A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease

NCT ID: NCT03131453

Last Updated: 2021-08-05

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-03

Study Completion Date

2020-03-26

Brief Summary

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The purpose of this study is to determine the effects of CNP520 on cognition, global clinical status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid.

Detailed Description

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This trial was a randomized, double-blind, placebo-controlled, parallel group, adaptive design with variable treatment duration planned in cognitively unimpaired participants aged 60 to 75 years, with at least one apolipoprotein E allele (APOE4), (homozygotes (HMs) or heterozygotes (HTs)) and, if HTs, with evidence of elevated brain amyloid. The participants were randomized to either CNP520 50 mg, CNP520 15 mg or placebo a 2:1:2 ratio and was stratified based on amyloid status. The planned treatment period of 5 to 8 years was not achieved due to early study termination.

Conditions

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Alzheimers Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CNP520 50 mg

50 mg capsule taken orally once daily

Group Type EXPERIMENTAL

CNP520 50mg

Intervention Type DRUG

50 mg capsule

CNP520 15 mg

15 mg capsule taken orally once daily

Group Type EXPERIMENTAL

CNP520 15mg

Intervention Type DRUG

15 mg capsule

Placebo

Matching placebo to 15 and 50 mg CNP520 taken orally once daily

Group Type PLACEBO_COMPARATOR

Matching placebo

Intervention Type OTHER

Matching placebo for 15 and 50 mg capsules

Interventions

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CNP520 50mg

50 mg capsule

Intervention Type DRUG

CNP520 15mg

15 mg capsule

Intervention Type DRUG

Matching placebo

Matching placebo for 15 and 50 mg capsules

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* consent to receive disclosure of their risk estimates to develop clinical symptoms of AD based on their APOE genotype and, if Heterozygotes, evidence of elevated brain amyloid.
* Male or female, age 60 to 75 years inclusive. Females must be considered post-menopausal and not of child bearing potential
* Cognitively unimpaired as evaluated by memory tests performed at screening.
* Participant's willingness to have a study partner.
* Carrier of at least one APOE4 gene if Heterozygotes, elevated brain amyloid (as measured by CSF Abeta or amyloid PET imaging).

Exclusion Criteria

* Any disability that could have prevented the participants from completing all study requirements. -
* Current medical or neurological condition that could have impacted cognition or performance on cognitive assessments.
* Advanced, severe progressive or unstable disease that could have interfered with the safety, tolerability and study assessments, or put the participant at special risk.
* History of malignancy of any organ system, treated or untreated, within the past 60 months.
* Indication for, or current treatment with ChEIs and/or another AD treatment (e.g. memantine).
* Contraindication or intolerance to MRI.
* Brain MRI results showing findings unrelated to AD that, in the opinion of the Investigator might be a leading cause to future cognitive decline, could have posed a risk to the participant, or could have prevented a satisfactory MRI assessment for safety monitoring.
* Suicidal Ideation in the past six months, or Suicidal Behavior in the past two years.
* A positive drug screen at Screening, if, in the Investigator's opinion, was is due to drug abuse.
* Significantly abnormal laboratory results at Screening, not as a result of a temporary condition.
* Current clinically significant ECG findings.
* Clinically relevant depigmenting or hypopigmenting conditions (e.g. albinism, vitiligo) or active / history of chronic urticaria in the past year.
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Amgen

INDUSTRY

Sponsor Role collaborator

Banner Alzheimer's Institute

OTHER

Sponsor Role collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Banner Alzheimer's Institute, 901 East Willetta Street

Phoenix, Arizona, United States

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Banner Sun Health Research Institute, 10515 West Santa Fe Drive, Building B

Sun City, Arizona, United States

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Novartis Investigative Site

Tucson, Arizona, United States

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ATP Clinical Research Inc, 3151 Airway Avenue T 3

Costa Mesa, California, United States

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Irvine Center for Clinical Res, 2515 McCabe Way

Irvine, California, United States

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Torrance Clinical Research Institute, 25043 Narbonne Avenue

Lomita, California, United States

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Novartis Investigative Site

Oxnard, California, United States

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Palo Alto, California, United States

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Novartis Investigative Site

San Diego, California, United States

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Syrentis Clinical Research, 1401 N Tustin Ave, Suite 130

