NCT06808321

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Mar 2025Jun 2026

First Submitted

Initial submission to the registry

January 26, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

January 26, 2025

Last Update Submit

September 2, 2025

Conditions

Keywords

Coronary artery diseaseHypertensionAngina pectoris

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Kepez State Hospital

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HypertensionAngina PectorisCoronary Artery Disease

Interventions

benidipine hydrochloride

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2025

First Posted

February 5, 2025

Study Start

March 1, 2025

Primary Completion

January 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

September 9, 2025

Record last verified: 2025-09

Locations