Shaheed Benazir Bhutto University Sheringal Dir Upper
Dīr, Khyber Pakhtunkhwa, Pakistan
Location contact
Dr.Abid Ullah, PhD
CONTACT
Professor Dr. Niaz Ali, PhD
SUB_INVESTIGATOR
Not Yet Recruiting
NCT Number: NCT07389304
[Effects of Selected Statins on Cardiovascular Parameters in Healthy Volunteers]
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–25 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
About this study
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. .
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Rosuvastatin (5mg, 20mg, 40mg)
DrugThe Rosuvastatin (5mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
Atorvastatin (10mg, 20mg, 40mg)
DrugThe Atorvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
Simvastatin (10mg, 20mg, 40m
DrugThe Simvastatin (10mg, 20mg, 40mg) group participants will be given the drug orally OD for two days
Primary outcomes
-
Blood Pressure Measurements
Time frame: 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
Time frame: 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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Shaheed Benazir Bhutto University Sheringal Dir Upper
Other
Collaborators
- Khyber Medical University Peshawar
Registry information
Official study title
[EFFECTS OF SELECTED STATINS ON CARDIOVASCULAR PARAMETERS IN HEALTHY VOLUNTEERS: A RANDAMOZIED PHASE I CLINICAL TRIAL]
Acronym: SBBU/IRC-25-31
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Feb 5, 2026
- Registry last updated
- Feb 5, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.