DyslipidemiaPhase 4Cor16NCT01613729
Efficacy and Safety Study of 5 mg and 10 mg Rosuvastatin
A Phase 4 study testing Rosuvastatin 5 mg and Rosuvastatin 10 mg in people with Dyslipidemia, run by D16 Pharma & Biotec Ltd. at 1 site in Bangladesh.
Trial summary
The primary objective of the study is to compare the efficacy of Rosuvastatin 5 mg once daily with Rosuvastatin 10 mg once daily by assessment of the number of patients with hypercholesterolemia reaching the LDL-C target goal of <100 mg/dL after 12 weeks of therapy. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Rosuvastatin 5 mg and Rosuvastatin 10 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteBangladesh
- Study dates
- Jul 2012to Dec 2013
- Phase
- Phase 4
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45 - 75 years
- LDL - C between 130 mg/dL and 250 mg/dL
- TG < 400 mg/dL
- HbA1c < 7%
- Written informed consent to participate in the trial
Who cannot join
- Known hypersensitivity or history of SAE with another HMG-CoA reductase inhibitor, in particular any history of myopathy
- Active liver disease/severe hepatic impairment
- Treatment with cyclosporin or any disallowed drug
- Patients with unstable angina pectoris
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Multi-centre, Phase IVb, Parallel Study Group to Compare the Efficacy and Safety of 5 mg and 10 mg Rosuvastatin
The primary objective of the study is to compare the efficacy of Rosuvastatin 5 mg once daily with Rosuvastatin 10 mg once daily by assessment of the number of patients with hypercholesterolemia reaching the LDL-C target goal of <100 mg/dL after 12 weeks of therapy.
Read the detailed description
This study will observe the followings:
- To compare the effect of 5 mg/10 mg Rosuvastatin by assessment of the number of patients reaching LDL-C target goal after 24 weeks of therapy.
- To compare the effect of 12 weeks therapy with 5 mg/10 mg Rosuvastatin on change in LDL-C (compare change from baseline).
- To investigate the effect of 12 weeks therapy with 10 mg Rosuvastatin on change in LDL-C (compare values week 0 vs. week 12).
- To investigate the safety of Rosuvastatin in regards to liver enzyme change, kidney function and muscle toxicity.
- To compare the effect of 12 weeks therapy with 5 mg/10 mg Rosuvastatin on change in TC, HDL-C, TG, LDL-C density and HbA1c (compare change from baseline).
- To investigate the effect of 12 weeks therapy with 10 mg Rosuvastatin on change in TC, HDL-C, TG, LDL-C density and HbA1c (compare values week 0 vs. week 12).
- To investigate the effect of 12 weeks therapy on change in microalbuminuria in each treatment group (compare change from baseline).
- To investigate the effect of 12 weeks therapy on change in BMI (compare change from baseline). The effects of the dose increase and the dose decrease from weeks 12 to 24 will be evaluated as follows:
- To investigate the change in LDL-C by increasing the dose from 5 mg to 10 mg (compare values week 12 vs. 24).
- To investigate the change in LDL-C by decreasing the dose from 10 mg to 5 mg (compare values week 12 vs. 24).
- To investigate the change in TC, HDL-C, TG, LDL-C density and HbA1c by increasing the dose from 5 mg to 10 mg (compare values week 12 vs. 24).
- To investigate the change in TC, HDL-C, TG, LDL-C density and HbA1c by decreasing the dose from 10 mg to 5 mg (compare values week 12 vs. 24).
- Conditions
- Dyslipidemia
- Being tested
- Rosuvastatin 5 mg, Rosuvastatin 10 mg
- Keywords
- Dyslipidemia, Rosuvastatin, Efficacy, Safety
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 5 mgDrug
Rosuvastatin 5 mg
Rosuvastatin 10 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastation 5 Initiator Arm | Active comparator | These patients will start the study with Rosuvastatin 5 mg and then after 12 weks they will be switched to Rosuvastatin 10 mg. Receives: Drug: Rosuvastatin 5 mg |
| Rosuvastatin 10 initiator arm | Active comparator | These patients will continue with Rosuvastatin 10 mg and after 12 weeks they will be switched to Rosuvastatin 5 mg Receives: Drug: Rosuvastatin 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Rosuvastatin 5 mg once daily with Rosuvastatin 10 mg once daily by assessment of the number of patients with hypercholesterolemia reaching the LDL-C target goal of <100 mg/dL after 12 weeks of therapy.
Measured: 24 weeks
Secondary outcomes (1)
To compare the safety
To investigate the effect of 12 weeks therapy on change in microalbuminuria in each treatment group (compare change from baseline).
To investigate the effect of 12 weeks therapy on change in BMI (compare change from baseline).
