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New treatment option for Essential Hypertension
Official title Study of Bisoprolol (Nerkardou - Nerhadou International) 5 and 10 mg Oral Dissolvable Film (ODF) Treatment in Egyptian Patients With Essential Hypertension
ClinicalTrials.gov ID: NCT05880056
What this study is testing
What is Nerkardou (5 mg) & (10 mg)?
Nerkardou (5 mg) & (10 mg) is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for essential hypertension.
Also referred to as Bisoprolol oral dissolved film ODF (5 mg) & (10 mg).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65
You may be able to join if
- The participant is willing and able to give informed consent for participation in the trial.
- Male or Female, aged ≥ 21 and \< 65 years.
- The subject with Body mass index (BMI) greater than or equal to 18.5 and below 30 kg/m2
- 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
You likely can't join if
- Grade III hypertension or malignant hypertension (Hypertensive crisis: Systolic over 180 and/or diastolic over 120).
- people who are not legible to discontinue current antihypertensives such as calcium channel blockers (CCB), ACE- inhibitors, or diuretics for reasons...
- people with heart rates less than (\<)80 beats at rest.
- people with renal impairment (serum creatinine \> 2.0 milligram per deciliter [mg/dL])
- people with unrecovered pulmonary edema
- people with a history of cardiovascular surgeries.
See the full eligibility criteria
- The participant is willing and able to give informed consent for participation in the trial.
- Male or Female, aged ≥ 21 and \< 65 years.
- The subject with Body mass index (BMI) greater than or equal to 18.5 and below 30 kg/m2
- 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.
- 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.
- Subject doesn't have other comorbidity according to the assessment of the medical history, electrocardiogram (ECG), echocardiogram vital signs, physical examination, and laboratory results.
- Subject with heart rate (HR) ≥ 80 (BPM) at baseline.
- Female people in childbearing period, and not on a reliable contraceptive method must adhere to the recommended contraceptive methods as detailed in Appendix I.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
- Grade III hypertension or malignant hypertension (Hypertensive crisis: Systolic over 180 and/or diastolic over 120).
- people 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.
- people with heart rates less than (\<)80 beats at rest.
- people with renal impairment (serum creatinine \> 2.0 milligram per deciliter [mg/dL])
- people with unrecovered pulmonary edema
- people with a history of cardiovascular surgeries.
- Significant history of hypersensitivity to bisoprolol, amlodipine, other dihydropyridines, or any related products (including excipients of the formulations)
- Presence of diabetes mellitus
- History or presence of asthma
- 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...
- 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...
- Acute conditions which might alter renal function (e.g., dehydration, severe infection)
- History of suicidal tendency, history of, or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
- Positive pregnancy test (only for females of child-bearing potential), or females breastfeeding a child.
- 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...
- 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...
- Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
The study team makes the final eligibility decision.
Where it's taking place
- Al Fayyum, Egypt
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Al Fayyum, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.