[Effects of Selected Statins on Cardiovascular Parameters in Healthy Volunteers]
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rosuvastatin (5mg, 20mg, 40mg), Atorvastatin (10mg, 20mg, 40mg), Simvastatin (10mg, 20mg, 40m.
- Who it may be relevant to
- Registry conditions: Lipid Profile,Blood Pressure. Basic parameters: 18 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
[EFFECTS OF SELECTED STATINS ON CARDIOVASCULAR PARAMETERS IN HEALTHY VOLUNTEERS: A RANDAMOZIED PHASE I CLINICAL TRIAL]
Overview
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
- Drug Rosuvastatin (5mg, 20mg, 40mg)
The Rosuvastatin (5mg, 20mg, 40mg) group participants will be given the drug orally OD for two days - Drug Atorvastatin (10mg, 20mg, 40mg)
The Atorvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days - Drug Simvastatin (10mg, 20mg, 40m
The Simvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
Primary outcome measures
- Blood Pressure Measurements [Time frame: before dosing and 2 days after dosing achieving peak plasma concentrations respectively]]
Secondary outcome measures (1)
- Electrocardiograms (ECGs) Measurements [Time frame: before dosing and 2 days after dosing achieving peak plasma concentrations respectively]]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Shaheed Benazir Bhutto University Sheringal Dir Upper — Dīr
Identifiers
NCT: NCT07389304 · [SBBU/PHM-25-32] · SBBU/IREC-25-32]