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

NCT07389304 — Phase 1, Not yet recruiting, 100 participants, Shaheed Benazir Bhutto University Sheringal Dir Upper

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[EFFECTS OF SELECTED STATINS ON CARDIOVASCULAR PARAMETERS IN HEALTHY VOLUNTEERS: A RANDAMOZIED PHASE I CLINICAL TRIAL]

Registry	NCT07389304, acronym SBBU/IRC-25-31
Status	Not yet recruiting
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	100 (Estimated)
Sponsor	Shaheed Benazir Bhutto University Sheringal Dir Upper (Other); collaborators: Khyber Medical University Peshawar
Conditions	Lipid Profile,Blood Pressure
Interventions	Rosuvastatin (5mg, 20mg, 40mg), Atorvastatin (10mg, 20mg, 40mg), Simvastatin (10mg, 20mg, 40m (Drug)
Dates	start 2026-03-01 (estimated), primary completion 2026-12-30 (estimated), completion 2027-02-20 (estimated), first posted 2026-02-05, last updated 2026-02-05
Locations	1 site in Pakistan

-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.

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+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. .

+Arms and interventions

Arm	Type	Interventions	Description
Rosuvastatin (5mg, 20mg, 40mg)	Experimental	Drug: Rosuvastatin (5mg, 20mg, 40mg)	The assigned participants will be given Rosuvastatin 5mg, 20mg, 40mg OD for two days
Atorvastatin (10mg,20mg, 40mg)	Experimental	Drug: Atorvastatin (10mg, 20mg, 40mg)	The assigned participants will be given Atorvastatin 10mg,20mg, 40mg OD for two days
Simvastatin (10mg, 20mg, 40mg)	Experimental	Drug: Simvastatin (10mg, 20mg, 40m	The assigned participants will be given Simvastatin 10mg, 20mg, 40mg OD for two days

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

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 25 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Shaheed Benazir Bhutto University Sheringal Dir Upper	Dīr, Khyber Pakhtunkhwa	Pakistan