A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia
Recruiting · NCT07610278 · Interventional (participants receive a specific treatment) · Lead sponsor: Novartis Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion 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 judgement, guidelines and local practice (if tolerated and not contraindicated) with or without bempedoic acid and with or without ezetimibe prescribed according to local guidance, at a stable dose for at least 4 weeks preceding Screening Visit 1.
- The following parameters must be confirmed at Screening Visit 2:
- Fasting serum LDL-C ≥70 mg/dL and \<190 mg/dL using Friedewald equation.
- Fasting triglyceride \<400 mg/dL.
Exclusion criteria
- Symptomatic orthostatic hypotension.
- Treatment with certain medications and/or unable to comply with prohibited medications requirements.
- ther protocol inclusion/exclusion criteria may apply
Where it is running
58 locations listed across 12 US states.
- G and L Research LLC - Foley, Alabama, United States
- G and L Research LLC - Foley, Alabama, United States
- The Center for Clinical Trials - Saraland, Alabama, United States
- The Center for Clinical Trials - Saraland, Alabama, United States
- Clinical Trials Research - Lincoln, California, United States
- Clinical Trials Research - Lincoln, California, United States
- Downtown L A Research Center Inc - Los Angeles, California, United States
- Downtown L A Research Center Inc - Los Angeles, California, United States
- Valley Clinical Trials - Northridge, California, United States
- Valley Clinical Trials - Northridge, California, United States
- Flourish Medical Clinical Trials - Boca Raton, Florida, United States
- Flourish Medical Clinical Trials - Boca Raton, Florida, United States
- Clinical Research of Brandon LLC - Brandon, Florida, United States
- Clinical Research of Brandon LLC - Brandon, Florida, United States
- ALL Medical Research LLC - Cooper City, Florida, United States
- ALL Medical Research LLC - Cooper City, Florida, United States
- AMR Miami - Coral Gables, Florida, United States
- AMR Miami - Coral Gables, Florida, United States
- Universal Axon Clinical Research - Doral, Florida, United States
- Universal Axon Clinical Research - Doral, Florida, United States
- East Coast Institute for Research - Jacksonville, Florida, United States
- East Coast Institute for Research - Jacksonville, Florida, United States
- Entrust Clinical Research - Miami, Florida, United States
- Entrust Clinical Research - Miami, Florida, United States
- Inpatient Research Clinical LLC - Miami Lakes, Florida, United States
- Inpatient Research Clinical LLC - Miami Lakes, Florida, United States
- Inpatient Research Clinical LLC - Miami Lakes, Florida, United States
- Inpatient Research Clinical LLC - Miami Lakes, Florida, United States
- American Research Centers of FL - Pembroke Pines, Florida, United States
- American Research Centers of FL - Pembroke Pines, Florida, United States
- East Coast Inst for Research LLC - Saint Augustine, Florida, United States
- East Coast Inst for Research LLC - Saint Augustine, Florida, United States
- East Coast Research - Canton, Georgia, United States
- East Coast Research - Canton, Georgia, United States
- Great Lakes Clinical Trials - Chicago, Illinois, United States
- Great Lakes Clinical Trials - Chicago, Illinois, United States
- AMR Chicago - Niles, Illinois, United States
- AMR Chicago - Niles, Illinois, United States
- Alliance for Multispecialty Research - Wichita, Kansas, United States
- Alliance for Multispecialty Research - Wichita, Kansas, United States
- Monroe Research Llc - West Monroe, Louisiana, United States
- Monroe Research Llc - West Monroe, Louisiana, United States
- Anderson Medical Research - Ft. Washington, Maryland, United States
- Anderson Medical Research - Ft. Washington, Maryland, United States
- Capitol Cardiology Associates - Lanham, Maryland, United States
- Capitol Cardiology Associates - Lanham, Maryland, United States
- Monroe Biomedical Research - Monroe, North Carolina, United States
- Monroe Biomedical Research - Monroe, North Carolina, United States
- Walker Family Care - Little River, South Carolina, United States
- Walker Family Care - Little River, South Carolina, United States
- Synergy Group Medical LLC - Houston, Texas, United States
- Synergy Group Medical LLC - Houston, Texas, United States
- Synergy Group Medical LLC - Houston, Texas, United States
- Synergy Group Medical LLC - Houston, Texas, United States
- Manassas Clinical Research Center - Manassas, Virginia, United States
- Manassas Clinical Research Center - Manassas, Virginia, United States
- Dominion Medical Associates - Richmond, Virginia, United States
- Dominion Medical Associates - Richmond, Virginia, United States