[Effects of Selected Statins on Cardiovascular Parameters in Healthy Volunteers]

ConditionLipid Profile,Blood Pressure

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-25

SponsorShaheed Benazir Bhutto University Sheringal Dir Upper

About this trial

This study is a Phase I randomized clinical trial aiming to investigate the short-term effects of three commonly prescribed statins i.e (Atorvastatin, Rosuvastatin, and Simvastatin) at different dose levels i.e lo,median and high doses on cardiovascular parameters i.e Blood pressure and ECG morphology in healthy volunteers. The study will assess changes in blood pressure and ECG morphology following two days of statin administration under controlled conditions.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy volunteers

Normal ECG

Normal Blood Pressure

Normal lipid levels

Disqualifiers

Participants with a history of diabetes mellitus,BP

With chronic diseases e.g heart disease, kidney disease

QTc ≥450 ms (men) or ≥470 ms (women)

ECG changes

Trial design

Design model

Parallel

Treatments tested in this trial

Rosuvastatin (5mg, 20mg, 40mg)
Drug
The Rosuvastatin (5mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
Atorvastatin (10mg, 20mg, 40mg)
Drug
The Atorvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
Simvastatin (10mg, 20mg, 40m
Drug
The Simvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days

Treatment groups

100 Participants

are divided into 3 treatment groups

Group A: Rosuvastatin (5mg, 20mg, 40mg)Experimental treatment 1 intervention

Group B: Atorvastatin (10mg,20mg, 40mg)Experimental treatment 1 intervention

Group C: Simvastatin (10mg, 20mg, 40mg)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Blood Pressure Measurements

Blood Pressure of the subjects will be determined by sphygmomanometer

Time frame

before dosing and 2 days after dosing achieving peak plasma concentrations respectively]

Secondary outcomes

Electrocardiograms (ECGs) Measurements

ECGs of the subjects will be determined by 12 Leads ECG Machine.QT interval and QRS complex in milliseconds will be analyzed to determine the effects of these statins on ECG morphology

Time frame

before dosing and 2 days after dosing achieving peak plasma concentrations respectively]

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shaheed Benazir Bhutto University Sheringal Dir Upper

Lead sponsor

Khyber Medical University Peshawar

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: