Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02557217