Benidipine in Hypertensive and/or Chronic Coronary Syndro... | NCT06808321

Studies
Benidipine in Hypertensive and/or Chronic Coronary Syndrome Patients

NCT06808321

Sponsor

The Society of Prevention and Awareness of Cardiovascular Diseases

Status

Enrolling by invitation

Last Update Posted

Sep 9, 2025Actual

Enrollment

800Estimated

Phase

Not provided

Conditions

Chronic Coronary Syndrome
Hypertension
Angina Pectoris

Interventions

Benidipine Hydrochloride

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2025Actual

Primary Completion Date

Jan 1, 2026Estimated

Completion Date

Jun 1, 2026Estimated

First Submitted Date

Jan 26, 2025

First Submission Date that Met QC Criteria

Jan 31, 2025

First Posted Date

Feb 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2025

Last Update Posted Date

Sep 9, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

800Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Benidipine Hydrochloride	Drug	The safety and efficacy of a dihydropyridine calcium channel blocker for the treatment of high blood pressure and/or angina pectoris

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Type	Date	Date Unknown
Release	Mar 15, 2026
Reset	Apr 2, 2026
Release	Apr 4, 2026
Reset	Apr 23, 2026
Release	Jun 9, 2026
Reset	Jul 6, 2026

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D000787	Angina Pectoris
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D017202	Myocardial Ischemia
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 15, 2026			Apr 2, 2026
Apr 4, 2026