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AZD8601

Phase 2

Heart Failure | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Oct 10, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment11

FDA Designations

No designations recorded

Clinical trial landscape

AZD8601 · 1 trial · 1 indication

Phase 2 1
NCT03370887AZD8601 Study in CABG PatientsHeart Failure
COMPLETED11 Analytics
PHASE2COMPLETED
AZD8601 Study in CABG Patients
Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Subjects With Adverse Events
From baseline to end of follow up at 6 months
Pulse Rate (Vital Sign)
From baseline to end of follow up at 6 months
Number of Subjects With an ECG Determined to be Abnormal and Clinically Significant
From baseline to end of follow up at 6 months
Number of Subjects With High Values of Leukocytes, Particle Concentration
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Oxygen Saturation (Vital Sign)
From baseline to end of follow up at 6 months
Systolic Blood Pressure (Vital Sign)
From baseline to end of follow up at 6 months
Number of Subjects With High Values of Erythrocytes, Particle Concentration
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Diastolic Blood Pressure (Vital Sign)
From baseline to end of follow up at 6 months
Number of Subjects With High Values of Erythrocyte, Volume Fraction
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Erythrocytes, Mean Cell Volume
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Hemoglobin
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Neutrophils
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Lymphocytes
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Monocytes
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Eosinophils
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Basophils
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Platelets
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Reticulocytes
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Prothrombin Complex INR
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Activated Partial Thromboplastin Time
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Fibrinogen
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Sodium
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Potassium
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Urea
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Creatinine
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Albumin
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Calcium
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Phosphate
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Alkaline Phosphatase
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Alanine Aminotransferase
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Aspartate Aminotransferase
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

Number of Subjects With High Values of Bilirubin, Total
From baseline to end of follow up at 6 months

Values are classified as high if they are above the normal reference range, based on local lab reference ranges.

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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Low dose AZD8601 (3 mg)EXPERIMENTAL8 patients will be randomised to receive 3 mg AZD8601
High dose AZD8601 (30 mg)EXPERIMENTAL8 patients will be randomised to receive 30 mg AZD8601
PlaceboPLACEBO_COMPARATOR8 patients will be randomised to receive placebo injections

Interventions

NameTypeDescription
AZD8601DRUGAZD8601 solution for injection, 0,5 mg/mL and 5 mg/mL will be given as 30 injections of 0.1 mg (3 mg per patient), or 1 mg (30 mg per patient) respectively on a single occasion
PlaceboDRUGPlacebo for AZ8601 injection for solution will be given as 30 injections per patient on a single occasion
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: For inclusion in the study patients should fulfil the following criteria at Visit 1 and/or 2: 1\. Provision of signed and dated informed consent prior to any study specific procedures Males and females: 1. Males must be surgically sterile or using an acceptable method of cont...

Countries:United StatesFinlandGermanyNetherlandsSweden
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Frequently asked questions about AZD8601

What is AZD8601 used for?

AZD8601 is an investigational small molecule being developed for heart failure. It is a cardiovascular therapeutic that has been studied in patients undergoing coronary artery bypass grafting, or CABG, surgery. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes AZD8601?

AZD8601 is being developed by AstraZeneca PLC, a multinational pharmaceutical company traded on the NASDAQ under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the safety and efficacy of AZD8601 in patients with heart failure.

What phase is AZD8601 in?

AZD8601 is in Phase 2 clinical development. A Phase 2 study of AZD8601 in CABG patients with heart failure has been completed. The drug is investigational and has not received regulatory approval for any indication.

What clinical trials is AZD8601 in?

AZD8601 has been studied in one clinical trial, registered as NCT03370887, titled 'AZD8601 Study in CABG Patients.' This Phase 2, randomized, double-blind, placebo-controlled trial enrolled 11 participants with heart failure and was conducted in the United States, Finland, Germany, Netherlands, and Sweden. The trial has been completed.

Is AZD8601 FDA approved?

No, AZD8601 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for heart failure. The completed Phase 2 trial, NCT03370887, evaluated AZD8601 in CABG patients, but the drug has not yet received marketing authorization from regulatory agencies.