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

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ClinicalTrials.gov Identifier: NCT03906799
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Omeicos Therapeutics GmbH

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: OMT-28 Drug: Placebo Phase 2

Detailed Description:

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. At randomization, the duration of the current episode of persistent AF must be shown to be greater than 7 days and not greater than 3 months, as confirmed by two ECGs (one ECG must be a 12-lead ECG) and further patient enquiry (including doctor visits, hospital admissions, symptom onset, etc.).

A sample size re-evaluation will be performed to avoid an underpowered study because of imprecise estimates for the study population or overoptimistic parameter estimates. Therefore, an interim analysis will re-evaluate sample size assumptions after approximately 15 patients per study arm (~50 % of planned sample) have completed the treatment phase (Visit 8) of the study. Predefined rules will govern the decision for adjustment of sample size.

Patients will be monitored for cardiac events throughout the study using an Implantable Cardiac Monitor (ICM). Safety will be monitored throughout the study. Blood samples will be collected in pre-specified windows for popPK analysis and at pre-specified timepoints for PK/PD analysis. Patients will be provided with a diary to record timing of drug administration and clinical symptoms while not on site. Diaries will be reviewed and checked for compliance at each non-resident visit to the clinical site.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-controlled, Double-blind, Randomized, Dose-finding Phase II Study on OMT-28 in MaIntenance of Sinus Rhythm After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation (PROMISE-AF)
Actual Study Start Date : March 19, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low OMT-28
Verum, low OMT-28
Drug: OMT-28
1 capsule given daily orally from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days).

Experimental: Middle OMT-28
Verum, middle OMT-28
Drug: OMT-28
1 capsule given daily orally from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days).

Experimental: High OMT-28
Verum, high OMT-28
Drug: OMT-28
1 capsule given daily orally from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days).

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




Primary Outcome Measures :
  1. Assessment of AF Burden After OMT-28 Administration [ Time Frame: Up to 4.5 months ]
    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


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Up to 4.5 months ]
    To assess the incidence of treatment-emergent Adverse Events of three different doses of OMT-28 administered once daily versus placebo after electrical DCC in patients with persistent AF.

  2. Assessment of Pharmacokinetic (PK) Parameters of OMT-28 - AUC [ Time Frame: Up to 3.5 months ]
    To assess the pharmacokinetic (PK) parameter AUC of OMT-28 administered once daily in patients with persistent AF, by means of population PK (popPK) analysis.

  3. Assessment of Pharmacokinetic (PK) Parameters of OMT-28 - Cmax [ Time Frame: Up to 3.5 months ]
    To assess the pharmacokinetic (PK) parameter Cmax of OMT-28 administered once daily in patients with persistent AF, by means of population PK (popPK) analysis.


Other Outcome Measures:
  1. Concentration of NT-proBNP [ Time Frame: Up to 3.5 months ]
    To assess the concentration of the exploratory, pharmacodynamic (PD) parameter NT-proBNP after once-daily administration of OMT-28 or placebo in patients with persistent AF.

  2. Concentration of GDF-15 [ Time Frame: Up to 3.5 months ]
    To assess the concentration of the exploratory, pharmacodynamic (PD) parameter GDF-15 after once-daily administration of OMT-28 or placebo in patients with persistent AF.

  3. Concentration of MMP-9 [ Time Frame: Up to 3.5 months ]
    To assess the concentration of the exploratory, pharmacodynamic (PD) parameter MMP-9 after once-daily administration of OMT-28 or placebo in patients with persistent AF.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Main Exclusion Criteria:

  • 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.
  • Patients with active cancer, chronic kidney disease or intercurrent illness.
  • Pregnant or breastfeeding women.
  • Patients taking concomitant medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03906799


Contacts
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Contact: Alexander Gebauer, Dr.med. +49 30 94894810 a.gebauer@omeicos.com
Contact: Luciana Summo, Dr.rer.nat. +49 30 94894810 l.summo@omeicos.com

Locations
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Bulgaria
Site 401 Recruiting
Sofia, Bulgaria, 1527
Site 404 Recruiting
Stara Zagora, Bulgaria, 6004
Site 402 Recruiting
Varna, Bulgaria, 9000
Czechia
Site 301 Recruiting
Kolín, Czechia, 28002
Site 303 Recruiting
Plzen, Czechia, 30460
Site 302 Recruiting
Slaný, Czechia, 27401
Hungary
Site 205 Recruiting
Budapest, Hungary, 1023
Site 201 Recruiting
Budapest, Hungary, 1122
Site 203 Recruiting
Debrecen, Hungary, 4032
Site 206 Recruiting
Hódmezővásárhely, Hungary, 6800
Site 202 Recruiting
Pécs, Hungary, 7624
Site 204 Recruiting
Zalaegerszeg, Hungary, 8900
Ukraine
Site 102 Recruiting
Cherkasy, Ukraine, 18009
Site 110 Recruiting
Ivano-Frankivs'k, Ukraine, 76018
Site 104 Recruiting
Kharkiv, Ukraine, 61018
Site 107 Recruiting
Kharkiv, Ukraine, 61176
Site 108 Recruiting
Khmelnytskyi, Ukraine, 29000
Site 113 Recruiting
Kiev, Ukraine, 02660
Site 106 Recruiting
Kiev, Ukraine, 03038
Site 101 Recruiting
Kiev, Ukraine, 03115
Site 109 Recruiting
Kiev, Ukraine, 03680
Site 112 Recruiting
Kiev, Ukraine, 04050
Site 105 Recruiting
Odesa, Ukraine, 65025
Site 103 Recruiting
Uzhgorod, Ukraine, 88000
Site 111 Recruiting
Zhytomyr, Ukraine, 10002
Sponsors and Collaborators
Omeicos Therapeutics GmbH
Investigators
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Study Director: Alexander Gebauer, Dr.med. Managing Director

Additional Information:
Publications:
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Responsible Party: Omeicos Therapeutics GmbH
ClinicalTrials.gov Identifier: NCT03906799     History of Changes
Other Study ID Numbers: OMT28-C0201
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Omeicos Therapeutics GmbH:
Atrial Fibrillation
Electrical Cardioversion
Dose-finding

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes