Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo

NCT ID: NCT02957682

Last Updated: 2021-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-02
• Study Completion Date: 2020-03-05

Brief Summary

The main purpose of this study is to evaluate the effect on mental state (known as "neurocognitive function") with use of Praluent.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1

Praluent Regimen - Administration through subcutaneous injection

Group Type: EXPERIMENTAL

Praluent (Alirocumab)

Intervention Type: DRUG

Group 2

Placebo matching Praluent - Administration through subcutaneous injection

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Interventions

Praluent (Alirocumab)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men and women ≥ age 40 years and ≤ age 85 years
• Patients with heterozygous familial hypercholesterolemia (heFH) or with non-familial hypercholesterolemia (non-FH) patients at high or very high cardiovascular risk
• Patients with history of coronary heart disease (CHD) not having adequate control of their hypercholesterolemia with LDL-C ≥70 mg/dL, or all other patients with LDL-C ≥100 mg/dL and be on maximally-tolerated dose of statin (unless they are statin-intolerant)
• Patients must have successfully completed the Motor Screening Task
• Patients must be willing and able to comply with clinic visits and study related procedures
• Patients must provide signed informed consent

Exclusion Criteria

• Patients with known Alzheimer's disease or other dementia, schizophrenia, bipolar disorder, severe depression, cognitive impairment, or patients with a sleep disorder requiring daily pharmacological treatment
• Recent (within 3 months prior to the screening visit) myocardial infarction, unstable angina leading to hospitalization, coronary artery bypass graft surgery, percutaneous coronary intervention, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease
• Certain laboratory findings obtained during the screening visit as defined in the protocol
• Any condition or situation, including other significant mental or neurological disorders that, in the investigator's opinion, may confound the study results, or may interfere significantly with the patient's participation in the study
• Pregnant or breastfeeding women
• A positive human immunodeficiency virus (HIV) test

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Regeneron Study Site

Auburn, Alabama, United States

Regeneron Study Site

Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Beverly Hills, California, United States

Regeneron Study Site

Los Gatos, California, United States

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North Hollywood, California, United States

Regeneron Study Site

Port Hueneme, California, United States

Regeneron Study Site

Westminster, California, United States

Regeneron Study Site 1

Aurora, Colorado, United States

Regeneron Study Site 2

Aurora, Colorado, United States

Regeneron Study Site

Colorado Springs, Colorado, United States

Regeneron Study Site

Lake Worth, Florida, United States

Regeneron Study Site

Lake Worth, Florida, United States

Regeneron Study Site

Miami Springs, Florida, United States

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Covington, Georgia, United States

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Champaign, Illinois, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Rock Island, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Ames, Iowa, United States

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Iowa City, Iowa, United States

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Waterloo, Iowa, United States

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Hutchinson, Kansas, United States

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Newton, Kansas, United States

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Overland Park, Kansas, United States

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Louisville, Kentucky, United States

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Bangor, Maine, United States

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Baltimore, Maryland, United States

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Oxon Hill, Maryland, United States

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Minneapolis, Minnesota, United States

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Olive Branch, Mississippi, United States

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Washington, Missouri, United States

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Buffalo, New York, United States

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New Hyde Park, New York, United States

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Cary, North Carolina, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Hickory, North Carolina, United States

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High Point, North Carolina, United States

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Raleigh, North Carolina, United States

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Rocky Mount, North Carolina, United States

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Salisbury, North Carolina, United States

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Statesville, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Dayton, Ohio, United States

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Duncansville, Pennsylvania, United States

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Charleston, South Carolina, United States

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Greenville, South Carolina, United States

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Summerville, South Carolina, United States

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Rapid City, South Dakota, United States

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Bristol, Tennessee, United States

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Knoxville, Tennessee, United States

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Knoxville, Tennessee, United States

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Knoxville, Tennessee, United States

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Powell, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Schertz, Texas, United States

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Shavano Park, Texas, United States

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Falls Church, Virginia, United States

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Winchester, Virginia, United States

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Burien, Washington, United States

Regeneron Study Site

Everett, Washington, United States

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Tacoma, Washington, United States

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Walla Walla, Washington, United States

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Manitowoc, Wisconsin, United States

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

Regeneron Study Site 1

Varna, , Bulgaria

Regeneron Study Site 2

Varna, , Bulgaria

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Osorno, , Chile

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San Miguel, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Temuco, , Chile

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Temuco, , Chile

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Viña del Mar, , Chile

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Paide, , Estonia

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Tallinn, , Estonia

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Tallinn, , Estonia

Regeneron Study Site 1

Tallinn, , Estonia

Regeneron Study Site 2

Tallinn, , Estonia

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Tallinn, , Estonia

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Tallinn, , Estonia

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Tartu, , Estonia

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Nishinomiya, Hogo, Japan

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Kahoku-gun, Ishikawa-ken, Japan

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Kawasaki, Kanagawa, Japan

Regeneron Study Site

Yokohama, Kanagawa, Japan

Regeneron Study Site

Uji-shi, Kyoto, Japan

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Nakagami-gun, Okinawa, Japan

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Iruma-gun, Saitama, Japan

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Bunkyō-Ku, Tokyo, Japan

Regeneron Study Site

Chuo Ku, Tokyo, Japan

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Hachiōji, Tokyo, Japan

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Itabashi-ku, Tokyo, Japan

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Shinagawa-Ku, Tokyo, Japan

Regeneron Study Site

Aguascalientes, , Mexico

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Cuernavaca, , Mexico

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Culiacán, , Mexico

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Distrito Federal, , Mexico

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Durango, , Mexico

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Guadalajara, , Mexico

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Guadalajara, , Mexico

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Guadalajara, , Mexico

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Mexico City, , Mexico

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Mexico City, , Mexico

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Mexico City, , Mexico

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Mérida, , Mexico

Regeneron Study Site 1

Monterrey, , Mexico

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Monterrey, , Mexico

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Monterrey, , Mexico

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Pachuca, , Mexico

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Querétaro, , Mexico

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San Juan del Río, , Mexico

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Torreón, , Mexico

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Ivanovo, , Russia

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Kirov, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Novosibirsk, , Russia

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Rostov-on-Don, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Tyumen, , Russia

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Yaroslavl, , Russia

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Yaroslavl, , Russia

Regeneron Study Site 1

Yaroslavl, , Russia

Regeneron Study Site 2

Yaroslavl, , Russia

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Kuils River, Cape Town, South Africa

Regeneron Study Site

Port Elizabeth, Eastern Cape, South Africa

Regeneron Study Site

Halfway House, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Pretoria West, Gauteng, South Africa

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Kempton Park, Johannesburg, South Africa

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Soweto, Johannesburg, South Africa

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Soweto, Johannesburg, South Africa

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Middelburg, Mpumalanga, South Africa

Regeneron Study Site

Cape Town, Western Cape, South Africa

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Cape Town, Western Cape, South Africa

Regeneron Study Site

Paarl, Western Cape, South Africa

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Somerset West, Western Cape, South Africa

Regeneron Study Site

Worcester, Western Cape, South Africa

Regeneron Study Site 1

Bloemfontein, , South Africa

Regeneron Study Site 2

Bloemfontein, , South Africa

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Claremont, , South Africa

Regeneron Study Site

Uzhhorod, Transcarpathian Region, Ukraine

Regeneron Study Site

Kharkiv, , Ukraine

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Kharkiv, , Ukraine

Regeneron Study Site 1

Kiev, , Ukraine

Regeneron Study Site 2

Kiev, , Ukraine

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Kyiv, , Ukraine

Regeneron Study Site 1

Kyiv, , Ukraine

Regeneron Study Site 2

Kyiv, , Ukraine

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Kyiv, , Ukraine

Regeneron Study Site 1

Kyiv, , Ukraine

Regeneron Study Site 2

Kyiv, , Ukraine

Regeneron Study Site 1

Kyiv, , Ukraine

Regeneron Study Site 2

Kyiv, , Ukraine

Regeneron Study Site

Kyiv, , Ukraine

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Kyiv, , Ukraine

Regeneron Study Site

Lviv, , Ukraine

Regeneron Study Site 1

Vinnitsa, , Ukraine

Regeneron Study Site 2

Vinnitsa, , Ukraine

Regeneron Study Site

Vinnitsa, , Ukraine

Countries

United States; Bulgaria; Chile; Estonia; Japan; Mexico; Russia; South Africa; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-003189-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R727-CL-1532

Identifier Type: -

Identifier Source: org_study_id