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New treatment option for Hypercholesterolaemia
Official title A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia
ClinicalTrials.gov ID: NCT07610278
What this study is testing
What is QCZ484?
QCZ484 is an investigational medicine, being studied as a potential treatment for hypercholesterolaemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Males or females aged 18 to 75 years.
- Diagnosis of primary hypertension.
- Treatment with either no, or up to 2 antihypertensive medications at a stable dose for at least 4 weeks preceding screening.
- Systolic blood pressure ≥140 and \<165 mmHg based on the mean of 3 sitting measurements based on office blood pressure monitoring.
- Diagnosis of hypercholesterolemia including heterozygous familial hypercholesterolemia unable to reach LDL-C goals with a stable dose of statin...
You likely can't join if
- Symptomatic orthostatic hypotension.
- Treatment with certain medications and/or unable to comply with prohibited medications requirements. Other protocol inclusion/exclusion criteria may...
See the full eligibility criteria
- Males or females aged 18 to 75 years.
- Diagnosis of primary hypertension.
- Treatment with either no, or up to 2 antihypertensive medications at a stable dose for at least 4 weeks preceding screening.
- Systolic blood pressure ≥140 and \<165 mmHg based on the mean of 3 sitting measurements based on office blood pressure monitoring.
- Diagnosis of hypercholesterolemia including heterozygous familial hypercholesterolemia unable to reach LDL-C goals with a stable dose of statin treatment for at least 4 weeks prior to screening as per Investigator...
- Fasting serum LDL-C ≥70 mg/dL and \<190 mg/dL using Friedewald equation.
- Fasting triglyceride \<400 mg/dL.
- Symptomatic orthostatic hypotension.
- Treatment with certain medications and/or unable to comply with prohibited medications requirements. Other protocol inclusion/exclusion criteria may apply
The study team makes the final eligibility decision.
Where it's taking place
- Foley, Alabama, United States
- Saraland, Alabama, United States
- Lincoln, California, United States
- Los Angeles, California, United States
- Northridge, California, United States
- Boca Raton, Florida, United States
- Cooper City, Florida, United States
- Coral Gables, Florida, United States
- Doral, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Pembroke Pines, Florida, United States
- Saint Augustine, Florida, United States
- Chicago, Illinois, United States
- Niles, Illinois, United States
- Wichita, Kansas, United States
- West Monroe, Louisiana, United States
- Ft. Washington, Maryland, United States
- Monroe, North Carolina, United States
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Foley, Alabama, United States; Saraland, Alabama, United States; Lincoln, California, United States; Los Angeles, California, United States; Northridge, California, United States; Boca Raton, Florida, United States and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.