The trial is designed to investigate the response of a single oral dose of bisoprolol ODF (investigational product) in the treatment of essential hypertension.~This is a Phase IV, open-label, single-arm, prospective trial where subjects will receive:~Bisoprolol at an initial dose of 5 (mg) milligrams once daily for 2 weeks (Responders).~If the blood pressure would be greater than or equal to 130/80 mmHg after 2 weeks, then the dose will be adjusted to 10 mg once daily (non-responders).~The total duration of study treatment will be 12 weeks. (Flow chart of trail design Appendix III) and the total sample size of the study will be 827 participants.~Among responders, one oral dissolved film of 5 mg bisoprolol for 2 weeks will be administered.~After the assessment of the response rate for patients, Study medication will be tapered down and stopped after 2 weeks for responders.~A BP response is defined as a ≥20 mmHg decrease in sitting through SBP and a ≥10 mmHg decrease in sitting through DBP, or a sitting through SBP of <130 mmHg and a sitting through DBP of <80 mmHg. Patients who had ⩾a 10% decrease in HR will be considered to have an HR response.~Subsequently, non-responders (defined that those with BP ≥130/80 mmHg after 2 weeks) will be crossed over to the higher dose medication and in the following 10 weeks, the same procedures will be repeated. After 2 weeks, the non-responders will receive one oral dissolved film of 10 mg bisoprolol.~Drug administration will be done without food in the fasting state.~The trial has a duration of approximately 12 weeks, including:~Screening (assessments to determine eligibility for entry into the trial, occurring on Day -7, and baseline visit on day 0)~Period 1 for 5 mg bisoprolol (duration of 14 days; Day 1- Day 14)~Period 2 for 10 mg bisoprolol (duration of 10 weeks; day 15 - to the end of week 12)~Early withdrawal~Follow-up (6 days; 6 consecutive visits occurring after week 12 through phone calls)
The goal of this prospective, open-label, single-arm interventional study is to Investigate the response, the efficacy of bisoprolol (Nerkardou)-(Oral Dissolvable Film) dosage form in treating patients with hypertension, measure patients' compliance to the (Oral Dissolvable Film) dosage form, especially being easy to carry and easy to use, and identify the onset of action of heart rate reduction.