Impact of Rosuvastatin Doses on LDL Levels, CPK Levels and Aspartate Aminotransferase Levels

NCT06910098 | Completed DMC

• 1 other identifier: PHRF/RCT/238
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

Particpants were divided into groups based on doses of rosuvastatin and were assessed and for CPK, LDL and AST levels

Conditions

LDL - Low Density Lipoprotein Receptor Disorder; Rosuvastatin

Outcome Measures

Primary Outcomes (3)

• impact of rosuvstatin over LDL, CPK and AST levels

  Pre- and post intervention levels of fasting serum low-density lipoprotein (LDL) in mg/dL were recorded and were compared in all study groups for assessment of the impact of various doses of rosuvastatin.

  12 weeks

• impact of rosuvstatin over LDL, CPK and AST levels

  Pre- and post-intervention levels of creatine phosphokinase (CPK) in mcg/L were recorded and were compared in all study groups for assessment of the impact of various doses of rosuvastatin in terms of rhabdomyolysis.

  12 weeks

• impact of rosuvstatin over LDL, CPK and AST levels

  Pre- and post-intervention levels of Aspartate Aminotransferase (AST) in U/L were recorded and were compared in all study groups for assessment of the impact of various doses of rosuvastatin in terms of liver damage.

  12 weeks

Study Arms (3)

Group 1

EXPERIMENTAL

receiving drug dose of 5mg

Drug: Rosuvastatin

Group 2

ACTIVE COMPARATOR

receiving grug dose of 10 mg

Drug: Rosuvastatin

Group 3

ACTIVE COMPARATOR

receiving dose of 20 mg

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

a dose of 5mg were given and were compared for the cpk, ast and ldl levels

Group 1

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who were already on statins

You may not qualify if:

• hereditary diseases including familial hypercholesterolemia and kidney diseases

Sponsors & Collaborators

• Central Park Medical College: lead

Study Sites (1)

Central Park Teaching Hospital

Lahore, 54600, Pakistan

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sikandar

  Central Park Medical College

  PRINCIPAL INVESTIGATOR

• Sikandar

  Central Park Medical College & Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: April 4, 2025
• Study Start: December 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 31, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-03

Locations

PA (1)