Treatment of essential hypertension with bisoprolol oral dissolvable film

A Prospective, Multicenter, Open-label, Single-arm Interventional Study of Bisoprolol (Nerkardou - Nerhadou International) 5 and 10 mg Oral Dissolvable Film (ODF) Treatment in Egyptian Patients With Essential Hypertension

This study is testing a new dissolvable film medication called bisoprolol to see if it can safely lower blood pressure in people with high blood pressure in Egypt.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 406 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: Genuine Research Center, Egypt (Industry-sponsored)
• Locations: 1 site (Al Fayyum)
• Trial ID: NCT05880056 on ClinicalTrials.gov

What this trial studies

This trial evaluates the safety and efficacy of bisoprolol, an oral dissolvable film, in treating essential hypertension in Egyptian patients. Participants will receive an initial dose of 5 mg daily for two weeks, with potential titration to 10 mg based on blood pressure response. The study is a Phase IV, open-label, single-arm trial involving 406 participants over a total treatment duration of 12 weeks. Blood pressure responses will be monitored bi-weekly to determine the effectiveness of the treatment.

Who should consider this trial

Good fit: Ideal candidates are newly diagnosed hypertensive patients aged 21 to 65 with grade 1 or 2 hypertension.

Not a fit: Patients with significant comorbidities or those who do not meet the specific hypertension criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and patient-compliant option for managing essential hypertension.

How similar studies have performed: Other studies have shown positive outcomes with beta-blockers in hypertension management, suggesting this approach may be effective.

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.

Where this trial is running

Al Fayyum

• Al-Fayoum University Hospital — Al Fayyum, Egypt (Recruiting)

Study contacts

• Principal investigator: Bassem El-Zarif, MD, Ph.D — National Heart Institute, Cairo, Egypt
• Study coordinator: Mohsen Fathallah, MD, Ph.D

Conditions Essential Hypertension