An observational study in Chronic Coronary Syndrome, Hypertension and Angina Pectoris, sponsored by The Society of Prevention and Awareness of Cardiovascular Diseases. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by The Society of Prevention and Awareness of Cardiovascular Diseases · Observational
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. 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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 1,659 is above the median of 350 across 1,163 observational studies indexed under Hypertension.
Browse Hypertension studies →This is the only study on the registry with The Society of Prevention and Awareness of Cardiovascular Diseases as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients presenting to cardiology outpatient clinics in Turkey with hypertension and/or angina pectoris (chronic coronary syndrome)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: Coniel
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Month 3
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.
Time frame: Baseline and Month 3
The study utilized a prospective, observational, "real-life" recruitment strategy to capture a representative sample of the Turkish cardiovascular patient population. Total Recruitment Goal: 1659 patients. Data were gathered from 45 centers across all seven geographical regions of Turkey, ensuring geographical and lifestyle diversity.
| Milestone | Benidipine Treatment Cohort |
|---|---|
| Started | 1659 |
| Completed | 1659 |
| Not completed | 0 |
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.
| mmHg | Benidipine Treatment Group |
|---|---|
| Change From Baseline in Systolic Blood Pressure at Month 3 | -12.5 ± 8.4 |
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.
| mmHg | Benidipine Treatment Group |
|---|---|
| Change From Baseline in Diastolic Blood Pressure at Month 3 | -6.74 ± 7.93 |
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.
| units on a scale | Benidipine Treatment Group |
|---|---|
| Change From Baseline in Seattle Angina Questionnaire Score at Month 3 | 8.08 ± 6.27 |
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.
| Participants | Benidipine Treatment Group |
|---|---|
| Treatment Persistence and Patient Compliance at Month 3 | 1532 |
Collected over 3 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Non-serious Adverse Events | 0/1,659 (0%) | 0/1,659 (0%) | 0/1,659 (0%) |
The baseline analysis population includes all enrolled participants (N=1,659) who met the inclusion criteria and received at least one dose of benidipine hydrochloride. Analysis Set was used for the assessment of demographic characteristics, medical history, and baseline clinical parameters.
| Age, Categorical(Participants) | Benidipine Treatment Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1493 |
| >=65 years | 166 |
| Age, Continuous(Years) | Benidipine Treatment Group |
|---|---|
| Mean | 58.4 ± 10.2 |
| Age, Continuous(years) | Benidipine Treatment Group |
|---|---|
| Median | 61 (18 to 92) |
| Sex/Gender, Customized(Participants) | Benidipine Treatment Group |
|---|---|
| Female | 896 |
| Male | 763 |
| Sex: Female, Male(Participants) | Benidipine Treatment Group |
|---|---|
| Female | 896 |
| Male | 763 |
| Sex: Female, Male(Participants) | Benidipine Treatment Group |
|---|---|
| Female | 896 |
| Male | 763 |
| Race (NIH/OMB)(Participants) | Benidipine Treatment Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 1659 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Benidipine Treatment Group |
|---|---|
| Turkey (Türkiye) | 1659 |
4 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2025 to primary completion in Jan 2026, 10 months.
Results were first posted in Nov 2026, 10 months after primary completion.
Of 345 non-industry observational studies under Hypertension, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 111. This study's 10 months is below that.
Counting every sponsor, half of 426 studies reached it within 38 months; a quarter within 17 and three quarters within 96.
Completion moved once since we started tracking on Sep 25, 2026: Jun 2026 → Jan 2026, on Nov 4, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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