Chronic Coronary SyndromeBenidipineTRNCT06808321

Benidipine in Hypertensive and/or Chronic Coronary Syndrome Patients

An observational study of Chronic Coronary Syndrome and Hypertension, run by The Society of Prevention and Awareness of Cardiovascular Diseases at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Evaluation of the clinical outcomes of Benidipine initiated by physician's preference in patients with hypertension and/or angina pectoris (chronic coronary syndrome) presenting to cardiology outpatient clinics in Türkiye. This is a prospective, multicenter, observational registry and is strictly non-interventional. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Chronic Coronary Syndrome, Hypertension, Angina Pectoris
What is being tested?: Benidipine Hydrochloride
Type of treatment: Pill or oral medicine
How many people: 1,659 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Mar 2025to 1 Jan 2026
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Adult, Older adult

Study population: Patients presenting to cardiology outpatient clinics in Turkey with hypertension and/or angina pectoris (chronic coronary syndrome)

Who may be able to join

Patients with hypertension and/or angina pectoris on the background of chronic coronary syndrome who have been receiving Benidipine treatment for at least 1 month and will continue to receive Benidipine treatment
Male or female outpatients, 18-80 years of age
Patients with mild to moderate essential hypertension who have been receiving or will continue Benidipine treatment for at least 1 month
Outpatients with clinically stable angina pectoris and patients who have been receiving or will continue Benidipine treatment for at least 1 month
Those who signed the written informed consent form

Who cannot join

Patients with secondary hypertension
Emergency hypertensive patients
Having to take other medications during the study that may affect blood pressure
Allergic to DHP calcium antagonists
Evidence of decompensated congestive heart failure, unstable angina or severe arrhythmia
Severe renal or hepatic dysfunction

Show all 9Show fewer

Pregnant or lactating women
Participation in other clinical trials within 3 months prior to this study
Patients who did not sign the consent form of the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Ege University
Izmir, Bornova

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Clinical Outcomes of Benidipine in Hypertensive and/or Chronic Coronary Syndrome Patients in the Turkish Population

This is a prospective, multicenter, observational registry and is strictly non-interventional. The decision to prescribe Benidipine is made by the treating physician as part of routine medical care, independent of and prior to study enrollment. No study-specific interventions, treatment assignments, or additional diagnostic procedures are mandated by the protocol. The study solely observes and records real-world clinical outcomes without any investigator interference in the standard management of the patient.

Read the detailed description

Benidipine is a dihydropyridine calcium channel blocker used in the treatment of hypertension and angina pectoris. There are currently no large-scale observational studies in these patient groups in Türkiye.
There is no record of benidipine in clinicaltrials.gov, which is an important database especially for the registration of drug and interventional studies.
Therefore, it will be extremely important to include this study in clinicaltrials.gov and to evaluate the clinical efficacy of Benidipine in patients with hypertensive and/or angina pectoris in 7 geographical regions of Türkiye.
The study does not involve any assignment of a therapeutic agent or a medical strategy to a participant that deviates from routine clinical practice. The decision to prescribe Benidipine is made by the treating physician prior to, and independently of, the decision to include the patient in the registry.
All diagnostic and therapeutic procedures follow the current institutional standards and clinical guidelines. No additional diagnostic or monitoring procedures are mandated by the protocol; all data collected are those generated during the course of routine medical follow-up.
The investigator does not influence the choice of treatment, the dosage, or the duration of the therapy. The registry serves solely to observe and record the outcomes of real-world clinical decisions and the natural course of the treatment provided as part of standard medical care.

