Comparative Study Between Antihyperlipidemic Agents in Tr... | NCT07313124

Studies
Comparative Study Between Antihyperlipidemic Agents in Treatment of Cardiovascular Diseases

NCT07313124

Sponsor

Beni-Suef University

Status

Completed

Last Update Posted

Jan 5, 2026Actual

Enrollment

66Actual

Phase

Phase 2Phase 3

Conditions

Cardiovascular Diseases (CVD)

Interventions

rosuvastatin drug
Patients received rosuvastatin ezetimibe10/10mg

Countries

Egypt

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2024Actual

Primary Completion Date

Nov 20, 2025Actual

Completion Date

Dec 1, 2025Actual

First Submitted Date

Dec 17, 2025

First Submission Date that Met QC Criteria

Dec 17, 2025

First Posted Date

Dec 31, 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

Dec 31, 2025

Last Update Posted Date

Jan 5, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hasnaa Osama, Lecturer of Clinical Pharmacy, Beni-Suef University, Egypt, Beni-Suef UniversityPrincipal Investigator

Lead Sponsor

Beni-Suef UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

The goal of this clinical trial is to study the efficiency and safety of using combinations of antihyperlipidemic agents with a single drug to treat cardiovascular diseases.

The main questions it aims to answer are:

Which approach is more effective rosuvastatin monotherapy or rosuvastatin ezetimibe combination antihyperlipidemic for patients with cardiovascular diseases (CVDs)?
What medical problems do participants could when taking antihyperlipidemic drugs? Researchers will compare rosuvastatin 20 mg or rosuvastatin ezetimibe10/10mg to see the effectiveness and safety of these drugs in patients with CVDs.

Participants will:

Patients will randomize to either rosuvastatin 20 mg or rosuvastatin ezetimibe10/10mg.
Patients will be followed up to 12 weeks after starting treatment.
All the patients will be subjected to: Full sheet taking, including detailed history and diagnosis of the case, Baseline Aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) tests& after 24 weeks of treatment, Lipid Profile, creatine kinase (CK) test, Creatine kinase-MB (CK-MB) test.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RosUvastatin	Experimental	Patients will receive to rosuvastatin 20 mg	Drug: rosuvastatin drug
rosuvastatin ezetimibe10/10mg.	Active Comparator	Patients will receive rosuvastatin ezetimibe10/10mg.	Combination Product: Patients received rosuvastatin ezetimibe10/10mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rosuvastatin drug	Drug	Patients randomized to receive rosuvastatin 20 mg	RosUvastatin

Measure	Description	Time Frame
Creatine Kinase		at baseline and after 12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults above 18 years, Dyslipidemic patients

Exclusion Criteria:

Young people under 18 years old pregnant women lactating women Children Hypersensitivity Renal failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beni-Suef University Hospital		Banī Suwayf	Beni Suweif Governorate	62521	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31559554	Background	Cote DJ, Rosner BA, Smith-Warner SA, Egan KM, Stampfer MJ. Statin use, hyperlipidemia, and risk of glioma. Eur J Epidemiol. 2019 Nov;34(11):997-1011. doi: 10.1007/s10654-019-00565-8. Epub 2019 Sep 26.