Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05880056
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-05-07
Brief Title:
Study of Bisoprolol Nerkardou - Nerhadou International 5 and 10 mg Oral Dissolvable Film ODF Treatment in Egyptian Patients With Essential Hypertension
Sponsor:
Genuine Research Center Egypt
Organization:
Genuine Research Center Egypt
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BETTER
Brief Summary:
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 13080 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
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 13080 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
Detailed Description:
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 patients compliance in the treatment of essential hypertension This is a Phase IV open-label single-arm prospective trial where subjects will receive
The subject will initially administer once daily 5 mg bisoprolol Nerkardou oral dissolvable film ODF for 2 weeks After the assessment of the subject being a responder study medication will be maintained till week 12 Response will be assessed for each patient every 2 weeks and dose-titration will be done based on the response and PI decision at any visit Then for responders once daily 5 mg bisoprolol Nerkardou oral dissolvable film ODF will be administered for the subsequent 2 weeks For non-responders once daily 10 mg bisoprolol Nerkardou oral dissolvable film ODF will be administered for the subsequent 2 weeks For those who are still not responding to the higher dose will be shifted to other alternatives according to their merit and they will be included to intention to treat
A responder is defined by BP response which is represented in the form of a 20 mmHg decreases in sitting through SBP and a 10 mmHg decreases in sitting through DBP or a sitting through SBP of 130 mmHg and a sitting through DBP of 80 mmHg
The total duration of study treatment will be 12 week 2days Flow chart of trail design Appendix III and the total sample size of the study will be 406 participants
The trial has a duration of approximately 14 weeks including
1 Screening assessments to determine eligibility for entry into the trial occurring within 14 days to day 1 before treatment initiation week -2 to week 0
2 Treatment duration 5 mg or 10 mg bisoprolol Nerkardou based on the response duration of 12 weeks from Day 1 week 1 to the end of day 84 2days week 12 2days
3 Premature withdrawal Early Discontinuation
The subject will initially administer once daily 5 mg bisoprolol Nerkardou oral dissolvable film ODF for 2 weeks After the assessment of the subject being a responder study medication will be maintained till week 12 Response will be assessed for each patient every 2 weeks and dose-titration will be done based on the response and PI decision at any visit Then for responders once daily 5 mg bisoprolol Nerkardou oral dissolvable film ODF will be administered for the subsequent 2 weeks For non-responders once daily 10 mg bisoprolol Nerkardou oral dissolvable film ODF will be administered for the subsequent 2 weeks For those who are still not responding to the higher dose will be shifted to other alternatives according to their merit and they will be included to intention to treat
A responder is defined by BP response which is represented in the form of a 20 mmHg decreases in sitting through SBP and a 10 mmHg decreases in sitting through DBP or a sitting through SBP of 130 mmHg and a sitting through DBP of 80 mmHg
The total duration of study treatment will be 12 week 2days Flow chart of trail design Appendix III and the total sample size of the study will be 406 participants
The trial has a duration of approximately 14 weeks including
1 Screening assessments to determine eligibility for entry into the trial occurring within 14 days to day 1 before treatment initiation week -2 to week 0
2 Treatment duration 5 mg or 10 mg bisoprolol Nerkardou based on the response duration of 12 weeks from Day 1 week 1 to the end of day 84 2days week 12 2days
3 Premature withdrawal Early Discontinuation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None