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Long Term Safety Study of PRALUENT

NCT ID: NCT03694197

Last Updated: 2021-06-15

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

1389 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-28

Study Completion Date

2020-04-08

Brief Summary

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The primary objective of the study was to evaluate the long term safety of PRALUENT in participants with heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH) participants at high or very high cardiovascular risk who completed the neurocognitive function study R727-CL-1532 (NCT02957682).

The secondary objectives of the study were:

* To evaluate the effect of PRALUENT on low-density lipoprotein cholesterol (LDL-C)
* To evaluate the effect of PRALUENT on other lipid parameters
* To evaluate the effect of PRALUENT on gonadal steroid hormones

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Detailed Description

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Conditions

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Heterozygous Familial Hypercholesterolemia Non-familial Hypercholesterolemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open label

Group Type EXPERIMENTAL

Praluent

Intervention Type DRUG

Subcutaneous (SC) administration

Interventions

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Praluent

Subcutaneous (SC) administration

Intervention Type DRUG

Other Intervention Names

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Alirocumab REGN727 SAR236553

Eligibility Criteria

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Inclusion Criteria

Participants randomized into the neurocognitive function study (R727-CL-1532) who completed treatment and the end of study (EOS) visit with no premature or permanent discontinuation of study drug.

Exclusion Criteria

1. Significant protocol deviation in the parent study (neurocognitive function study R727-CL-1532: NCT02957682) based on the investigator's or sponsor's judgment, such as noncompliance
2. Any participant who experienced an AE leading to permanent discontinuation from the neurocognitive function study R727-CL-1532 (NCT02957682).
3. Any new condition or worsening of an existing condition which, in the opinion of the investigator or per the PRALUENT local label, would make the participant unsuitable for enrollment or could interfere with the participant participating in or completing the open-label extension (OLE) study
4. Known hypersensitivity to monoclonal antibody or any component of the drug product
5. Pregnant or breastfeeding women
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Regeneron Research Site

Auburn, Alabama, United States

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Regeneron Research Site

Mobile, Alabama, United States

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Beverly Hills, California, United States

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Los Gatos, California, United States

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North Hollywood, California, United States

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Port Hueneme, California, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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Lake Worth, Florida, United States

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Miami Springs, Florida, United States

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Champaign, 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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Newton, 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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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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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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Charleston, 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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Schertz, Texas, United States

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Shavano Park, 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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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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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Varna, , Bulgaria

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Tallinn, Harju, Estonia

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Paide, , Estonia

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Tallinn, , Estonia

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Tallinn, , Estonia

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Tartu, , Estonia

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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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Saratov, , Russia

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Sverdlovskaya, , Russia

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Tyumen, , Russia

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Yaroslavl, , Russia

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Yaroslavl, , Russia

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Yekaterinburg, , Russia

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Kuilsrivier, Cape Town, South Africa

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Parow, Cape Town, South Africa

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Port Elizabeth, Eastern Cape, South Africa

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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, 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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Cape Town, Western Cape, South Africa

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Cape Town, Western Cape, South Africa

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George, Western Cape, South Africa

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Paarl, Western Cape, South Africa

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Somerset West, Western Cape, South Africa

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Worcester, Western Cape, South Africa

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Bloemfontein, , South Africa

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Claremont, , South Africa

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Johannesburg, , South Africa

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Regeneron Research Site #2

Kharkiv, , Ukraine

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Kharkiv, , Ukraine

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Kiev, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Regeneron Research Site #2

Kyiv, , Ukraine

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Kyiv, , Ukraine

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Lviv, , Ukraine

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Uzhhorod, , Ukraine

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Vinnitsa, , Ukraine

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Vinnitsya, , Ukraine

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Vinnytsia, , Ukraine

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Countries

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United States Bulgaria Estonia Russia South Africa Ukraine

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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2018-002810-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R727-CL-1609

Identifier Type: -

Identifier Source: org_study_id

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