Open Label Study of Long Term Evaluation Against LDL-C Trial (OSLER)

September 8, 2022 updated by: Amgen

A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145 (Evolocumab)

The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1324

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2015
        • Research Site
      • Maroubra, New South Wales, Australia, 2035
        • Research Site
      • Sydney, New South Wales, Australia, 2022
        • Research Site
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Research Site
  • Belgium
      • Anthée, Belgium, 5520
        • Research Site
      • Bruxelles, Belgium, 1200
        • Research Site
      • Gozee, Belgium, 6534
        • Research Site
      • Gribomont, Belgium, 6887
        • Research Site
      • Halen, Belgium, 3545
        • Research Site
      • Ham, Belgium, 3945
        • Research Site
      • Linkebeek, Belgium, 1630
        • Research Site
      • Ukkel, Belgium, 1180
        • Research Site
  • Canada
      • Quebec, Canada, G1V 4M6
        • Research Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1V6
        • Research Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
        • Research Site
      • Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
        • Research Site
      • St. John's, Newfoundland and Labrador, Canada, A1A 3R5
        • Research Site
    • Ontario
      • Cambridge, Ontario, Canada, N1R 6V6
        • Research Site
      • London, Ontario, Canada, N5W 6A2
        • Research Site
      • London, Ontario, Canada, N6A 5B7
        • Research Site
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Research Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Research Site
      • Sudbury, Ontario, Canada, P3C 5K7
        • Research Site
      • Toronto, Ontario, Canada, M9V 4B4
        • Research Site
      • Toronto, Ontario, Canada, M9W 4L6
        • Research Site
      • Toronto, Ontario, Canada, M8V 3X8
        • Research Site
      • Woodstock, Ontario, Canada, N4S 5P5
        • Research Site
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Research Site
      • Gatineau, Quebec, Canada, J8Y 6S9
        • Research Site
      • Granby, Quebec, Canada, J2G 8Z9
        • Research Site
      • Lachine, Quebec, Canada, H8S 2E4
        • Research Site
      • Pointe-Claire, Quebec, Canada, H9R 3J1
        • Research Site
  • Czechia
      • Brno, Czechia, 625 00
        • Research Site
      • Brno, Czechia, 603 00
        • Research Site
      • Brno, Czechia, 601 77
        • Research Site
      • Olomouc, Czechia, 775 20
        • Research Site
      • Praha 2, Czechia, 120 00
        • Research Site
      • Praha 4, Czechia, 140 21
        • Research Site
      • Slany, Czechia, 274 01
        • Research Site
      • Svitavy, Czechia, 568 25
        • Research Site
      • Usti nad Orlici, Czechia, 562 18
        • Research Site
      • Znojmo, Czechia, 669 02
        • Research Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Research Site
      • Ballerup, Denmark, 2750
        • Research Site
      • Vejle, Denmark, 7100
        • Research Site
  • Finland
      • Helsinki, Finland, 00290
        • Research Site
      • OYS, Finland, 90029
        • Research Site
  • Germany
      • Berlin, Germany, 13353
        • Research Site
      • Köln, Germany, 50937
        • Research Site
  • Hong Kong
      • New Territories, Hong Kong
        • Research Site
  • Hungary
      • Budapest, Hungary, 1096
        • Research Site
      • Debrecen, Hungary, 4032
        • Research Site
      • Dunaujvaros, Hungary, 2400
        • Research Site
      • Gyula, Hungary, 5700
        • Research Site
      • Kecskemet, Hungary, 6000
        • Research Site
      • Komarom, Hungary, 2921
        • Research Site
      • Szolnok, Hungary, 5004
        • Research Site
      • Zalaegerszeg, Hungary, 8900
        • Research Site
  • Japan
    • Aichi
      • Nagoya-shi, Aichi, Japan, 455-8530
        • Research Site
      • Nagoya-shi, Aichi, Japan, 454-0933
        • Research Site
      • Nagoya-shi, Aichi, Japan, 462-0825
        • Research Site
    • Fukui
      • Fukui-shi, Fukui, Japan, 910-0837
        • Research Site
    • Fukuoka
      • Kasuga-shi, Fukuoka, Japan, 816-0864
        • Research Site
    • Gunma
      • Fujioka-shi, Gunma, Japan, 375-0015
        • Research Site
      • Maebashi-shi, Gunma, Japan, 371-0022
        • Research Site
      • Maebashi-shi, Gunma, Japan, 371-0046
        • Research Site
      • Takasaki-shi, Gunma, Japan, 370-0829
        • Research Site
    • Hyogo
      • Kawanishi-shi, Hyogo, Japan, 666-0125
        • Research Site
      • Kobe-shi, Hyogo, Japan, 657-0068
        • Research Site
    • Ibaraki
      • Hitachi-shi, Ibaraki, Japan, 317-0077
        • Research Site
      • Koga-shi, Ibaraki, Japan, 306-0041
        • Research Site
      • Mito-shi, Ibaraki, Japan, 311-4198
        • Research Site
    • Ishikawa
      • Komatsu-shi, Ishikawa, Japan, 923-8560
        • Research Site
    • Kagawa
      • Takamatsu-shi, Kagawa, Japan, 760-8557
        • Research Site
    • Kochi
      • Kochi-shi, Kochi, Japan, 781-8555
        • Research Site
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 615-8125
        • Research Site
      • Kyoto-shi, Kyoto, Japan, 613-0911
        • Research Site
    • Nagano
      • Ina-shi, Nagano, Japan, 396-8555
        • Research Site
      • Matsumoto-shi, Nagano, Japan, 390-0848
        • Research Site
      • Suwa-shi, Nagano, Japan, 392-8510
        • Research Site
    • Osaka
      • Ibaraki-shi, Osaka, Japan, 567-0876
        • Research Site
      • Toyonaka-shi, Osaka, Japan, 560-0082
        • Research Site
    • Saitama
      • Hanyu-shi, Saitama, Japan, 348-8505
        • Research Site
      • Sayama-shi, Saitama, Japan, 350-1305
        • Research Site
      • Toda-shi, Saitama, Japan, 335-0023
        • Research Site
    • Tokyo
      • Chiyoda-ku, Tokyo, Japan, 101-0041
        • Research Site
      • Hachioji-shi, Tokyo, Japan, 192-0918
        • Research Site
      • Itabashi-ku, Tokyo, Japan, 173-8610
        • Research Site
      • Shinagawa-ku, Tokyo, Japan, 141-0001
        • Research Site
      • Toshima-ku, Tokyo, Japan, 171-0021
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Research Site
      • Hoorn, Netherlands, 1625 HV
        • Research Site
      • Utrecht, Netherlands, 3584 CX
        • Research Site
