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])
Single group
Nerkardou (5 mg) & (10 mg)
DrugBisoprolol 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.
The frequency of the first dose hypotension
The frequency of occurrence of the first dose hypotension, which is defined as a fall in systolic blood pressure of 20 mm Hg or more, or to a systolic blood pressure of less than 100 mm Hg, with or without associated symptoms.
Identifying Bradycardia manifestation Assess the safety of Nerkardou ODF.
Identify the number of patients with bradycardia manifestation, which is defined as heart rate reduction \< 60 (bpm) after drug administration
Assess the safety of Nerkardou ODF.
Number of reported AEs
Investigate the efficacy of (Nerkardou) in treating patients with hypertension
Measuring the response rate for a patient's BP response, which is defined as a ≥20mmHg decrease in sitting through SBP and a ≥10mmHg decrease in sitting through DBP， or a sitting through SBP of \<130mmHg and a sitting through DBP of \<80mmHg
Investigate the overall response of (Nerkardou) in treating patients with hypertension
The change of systolic blood pressure from baseline will be measured. The change of diastolic blood pressure from baseline will be measured
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Genuine Research Center, Egypt
Lead sponsor
Nerhadou International for pharmaceutical & Nutraceutical, Egypt
Collaborator
