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Study of Bisoprolol (Nerkardou - Nerhadou International) 5 and 10 mg Oral Dissolvable Film (ODF) Treatment in Egyptian Patients With Essential Hypertension

NCT05880056 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2024-08-19

No results posted yet for this study

Summary

The trial is designed to assess the safety and investigation of the efficacy of a single oral dose of bisoprolol (Nerkardou - Nerhadou) oral dissolvable film (ODF) 5 \& 10 mg, and patients' compliance in the treatment of essential hypertension. This is a Phase IV, open-label, single-arm, prospective trial where subjects will receive:

1. Bisoprolol (Nerkardou) at an initial dose of 5 (mg) milligrams once daily for 2 weeks.
2. If the blood pressure would be greater than or equal to 130/80 mmHg after 2 weeks, then the dose will be titrated to 10 mg once daily (non-responders). Dose-Titration will be done at any follow-up visit based on the response.
3. The total duration of study treatment will be 12 weeks ±2 days, and the total sample size of the study will be 406 participants.

Conditions

  • Essential Hypertension

Interventions

DRUG

Nerkardou (5 mg) & (10 mg)

Bisoprolol oral dissolved film ODF(5 mg): equivalent to 5 mg of bisoprolol fumarate Bisoprolol oral dissolved film ODF (10 mg): equivalent to 10 mg of bisoprolol fumarate.

Sponsors & Collaborators

  • Nerhadou International for pharmaceutical & Nutraceutical, Egypt

    collaborator UNKNOWN

  • Genuine Research Center, Egypt

    lead INDUSTRY

Principal Investigators

  • Bassem El-Zarif, MD, Ph.D · National Heart Institute, Cairo, Egypt

  • Khaled AlKhashab, MD, Ph.D · Faculty of Medicine, Fayoum University Hospital, Egypt

  • Heba Hamdy, MD, Ph.D · Faculty of Medicine, Beni-Suef University Hospital, Egypt

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-08
Primary Completion
2025-04-01
Completion
2025-04-01

Countries

  • Egypt

Study Locations

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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 NCT05880056 on ClinicalTrials.gov