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CompletedNCT07313124Updated Jan 5, 2026

Comparative Study Between Antihyperlipidemic Agents in Treatment of Cardiovascular Diseases

A Phase 2/3 interventional study of rosuvastatin drug and Patients received rosuvastatin ezetimibe10/10mg in Cardiovascular Diseases (CVD), sponsored by Beni-Suef University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-05.

Sponsored by Beni-Suef University · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Dec 2024, registered Dec 2025).
Phase
Phase 2/3
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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.
02

Conditions studied

  • Cardiovascular Diseases (CVD)

Keywords

  • Antihyperlipidemic
  • Cardiovascular diseases
  • Rosuvastatin
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 66 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Beni-Suef University is the lead sponsor of 333 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Adults above 18 years, Dyslipidemic patients

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    RosUvastatin

    Patients will receive to rosuvastatin 20 mg

    Drug: rosuvastatin drug

  • Active comparator
    rosuvastatin ezetimibe10/10mg.

    Patients will receive rosuvastatin ezetimibe10/10mg.

    Combination Product: Patients received rosuvastatin ezetimibe10/10mg

Interventions

  • Drugrosuvastatin drug

    Patients randomized to receive rosuvastatin 20 mg

  • Combination productPatients received rosuvastatin ezetimibe10/10mg

    Patients received rosuvastatin ezetimibe10/10mg

06

What researchers measure

Primary outcomes

  1. Creatine Kinase

    Time frame: at baseline and after 12 weeks

07

Study locations

1 site
  • Beni-Suef University Hospital
    Banī Suwayf, Beni Suweif Governorate 62521, Egypt
08

References and documents

Publications

  • 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. PubMed 31559554 ↗

Related links

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07313124
Lead sponsor
Beni-Suef University
Responsible party
Hasnaa Osama (Lecturer of Clinical Pharmacy, Beni-Suef University, Egypt, Beni-Suef University) — Principal investigator
First posted
Dec 31, 2025
Start date
Dec 15, 2024
Primary completion
Nov 20, 2025
Completion
Dec 1, 2025
Last update
Jan 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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