Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia (V-DIFFERENCE)
Efficacy, Safety, Tolerability and Quality of Life of Ongoing Individually Optimized Lipid-lowering Therapy With or Without Inclisiran (KJX839) - a Randomized, Placebo-controlled, Double-blind Multicenter Phase IV Study in Participants With Hypercholesterolemia
Sponsor: Novartis Pharmaceuticals
A observational or N/A phase clinical study on Hypercholesterolemia, this trial is completed. The trial is conducted by Novartis Pharmaceuticals and has accumulated 28 data snapshots since 2022. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)This was a double-blind, placebo-controlled multicenter study in adult participants with very high or high cardiovascular risk who did not meet their individual LDL-C target despite being treated with their individual maximum tolerated dose (MTD) of a statin, and if applicable, further Lipid-Lowering Therapy (LLT).
The purpose of this study was to demonstrate the superiority of inclisiran compared to placebo, both on top of ongoing individually optimized LLT, on reaching a participant's LDL-C target (\< 55 mg/dL or \< 70 mg/dL, depending on the cardiovascular risk category), according to the 2019 ESC/EAS guidelines for the management of dyslipidemias as well as on patient-relevant safety, tolerability outcomes and quality of life.
This was a double-blind, placebo-controlled multicenter study in adult participants with very high or high cardiovascular risk who did not meet their individual LDL-C target despite being treated with their individual maximum tolerated dose (MTD) of a statin, and if applicable, further Lipid-Lowering Therapy (LLT).
The purpose of this study was to demonstrate the superiority of inclisiran compared to placebo, both on top of ongoing individually optimized LLT, on reaching a participant's LDL-C target (\< 55 mg/dL or \< 70 mg/dL, depending on the cardiovascular risk category), according to the 2019 ESC/EAS guidelines for the management of dyslipidemias as well as on patient-relevant safety, tolerability outcomes and quality of life.
Status Flow
Change History
28 versions recorded-
Apr 16, 2026 — Present [daily]
Completed
Phase: PHASE4 → None
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Sep 2025 — Apr 2026 [monthly]
Completed PHASE4
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Completed PHASE4
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Completed PHASE4
Status: Active Not Recruiting → Completed
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Active Not Recruiting PHASE4
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Recruiting PHASE4
Status: Not Yet Recruiting → Recruiting
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Feb 2022 — Jun 2022 [monthly]
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First recorded
Eligibility Summary
Study of efficacy, safety, tolerability and quality of life of inclisiran (KJX839) vs placebo, on top of ongoing individually optimized lipid-lowering therapy, in participants with hypercholesterolemia
Contact Information
- Novartis Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Amiens, France , Bad Gottleuba, Germany , Bad Homburg, Germany , Bad Krozingen, Germany , Bad Oeynhausen, Germany , Bamberg, Germany , Barcelona, Spain , Barcelona, Spain , Berlin, Germany , Berlin, Germany and 126 more locations