The effects of the dose increase and the dose decrease from weeks 12 to 24 will be evaluated
to investigate the safety of Rosuvastatin in regards to Liver enzyme change, kidney function and muscle toxicity.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D16 Pharma & Biotec Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, Dhaka Medical College, National Institute of Cardiovascular Diseases
- Responsible party
- Sponsor
- Investigators
- Nazrul Islam, FCPS, Principal investigator, Professor of CardiologyPinaki Bhattacharya, MBBS, Study director, D16 Pharma & Biotec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613729
- Sponsor's protocol ID
- corestin/bd/2012-16
- Acronym
- Cor16
- Status last verified
- Sep 2012
- First submitted
- 4 Jun 2012
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multi-centre, Phase IVb, Parallel Study Group to Compare the Efficacy and Safety of 5 mg and 10 mg Rosuvastatin
- ClinicalTrials.gov ID
- NCT01613729
- Acronym / sponsor ID
- Cor16 / corestin/bd/2012-16
- Conditions
- Dyslipidemia
- Keywords
- Dyslipidemia, Rosuvastatin, Efficacy, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- D16 Pharma & Biotec Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, Dhaka Medical College, National Institute of Cardiovascular Diseases
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 7 Jun 2012 (estimated)
- 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.
The primary objective of the study is to compare the efficacy of Rosuvastatin 5 mg once daily with Rosuvastatin 10 mg once daily by assessment of the number of patients with hypercholesterolemia reaching the LDL-C target goal of <100 mg/dL after 12 weeks of therapy.
Detailed description
This study will observe the followings:
- To compare the effect of 5 mg/10 mg Rosuvastatin by assessment of the number of patients reaching LDL-C target goal after 24 weeks of therapy.
- To compare the effect of 12 weeks therapy with 5 mg/10 mg Rosuvastatin on change in LDL-C (compare change from baseline).
- To investigate the effect of 12 weeks therapy with 10 mg Rosuvastatin on change in LDL-C (compare values week 0 vs. week 12).
- To investigate the safety of Rosuvastatin in regards to liver enzyme change, kidney function and muscle toxicity.
- To compare the effect of 12 weeks therapy with 5 mg/10 mg Rosuvastatin on change in TC, HDL-C, TG, LDL-C density and HbA1c (compare change from baseline).
- To investigate the effect of 12 weeks therapy with 10 mg Rosuvastatin on change in TC, HDL-C, TG, LDL-C density and HbA1c (compare values week 0 vs. week 12).
- To investigate the effect of 12 weeks therapy on change in microalbuminuria in each treatment group (compare change from baseline).
- To investigate the effect of 12 weeks therapy on change in BMI (compare change from baseline). The effects of the dose increase and the dose decrease from weeks 12 to 24 will be evaluated as follows:
- To investigate the change in LDL-C by increasing the dose from 5 mg to 10 mg (compare values week 12 vs. 24).
- To investigate the change in LDL-C by decreasing the dose from 10 mg to 5 mg (compare values week 12 vs. 24).
- To investigate the change in TC, HDL-C, TG, LDL-C density and HbA1c by increasing the dose from 5 mg to 10 mg (compare values week 12 vs. 24).
- To investigate the change in TC, HDL-C, TG, LDL-C density and HbA1c by decreasing the dose from 10 mg to 5 mg (compare values week 12 vs. 24).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastation 5 Initiator Arm | Active comparator | Drug: Rosuvastatin 5 mgThese patients will start the study with Rosuvastatin 5 mg and then after 12 weks they will be switched to Rosuvastatin 10 mg. |
| Rosuvastatin 10 initiator arm | Active comparator | Drug: Rosuvastatin 10 mgThese patients will continue with Rosuvastatin 10 mg and after 12 weeks they will be switched to Rosuvastatin 5 mg |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 45 - 75 years
- LDL - C between 130 mg/dL and 250 mg/dL
- TG < 400 mg/dL
- HbA1c < 7%
- Written informed consent to participate in the trial
Key exclusion criteria (4 listed)
- Known hypersensitivity or history of SAE with another HMG-CoA reductase inhibitor, in particular any history of myopathy
- Active liver disease/severe hepatic impairment
- Treatment with cyclosporin or any disallowed drug
- Patients with unstable angina pectoris
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 |
|---|---|---|
| Rosuvastatin 5 mgRosuvastatin 5 mg | Drug | Rosuvastation 5 Initiator Arm |
| Rosuvastatin 10 mg | Drug | Rosuvastatin 10 initiator arm |
Primary outcome
Efficacy of Rosuvastatin 5 mg once daily with Rosuvastatin 10 mg once daily by assessment of the number of patients with hypercholesterolemia reaching the LDL-C target goal of <100 mg/dL after 12 weeks of therapy.
Time frame: 24 weeks
1 secondary outcome
To compare the safety
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2012.
Related trials for Dyslipidemia
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
Not yet recruitingPhase 2
Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health
Dyslipidemia
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.
Nazrul Islam, FCPS principal investigator
Professor of Cardiology
Pinaki Bhattacharya, MBBS study director
D16 Pharma & Biotec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin 5 mg and Rosuvastatin 10 mg in people with Dyslipidemia, run by D16 Pharma & Biotec Ltd. at 1 site in Bangladesh.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Sep 2012. 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 Bangladesh. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Efficacy of Rosuvastatin 5 mg once daily with Rosuvastatin 10 mg once daily by assessment of the number of patients with hypercholesterolemia reaching the LDL-C target goal of <100 mg/dL after 12 weeks of therapy. (time frame: 24 weeks). 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 25 Sep 2012.