Investigate the Effect of Ezetimibe, Simvastatin, and Ome... | NCT05080140

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

NCT05080140

Sponsor

Misr University for Science and Technology

Status

Unknown status

Last Update Posted

Oct 15, 2021Actual

Enrollment

3Estimated

Phase

Not provided

Conditions

Hyperlipidemia; Mixed

Interventions

Ezetimibe 10mg

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2019Actual

Primary Completion Date

Jul 1, 2021Actual

Completion Date

Mar 20, 2022Estimated

First Submitted Date

Oct 2, 2021

First Submission Date that Met QC Criteria

Oct 2, 2021

First Posted Date

Oct 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2021

Last Update Posted Date

Oct 15, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yasmine Farouk, Teacher Assistant - clinical pharmacy department, Misr University for Science and TechnologyPrincipal Investigator

Lead Sponsor

Misr University for Science and TechnologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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 the elderly cases under investigation.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Simvastatin
Ezetimibe			Drug: Ezetimibe 10mg
Omega -3 fatty acids-
Simvastatin+ Ezetimibe			Drug: Ezetimibe 10mg
Simvastain + ezetimibe + omega			Drug: Ezetimibe 10mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ezetimibe 10mg	Drug	Effect of ezetimibe on hyperlipidemia on patients with diabetes mellites	Ezetimibe Simvastain + ezetimibe + omega Simvastatin+ Ezetimibe

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Misr University for science and technology		Giza		002	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

result and conclusion sharing

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006938	Hyperlipoproteinemia Type II

Ancestor Terms

ID	Term
D008052	Lipid Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069438	Ezetimibe

Ancestor Terms

ID	Term
D001384	Azetidines
D001385	Azetines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided