Cardiovascular Diseases (CVD)Phase 2/3NCT07313124
Comparative Study Between Antihyperlipidemic Agents in Treatment of Cardiovascular Diseases
A Phase 2/3 study testing rosuvastatin drug and Patients received rosuvastatin ezetimibe10/10mg in people with Cardiovascular Diseases (CVD), run by Beni-Suef University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardiovascular Diseases (CVD)
- What is being tested?
- rosuvastatin drug and Patients received rosuvastatin ezetimibe10/10mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to 1 Dec 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults above 18 years, Dyslipidemic patients
Who cannot join
- Young people under 18 years old pregnant women lactating women Children Hypersensitivity Renal failure
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Beni-Suef University Hospital
Banī Suwayf, Beni Suweif Governorate, 62521
About this study
Official title: 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:
Read more
- 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)
- Being tested
- rosuvastatin drug, Patients received rosuvastatin ezetimibe10/10mg
- Keywords
- Antihyperlipidemic, Cardiovascular diseases, Rosuvastatin
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosuvastatin drugDrug
Patients randomized to receive rosuvastatin 20 mg
Patients received rosuvastatin ezetimibe10/10mgCombination product
Patients received rosuvastatin ezetimibe10/10mg
| Study group | Role | What they receive |
|---|---|---|
| RosUvastatin | Experimental | Patients will receive to rosuvastatin 20 mg Receives: Drug: rosuvastatin drug |
| rosuvastatin ezetimibe10/10mg. | Active comparator | Patients will receive rosuvastatin ezetimibe10/10mg. Receives: Combination Product: Patients received rosuvastatin ezetimibe10/10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatine Kinase
Measured: at baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start15 Dec 2024
- Primary completion20 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Diseases (CVD)Studies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasnaa Osama, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313124
- Sponsor's protocol ID
- FMBSUREC/05012025/Elsaid
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency and Safety of Single Drug Versus Combinations of Antihyperlipidemic Agents in Treatment of Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT07313124
- Acronym / sponsor ID
- FMBSUREC/05012025/Elsaid
- Conditions
- Cardiovascular Diseases (CVD)
- Keywords
- Antihyperlipidemic, Cardiovascular diseases, Rosuvastatin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RosUvastatin | Experimental | Drug: rosuvastatin drugPatients will receive to rosuvastatin 20 mg |
| rosuvastatin ezetimibe10/10mg. | Active comparator | Combination Product: Patients received rosuvastatin ezetimibe10/10mgPatients will receive rosuvastatin ezetimibe10/10mg. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults above 18 years, Dyslipidemic patients
Key exclusion criteria (1 listed)
- Young people under 18 years old pregnant women lactating women Children Hypersensitivity Renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rosuvastatin drugPatients randomized to receive rosuvastatin 20 mg | Drug | RosUvastatin |
| Patients received rosuvastatin ezetimibe10/10mgPatients received rosuvastatin ezetimibe10/10mg | Combination product | rosuvastatin ezetimibe10/10mg. |
Primary outcome
Creatine Kinase
Time frame: at baseline and after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Background: PubMed 31559554Cote 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing rosuvastatin drug and Patients received rosuvastatin ezetimibe10/10mg in people with Cardiovascular Diseases (CVD), run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creatine Kinase (time frame: at baseline and after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07313124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.