Actively Recruiting

Phase 4
Age: 21Years - 65Years
All Genders
NCT05880056

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

Led by Genuine Research Center, Egypt · Updated on 2024-08-19

406

Participants Needed

1

Research Sites

33 weeks

Total Duration

On this page

Sponsors

G

Genuine Research Center, Egypt

Lead Sponsor

N

Nerhadou International for pharmaceutical & Nutraceutical, Egypt

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to give informed consent to participate
  • Male or female aged 21 years or older and under 65 years
  • Body mass index (BMI) between 18.5 and 30 kg/m2
  • Newly diagnosed with grade 1 hypertension (SBP 140 to 159 mmHg and/or DBP 90 to 99 mmHg) or grade 2 hypertension (SBP 160 to 179 mmHg and/or DBP 100 to 109 mmHg) at screening
  • Non-responders to first-line hypertension treatments other than beta blockers who can safely switch to bisoprolol
  • No other significant health conditions based on medical history, ECG, echocardiogram, vital signs, physical exam, and lab tests
  • Resting heart rate of 80 beats per minute or higher at baseline
  • For women of childbearing potential not using reliable contraception, must agree to recommended contraceptive methods
  • Willing to allow their general practitioner and consultant to be informed of their participation
Not Eligible

You will not qualify if you...

  • Grade III or malignant hypertension (systolic over 180 and/or diastolic over 120)
  • Unable to stop current antihypertensive medications like calcium channel blockers, ACE inhibitors, or diuretics if used for other reasons
  • Resting heart rate below 80 beats per minute
  • Renal impairment with serum creatinine over 2.0 mg/dL
  • Unrecovered pulmonary edema
  • History of cardiovascular surgeries
  • Known allergy to bisoprolol, amlodipine, dihydropyridines, or related products
  • Diabetes mellitus
  • History or presence of asthma
  • Significant gastrointestinal, liver, or kidney disease or conditions affecting drug metabolism or absorption
  • Use of enzyme-modifying drugs affecting CYP enzymes within 28 days before study start
  • Acute conditions affecting kidney function such as dehydration or severe infection
  • History of suicidal tendencies, seizures, confusion, or serious psychiatric illness
  • Positive pregnancy test or breastfeeding
  • High consumption of caffeine (over 600 mg per day)
  • Life expectancy under 6 months or conditions unsuitable for bisoprolol such as acute heart failure, cardiogenic shock, serious heart conduction issues, severe asthma or COPD, advanced peripheral artery disease, untreated pheochromocytoma, or metabolic acidosis
  • Participation in another investigational drug trial within the past 12 weeks

AI-Screening

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Trial Site Locations

Total: 1 location

1

Al-Fayoum University Hospital

Al Fayyum, Egypt, 63611

Actively Recruiting

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Research Team

M

Mohsen Fathallah, MD, Ph.D

CONTACT

S

Sally Khairat, B.Sc.Pharma

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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