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AZD3427 Dose A for Pulmonary Hypertension

Research Site, Baltimore, MD
Pulmonary Hypertension+1 More ConditionsAZD3427 - Drug
Eligibility
18 - 130
All Sexes
What conditions do you have?
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Study Summary

This trial studies a drug to treat heart failure and pulmonary hypertension by reducing pulmonary vascular resistance.

Eligible Conditions
  • Pulmonary Hypertension
  • Heart Failure

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
LAM-001
1
Children ≥1 to <18 years old
1
Treprostinil Palmitil

Study Objectives

1 Primary · 25 Secondary · Reporting Duration: On Day 15, Day 29, Day 85, Day 127, Day 169, and Day 211

Week 25
Change from baseline in N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
Change from baseline in cystatin C
Change from baseline in eGFR (estimated glomerular filtration rate)
Change from baseline in serum creatinine
Baseline to Week 25
Change from baseline in 6-minute walking distance (6MWD)
Change from baseline in Ejection fraction (EF)
Change from baseline in Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ TSS)
Change from baseline in Mean pulmonary arterial pressure (mPAP)
Change from baseline in New York Heart Association Functional Class (NYHA FC)
Change from baseline in Pulmonary Vascular Resistance (PVR)
Change from baseline in Pulmonary artery wedge pressure (PAWP)
Change from baseline in Stroke Volume (SV)
Change from baseline in TAPSE/PASP [Tricuspid annular plane systolic excursion/ Pulmonary arterial systolic pressure]
Change from baseline in Tricuspid regurgitation velocity (TRV)
Change from baseline in cardiac output
Change from baseline in inferior vena cava (IVC) diameter with inspiratory collapse
Change from baseline in left ventricular global longitudinal strain (LVGLS)
Change from baseline in pulmonary arterial systolic pressure (PASP)
Change from baseline in right ventricle/left ventricle (RV/LV) ratio
Change from baseline in right ventricular outflow tract acceleration time (RVOT AT)
Change from baseline in right ventricular strain/pulmonary arterial systolic pressure (RVS/PASP)
Change from baseline in systemic vascular resistance
Day 211
Number of participants with adverse events and serious adverse events
Day 211
Evaluation of positive ADA titer
Number of participants with presence of Anti-drug antibody (ADAs)
Number of participants with presence of Neutralising antibodies (NAbs)
Day 211
Pharmacokinetics (AZD3427 serum exposure)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

2
LAM-001
2
Children ≥1 to <18 years old
2
Treprostinil Palmitil

Trial Design

4 Treatment Groups

AZD3427 Dose A
1 of 4
AZD3427 Dose B
1 of 4
AZD3427 Dose C
1 of 4
Placebo
1 of 4

Experimental Treatment

Non-Treatment Group

220 Total Participants · 4 Treatment Groups

Primary Treatment: AZD3427 Dose A · Has Placebo Group · Phase 2

AZD3427 Dose A
Drug
Experimental Group · 1 Intervention: AZD3427 · Intervention Types: Drug
AZD3427 Dose B
Drug
Experimental Group · 1 Intervention: AZD3427 · Intervention Types: Drug
AZD3427 Dose C
Drug
Experimental Group · 1 Intervention: AZD3427 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD3427
2020
Completed Phase 1
~110

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: on day 15, day 29, day 85, day 127, day 169, and day 211

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,051 Previous Clinical Trials
240,384,644 Total Patients Enrolled
ParexelIndustry Sponsor
285 Previous Clinical Trials
93,497 Total Patients Enrolled

Eligibility Criteria

Age 18 - 130 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Maryland100.0%
What site did they apply to?
Research Site100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
Why did patients apply to this trial?
  • "Trying to help and need money"
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

Does this trial include participants of a younger age demographic?

"The requirements for admission to this trial are patients aged between 18 and 130 years old. There exists 79 studies catering exclusively toward those younger than 18, while 1363 trials address the needs of individuals over 65." - Anonymous Online Contributor

Unverified Answer

What is the current enrolment for this clinical research?

"Confirmed. Various details on clinicaltrials.gov suggest that this medical study, initially published on April 24th 2023, is actively looking for participants to enrol in the trial. Across 45 different locations 220 patients are being sought." - Anonymous Online Contributor

Unverified Answer

Has the Food and Drug Administration sanctioned the use of AZD3427 Dose A?

"While the efficacy of AZD3427 Dose A is yet to be established, its safety has been investigated and earned a score of 2." - Anonymous Online Contributor

Unverified Answer

Are there any open enrollment opportunities for this experiment?

"Affirmative. Sources on clinicaltrials.gov demonstrate that this trial, which first launched on April 24th 2023, is still recruiting participants. 220 volunteers are being sought from 45 different sites for the study." - Anonymous Online Contributor

Unverified Answer

How many settings are conducting this research project?

"45 sites are currently participating in this medical trial. These locations, which span from New Haven to Saint Louis, have been carefully chosen so that participants can easily access the nearest one and reduce travel requirements if they choose to enroll." - Anonymous Online Contributor

Unverified Answer

What is the participant criteria for this research endeavor?

"This clinical trial is in search of two hundred and twenty individuals aged between 18 to 130 who suffer from pulmonary hypertension. Potential participants must fulfil the following requirements: be of legal age, have a pre-existing heart failure diagnosis (NYHA FC II - IV), possess combined echocardiographic readings that are indicative of intermediate or high probability for PH (ESC/ERS 2022 Guidelines); exhibit an elevated PAWP (>15 mmHg) and mPAP (>20mmHG); have a minimum body weight of 50kg; provide valid consenting documentation." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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