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AZD0780 for Cardiovascular Disease (AZD0780-ABPM Trial)

Phase 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Participants with a history of ASCVD defined as myocardial infarction, stroke, or symptomatic peripheral arterial disease, or with risk factors hereof.
Must not have
Poorly controlled type 2 diabetes mellitus, defined as HbA1c > 10% at screening.
Lomitapide within 12 months prior to Period 1 Day -1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4

Summary

"This trial aims to see the impact of AZD0780 Dose 1 on systolic blood pressure compared to a placebo in participants with heart disease or risk factors. They will be monitored for

Who is the study for?
This trial is for people with cardiovascular disease or atherosclerosis and LDL cholesterol levels of 70 mg/dL or higher, who are on stable medication. Participants should be willing to have their blood pressure monitored for 24 hours.
What is being tested?
The study tests the effect of AZD0780 compared to a placebo on systolic blood pressure after four weeks. It's a Phase II trial where participants will receive either the drug or placebo randomly and then switch, without knowing which one they're taking.
What are the potential side effects?
While specific side effects aren't listed here, common ones for blood pressure medications can include dizziness, headaches, fatigue, and sometimes swelling in parts of the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My current medications for other health issues have been stable for at least 4 weeks.
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I have a history of heart attack, stroke, or symptoms of poor blood flow in my limbs.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My diabetes is not well-managed, with an HbA1c level over 10%.
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I have not taken Lomitapide in the last 12 months.
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I am not taking fibrate medications or their derivatives.
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I have severe heart failure.
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My kidney function is low, as shown by a specific test.
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I am taking or have recently taken a medication that can cause serious heart rhythm problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory 24-hour average SBP at Week 4
Secondary study objectives
To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory 24-hour average DBP at Week 4
To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory daytime average DBP at Week 4
To assess the effect of treatment with AZD0780 dose 1 versus placebo on ambulatory daytime average SBP at Week 4
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AZD0780Experimental Treatment1 Intervention
Following randomization to treatment sequence, participants receive AZD0780 during period 1 or 2.
Group II: PlaceboPlacebo Group1 Intervention
Following randomization to treatment sequence, participants receive Placebo during period 1 or 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD0780
2024
Completed Phase 2
~630

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,403 Previous Clinical Trials
289,124,837 Total Patients Enrolled
FortreaIndustry Sponsor
18 Previous Clinical Trials
5,251 Total Patients Enrolled
~115 spots leftby Apr 2025
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