Study of Bisoprolol (Nerkardou - Nerhadou International) 5 and 10 mg Oral Dissolvable Film (ODF) Treatment in Egyptian Patients With Essential Hypertension

Launched by GENUINE RESEARCH CENTER, EGYPT · May 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called bisoprolol, which comes in a dissolvable film form, to see how well it can help Egyptian patients with essential hypertension, or high blood pressure. The trial will evaluate the safety and effectiveness of two different doses (5 mg and 10 mg) of this medication. Participants will take the 5 mg dose daily for two weeks, and if their blood pressure remains high, they will increase to the 10 mg dose. The entire study will last for about 12 weeks and involve around 406 participants.

To join the trial, candidates must be between 21 and 64 years old, newly diagnosed with mild to moderate high blood pressure, and willing to follow the study guidelines. Participants should not have serious complications from high blood pressure or other significant health issues. Throughout the trial, participants will have regular check-ins to monitor their blood pressure and overall health. This study aims to find out if bisoprolol is a good option for people struggling to manage their blood pressure with other treatments. If you or someone you know might be interested, it's important to discuss this with a healthcare provider to see if they qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The participant is willing and able to give informed consent for participation in the trial.
• • 2. Male or Female, aged ≥ 21 and \< 65 years.
• • 3. The subject with Body mass index (BMI) greater than or equal to 18.5 and below 30 kg/m2
• 4. Newly diagnosed hypertensive patients with grade 1 and 2 are defined according to the recent ESC/ESH guidelines as follows:
• • Grade 1 hypertension: SBP 140 to 159mmHg and/or DBP 90 to 99mmHg
• • 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 other than beta blocker and can be safely switched to Bisoprolol (Nerkardou) according to PI decision.
• • 6. Subject doesn't have other comorbidity according to the assessment of the medical history, electrocardiogram (ECG), echocardiogram vital signs, physical examination, and laboratory results.
• • 7. Subject with heart rate (HR) ≥ 80 (BPM) at baseline.
• • 8. Female subjects in childbearing period, and not on a reliable contraceptive method must adhere to the recommended contraceptive methods as detailed in Appendix I.
• • 9. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
• Exclusion Criteria:
• • 1. Grade III hypertension or malignant hypertension (Hypertensive crisis: Systolic over 180 and/or diastolic over 120).
• • 2. 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.
• • 3. Subjects with heart rates less than (\<)80 beats at rest.
• • 4. Subjects with renal impairment (serum creatinine \> 2.0 milligram per deciliter \[mg/dL\])
• • 5. Subjects with unrecovered pulmonary edema
• • 6. Subjects with a history of cardiovascular surgeries.
• • 7. Significant history of hypersensitivity to bisoprolol, amlodipine, other dihydropyridines, or any related products (including excipients of the formulations)
• • 8. Presence of diabetes mellitus
• • 9. History or presence of asthma
• • 10. 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.
• • 11. 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
• • 12. Acute conditions which might alter renal function (e.g., dehydration, severe infection)
• • 13. History of suicidal tendency, history of, or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
• • 14. Positive pregnancy test (only for females of child-bearing potential), or females breastfeeding a child.
• • 15. 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)
• • 16. A participant with a life expectancy of fewer than 6 months, or inappropriate for the medication as defined in the Product Information such as acute heart failure or decompensation of heart insufficiency, that requires a therapy with inotropic agents; cardiogenic shock; AV block grade II or III, sick sinus syndrome, sinoatrial heart block; symptomatic bradycardia; symptomatic hypotonia; severe asthma bronchiolus or severe chronic obstructive airways disease; advanced stages of peripheral arterial disease or Raynaud's Syndrome; untreated pheochromocytoma, metabolic acidosis.
• • 17. Participants who have participated in another research trial involving an investigational product in the past 12 weeks.