Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)

October 7, 2015 updated by: Sanofi

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9).

Primary Objective of the study:

  • To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high cardiovascular (CV) risk participants with hypercholesterolemia

Secondary Objectives:

  • To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points
  • To evaluate the effect of alirocumab on other lipid parameters
  • To evaluate the safety and tolerability of alirocumab

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.

Detailed Description

The maximum study duration was 62 weeks per participant, including a 2-week screening period, 52-week randomized treatment period, and 8-week follow-up period.

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.
316

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 3

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Investigational Site Number 840857
      • Mobile, Alabama, United States, 36693
        • Investigational Site Number 840891
      • Montgomery, Alabama, United States, 36109
        • Investigational Site Number 840876
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Investigational Site Number 840865
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Investigational Site Number 840826
    • California
      • Burbank, California, United States, 91505
        • Investigational Site Number 840870
      • Los Angeles, California, United States, 90057
        • Investigational Site Number 840851
      • Los Gatos, California, United States, 95032
        • Investigational Site Number 840845
      • Sacramento, California, United States, 95823
        • Investigational Site Number 840844
      • San Jose, California, United States, 95116
        • Investigational Site Number 840801
      • Tarzana, California, United States, 91356
        • Investigational Site Number 840886
      • Torrance, California, United States, 90505
        • Investigational Site Number 840862
      • Vista, California, United States, 92083
        • Investigational Site Number 840893
    • Florida
      • Boca Raton, Florida, United States, 33432
        • Investigational Site Number 840867
      • Boynton Beach, Florida, United States, 33472
        • Investigational Site Number 840884
      • Clearwater, Florida, United States, 33761
        • Investigational Site Number 840836
      • Coral Gables, Florida, United States, 33134
        • Investigational Site Number 840866
      • Ft. Lauderdale, Florida, United States, 33308-4311
        • Investigational Site Number 840895
      • Hialeah, Florida, United States
        • Investigational Site Number 840820
      • Miami, Florida, United States, 33143
        • Investigational Site Number 840805
      • Oviedo, Florida, United States, 32765
        • Investigational Site Number 840811
      • Port Orange, Florida, United States, 32127
        • Investigational Site Number 840881
      • West Palm Beach, Florida, United States
        • Investigational Site Number 840816
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Investigational Site Number 840850
    • Idaho
      • Eagle, Idaho, United States
        • Investigational Site Number 840840
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Investigational Site Number 840842
      • Evanston, Illinois, United States, 60201
        • Investigational Site Number 840898
      • Morton, Illinois, United States, 61550
        • Investigational Site Number 840847
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Investigational Site Number 840896
      • Michigan City, Indiana, United States, 46360
        • Investigational Site Number 840894
      • Mishawaka, Indiana, United States, 46545
        • Investigational Site Number 840838
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Investigational Site Number 840823
    • Louisiana
      • Eunice, Louisiana, United States, 70535
        • Investigational Site Number 840858
      • New Orleans, Louisiana, United States, 70119
        • Investigational Site Number 840802
    • Massachusetts
      • Salisbury, Massachusetts, United States, 01952
        • Investigational Site Number 840855
    • Michigan
      • Battle Creek, Michigan, United States, 49015
        • Investigational Site Number 840890
      • Southfield, Michigan, United States, 48034
        • Investigational Site Number 840832
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Investigational Site Number 840839
      • Minneapolis, Minnesota, United States, 55455
        • Investigational Site Number 840888
    • Mississippi
      • Port Gibson, Mississippi, United States, 39150
        • Investigational Site Number 840837
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Investigational Site Number 840814
    • Nevada
      • Sparks, Nevada, United States
        • Investigational Site Number 840833
    • New Hampshire
      • Newington, New Hampshire, United States, 3801
        • Investigational Site Number 840817
    • New York
      • New Windsor, New York, United States, 12553
        • Investigational Site Number 840853
      • Rochester, New York, United States, 14609
        • Investigational Site Number 840822
    • North Carolina
      • Cary, North Carolina, United States
        • Investigational Site Number 840824
      • Smithfield, North Carolina, United States
        • Investigational Site Number 840880
      • Winston-Salem, North Carolina, United States, 27103
        • Investigational Site Number 840502
      • Winston-Salem, North Carolina, United States, 27103
        • Investigational Site Number 840852
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Investigational Site Number 840846
      • Cincinnati, Ohio, United States, 45245
        • Investigational Site Number 840899
      • Columbus, Ohio, United States, 43231
        • Investigational Site Number 840831
      • Kettering, Ohio, United States, 45429
        • Investigational Site Number 840860
      • Willoughby Hills, Ohio, United States, 44094
        • Investigational Site Number 840809
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Investigational Site Number 840818
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Investigational Site Number 840812
    • Pennsylvania
      • Downington, Pennsylvania, United States, 19335
        • Investigational Site Number 840803
      • Philadelphia, Pennsylvania, United States, 19146
        • Investigational Site Number 840869
      • Pittsburgh, Pennsylvania, United States, 15206
        • Investigational Site Number 840825
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Investigational Site Number 840872
      • Charleston, South Carolina, United States, 29407
        • Investigational Site Number 840885
      • Greer, South Carolina, United States, 29651
        • Investigational Site Number 840813
      • Mt. Pleasant, South Carolina, United States, 29464
        • Investigational Site Number 840827
    • Texas
      • Corpus Christi, Texas, United States, 78404
        • Investigational Site Number 840868
      • Houston, Texas, United States, 77070
        • Investigational Site Number 840877
      • Houston, Texas, United States, 77072
        • Investigational Site Number 840841
      • San Antonio, Texas, United States, 78224
        • Investigational Site Number 840830
      • San Antonio, Texas, United States, 78229
        • Investigational Site Number 840854
      • San Antonio, Texas, United States, 78258
        • Investigational Site Number 840883
      • Tomball, Texas, United States, 77375
        • Investigational Site Number 840889
    • Utah
      • Bountiful, Utah, United States, 84010
        • Investigational Site Number 840878
      • Orem, Utah, United States, 84058
        • Investigational Site Number 840819
      • Salt Lake City, Utah, United States, 84102
        • Investigational Site Number 840863
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Investigational Site Number 840804
      • Norfolk, Virginia, United States, 23507
        • Investigational Site Number 840882
      • Weber City, Virginia, United States, 24290
        • Investigational Site Number 840810