Santa Ana, California, United States

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Novartis Investigative Site

Sebastopol, California, United States

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Novartis Investigative Site

Sherman Oaks, California, United States

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Mountain Neurological Research, 350 Market Street, Suite 316

Basalt, Colorado, United States

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Colorado Springs Neurological, 2312 North Nevada Avenue, Suite 100

Colorado Springs, Colorado, United States

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Denver Neurological Clinic, 950 E Harvard Ave

Denver, Colorado, United States

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Yale University, One Church Street, Suite 600

New Haven, Connecticut, United States

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Novartis Investigative Site

Stamford, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Novartis Investigative Site

Atlantis, Florida, United States

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Quantum Laboratories

Deerfield Beach, Florida, United States

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Brain Matters Research, Inc., 800 NW 17th Avenue

Delray Beach, Florida, United States

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Infinity Clinical Research LLC, 4925 Sheridan Street, Suite 200

Hollywood, Florida, United States

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Alzheimer's Research and Treatment Center, 5065 State Road 7, Suite 102

Lake Worth, Florida, United States

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Meridien Research, 2300 Maitland center, Pkwy Ste 230

Maitland, Florida, United States

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Novartis Investigative Site

Melbourne, Florida, United States

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Merritt Island, Florida, United States

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Novartis Investigative Site

Miami, Florida, United States

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Novartis Investigative Site

Miami, Florida, United States

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New Horizon Research Center, 11880 SW 40 St., Suite 405

Miami, Florida, United States

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Miami-Dade Medical Research, 8955 SW 87 CT, Suite 112

Miami, Florida, United States

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Novartis Investigative Site

Miami Beach, Florida, United States

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Compass Research, LLC,100 West Gore Street, Suite 202

Orlando, Florida, United States

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Novartis Investigative Site

Orlando, Florida, United States

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Ormond Beach, Florida, United States

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Palm Beach Gardens, Florida, United States

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Port Orange, Florida, United States

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Roskamp Institute, Inc., 2040 Whitfield Avenue

Sarasota, Florida, United States

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Novartis Investigative Site

Tallahassee, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Columbus, Georgia, United States

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Novartis Investigative Site

Decatur, Georgia, United States

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Hawaii Pacific Neuroscience, 2230 Liliha st 104

Honolulu, Hawaii, United States

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Advanced Clinical Research, 2950 E Magic View Dr, Suite 182

Meridian, Idaho, United States

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Novartis Investigative Site

Chicago, Illinois, United States

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Novartis Investigative Site

Chicago, Illinois, United States

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Alexian Brothers Neuroscience, 800 Biesterfield Rd, Neuroscience Institute Brock

Elk Grove Village, Illinois, United States

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Novartis Investigative Site

Indianapolis, Indiana, United States

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Fairway, Kansas, United States

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Wichita, Kansas, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Bangor, Maine, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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QUEST Research Institute, 28595 Orchard Lake Road, Suite 301

Farmington Hills, Michigan, United States

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Kalamazoo, Michigan, United States

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Rochester, Minnesota, United States

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Hattiesburg Clinic, 415 South 28th Avenue

Hattiesburg, Mississippi, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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West Long Branch, New Jersey, United States

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Albuquerque Neuroscience, 101 Hospital Loop ne, 209 209

Albuquerque, New Mexico, United States

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Novartis Investigative Site

Brooklyn, New York, United States

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East Syracuse, New York, United States

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Latham, New York, United States

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NYU Langone Medical Center, 145 East 32nd Street, 2nd Floor, Room 226

New York, New York, United States

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Novartis Investigative Site

Orangeburg, New York, United States

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Novartis Investigative Site

Rochester, New York, United States

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ANI Neurology, PLLC dba Alzhe, 7809 Sardis Road

Charlotte, North Carolina, United States

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Novartis Investigative Site

Durham, North Carolina, United States

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Greensboro, North Carolina, United States

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Cincinnati, Ohio, United States

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Novartis Investigative Site

Oklahoma City, Oklahoma, United States

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Tulsa Clinical Research LLC, 1705 E 19th ST., STE 406/408

Tulsa, Oklahoma, United States

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Summit Research Network, 2701 NW Vaughn St, Suite 350

Portland, Oregon, United States

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Novartis Investigative Site

Portland, Oregon, United States

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Jenkintown, Pennsylvania, United States

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Novartis Investigative Site

Philadelphia, Pennsylvania, United States

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Abington Neurological Associate Ltd., 2325 Maryland Road, Suite 100

Willow Grove, Pennsylvania, United States

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Rhode Island Hospital and Memory Research Institute, 1018 Waterman Ave

East Providence, Rhode Island, United States

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Butler Hospital, 345 Blackstone Blvd.

