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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Lipid Profile,Blood Pressure
• Intervention / Treatment: Drug: Rosuvastatin (5mg, 20mg, 40mg); Drug: Atorvastatin (10mg, 20mg, 40mg); Drug: Simvastatin (10mg, 20mg, 40m

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. .

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dr Abid Ullah, Ph.D; Phone Number: 527 09448850; Email: abid@sbbu.edu.pk

Study Locations

• Pakistan
  • Khyber Pakhtunkhwa
    • Dīr, Khyber Pakhtunkhwa, Pakistan
      • Shaheed Benazir Bhutto University Sheringal Dir Upper
      • Contact: Dr.Abid Ullah, PhD; Phone Number: 0944885400; Email: abid@sbbu.edu.pk
      • Sub-Investigator: Professor Dr. Niaz Ali, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rosuvastatin (5mg, 20mg, 40mg); The assigned participants will be given Rosuvastatin 5mg, 20mg, 40mg OD for two days	Drug: Rosuvastatin (5mg, 20mg, 40mg); The Rosuvastatin (5mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
Experimental: Atorvastatin (10mg,20mg, 40mg); The assigned participants will be given Atorvastatin 10mg,20mg, 40mg 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
Experimental: Simvastatin (10mg, 20mg, 40mg); The assigned participants will be given Simvastatin 10mg, 20mg, 40mg 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure Measurements	Blood Pressure of the subjects will be determined by sphygmomanometer	before dosing and 2 days after dosing achieving peak plasma concentrations respectively]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	before dosing and 2 days after dosing achieving peak plasma concentrations respectively]

Collaborators and Investigators

• Sponsor: Shaheed Benazir Bhutto University Sheringal Dir Upper
• Collaborators: Khyber Medical University Peshawar

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 20, 2027

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: sBlood Pressure,ECG change
• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Amides; Pyrimidines; Hydrocarbons, Halogenated; Pyrroles; Heptanoic Acids; Sulfonamides; Sulfones; Fluorobenzenes; Hydrocarbons, Fluorinated; Lovastatin; Atorvastatin; Rosuvastatin Calcium; Simvastatin
• Other Study ID Numbers: [SBBU/PHM-25-32]; SBBU/IREC-25-32] (Other Identifier: [ShaheedBenazirBhuttoUSheringalDU])

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study results will be shared in well reputable Journals without the participant identifiers
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No