Benidipine in Hypertensive and/or Chronic Coronary Syndrome Patients

NCT ID: NCT06808321

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-06-01

Brief 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 Turkey.

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 Turkey.
• 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 Bendipine in patients with hypertensive and/or angina pectoris in 7 geographical regions of Turkey.

Conditions

Chronic Coronary Syndrome; Hypertension; Angina Pectoris

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Benidipine Hydrochloride

The safety and efficacy of a dihydropyridine calcium channel blocker for the treatment of high blood pressure and/or angina pectoris

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Society of Prevention and Awareness of Cardiovascular Diseases

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Antalya Kepez State Hospital

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2025-01

Identifier Type: -

Identifier Source: org_study_id