Statins (Cardiovascular Agents) for Lipidemia

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Lipidemia+1 More
Statins (Cardiovascular Agents) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cholesterol-lowering drug in kidney transplant patients to see if it is safe and tolerable.

Eligible Conditions
  • Lipidemia

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 12 months

12 months
Percent change from baseline in the LDL cholesterol level
absolute change from baseline in the LDL cholesterol level

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Evolocumab plus statin
1 of 2
Evolocumab only
1 of 2
Experimental Treatment

120 Total Participants · 2 Treatment Groups

Primary Treatment: Statins (Cardiovascular Agents) · No Placebo Group · Phase 4

Evolocumab plus statinExperimental Group · 2 Interventions: Evolocumab, Statins (Cardiovascular Agents) · Intervention Types: Drug, Drug
Evolocumab only
Drug
Experimental Group · 1 Intervention: Evolocumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Evolocumab
FDA approved
Statins (Cardiovascular Agents)
2019
Completed Phase 3
~480

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

AmgenIndustry Sponsor
1,291 Previous Clinical Trials
1,306,934 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,468 Previous Clinical Trials
9,703,534 Total Patients Enrolled
Anil K Chandraker, MDPrincipal InvestigatorBrigham and Women's Hospital
2 Previous Clinical Trials
50 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are aged > 18 years and have a documented ASCVD or diabetes and 1 or more risk factors for ASCVD, including, but not limited to obesity, inactive lifestyle, hypertension, smoking, and family history.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: October 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References