Condition: Essential Hypertension · Sponsor: Genuine Research Center, Egypt
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.
This description comes directly from the study's public registry record.
Mohsen Fathallah, MD, Ph.D · Telephone: +224514516 · mohsen.fathallah@grc-me.com
Sally Khairat, B.Sc.Pharma · Telephone: +224514516 · sally.khairat@grc-me.com
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| Al-Fayoum University Hospital | Al Fayyum, Egypt | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05880056