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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNovartis Pharmaceuticals

About 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Symptomatic orthostatic hypotension.

Treatment with certain medications and/or unable to comply with prohibited medications requirements.

Trial design

Treatments tested in this trial

  • QCZ484
  • Inclisiran
  • QCZ484 placebo
  • Inclisiran placebo

Treatment groups

120 Participants
are divided into 4 treatment groups

Sponsors and collaborators