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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02557217




Registration number
NCT02557217
Ethics application status
Date submitted
7/09/2015
Date registered
23/09/2015
Date last updated
28/06/2017

Titles & IDs
Public title
NP202 for Treatment of Post -STEMI Left Ventricular Systolic Dysfunction
Scientific title
A Phase II Randomised, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Oral NP202 in Adults Who Have Left Ventricular Systolic Dysfunction Following Myocardial Infarction
Secondary ID [1] 0 0
ACTRN12615000609550
Secondary ID [2] 0 0
NP202-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ST Elevation Myocardial Infarction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NP202
Other interventions - Placebo

Experimental: NP202 - 1000mg oral NP202 daily for 90 days

Placebo Comparator: Placebo - Oral placebo daily for 90 days


Treatment: Drugs: NP202
Active

Other interventions: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy as measured by Change from baseline in left ventricular end systolic volume index (LVESVi)
Timepoint [1] 0 0
From baseline to 3 months post MI
Secondary outcome [1] 0 0
Efficacy as measured by Change from baseline in LV end diastolic volume index (LVEDVi)
Timepoint [1] 0 0
From baseline to 3 months post MI
Secondary outcome [2] 0 0
Efficacy as measured by Change from baseline in LV ejection fraction (LVEF)
Timepoint [2] 0 0
From baseline to 3 months post MI
Secondary outcome [3] 0 0
Efficacy as measured by Change from baseline in LV diastolic function
Timepoint [3] 0 0
From baseline to 3 months post MI
Secondary outcome [4] 0 0
Efficacy as measured by Change from baseline in relative infarct size
Timepoint [4] 0 0
From baseline to 3 months post MI

Eligibility
Key inclusion criteria
- Have had a confirmed ST elevation myocardial infarction (STEMI) in the previous 5
days, which met all of the following criteria;

- = 0.2mV ST elevation in 2 or more V1 - V6 leads with presentation in a maximum of
12 hours of onset of symptoms

- Troponin levels >10 x upper limit of normal (ULN) at the site's local laboratory.

- Successful revascularisation by Percutaneous Coronary Intervention (PCI)

- Have left ventricular dysfunction post STEMI as evidenced by left ventricular ejection
fraction (LVEF) =40% confirmed by echocardiogram at screening.

- Are receiving guideline-directed medical therapy for acute MI and post-MI left
ventricular (LV) dysfunction according to national cardiology society/heart
association STEMI guidelines.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known cardiomyopathy or heart failure prior to MI.

- Cardiogenic shock and/or systolic blood pressure <85mmHg at Screening.

- Clinical history of ejection fraction =40% prior to this MI, or multiple prior MIs.

- Daily use of non-steroidal anti-inflammatory drugs (NSAIDs) and/or cyclooxygenase-2
(COX-2) inhibitors in the past month.

- Presence of device/hardware incompatible with MRI

- Estimated glomerular filtration rate (eGFR) <30ml/min

- Liver function tests 3 x ULN due to non-cardiac disease

- Have received any investigational research agent within 30 days or 5 half-lives
(whichever is longer) prior to the first dose of investigational product.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2018
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
John Hunter Hospital - Newcastle
Recruitment postcode(s) [1] 0 0
2305 - Newcastle

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Armaron Bio Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
NP202 is an experimental drug being developed by Armaron Bio Pty Ltd for potential use as a
treatment for people after they have had a heart attack (MI).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02557217
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Grant McLachlan
Address 0 0
Sponsor GmbH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Grant McLachlan
Address 0 0
Country 0 0
Phone 0 0
+61 3 9652 2117
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02557217