Conditions: Chronic Coronary Syndrome, Hypertension, Angina Pectoris
Being tested: Benidipine Hydrochloride
Keywords: Coronary artery disease, Hypertension, Angina pectoris
Medical subject headings: Hypertension, Angina Pectoris, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Benidipine HydrochlorideDrug
Also called Coniel
Participants receive oral benidipine hydrochloride (4 mg or 8 mg tablets) once daily for a duration of 12 weeks, with dosage adjustments permitted based on clinical investigator judgment to achieve blood pressure targets in a real-world observational setting.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Systolic Blood Pressure at Month 3
Change in systolic blood pressure (SBP), measured in mmHg, from baseline to Month 3. The change is calculated as the SBP value at Month 3 minus the baseline SBP value (Month 3 SBP - Baseline SBP). Positive values indicate an increase in systolic blood pressure, whereas negative values indicate a decrease in systolic blood pressure.
Measured: Baseline and Month 3
Change From Baseline in Diastolic Blood Pressure at Month 3
Change in diastolic blood pressure (DBP), measured in mmHg, from baseline to Month 3. The change is calculated as the DBP value at Month 3 minus the baseline DBP value (Month 3 DBP - Baseline DBP). Positive values indicate an increase in diastolic blood pressure, whereas negative values indicate a decrease in diastolic blood pressure.
Measured: Baseline and Month 3
Change From Baseline in Seattle Angina Questionnaire Score at Month 3
The Seattle Angina Questionnaire (SAQ) is a disease-specific questionnaire used to assess health status in patients with coronary artery disease. The SAQ score ranges from 0 to 100, with higher scores indicating better angina-related health status. Change from baseline to Month 3 is calculated as the Month 3 score minus the baseline score. Positive values indicate an increase in the SAQ score, whereas negative values indicate a decrease in the SAQ score.
Measured: Baseline and Month 3

Secondary outcomes (1)

Treatment Persistence and Patient Compliance at Month 3
Evaluation of the percentage of participants who continued their prescribed Benidipine treatment without interruption and adhered to the clinical follow-up protocol over a 3-month period. Persistence is defined as the continued use of the medication from baseline to the final visit.
Measured: Baseline and Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20251 Jan 2026

First posted5 Feb 2025
Study start1 Mar 2025
Primary completion1 Jan 2026
Study completion1 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,659 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06808321
Sponsor's protocol ID: 2025-01
Acronym: BenidipineTR
Status last verified: Oct 2026
First submitted: 26 Jan 2025
Last updated: 4 Nov 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Coronary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Clinical Outcomes of Benidipine in Hypertensive and/or Chronic Coronary Syndrome Patients in the Turkish Population
ClinicalTrials.gov ID: NCT06808321
Acronym / sponsor ID: BenidipineTR / 2025-01
Conditions: Chronic Coronary Syndrome, Hypertension, Angina Pectoris
Keywords: Coronary artery disease, Hypertension, Angina pectoris
Study type: Observational
Recruitment status: Completed
Enrolment: 1,659 participants (actual)
Lead sponsor: The Society of Prevention and Awareness of Cardiovascular DiseasesUniversity, hospital or other
Study start: 1 Mar 2025 (actual)
Primary completion: 1 Jan 2026 (actual)
Study completion: 1 Jan 2026 (actual)
First posted: 5 Feb 2025 (actual)
Results: Posted 4 Nov 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Benidipine is a dihydropyridine calcium channel blocker used in the treatment of hypertension and angina pectoris. There are currently no large-scale observational studies in these patient groups in Türkiye.
There is no record of benidipine in clinicaltrials.gov, which is an important database especially for the registration of drug and interventional studies.
Therefore, it will be extremely important to include this study in clinicaltrials.gov and to evaluate the clinical efficacy of Benidipine in patients with hypertensive and/or angina pectoris in 7 geographical regions of Türkiye.
The study does not involve any assignment of a therapeutic agent or a medical strategy to a participant that deviates from routine clinical practice. The decision to prescribe Benidipine is made by the treating physician prior to, and independently of, the decision to include the patient in the registry.
All diagnostic and therapeutic procedures follow the current institutional standards and clinical guidelines. No additional diagnostic or monitoring procedures are mandated by the protocol; all data collected are those generated during the course of routine medical follow-up.
The investigator does not influence the choice of treatment, the dosage, or the duration of the therapy. The registry serves solely to observe and record the outcomes of real-world clinical decisions and the natural course of the treatment provided as part of standard medical care.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 80 years
Sex: All
Age groups: Adult, Older adult
Study population: Patients presenting to cardiology outpatient clinics in Turkey with hypertension and/or angina pectoris (chronic coronary syndrome)

Key inclusion criteria (5 listed)

Patients with hypertension and/or angina pectoris on the background of chronic coronary syndrome who have been receiving Benidipine treatment for at least 1 month and will continue to receive Benidipine treatment
Male or female outpatients, 18-80 years of age
Patients with mild to moderate essential hypertension who have been receiving or will continue Benidipine treatment for at least 1 month
Outpatients with clinically stable angina pectoris and patients who have been receiving or will continue Benidipine treatment for at least 1 month
Those who signed the written informed consent form

