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A Randomized, Multi-Center, Placebo-Controlled, Parallel Group Study to Determine the Effects of AMG 145 Treatment on Atherosclerotic Disease Burden As Measured By Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization (GLAGOV study, 20120153)

Primary: To evaluate the effect of AMG 145 on the change in burden of coronary atherosclerosis as measured by percent atheroma volume (assessed with intravascular ultrasound, IVUS) in patients with coronary artery disease requiring angiography for a…

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

To characterize the safety and tolerability of long-term administration of evolocumab in subjects with known coronary artery disease andhypercholesterolemia.

A RaNdomized Double-blInd Placebo ConTrolled Study Characterizing THe Effects of PCSK9 Inhibition On Arterial Wall Inflammation in Patients With Elevated Lp(a) (ANITSCHKOW)

Patients with hyperlipidemie and an elevated Lp(a) will be asked to partipate in this study. This part potentially increases the risk of cardiovascular diseases. One of the reasons why Lp(a) is expected to increases this risk is that Lp(a)…

A multicenter, randomized, double-blind, placebo-controlled, crossover trial to evaluate the effects of evolocumab added to standard lipid-lowering therapy on fasting and post fat load lipids in patients with Familial Dysbetalipoproteinemia.

To evaluate the effect of 12 weeks subcutaneous evolocumab (140 mg pre-filled pen every 2 weeks) compared to placebo on post fat load non-HDL-C levels in 30 subjects with FD, in a multicenter, randomized, placebo-controlled, double-blind, crossover…

Dose response and safety of an oral PCSK9i, NNC0385-0434, in patients with established atherosclerotic cardiovascular disease (ASCVD) or ASCVD risk on maximally tolerated statin dose and other lipid-lowering therapy requiring further LDL-C reduction

Primary objective:To demonstrate superiority of three dose levels of oral NNC0385-0434 versus placebo on percent change in LDL-C from baseline to week 12 in patients with established ASCVD or ASCVD risk on maximally tolerated statin dose and other…

High-Resolution Assessment of Coronary Plaques in a Global Evolocumab Randomized Study (HUYGENS)

* Primary Objective: To evaluate the effect of evolocumab on fibrous cap thickness (FCT) in subjects with non ST elevation acute coronary syndrome (NSTE ACS) who are taking maximally tolerated statin therapy.* Secondary Objective(s): To evaluate the…

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke

This study has been transitioned to CTIS with ID 2023-503673-38-00 check the CTIS register for the current data. - To evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for coronary heart disease (CHD) death,…

Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH)

PrimaryTo describe the safety and tolerability of 80 weeks of SC evolocumab when added to standard of care in pediatric subjects 10 to 17 years of age with HeFH or HoFH. Secondary Efficacy* To describe percent change and change from baseline in LDL-…

An open label, active comparator extension trial to assess the effect of long term dosing of inclisiran and evolocumab given as subcutaneous injections in subjects with high cardiovascular risk and elevated LDL C (ORION-3)

Primary:• To evaluate the effect of inclisiran treatment on low density lipoprotein cholesterol (LDL-C) levels at Day 210 compared to Day 1 of this extension study. Secondary:• To evaluate the effects of inclisiran on the following: LDL-C levels…