  • Norway
      • Oslo, Norway, 0373
        • Research Site
  • Singapore
      • Singapore, Singapore, 169609
        • Research Site
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Research Site
      • Midrand, Gauteng, South Africa, 1685
        • Research Site
    • Western Cape
      • Observatory, Western Cape, South Africa, 7925
        • Research Site
      • Parow, Western Cape, South Africa, 7505
        • Research Site
  • Spain
      • Madrid, Spain, 28040
        • Research Site
    • Andalucía
      • Cordoba, Andalucía, Spain, 14004
        • Research Site
    • Aragón
      • Zaragoza, Aragón, Spain, 50009
        • Research Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08036
        • Research Site
      • Reus, Cataluña, Spain, 43204
        • Research Site
  • Sweden
      • Göteborg, Sweden, 412 63
        • Research Site
      • Lund, Sweden, 222 21
        • Research Site
      • Stockholm, Sweden, 141 86
        • Research Site
      • Stockholm, Sweden, 111 35
        • Research Site
  • United Kingdom
      • London, United Kingdom, SW10 9NH
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Research Site
      • Birmingham, Alabama, United States, 35216
        • Research Site
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
      • Malvern, Arkansas, United States, 72104
        • Research Site
    • California
      • Anaheim, California, United States, 92801
        • Research Site
      • Carmichael, California, United States, 95608
        • Research Site
      • Inglewood, California, United States, 90301
        • Research Site
      • Mission Viejo, California, United States, 92691
        • Research Site
      • Newport Beach, California, United States, 92663
        • Research Site
      • Thousand Oaks, California, United States, 91360
        • Research Site
      • Tustin, California, United States, 92780
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Research Site
      • Littleton, Colorado, United States, 80120
        • Research Site
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Research Site
      • DeLand, Florida, United States, 32720
        • Research Site
      • Green Cove Springs, Florida, United States, 32043
        • Research Site
      • Jacksonville, Florida, United States, 32216
        • Research Site
      • Jacksonville, Florida, United States, 32223
        • Research Site
      • Melbourne, Florida, United States, 32901
        • Research Site
      • Miami, Florida, United States, 33173
        • Research Site
      • Miami, Florida, United States, 33144
        • Research Site
      • Ponte Vedra, Florida, United States, 32081
        • Research Site
      • Port Charlotte, Florida, United States, 33952
        • Research Site
      • Sanford, Florida, United States, 32771
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Research Site
      • Savannah, Georgia, United States, 31406
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60654
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Research Site
      • Munster, Indiana, United States, 46321
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Research Site
    • Maine
      • Auburn, Maine, United States, 04210
        • Research Site
      • Portland, Maine, United States, 04101
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Research Site
      • Chevy Chase, Maryland, United States, 20815
        • Research Site
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Research Site
    • Michigan
      • Marquette, Michigan, United States, 49855
        • Research Site
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • Research Site
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Research Site
    • Montana
      • Great Falls, Montana, United States, 59405
        • Research Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Research Site
      • Las Vegas, Nevada, United States, 89148
        • Research Site
      • Las Vegas, Nevada, United States, 89117
        • Research Site
    • New York
      • Cortlandt Manor, New York, United States, 10567
        • Research Site
      • Endwell, New York, United States, 13760
        • Research Site
      • New York, New York, United States, 10029
        • Research Site
      • Williamsville, New York, United States, 14221
        • Research Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Research Site
      • Raleigh, North Carolina, United States, 27612
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Research Site
    • Ohio
      • Akron, Ohio, United States, 44311
        • Research Site
      • Cadiz, Ohio, United States, 43907
        • Research Site
      • Cincinnati, Ohio, United States, 45219
        • Research Site
      • Cincinnati, Ohio, United States, 45227
        • Research Site
      • Cincinnati, Ohio, United States, 45246
        • Research Site
      • Cleveland, Ohio, United States, 44122
        • Research Site
      • Dayton, Ohio, United States, 45414
        • Research Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Research Site
      • Oklahoma City, Oklahoma, United States, 73103
        • Research Site
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Research Site
      • Duncansville, Pennsylvania, United States, 16635
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15216
        • Research Site
      • York, Pennsylvania, United States, 17405
        • Research Site
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Research Site
      • Rapid City, South Dakota, United States, 57701
        • Research Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Research Site
    • Texas
      • Arlington, Texas, United States, 76018
        • Research Site
      • Houston, Texas, United States, 77074
        • Research Site
      • Houston, Texas, United States, 77002
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Research Site
      • Richmond, Virginia, United States, 23294
        • Research Site
    • Washington
      • Renton, Washington, United States, 98057
        • Research Site
      • Seattle, Washington, United States, 98122
        • Research Site
      • Tacoma, Washington, United States, 98405
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Complete a qualifying evolocumab (AMG 145) parent study protocol, including: 20101154 (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764), and 20110231 (NCT01652703)

