Status:
COMPLETED
Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Atherosclerotic Cardiovascular Disease
Atherosclerotic Cardiovascular Disease Risk Equivelents
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study was to evaluate the implementation of inclisiran in a regional primary care setting in the UK Inclisiran, also known as KJX839, is a medication made to reduce the level of "...
Detailed Description
A phase IIIb, multicenter, randomized controlled study to evaluate the implementation, preference, and utility for administration of inclisiran sodium in participants on established lipid lowering med...
Eligibility Criteria
Inclusion
- Signed informed consent had to be obtained prior to participation in the study.
- Patients on established lipid lowering medication or, have been recommended lipid lowering therapy by their health care provider but were unable to tolerate treatment.
- A total cholesterol measurement at screening that was ≥4 mmol/L \[approximately 160 mg/dL\].
- Participants on lipid-lowering therapies had to be on a stable dose for ≥30 days before screening with no planned medication or dose change.
Exclusion
- Medical or surgical history that might limit the individual's ability to take study treatments for the duration of the study and/or put the participant at significant risk .
- Current or planned renal dialysis or transplantation.
- Acute coronary syndrome or stroke less than 4 weeks before the screening visit.
- Coronary revascularization procedure planned within the next 6 months.
- Women of child-bearing potential, unless they agree to abstinence or, if sexually active, agree to the use of effective methods of contraception during the study.
- Women who are pregnant or breast-feeding.
- Previous, current or planned treatment with a monoclonal antibody targeting PCSK9, or with a drug known to be contra-indicated with inclisiran.
- Previous exposure to inclisiran or participation in a randomised study of inclisiran.
- Current or previous participation in a clinical study with an unlicensed drug or device within 30 days or five half-lives of the screening visit, whichever is longer.
- Participants who planed to move away from the geographical area where the study is being conducted during the study period.
- A triglyceride measurement at screening that is greater than or equal to 4.52 mmol/L
Key Trial Info
Start Date :
July 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2023
Estimated Enrollment :
892 Patients enrolled
Trial Details
Trial ID
NCT04807400
Start Date
July 7 2021
End Date
January 13 2023
Last Update
October 9 2024
Active Locations (17)
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1
Novartis Investigative Site
Sale, Cheshire, United Kingdom, M33 4BR
2
Novartis Investigative Site
Altrincham, Manchester, United Kingdom, WA14 1PF
3
Novartis Investigative Site
Davyhulme, Manchester, United Kingdom, M41 7WJ
4
Novartis Investigative Site
Didsbury, Manchester, United Kingdom, M20 6BA