CompletedPhase 2

A Study to Assess the Effect of AZD0780 on Ambulatory Blood Pressure

United States202 participantsStarted 2024-10-30

Plain-language summary

This is a Phase II, multi-centre, randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of AZD0780 Dose 1 versus placebo on systolic blood pressure (SBP) at Week 4, as measured by 24-hour ambulatory blood pressure monitoring (ABPM) in participants with ASCVD or risk equivalents and LDL-C ≥ 70 mg/dL, on stable medication.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Participant must be ≥ 18 years of age at the time of signing the informed consent.
✓. Participants with a history of ASCVD defined as myocardial infarction, stroke, or symptomatic peripheral arterial disease, or with risk factors hereof.
✓. Participants with a fasting serum LDL-C ≥ 70 mg/dL (1.8 mmol/L) at screening.
✓. Should be receiving stable SoC therapy for their comorbidities for at least 4 weeks prior to screening. There should be no planned medication or dose changes during study participation.
✓. Body mass index ≥ 19.0 kg/m2.
✓. Sex: males and females (females of non-childbearing potential).

Exclusion criteria

✕. eGFR \< 45 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (2021) at screening.
✕. History or presence of gastrointestinal, hepatic, or renal disease, or any other conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs.
✕. family history of long QT syndrome;
✕. PR interval prolongation \> 240 ms;
✕. QTcF \> 450 ms; (\> 470 ms in participants with bundle branch block)
✕. any intermittent or persistent high degree atrioventricular-block grade II-III and sinus node dysfunction with significant sinus pause untreated with pacemaker; and cardiac tachyarrhythmias requiring treatment.

What they're measuring

To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory 24-hour average SBP at Week 4

Timeframe: Week 4

Trial details

NCT IDNCT06692764

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-18

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