Exclusion Criteria:

  • Experienced a treatment-related serious adverse event that led to investigational product (IP) discontinuation in the parent study
  • Have an unstable medical condition, in the judgment of the investigator
  • Known sensitivity to any of the products to be administered during dosing
  • Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard of Care
Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 52 participants began treatment with evolocumab 420 mg once a month (QM) for 4 years during the all-investigational product [all-IP] period.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
Other: Standard of care
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Experimental: Evolocumab + SOC
Participants received evolocumab 420 mg once a month plus standard of care for the first year of the study (SOC-controlled period). At week 52 participants continued treatment with evolocumab 420 mg QM for another 4 years during the all-IP period.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months.
Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.03, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.
52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52
Time Frame: Baseline of parent study and extension study weeks 24 and 52
Baseline of parent study and extension study weeks 24 and 52
Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52
Time Frame: Baseline of parent study and extension study weeks 24 and 52
Baseline of parent study and extension study weeks 24 and 52
Apolipoprotein B Level at Week 24 and Week 52
Time Frame: Baseline of parent study and extension study weeks 24 and 52
Baseline of parent study and extension study weeks 24 and 52
Total Cholesterol/HDL-C Ratio at Week 24 and Week 52
Time Frame: Baseline of parent study and extension study weeks 24 and 52
Baseline of parent study and extension study weeks 24 and 52
Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52
Time Frame: Baseline of parent study and extension study weeks 24 and 52
Baseline of parent study and extension study weeks 24 and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20110110
  • 2011-001915-29 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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