NCT07389304

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
10mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Mar 2026Feb 2027

First Submitted

Initial submission to the registry

January 20, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2027

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

January 20, 2026

Last Update Submit

January 30, 2026

Conditions

Lipid Profile,Blood Pressure

Keywords

sBlood Pressure,ECG change

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Electrocardiograms (ECGs) Measurements

    before dosing and 2 days after dosing achieving peak plasma concentrations respectively]

Study Arms (3)

Rosuvastatin (5mg, 20mg, 40mg)

EXPERIMENTAL

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

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

Atorvastatin (10mg,20mg, 40mg)

EXPERIMENTAL

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

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

Simvastatin (10mg, 20mg, 40mg)

EXPERIMENTAL

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

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

Interventions

Rosuvastatin (5mg, 20mg, 40mg)DRUG

The Rosuvastatin (5mg, 20mg, 40mg) group participants will be given the drug orally OD for two days

Rosuvastatin (5mg, 20mg, 40mg)
Atorvastatin (10mg, 20mg, 40mg)DRUG

The Atorvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days

Atorvastatin (10mg,20mg, 40mg)
Simvastatin (10mg, 20mg, 40mDRUG

The Simvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days

Simvastatin (10mg, 20mg, 40mg)

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers
  • Normal ECG
  • Normal Blood Pressure
  • Normal lipid levels

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaheed Benazir Bhutto University Sheringal Dir Upper

Dīr, Khyber Pakhtunkhwa, Pakistan

Location

MeSH Terms

Interventions

Rosuvastatin CalciumAtorvastatinSimvastatin

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipidsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic Compounds

Central Study Contacts

Dr Abid Ullah, Ph.D

CONTACT

09448850abid@sbbu.edu.pk

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 20, 2026

First Posted

February 5, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

February 20, 2027

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The study results will be shared in well reputable Journals without the participant identifiers

Shared Documents
CSR

Locations

PA(1)