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AZD8601

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment11
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03370887AZD8601 Study in CABG PatientsPHASE2 COMPLETED 11Feb 5, 2018Jun 30, 2021Oct 10, 202410 United States, Finland +3
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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 — 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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