LDL - Low Density Lipoprotein Receptor DisorderNCT06910098
Impact of Rosuvastatin Doses on LDL Levels, CPK Levels and Aspartate Aminotransferase Levels
A study testing Rosuvastatin in people with LDL - Low Density Lipoprotein Receptor Disorder and Rosuvastatin, run by Central Park Medical College at 1 site in Pakistan.
Trial summary
Particpants were divided into groups based on doses of rosuvastatin and were assessed and for CPK, LDL and AST levels Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- LDL - Low Density Lipoprotein Receptor Disorder, Rosuvastatin
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients who were already on statins
Who cannot join
- hereditary diseases including familial hypercholesterolemia and kidney diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Being tested
- Rosuvastatin
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
a dose of 5mg were given and were compared for the cpk, ast and ldl levels
RosuvastatinDrug
a dose of 10 mg were given and were compared for the cpk, ast and ldl levels
RosuvastatinDrug
a dose of 20 mg were given and were compared for the cpk, ast and ldl levels
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | receiving drug dose of 5mg Receives: Drug: Rosuvastatin |
| Group 2 | Active comparator | receiving grug dose of 10 mg Receives: Drug: Rosuvastatin |
| Group 3 | Active comparator | receiving dose of 20 mg Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Dec 2023
- Primary completion30 Jun 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LDL - Low Density Lipoprotein Receptor DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Park Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirza Zeeshan Sikandar, Central Park Medical College
- Investigators
- Sikandar, Principal investigator, Central Park Medical CollegeSikandar, Principal investigator, Central Park Medical College & Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910098
- Sponsor's protocol ID
- PHRF/RCT/238
- Status last verified
- Mar 2025
- First submitted
- 22 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Impact of Rosuvastatin Doses on Low Density Lipoprotein Levels, Creatinine Phosphokinase Levels and Aspartate Aminotransferase Levels: A Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT06910098
- Acronym / sponsor ID
- PHRF/RCT/238
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Central Park Medical CollegeUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Particpants were divided into groups based on doses of rosuvastatin and were assessed and for CPK, LDL and AST levels
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Rosuvastatinreceiving drug dose of 5mg |
| Group 2 | Active comparator | Drug: Rosuvastatinreceiving grug dose of 10 mg |
| Group 3 | Active comparator | Drug: Rosuvastatinreceiving dose of 20 mg |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who were already on statins
Key exclusion criteria (1 listed)
- hereditary diseases including familial hypercholesterolemia and kidney diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatina dose of 5mg were given and were compared for the cpk, ast and ldl levels | Drug | Group 1 |
| Rosuvastatina dose of 10 mg were given and were compared for the cpk, ast and ldl levels | Drug | Group 2 |
| Rosuvastatina dose of 20 mg were given and were compared for the cpk, ast and ldl levels | Drug | Group 3 |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
Related trials for LDL - Low Density Lipoprotein Receptor Disorder
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruitingObservational study
An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia
Hypercholesterolaemia, Familial Hypercholesterolaemia
Recruiting
Computerized Decision Support for Identification and Management of Familial Hypercholesterolemia
Familial Hypercholesterolaemia
Not yet recruitingPhase 3
A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events
Coronary Atherosclerosis, Mixed Dyslipidemia
RecruitingObservational study
The Spanish Familial Hypercholesterolaemia Cohort Study
Familial Hypercholesterolaemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sikandar principal investigator
Central Park Medical College
Sikandar principal investigator
Central Park Medical College & Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rosuvastatin in people with LDL - Low Density Lipoprotein Receptor Disorder and Rosuvastatin, run by Central Park Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
impact of rosuvstatin over LDL, CPK and AST levels (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.