Lipid Profile,Blood Pressure
Conditions
Keywords
sBlood Pressure,ECG change
Brief summary
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.
Detailed description
The goal of this study is to evaluate the effects of these three statins on the cardiovascular parameters in a dose-dependent manner. In this Phase 1 clinical trial we will enroll healthy volunteers who will be randomized to receive one of three statins at low, moderate, or high doses for two days. .
Interventions
The Rosuvastatin (5mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
The Atorvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
DRUGSimvastatin (10mg, 20mg, 40m
The Simvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
Sponsors
Shaheed Benazir Bhutto University Sheringal Dir Upper
Khyber Medical University Peshawar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The PI will give the assigned medication to each participant according to randomization and allocation. All the personnel involved in the study will be kept blind.
Intervention model description
The selected statins i.e Simvastatin (5mg, 20mg, 40mg), atorvastatin (10mg,20mg, 40mg) and simvastatin(10mg, 20mg, 40mg) will be given orally to the participants of different assigned randomized participants groups in once daily dosing for two days to assess the effect on blood pressure and ECG.
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers * Normal ECG * Normal Blood Pressure * Normal lipid levels
Exclusion criteria
* 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 * Electrolyte imbalance, * Participants taking other medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Measurements | before dosing and 2 days after dosing achieving peak plasma concentrations respectively] | Blood Pressure of the subjects will be determined by sphygmomanometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electrocardiograms (ECGs) Measurements | before dosing and 2 days after dosing achieving peak plasma concentrations respectively] | 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 |
Countries
Pakistan
Contacts
CONTACTDr Abid Ullah, Ph.D
Outcome results
None listed