[Effects of Selected Statins on Cardiovascular Parameters in Healthy Volunteers] (SBBU/IRC-25-31)

Shaheed Benazir Bhutto University Sheringal Dir Upper

Status and phase: Begins enrollment this month; Phase 1

Conditions: Lipid Profile,Blood Pressure

Treatments: Drug: Rosuvastatin (5mg, 20mg, 40mg); Drug: Atorvastatin (10mg, 20mg, 40mg); Drug: Simvastatin (10mg, 20mg, 40m

Study type: Interventional

Funder types: Other

Identifiers

NCT07389304

SBBU/IREC-25-32] (Other Identifier)

[SBBU/PHM-25-32]

Details and patient eligibility

About

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.

Full 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. .

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 3 patient groups

Rosuvastatin (5mg, 20mg, 40mg)

Experimental group

Description:

The assigned participants will be given Rosuvastatin 5mg, 20mg, 40mg OD for two days

Treatment:

Drug: Rosuvastatin (5mg, 20mg, 40mg)

Atorvastatin (10mg,20mg, 40mg)

Experimental group

Description:

The assigned participants will be given Atorvastatin 10mg,20mg, 40mg OD for two days

Treatment:

Drug: Atorvastatin (10mg, 20mg, 40mg)

Simvastatin (10mg, 20mg, 40mg)

Experimental group

Description:

The assigned participants will be given Simvastatin 10mg, 20mg, 40mg OD for two days

Treatment:

Drug: Simvastatin (10mg, 20mg, 40m