A Prospective, Multicentre, Open-label, Single-arm Interventional Study of Bisoprolol (Nerkardou) (Between Low Dose and High Dose) 5 and 10 mg ODF Treatment In Egyptian Patients With Essential Hypertension

• Status: Not yet recruiting
• Trial end date: 2024-07-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genuine Research Center, Egypt
• Collaborator: Nerhadou International for pharmaceutical & Nutraceutical, Egypt

Criteria

Inclusion Criteria:

1. The participant is willing and able to give informed consent for participation in the trial.

2. Male or Female, aged 18 years or above.

3. Body mass index (BMI) greater than or equal to 18 and below 32 kg/m2

4. Newly diagnosed Hypertensive patients with stages 1 and 2 are defined according to the recent ESC/ESH guidelines as follows:

1. Grade 1 hypertension: SBP 140 to 159mmHg and/or DBP 90 to 99mmHg

2. Grade 2 hypertension: SBP 160 to 179mmHg and/or DBP 100 to 109mmHg at screening.

5. Non-responders to the 1ST line of therapy for hypertension.

6. Patients who can be safely switched to Bisoprolol according to PI decision.

7. Healthy according to the assessment of the medical history, electrocardiogram (ECG), vital signs, physical examination, laboratory results, and negative serology tests (except results after vaccination).

8. Each subject must be capable of understanding the trial procedures and sign the ICF before they participate in the trial.

9. Subjects must consent to adhere to the recommended contraceptive methods as detailed in Appendix I.

10. In the Investigator's opinion, is able and willing to comply with all trial requirements.

11. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.

Exclusion Criteria:

1. A subject who cannot understand or does not agree with the study's contents.

2. Grade III hypertension or malignant hypertension (Hypertensive crisis: Systolic over 180 and/or diastolic over 120).

3. Subjects who are unable to discontinue all prior antihypertensive medications.

4. Subjects with heart rates less than (<) 60 beats at rest

5. Subjects with renal failure (serum creatinine > 2.0 milligram per decilitre [mg/dL])

6. Subjects with unrecovered pulmonary edema

7. Subjects have a history or currently have cardiovascular disease.

8. Subjects with a history of cardiovascular surgeries.

9. Subjects with a history of treated or untreated malignant tumors within the past 5 years

10. Significant history of hypersensitivity to bisoprolol, amlodipine, other dihydropyridines, or any related products (including excipients of the formulations)

11. Significant history of severe hypersensitivity reactions (e.g., angioedema) to any drugs

12. Pulse rate (in supine position) less than 60 beats per minute (bpm) or more than 100 bpm at screening

13. History or presence of peripheral arterial occlusion or Raynaud's syndrome

14. Presence of diabetes mellitus

15. History or presence of asthma

16. Presence of significant gastrointestinal, liver, kidney disease, surgery, or any other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs or known to potentiate or predispose to undesired effects.

17. Use of any enzyme-modifying drugs, including strong inhibitors of CYP enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem, and human immunodeficiency virus [HIV] antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin, St. John's wort or other herbal medicine known with effect on CYP enzymes) within 28 days before Day 1 of this trial

18. Acute conditions which might alter renal function (e.g., dehydration, severe infection)

19. Surgery in the previous 28 days before Day 1 of this trial

20. Any history of tuberculosis and/or prophylaxis for tuberculosis within 10 years of Day 1 of the trial

21. Positive results to HIV antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or treponema pallidum (TP) antibody tests

22. Donation of 50 mL or more of blood within 28 days before Day 1 of the trial; donation of 500 mL or more of blood within 56 days before Day 1 of the trial

23. History of suicidal tendency, history of, or disposition to seizures, state of confusion, clinically relevant psychiatric diseases

24. Positive pregnancy test (only for females of child-bearing potential), or females breastfeeding a child.

25. Consumption of large quantities of methylxanthine-containing beverages (more than 600 mg caffeine/day: 1 cup (250 mL) of coffee contains approximately 100 mg of caffeine, 1 cup of black or green tea contains approximately 30 mg and 1 glass of cola contains approximately 20 mg caffeine)

26. A participant with a life expectancy of fewer than 6 months, or inappropriate for the medication.

27. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

28. Participants who have participated in another research trial involving an investigational product in the past 12 weeks.