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Echocardiographic Study of a Single Dose Bisoprolol Versus Nebivolol in Healthy Subjects

NCT ID: NCT04432610

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2030-01-31

Study Completion Date

2030-12-31

Brief Summary

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This is a randomized, double-blind, crossover study in healthy adult subjects. Each subject will receive a single dose of bisoprolol 5 mg p.o. and nebivolol 5 mg p.o. with 1 week washout period. All subjects will undergo a physical examination, 12-lead electrocardiography and a comprehensive echocardiographic study before the administration of the study drug and 5 hours thereafter.

Detailed Description

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Conditions

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Bisoprolol Adverse Reaction Nebivolol Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bisoprolol first, Nebivolol Second

In this arm, patient will first receive bisoprolol, and after 1 week washout period, nebivolol

Group Type EXPERIMENTAL

Bisoprolol versus Nebivolol

Intervention Type DRUG

All subjects will receive both drugs, but at different time periods determined by randomization, with 1 week washout period

Nebivolol first, Bisoprolol second

In this arm, patient will first receive nebivolol, and after 1 week washout period, bisoprolol

Group Type EXPERIMENTAL

Bisoprolol versus Nebivolol

Intervention Type DRUG

All subjects will receive both drugs, but at different time periods determined by randomization, with 1 week washout period

Interventions

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Bisoprolol versus Nebivolol

All subjects will receive both drugs, but at different time periods determined by randomization, with 1 week washout period

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy subjects (male and female)
2. Age interval: 20-60 years old (inclusive)

Exclusion Criteria

1. Any known absolute or relative contraindication to beta-blocker therapy
2. Poor echogenicity
3. A resting heart rate \<60 bpm
4. A resting blood pressure \< 110/70 mmHg
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clinical Hospital Center Zemun

OTHER

Sponsor Role lead

Responsible Party

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Ivan Stankovic

Head of Echocardiography

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Hospital Centre Zemun

Belgrade, , Serbia

Site Status

Countries

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Serbia

Other Identifiers

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01-2020

Identifier Type: -

Identifier Source: org_study_id