Study on OMT-28 in Maintenance of Sinus Rhythm in Patients With Persistent Atrial Fibrillation (AF)

NCT03906799 | Completed Phase 2 DMC

• 1 other identifier: OMT28-C0201
• Study Type: interventional
• Target: 136
• Locations: 4 countries
• Sites: 25

Brief Summary

This is a randomized, double-blind, dose-finding, placebo-controlled, parallel group, multicenter, phase II study to evaluate the efficacy, safety, and popPK of three different doses of OMT-28 given once daily versus placebo in patients with persistent AF.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Electrical Cardioversion; Dose-finding

Outcome Measures

Primary Outcomes (1)

• Assessment of AF Burden After OMT-28 Administration

  To assess the AF burden, based on data collected via the implantable cardiac monitor BioMonitor 2-AF, of three different doses of OMT-28 administered once daily versus placebo in the maintenance of normal sinus rhythm after electrical direct current cardioversion (DCC) in patients with persistent AF

  Up to 4.5 months

Secondary Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events

  Up to 4.5 months

• Assessment of Pharmacokinetic (PK) Parameters of OMT-28 - AUC

  Up to 3.5 months

• Assessment of Pharmacokinetic (PK) Parameters of OMT-28 - Cmax

  Up to 3.5 months

Other Outcomes (3)

• Concentration of NT-proBNP

  Up to 3.5 months

• Concentration of GDF-15

  Up to 3.5 months

• Concentration of MMP-9

  Up to 3.5 months

Study Arms (4)

Low OMT-28

EXPERIMENTAL

Verum, low OMT-28

Drug: OMT-28

Middle OMT-28

EXPERIMENTAL

Verum, middle OMT-28

Drug: OMT-28

High OMT-28

EXPERIMENTAL

Verum, high OMT-28

Drug: OMT-28

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

OMT-28 DRUG

1 capsule given daily orally from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days).

High OMT-28; Low OMT-28; Middle OMT-28

Placebo DRUG

1 capsule given daily orally from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days).

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females between 18 and 85 years of age.
• Patients with persistent AF for \> 7 days but ≤ 3 months suitable for electrical DCC.
• Male patients must be surgically sterile for at least 90 days or will be required to use a male condom with spermicide, and will refrain from donating sperm from the time of the first dose until 90 days after the last dose of study medication.
• Females of childbearing potential (postmenarchal, not surgically sterile, premenopausal) will agree to follow contraception requirements from the time of signing the Informed Consent Form (ICF) until 90 days after the last administration of study drug.
• Willing and able to give written informed consent before any study-related procedure.
• Willing and able to attend all the visits scheduled in the study.

You may not qualify if:

• Patients with known concurrent temporary secondary causes of AF
• Patients that have undergone surgical or catheter ablation for AF or atrial flutter.
• Patients with an existing cardiac treatment device, pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy.
• Patients with a history of ECG abnormalities that, in the opinion of the investigator (or designee), render the patient unsuitable for the study.
• Patients with congestive heart failure (NYHA class III and IV).
• Patients with left atrium size ≥ 55 mm.
• Patients with left ventricular ejection fraction ≤ 40 %.
• Known presence of a thrombus in the left atrial appendage, left atrium, left ventricle, aorta, or intracardial mass.
• Patients with moderate or severe mitral stenosis, mitral valve rheumatic disease, unresected atrial myxoma, or a mechanical heart valve and/or other conditions, such as pulmonary embolism, considered to be formal indication for conventional anticoagulation.
• Patients with any acute coronary event, stroke, or percutaneous coronary intervention within 6 months prior to randomization or who are receiving dual antiplatelet therapy.
• Uncontrolled/therapy-resistant bradycardia and/or uncontrolled/therapy-resistant hypertension within a 3-month period prior to randomization.
• Patients having more than two DCCs in the last 6 months. Any unsuccessful pharmacological and/or electrical cardioversion (within prior 3 months).
• Patients with signs of bleeding or conditions associated with a high risk of bleeding.
• Patients taking antiarrhythmic agents within 3 days of planned randomization will be excluded.
• Patients concurrently participating in another study or unable to communicate.

Sponsors & Collaborators

• Omeicos Therapeutics GmbH: lead

Study Sites (25)

Site 401

Sofia, 1527, Bulgaria

Location

Site 404

Stara Zagora, 6004, Bulgaria

Location

Site 402

Varna, 9000, Bulgaria

Location

Site 301

Kolín, 28002, Czechia

Location

Site 303

Pilsen, 30460, Czechia

Location

Site 302

Slaný, 27401, Czechia

Location

Site 205

Budapest, 1023, Hungary

Location

Site 201

Budapest, 1122, Hungary

Location

Site 203

Debrecen, 4032, Hungary

Location

Site 206

Hódmezővásárhely, 6800, Hungary

Location

Site 202

Pécs, 7624, Hungary

Location

Site 204

Zalaegerszeg, 8900, Hungary

Location

Site 102

Cherkasy, 18009, Ukraine

Location

Site 110

Ivano-Frankivsk, 76018, Ukraine

Location

Site 104

Kharkiv, 61018, Ukraine

Location

Site 107

Kharkiv, 61176, Ukraine

Location

Site 108

Khmelnytskyi, 29000, Ukraine

Location

Site 113

Kiev, 02660, Ukraine

Location

Site 106

Kiev, 03038, Ukraine

Location

Site 101

Kiev, 03115, Ukraine

Location

Site 109

Kiev, 03680, Ukraine

Location

Site 112

Kiev, 04050, Ukraine

Location

Site 105

Odesa, 65025, Ukraine

Location

Site 103

Uzhhorod, 88000, Ukraine

Location

Site 111

Zhytomyr, 10002, Ukraine

Location

Related Publications (2)

• Schunck WH, Konkel A, Fischer R, Weylandt KH. Therapeutic potential of omega-3 fatty acid-derived epoxyeicosanoids in cardiovascular and inflammatory diseases. Pharmacol Ther. 2018 Mar;183:177-204. doi: 10.1016/j.pharmthera.2017.10.016. Epub 2017 Nov 7.

  PMID: 29080699 BACKGROUND

• Fischer R, Konkel A, Mehling H, Blossey K, Gapelyuk A, Wessel N, von Schacky C, Dechend R, Muller DN, Rothe M, Luft FC, Weylandt K, Schunck WH. Dietary omega-3 fatty acids modulate the eicosanoid profile in man primarily via the CYP-epoxygenase pathway. J Lipid Res. 2014 Jun;55(6):1150-64. doi: 10.1194/jlr.M047357. Epub 2014 Mar 16.

  PMID: 24634501 BACKGROUND

Related Links

• OMEICOS Therapeutics GmbH

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Gebauer, Dr.med.

  Managing Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: April 8, 2019
• Study Start: March 19, 2019
• Primary Completion: November 20, 2019
• Study Completion: March 20, 2020
• Last Updated: September 9, 2021

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (3); BU (3); HU (6); UA (13)