Key exclusion criteria (9 listed)

Patients with secondary hypertension
Emergency hypertensive patients
Having to take other medications during the study that may affect blood pressure
Allergic to DHP calcium antagonists
Evidence of decompensated congestive heart failure, unstable angina or severe arrhythmia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Benidipine HydrochlorideAlso: ConielParticipants receive oral benidipine hydrochloride (4 mg or 8 mg tablets) once daily for a duration of 12 weeks, with dosage adjustments permitted based on clinical investigator judgment to achieve blood pressure targets in a real-world observational setting.	Drug	–

Primary outcome

Change From Baseline in Systolic Blood Pressure at Month 3
Time frame: Baseline and Month 3
Change in systolic blood pressure (SBP), measured in mmHg, from baseline to Month 3. The change is calculated as the SBP value at Month 3 minus the baseline SBP value (Month 3 SBP - Baseline SBP). Positive values indicate an increase in systolic blood pressure, whereas negative values indicate a decrease in systolic blood pressure.
Change From Baseline in Diastolic Blood Pressure at Month 3
Time frame: Baseline and Month 3
Change in diastolic blood pressure (DBP), measured in mmHg, from baseline to Month 3. The change is calculated as the DBP value at Month 3 minus the baseline DBP value (Month 3 DBP - Baseline DBP). Positive values indicate an increase in diastolic blood pressure, whereas negative values indicate a decrease in diastolic blood pressure.
Change From Baseline in Seattle Angina Questionnaire Score at Month 3
Time frame: Baseline and Month 3
The Seattle Angina Questionnaire (SAQ) is a disease-specific questionnaire used to assess health status in patients with coronary artery disease. The SAQ score ranges from 0 to 100, with higher scores indicating better angina-related health status. Change from baseline to Month 3 is calculated as the Month 3 score minus the baseline score. Positive values indicate an increase in the SAQ score, whereas negative values indicate a decrease in the SAQ score.

1 secondary outcome

Treatment Persistence and Patient Compliance at Month 3
Time frame: Baseline and Month 3

Results and safety

Results posted to the registry on 4 Nov 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Benidipine Treatment Cohort	1,659	1,659

Primary outcome: Change From Baseline in Systolic Blood Pressure at Month 3

Time frame: Baseline and Month 3. Mean (Standard Deviation). Unit: mmHg

Measure	Benidipine Treatment Group n = 1659
Value	-12.5 (8.4)

Population analysed: Participants who met the eligibility criteria, received benidipine as part of routine clinical care, completed the Month 3 follow-up, and had systolic blood pressure measurements available at both baseline and Month 3.

Primary outcome: Change From Baseline in Diastolic Blood Pressure at Month 3

Time frame: Baseline and Month 3. Mean (Standard Deviation). Unit: mmHg

Measure	Benidipine Treatment Group n = 1659
Value	-6.74 (7.93)

Population analysed: Participants who met the eligibility criteria, received benidipine as part of routine clinical care, completed the Month 3 follow-up, and had diastolic blood pressure measurements available at both baseline and Month 3.

Primary outcome: Change From Baseline in Seattle Angina Questionnaire Score at Month 3

Time frame: Baseline and Month 3. Mean (Standard Deviation). Unit: units on a scale

Measure	Benidipine Treatment Group n = 1659
Value	8.08 (6.27)

Population analysed: Participants who met the eligibility criteria, received benidipine as part of routine clinical care, completed the Month 3 follow-up, and had Seattle Angina Questionnaire assessments available at both baseline and Month 3.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non-serious Adverse Events	0 of 1,659 (0%)	0 of 1,659 (0%)	0 of 1,659

Limitations and caveats (from the sponsor): Unlike a Randomized Controlled Trial (RCT), this was an observational study. The study utilized physician preference for treatment assignment. The outcome data time frame was 3 months. Both the physicians and the patients knew they were using Benidipine (Open-Label).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

ayşegül Ülgen Kunak, M.D. principal investigator

aysegululgen@yahoo.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Coronary Syndrome and Hypertension, run by The Society of Prevention and Awareness of Cardiovascular Diseases at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Systolic Blood Pressure at Month 3 (time frame: Baseline and Month 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06808321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.