QCZ484 + Inclisiran for Hypertension and High Cholesterol
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a multicenter, randomized, double-blind, factorial design Phase 2 study to evaluate the pharmacodynamics, safety and tolerability of a combination of QCZ484 and inclisiran compared to QCZ484, inclisiran, and placebo in participants with hypertension and concomitant hypercholesterolemia.
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for adults aged 18–75 who have high blood pressure (systolic BP between 140 and 165) and high cholesterol that isn't controlled by current medications. Participants can be on up to two stable blood pressure medicines and must have LDL cholesterol between 70–190 mg/dL.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive a combination of QCZ484 and inclisiran, QCZ484, inclisiran, or placebo once on Day 1 at the Baseline/Randomization visit
Safety Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Eligible participants who complete the treatment period have the option to participate in an open-label extension study
What Are the Treatments Tested in This Trial?
Trial Overview
The study tests the effects of combining QCZ484 with inclisiran versus each drug alone or placebo in people with both high blood pressure and high cholesterol. Participants are randomly assigned to different groups, and neither they nor their doctors know which treatment they're getting.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Placebo Group
QCZ484 + inclisiran, once on Day 1
QCZ484 + inclisiran placebo, once on Day 1
Inclisiran + QCZ484 placebo, once on Day 1
QCZ484 placebo + inclisiran placebo, once on Day 1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.