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

NCT03906799 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2021-09-09

No results posted yet for this study

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

Interventions

DRUG

OMT-28

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Omeicos Therapeutics GmbH

    lead INDUSTRY

Principal Investigators

  • Alexander Gebauer, Dr.med. · Managing Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2019-11-20
Completion
2020-03-20

Countries

  • Bulgaria
  • Czechia
  • Hungary
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03906799 on ClinicalTrials.gov