- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06910098
Impact of Rosuvastatin Doses on LDL Levels, CPK Levels and Aspartate Aminotransferase Levels
March 27, 2025 updated by: Mirza Zeeshan Sikandar, Central Park Medical College
Assessment of Impact of Rosuvastatin Doses on Low Density Lipoprotein Levels, Creatinine Phosphokinase Levels and Aspartate Aminotransferase Levels: A Randomized Controlled Trail
Particpants were divided into groups based on doses of rosuvastatin and were assessed and for CPK, LDL and AST levels
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
195
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lahore, Pakistan, 54600
- Central Park Teaching Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
patients who were already on statins
Exclusion Criteria:
hereditary diseases including familial hypercholesterolemia and kidney diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
receiving drug dose of 5mg
|
a dose of 5mg were given and were compared for the cpk, ast and ldl levels
a dose of 10 mg were given and were compared for the cpk, ast and ldl levels
a dose of 20 mg were given and were compared for the cpk, ast and ldl levels
|
|
Active Comparator: Group 2
receiving grug dose of 10 mg
|
a dose of 5mg were given and were compared for the cpk, ast and ldl levels
a dose of 10 mg were given and were compared for the cpk, ast and ldl levels
a dose of 20 mg were given and were compared for the cpk, ast and ldl levels
|
|
Active Comparator: Group 3
receiving dose of 20 mg
|
a dose of 5mg were given and were compared for the cpk, ast and ldl levels
a dose of 10 mg were given and were compared for the cpk, ast and ldl levels
a dose of 20 mg were given and were compared for the cpk, ast and ldl levels
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
impact of rosuvstatin over LDL, CPK and AST levels
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sikandar, Central Park Medical College
- Principal Investigator: Sikandar, Central Park Medical College & Teaching Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2023
Primary Completion (Actual)
June 30, 2024
Study Completion (Actual)
August 31, 2024
Study Registration Dates
First Submitted
March 22, 2025
First Submitted That Met QC Criteria
March 27, 2025
First Posted (Actual)
April 4, 2025
Study Record Updates
Last Update Posted (Actual)
April 4, 2025
Last Update Submitted That Met QC Criteria
March 27, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolism, Inborn Errors
- Genetic Diseases, Inborn
- Metabolic Diseases
- Hyperlipidemias
- Dyslipidemias
- Lipid Metabolism Disorders
- Lipid Metabolism, Inborn Errors
- Hyperlipoproteinemias
- Hyperlipoproteinemia Type II
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Rosuvastatin Calcium
Other Study ID Numbers
- PHRF/RCT/238
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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