Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05880056
PHASE4

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

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

21 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

406

Start Date

2024-08-08

Completion Date

2025-04-01

Last Updated

2024-08-19

Healthy Volunteers

No

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.

Locations (1)

Al-Fayoum University Hospital

Al Fayyum, Egypt