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A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia

RecruitingPhase 2Ages 18 Years - 75 YearsAllNovartis Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ140 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 โ‰ฅ70 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. Other protocol inclusion/exclusion criteria may apply
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What it tests

  • QCZ484
  • Inclisiran
  • QCZ484 placebo
  • Inclisiran placebo
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Where

29 sites
G and L Research LLC
Foley, United States
The Center for Clinical Trials
Saraland, United States
Clinical Trials Research
Lincoln, United States
Downtown L A Research Center Inc
Los Angeles, United States
Valley Clinical Trials
Northridge, United States
Flourish Medical Clinical Trials
Boca Raton, United States
Clinical Research of Brandon LLC
Brandon, United States
ALL Medical Research LLC
Cooper City, United States

โ€ฆand 21 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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