Comparative Study Between Antihyperlipidemic Agents in Treatment of Cardiovascular Diseases

NCT07313124 | Completed Phase 2

• 1 other identifier: FMBSUREC/05012025/Elsaid
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases (CVD)

Keywords

Antihyperlipidemic; Cardiovascular diseases; Rosuvastatin

Outcome Measures

Primary Outcomes (1)

• Creatine Kinase

  at baseline and after 12 weeks

Study Arms (2)

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

rosuvastatin drug DRUG

Patients randomized to receive rosuvastatin 20 mg

RosUvastatin

Patients received rosuvastatin ezetimibe10/10mg COMBINATION_PRODUCT

Patients received rosuvastatin ezetimibe10/10mg

rosuvastatin ezetimibe10/10mg.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults above 18 years, Dyslipidemic patients

You may not qualify if:

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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Location

Related Publications (1)

• 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.

  PMID: 31559554 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy, Beni-Suef University, Egypt

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 31, 2025
• Study Start: December 15, 2024
• Primary Completion: November 20, 2025
• Study Completion: December 1, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

EG (1)