Trials / Completed
CompletedNCT06692764
A Study to Assess the Effect of AZD0780 on Ambulatory Blood Pressure
A Phase II Study to Assess the Effect of AZD0780 on Ambulatory Blood Pressure in Participants With Atherosclerotic Cardiovascular Disease or Risk Equivalents and Elevated Low-Density Lipoprotein Cholesterol
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 202 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | 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. |
| DRUG | AZD0780 | 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. |
Timeline
- Start date
- 2024-10-30
- Primary completion
- 2025-04-18
- Completion
- 2025-05-02
- First posted
- 2024-11-18
- Last updated
- 2026-02-18
Locations
26 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06692764. Inclusion in this directory is not an endorsement.