Hyperlipidemia; MixedNCT05080140
Investigate the Effect of Ezetimibe, Simvastatin, and Omega 3- Fatty Acids on Dyslipidemia Patients: a Pharmacokinetics Based Study
An observational study of Hyperlipidemia; Mixed, run by Misr University for Science and Technology at 1 site in Egypt.
Trial summary
This randomized controlled pharmacokinetic based study will be carried out on patients with both sexes and various ages, plasma triglycerides levels, clinical health disorders and using different agents for treatment of their hyperlipidemia in order to access the optimal drug therapy with best cost effectiveness in… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hyperlipidemia; Mixed
- What is being tested?
- Ezetimibe 10mg
- How many people
- 3 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 20 Mar 2022
- Phase
- Observational
- 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
Study population: least 80 adult patients both sexes suffering from mixed dyslipidemia with high triglyceride level admitted at Sauad Kaffafi Hospital, Misr University for science and technology.
Who may be able to join
- Patients of dyslipidemia with high triglyceride level (200 to 499 mg/100 ml).
- Total cholesterol level more than 200 mg/100 ml
- Male and female
- Age 35 - 70 years
Who cannot join
- - Hypersensitivity of drugs
- Liver toxicity
- -Patients suffering from renal dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled pharmacokinetic based study will be carried out on patients with both sexes and various ages, plasma triglycerides levels, clinical health disorders and using different agents for treatment of their hyperlipidemia in order to access the optimal drug therapy with best cost effectiveness in the elderly cases under investigation.
- Conditions
- Hyperlipidemia; Mixed
- Being tested
- Ezetimibe 10mg
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezetimibe 10mgDrug
Effect of ezetimibe on hyperlipidemia on patients with diabetes mellites
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Not described | |
| Ezetimibe | Not described Receives: Drug: Ezetimibe 10mg | |
| Omega -3 fatty acids- | Not described | |
| Simvastatin+ Ezetimibe | Not described Receives: Drug: Ezetimibe 10mg | |
| Simvastain + ezetimibe + omega | Not described Receives: Drug: Ezetimibe 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Total cholesterol
reduction of LDL
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Jun 2019
- Primary completion1 Jul 2021
- Study completion20 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperlipidemia; MixedStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmine Farouk, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080140
- Sponsor's protocol ID
- 1606YAS141008
- Status last verified
- Oct 2021
- First submitted
- 2 Oct 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: result and conclusion sharing
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigate the Effect of Ezetimibe, Simvastatin, and Omega 3- Fatty Acids on Dyslipidemia Patients: a Pharmacokinetics Based Study
- ClinicalTrials.gov ID
- NCT05080140
- Acronym / sponsor ID
- 1606YAS141008
- Conditions
- Hyperlipidemia; Mixed
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 20 Mar 2022 (estimated)
- First posted
- 15 Oct 2021 (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.
This randomized controlled pharmacokinetic based study will be carried out on patients with both sexes and various ages, plasma triglycerides levels, clinical health disorders and using different agents for treatment of their hyperlipidemia in order to access the optimal drug therapy with best cost effectiveness in the elderly cases under investigation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | – | – |
| Ezetimibe | – | Drug: Ezetimibe 10mg |
| Omega -3 fatty acids- | – | – |
| Simvastatin+ Ezetimibe | – | Drug: Ezetimibe 10mg |
| Simvastain + ezetimibe + omega | – | Drug: Ezetimibe 10mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- least 80 adult patients both sexes suffering from mixed dyslipidemia with high triglyceride level admitted at Sauad Kaffafi Hospital, Misr University for science and technology.
Key inclusion criteria (4 listed)
- Patients of dyslipidemia with high triglyceride level (200 to 499 mg/100 ml).
- Total cholesterol level more than 200 mg/100 ml
- Male and female
- Age 35 - 70 years
Key exclusion criteria (3 listed)
- - Hypersensitivity of drugs
- Liver toxicity
- -Patients suffering from renal dysfunction
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 |
|---|---|---|
| Ezetimibe 10mgEffect of ezetimibe on hyperlipidemia on patients with diabetes mellites | Drug | Ezetimibe, Simvastain + ezetimibe + omega, Simvastatin+ Ezetimibe |
Primary outcome
Reduction of Total cholesterol
Time frame: 3 months
reduction of LDL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: No. result and conclusion sharing
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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?
An observational study of Hyperlipidemia; Mixed, run by Misr University for Science and Technology 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Oct 2021. 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.
Are results available for this study?
Results are not available in the source record.
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?
Reduction of Total cholesterol (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2021.