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.
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. Approximately 30 sites in the United Sites will enroll adult participants with Atherosclerotic Cardiovascular Disease or Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol. Eligible participants will be randomized (1:1) on Period One (1) Day One (1) to One (1) of Two (2) treatment sequences. Potential participants will be screened to assess their eligibility to enter the study up to 7 days prior to first administration of study intervention. Eligible participants will be randomized to Treatment Sequence AB or BA on Period One (1) Day One (1). A 14-day washout period will be required between the final dose in Period One (1) and start of baseline ABPM in Period Two (2). In Periods One (1) and Two (2), participants will return to the study site for an outpatient visit (OPV) on Day -1 for the start of the baseline ABPM. The ABPM device will be worn for 25 hours. Participants will return to the study site for an OPV on the following day (Day 1) for removal of the ABPM device and to begin self-administration of AZD0780 or placebo for 29 ± 2 days as per the randomization scheme. First dose of study intervention will be taken after the ABPM device is removed on Day 1 at the study site after the baseline ABPM is qualified (i.e., determined not to require repeat). Additional OPVs will be required on Days 14 (± 2 days), 28 (± 2 days), and 29 (day after Day 28 \[± 2 days\]). On Days 28 and 29 of each period, the ABPM device will be worn for 25 hours. Study intervention will continue to be taken on each day after the start of Week 4 (Days 28 and 29) 24-hour ABPM for Periods 1 and 2 until a qualified ABPM is obtained. Only 1 repeat may be attempted within 2 days of the end of the first ABPM attempt. Participants will return to the study site for a follow-up visit 14 (± 2) days after the last dose of study intervention in Period Two (2). Serial pharmacokinetic blood samples will be collected predose and up to 7 hours postdose on Day 14 and predose on Day 28 in each period. Monitoring of adverse events, vital sign measurements, 12-lead electrocardiograms, clinical laboratory tests, and physical examinations will be performed to assess safety and tolerability.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
202
0 mg (Placebo). Participants will receive three bottles, each containing 35 tablets with placebo tablets. Participants will take 1 tablet from each bottle on each scheduled day of study intervention, which will provide the placebo dose.
Dose 1 Participants will receive three bottles, each containing 35 tablets: * 1 bottle of dose a AZD0780 tablets * 1 bottle of dose b AZD0780 tablets * 1 bottle of dose c AZD0780 tablets Participants will take 1 tablet from each bottle on each scheduled day of study intervention, which will provide the AZD0780 dose.
Research Site
Inglewood, California, United States
To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory 24-hour average SBP at Week 4
Change from baseline in ambulatory 24-hour average systolic blood pressure (SBP) at Week 4
Time frame: Week 4
To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory 24-hour average DBP at Week 4
Change from baseline in ambulatory 24-hour average diastolic blood pressure (DBP) at Week 4
Time frame: Week 4
To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory nighttime average SBP at Week 4
Change from baseline in ambulatory nighttime average systolic blood pressure (SBP) at Week 4
Time frame: 4 Weeks
To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory daytime average SBP at Week 4
Change from baseline in ambulatory daytime average systolic blood pressure (SBP) at Week 4
Time frame: 4 Weeks
To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory nighttime average DBP at Week 4
Change from baseline in ambulatory nighttime average diastolic blood pressure (DBP) at Week 4
Time frame: 4 Weeks
To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory daytime average DBP at Week 4
Change from baseline in ambulatory daytime average diastolic blood pressure (DBP) at Week 4
Time frame: 4 Weeks
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Research Site
Northridge, California, United States
Research Site
Pomona, California, United States
Research Site
Boca Raton, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
...and 16 more locations