NCT05080140

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2022

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

2.1 years

First QC Date

October 2, 2021

Last Update Submit

October 2, 2021

Conditions

Hyperlipidemia; Mixed

Outcome Measures

Primary Outcomes (1)

  • Reduction of Total cholesterol

    reduction of LDL

    3 months

Study Arms (5)

Simvastatin

Ezetimibe

Drug: Ezetimibe 10mg

Omega -3 fatty acids-

Simvastatin+ Ezetimibe

Drug: Ezetimibe 10mg

Simvastain + ezetimibe + omega

Drug: Ezetimibe 10mg

Interventions

Ezetimibe 10mgDRUG

Effect of ezetimibe on hyperlipidemia on patients with diabetes mellites

EzetimibeSimvastain + ezetimibe + omegaSimvastatin+ Ezetimibe

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misr University for science and technology

Giza, 002, Egypt

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teacher Assistant - clinical pharmacy department

Study Record Dates

First Submitted

October 2, 2021

First Posted

October 15, 2021

Study Start

June 1, 2019

Primary Completion

July 1, 2021

Study Completion

March 20, 2022

Last Updated

October 15, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

result and conclusion sharing

Locations

EG(1)