Providence, Rhode Island, United States

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Roper Hospital, 316 Calhoun Street 5th Floor

Charleston, South Carolina, United States

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Novartis Investigative Site

Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, 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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San Antonio, Texas, United States

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Bennington, Vermont, United States

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Tacoma, Washington, United States

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Milwaukee, Wisconsin, United States

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CABA, Buenos Aires, Argentina

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Buenos Aires, , Argentina

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Darlinghurst, New South Wales, Australia

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Heidelberg West, Victoria, Australia

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Nedlands, Western Australia, Australia

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Ghent, , Belgium

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Leuven, , Belgium

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Kelowna, British Columbia, Canada

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Kentville, Nova Scota, Canada

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Halifax, Nova Scotia, Canada

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Ottawa, Ontario, Canada

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Toronto Memory Program, 1 Valleybrook Drive Suite 400

Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Gatineau, Quebec, Canada

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Greenfield Park, Quebec, Canada

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Québec, Quebec, Canada

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Santiago, , Chile

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Santiago, , Chile

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Shanghai, Shanghai Municipality, China

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Beijing, , China

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Guangdong, , China

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Kuopio, , Finland

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Turku, , Finland

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Strasbourg, Cedex, France

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Lille, , France

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Paris, , France

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Rouen, , France

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Toulouse, , France

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Villeurbanne, , France

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Bayreuth, , Germany

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Berlin, , Germany

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Cologne, , Germany

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Leipzig, , Germany

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Mannheim, , Germany

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Siegen, , Germany

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Kopavogur, , Iceland

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Ashkelon, , Israel

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Haifa, , Israel

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Petah Tikva, , Israel

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Ramat Gan, , Israel

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Tel Aviv, , Israel

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Brescia, BS, Italy

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Rome, Lazio, Italy

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Monza, MB, Italy

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Milan, , Italy

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Tōon, Ehime, Japan

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Fukuoka, Fukuoka, Japan

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Yokohama, Kanagawa, Japan

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Suita, Osaka, Japan

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Bunkyo Ku, Tokyo, Japan

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Bunkyo Ku, Tokyo, Japan

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Kodaira, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Chiba, , Japan

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Osaka, , Japan

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Mexico City, Mexico CP, Mexico

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Monterrey, Nuevo León, Mexico

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Culiacán, Sinaloa, Mexico

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's-Hertogenbosch, North Brabant, Netherlands

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Amsterdam, , Netherlands

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Torres Vedras, Lisbon District, Portugal

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Coimbra, , Portugal

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Lisbon, , Portugal

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Matosinhos Municipality, , Portugal

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Inspira Clinical Research, Ave Hostos 405

San Juan, , Puerto Rico

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Singapore, , Singapore

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Rosebank, Johannesburg, South Africa

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Cape Town, Western Cape, South Africa

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George, ZAF, South Africa

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Suwon, Gyeonggi-do, South Korea

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Busan, , South Korea

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Incheon, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Terrassa, Barcelona, Spain

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Pozuelo de Alarcón, Madrid, Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Donostia / San Sebastian, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Basel, CH, Switzerland

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Geneva, , Switzerland

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Lausanne, , Switzerland

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Kaoshiung, , Taiwan

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New Taipei City, , Taiwan

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Taipei, , Taiwan

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Exeter, Devon, United Kingdom

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Plymouth, Devon, United Kingdom

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London, GBR, United Kingdom

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Guildford, Surrey, United Kingdom

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Avon, , United Kingdom

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Birmingham, , United Kingdom

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Bristol, , United Kingdom

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Dundee, , United Kingdom

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Glasgow, , United Kingdom

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London, , United Kingdom

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Novartis Investigative Site

London, , United Kingdom

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Countries

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United States Argentina Australia Belgium Canada Chile China Finland France Germany Iceland Israel Italy Japan Mexico Netherlands Portugal Puerto Rico Singapore South Africa South Korea Spain Switzerland Taiwan United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2016-002976-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CCNP520A2202J

Identifier Type: -

Identifier Source: org_study_id

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