Primary HypercholesterolemiaNCT03516955
Efficacy and Safety of a Generic Rosuvastatin in a Real-world Setting
An observational study of Primary Hypercholesterolemia, run by Hikma Pharmaceuticals LLC.
Trial summary
This study assessed the safety and efficacy of generic Rosuvastatin in reducing plasma low density lipoprotein (LDL) cholesterol in Lebanese adult patients (18 years or older) with dyslipidemia for both primary and secondary prevention based on their total cardiovascular risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hypercholesterolemia
- What is being tested?
- Rosuvastatin
- Type of treatment
- Pill or oral medicine
- How many people
- 317 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Aug 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were recruited from 24 cardiology, endocrinology and general practitioner outpatient clinics in Lebanon
Who may be able to join
- Males and females ≥ 18 years of age
- Patients with dyslipidemia requiring statin therapy according to CV risk factors as per the ESC/EAS 2011 guidelines for primary or secondary prevention
- Patients provided written informed consent
Who cannot join
- Age <18 years
- Statin use in the past 3 months
- Any contraindication to HMG-CoA reductase inhibitors
- Co-administration of non-statin lipid lowering agent (ezitimibe, fibrates, niacin, omega 3)
- Conditions which may cause secondary dyslipidemia
- Any of the following abnormal laboratory tests:
- TG level of > 400 mg/dL, Abnormal liver enzymes (AST or ALT) ≥ 3 ULN, Abnormal serum creatine kinase (CK) > 5 ULN
About this study
Official title: Observational Study of Superstat® (Rosuvastatin) in Hypercholesterolemia Patients in Lebanon
This study assessed the safety and efficacy of generic Rosuvastatin in reducing plasma low density lipoprotein (LDL) cholesterol in Lebanese adult patients (18 years or older) with dyslipidemia for both primary and secondary prevention based on their total cardiovascular risk. No visits or interventions, additional to the routine clinical practice, were requested or performed.
Read the detailed description
An observational, multicenter, prospective study of Lebanese adult (18 years or older) hypercholesterolemic patients administered generic Rosuvastatin (Superstat®).
Eligible newly diagnosed hypercholesterolemic patients took generic Rosuvastatin as prescribed by their treating physician. Assigning patients to generic Rosuvastatin was decided within the current practice and medical indication and was independent from the recruitment into the study.
Patients were followed-up at the clinic as per the standard practice of care. Each patient was followed-up for a period of 2 months.
- Conditions
- Primary Hypercholesterolemia
- Being tested
- Rosuvastatin
- Keywords
- Superstat, Rosuvastatin, Statins, LDL-C, Cholesterol, Hypercholesterolemia, Dyslipidemia, Coronary Artery Disease, Cardiovascular Disease
- Medical subject headings
- Hypercholesterolemia, Dyslipidemias, Coronary Artery Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Superstat ®
Superstat ® Tablets 10mg, 20mg
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in mean low-density lipoproteins (LDL-C)
Measured: 2 months
Secondary outcomes (3)
Percent change in mean total cholesterol, triglycerides, high density lipoprotein (HDL-C)
Measured: 2 months
Proportion of patients who meet their target (LDL-C)
Measured: 2 months
Incidence rate of adverse events (AEs) in association with generic rosuvastatin
Rate of AEs which might include the worsening in baseline medical conditions, the occurrence of new conditions, or a significant change in vital signs or laboratory values.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study startNov 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HypercholesterolemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hikma Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516955
- Sponsor's protocol ID
- SPS-LBN-2014-05
- Status last verified
- Apr 2018
- First submitted
- 24 Apr 2018
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Superstat® (Rosuvastatin) in Hypercholesterolemia Patients in Lebanon
- ClinicalTrials.gov ID
- NCT03516955
- Acronym / sponsor ID
- SPS-LBN-2014-05
- Conditions
- Primary Hypercholesterolemia
- Keywords
- Superstat, Rosuvastatin, Statins, LDL-C, Cholesterol, Hypercholesterolemia, Dyslipidemia, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Hikma Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2014 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 7 May 2018 (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.
This study assessed the safety and efficacy of generic Rosuvastatin in reducing plasma low density lipoprotein (LDL) cholesterol in Lebanese adult patients (18 years or older) with dyslipidemia for both primary and secondary prevention based on their total cardiovascular risk. No visits or interventions, additional to the routine clinical practice, were requested or performed.
Detailed description
An observational, multicenter, prospective study of Lebanese adult (18 years or older) hypercholesterolemic patients administered generic Rosuvastatin (Superstat®).
Eligible newly diagnosed hypercholesterolemic patients took generic Rosuvastatin as prescribed by their treating physician. Assigning patients to generic Rosuvastatin was decided within the current practice and medical indication and was independent from the recruitment into the study.
Patients were followed-up at the clinic as per the standard practice of care. Each patient was followed-up for a period of 2 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were recruited from 24 cardiology, endocrinology and general practitioner outpatient clinics in Lebanon
Key inclusion criteria (3 listed)
- Males and females ≥ 18 years of age
- Patients with dyslipidemia requiring statin therapy according to CV risk factors as per the ESC/EAS 2011 guidelines for primary or secondary prevention
- Patients provided written informed consent
Key exclusion criteria (7 listed)
- Age <18 years
- Statin use in the past 3 months
- Any contraindication to HMG-CoA reductase inhibitors
- Co-administration of non-statin lipid lowering agent (ezitimibe, fibrates, niacin, omega 3)
- Conditions which may cause secondary dyslipidemia
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 |
|---|---|---|
| RosuvastatinAlso: Superstat ®Superstat ® Tablets 10mg, 20mg | Drug | – |
Primary outcome
Percent change in mean low-density lipoproteins (LDL-C)
Time frame: 2 months
3 secondary outcomes
Percent change in mean total cholesterol, triglycerides, high density lipoprotein (HDL-C)
Time frame: 2 months
Proportion of patients who meet their target (LDL-C)
Time frame: 2 months
Incidence rate of adverse events (AEs) in association with generic rosuvastatin
Time frame: 2 months
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 7 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hypercholesterolemia, run by Hikma Pharmaceuticals LLC.
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 3 inclusion and 7 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 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Percent change in mean low-density lipoproteins (LDL-C) (time frame: 2 months). 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 7 May 2018.