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who were not adequately controlled with a maximally tolerated daily dose of statin with or without other LMT, both at stable dose for at least 4 weeks to 6 weeks prior to screening (Week -2)

Exclusion criteria:

  • Age <18 or legal age of adulthood, whichever was greater
  • Participants without established CHD or CHD risk equivalent
  • LDL-C <70 mg/dL (<1.81 mmol/L) and participants with a history of documented cardiovascular disease
  • LDL-C <100 mg/dL (<2.59 mmol/L) and participants without a history of documented cardiovascular disease
  • Not on a stable dose of LMT (including statin) for at least 4 weeks and/or fenofibrate for at least 6 weeks, as applicable, prior to the screening visit (Week -2) and from screening to randomization
  • Fasting serum triglycerides > 400 mg/dL (>4.52 mmol/L)

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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: Quadruple

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.
Placebo Comparator: Placebo Q2W
Placebo (for alirocumab) every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 52 weeks.
Drug: Lipid-Modifying Therapy (LMT)
Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.
Drug: Placebo (for alirocumab)
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector (also known as pre-filled pen).
Experimental: Alirocumab
Alirocumab 75 mg Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Drug: Lipid-Modifying Therapy (LMT)
Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.
Drug: Alirocumab
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector (also known as pre-filled pen).
Other Names:
  • SAR236553
  • REGN727

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
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis
Time Frame: From Baseline to Week 52
Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).
From Baseline to Week 52

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
Measure Description
Time Frame
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
Time Frame: From Baseline to Week 52
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From Baseline to Week 52
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis
Time Frame: From Baseline to Week 52
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From Baseline to Week 52
Percent Change From Baseline in Apo B at Week 12 - ITT Analysis
Time Frame: From Baseline to Week 52
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From Baseline to Week 52
Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis
Time Frame: From Baseline to Week 52
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).
From Baseline to Week 52
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis
Time Frame: From Baseline to Week 52
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From Baseline to Week 52
Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
Time Frame: From Baseline to Week 52
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From Baseline to Week 52
Percent Change From Baseline in Total-C at Week 12 - ITT Analysis
Time Frame: From Baseline to Week 52
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From Baseline to Week 52
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis
Time Frame: Up to Week 52
Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.
Up to Week 52
Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis
Time Frame: From Baseline to Week 52
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From Baseline to Week 52
Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
Time Frame: From Baseline to Week 52
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From Baseline to Week 52
Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis
Time Frame: From Baseline to Week 52
Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From Baseline to Week 52
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
Time Frame: From Baseline to Week 52
Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).
From Baseline to Week 52
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis
Time Frame: From baseline to Week 52
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From baseline to Week 52
Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis
Time Frame: From Baseline to Week 52
Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).
From Baseline to Week 52
Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis
Time Frame: From Baseline to Week 52
Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).
From Baseline to Week 52
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-treatment Analysis
Time Frame: Up to Week 52
Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.
Up to Week 52
Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis
Time Frame: From baseline to Week 52
Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.
From baseline to Week 52
Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
Time Frame: From Baseline to Week 52
Adjusted means and standard errors at Week 24 from multiple imputation approach followed be robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From Baseline to Week 52
Percent Change From Baseline in Apolipoprotein A-1 at Week 24 - ITT Analysis
Time Frame: From Baseline to Week 52
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From Baseline to Week 52
Percent Change From Baseline in Lipoprotein(a) at Week 12- ITT Analysis
Time Frame: From Baseline to Week 52
Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From Baseline to Week 52
Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
Time Frame: From Baseline to Week 52
Adjusted means and standard errors at Week 12 from multiple imputation approach followed by a robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From Baseline to Week 52
Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis
Time Frame: From Baseline to Week 52
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From Baseline to Week 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.
Sanofi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Regeneron Pharmaceuticals

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

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

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.
July 1, 2012

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.
April 1, 2014

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.
April 1, 2014

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).
July 16, 2012

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.
July 16, 2012

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.
July 18, 2012

Study Record Updates

Last Update Posted (Estimate)

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.
November 6, 2015

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.
October 7, 2015

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.
October 1, 2015

More Information

Terms related to this study

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.
  • EFC11568
  • U1111-1121-4356 (Other Identifier: UTN)

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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