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.
The participant is willing and able to give informed consent for participation in the trial.
Male or Female, aged ≥ 21 and < 65 years.
The subject with Body mass index (BMI) greater than or equal to 18.5 and below 30 kg/m2
Grade 1 hypertension: SBP 140 to 159mmHg and/or DBP 90 to 99mmHg
Grade III hypertension or malignant hypertension (Hypertensive crisis: Systolic over 180 and/or diastolic over 120).
Subjects who are not legible to discontinue current antihypertensives such as calcium channel blockers (CCB), ACE- inhibitors, or diuretics for reasons other than hypertension, or responders to current therapy.
Subjects with heart rates less than (<)80 beats at rest.
Subjects with renal impairment (serum creatinine > 2.0 milligram per deciliter [mg/dL])
Genuine Research Center, Egypt
Lead sponsor
Nerhadou International for pharmaceutical & Nutraceutical, Egypt
Collaborator