RecruitingPhase 4NCT05880056

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

A Prospective, Multicenter, Open-label, Single-arm Interventional Study of Bisoprolol (Nerkardou - Nerhadou International) 5 and 10 mg Oral Dissolvable Film (ODF) Treatment in Egyptian Patients With Essential Hypertension


Sponsor

Genuine Research Center, Egypt

Enrollment

406 participants

Start Date

Aug 8, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests bisoprolol — a heart rate-lowering blood pressure medication — in a new oral dissolving film (ODF) form in Egyptian patients with grade 1 or grade 2 high blood pressure who have not responded adequately to their current medication. The ODF form dissolves in the mouth and may be easier to take for some patients. **You may be eligible if...** - You are between 21 and 65 years old - You have newly diagnosed grade 1 or grade 2 hypertension (blood pressure between 140-179 mmHg systolic and/or 90-109 mmHg diastolic) - Your resting heart rate is 80 beats per minute or higher - You have not responded adequately to your current blood pressure medication and can safely switch to bisoprolol - Your BMI is between 18.5 and 30 **You may NOT be eligible if...** - Your blood pressure is in grade 3 (severely elevated, over 180/120 mmHg) - You have asthma or severe lung disease - You have diabetes, severe kidney or liver disease - You have a history of heart surgery or cardiovascular operations - You are pregnant or breastfeeding - You take certain medications that interact with bisoprolol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNerkardou (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.


Locations(1)

Al-Fayoum University Hospital

Al Fayyum, Egypt

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NCT05880056


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