Comparative Study Between Antihyperlipidemic Agents in Treatment of Cardiovascular Diseases

December 31, 2025 updated by: Hasnaa Osama, Beni-Suef University

The Efficiency and Safety of Single Drug Versus Combinations of Antihyperlipidemic Agents in Treatment of Cardiovascular Diseases

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egypt, 62521
        • Beni-suef university Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Adults above 18 years, Dyslipidemic patients

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RosUvastatin
Patients will receive to rosuvastatin 20 mg
Drug: rosuvastatin drug
Patients randomized to receive rosuvastatin 20 mg
Active Comparator: rosuvastatin ezetimibe10/10mg.
Patients will receive rosuvastatin ezetimibe10/10mg.
Combination product: Patients received rosuvastatin ezetimibe10/10mg
Patients received rosuvastatin ezetimibe10/10mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Creatine Kinase
Time Frame: at baseline and after 12 weeks
at baseline and after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2024

Primary Completion (Actual)

November 20, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Estimated)

December 31, 2025

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 31, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMBSUREC/05012025/Elsaid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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