Investigate the Effect of Ezetimibe, Simvastatin, and Omega 3- Fatty Acids on Dyslipidemia Patients: a Pharmacokinetics Based Study

October 2, 2021 updated by: Yasmine Farouk, Misr University for Science and Technology
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

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
      • Giza, Egypt, 002
        • Misr University for Science and Technology

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • - Hypersensitivity of drugs
  • Liver toxicity
  • -Patients suffering from renal dysfunction

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Simvastatin
Ezetimibe
Drug: Ezetimibe 10mg
Effect of ezetimibe on hyperlipidemia on patients with diabetes mellites
Omega -3 fatty acids-
Simvastatin+ Ezetimibe
Drug: Ezetimibe 10mg
Effect of ezetimibe on hyperlipidemia on patients with diabetes mellites
Simvastain + ezetimibe + omega
Drug: Ezetimibe 10mg
Effect of ezetimibe on hyperlipidemia on patients with diabetes mellites

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Total cholesterol
Time Frame: 3 months
reduction of LDL
3 months

Collaborators and Investigators

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

Sponsor

Misr University for Science and Technology

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)

June 1, 2019

Primary Completion (Actual)

July 1, 2021

Study Completion (Anticipated)

March 20, 2022

Study Registration Dates

First Submitted

October 2, 2021

First Submitted That Met QC Criteria

October 2, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 2, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1606YAS141008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

result and conclusion sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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