Benidipine in Hypertensive And/or Chronic Coronary Syndrome Patients

Not yet recruiting

• Conditions: Chronic Coronary Syndrome; Hypertension; Angina Pectoris

• Registration Number: NCT06808321
• Lead Sponsor: The Society of Prevention and Awareness of Cardiovascular Diseases

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-26
• Study First Submitted QC: 2025-01-31
• Last Update Submitted: 2025-01-31
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05
• Study Start: 2025-06-01
• Primary Completion: 2025-11-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85	3 months
Change in angina symptom severity as measured by the Seattle Angina Questionnaire score from baseline to the end of study	3 months