United Kingdom

Site Status

Novartis Investigative Site

Redhill, Surrey, United Kingdom

Site Status

Novartis Investigative Site

South Shields, Tyne and Wear, United Kingdom

Site Status

Novartis Investigative Site

Sunderland, Tyne and Wear, United Kingdom

Site Status

Novartis Investigative Site

Dudley, West Midlands, United Kingdom

Site Status

Novartis Investigative Site

Cheshire, , United Kingdom

Site Status

Novartis Investigative Site

Coventry, , United Kingdom

Site Status

Novartis Investigative Site

Exeter, , United Kingdom

Site Status

Novartis Investigative Site

Kent, , United Kingdom

Site Status

Novartis Investigative Site

Manchester, , United Kingdom

Site Status

Novartis Investigative Site

Milton Keynes, , United Kingdom

Site Status

Novartis Investigative Site

Newport, , United Kingdom

Site Status

Novartis Investigative Site

Newport, , United Kingdom

Site Status

Novartis Investigative Site

Norwich, , United Kingdom

Site Status

Novartis Investigative Site

Poole, , United Kingdom

Site Status

Novartis Investigative Site

Rotherham, , United Kingdom

Site Status

Novartis Investigative Site

Worcester, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Belgium Brazil Bulgaria Canada Chile Czechia Denmark Estonia Finland France Germany Guatemala Hong Kong Hungary India Israel Italy Latvia Lithuania Malaysia Mexico Netherlands Panama Peru Philippines Poland Portugal Romania Russia Singapore Slovakia South Africa South Korea Spain Sweden Taiwan Thailand Turkey (Türkiye) United Kingdom

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014-001971-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLCZ696B2317

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.