HypercholesterolemiaNCT01982461
A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Hypercholesterolemia.
A study testing Rosuvastatin and Crestor® in people with Hypercholesterolemia, run by Pin Siang Medical Biotechnology Co., Ltd. at 1 site in Taiwan.
Trial summary
The objective of this trial is to assess the efficacy of reducing plasma low-density lipoprotein(LDL) cholesterol and safety in two different brand drugs, Roty F.C. Tablets 10mg and Crestor 10mg F.C. Tablets in hypercholesterolemia population. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Rosuvastatin and Crestor®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2013to Jan 2014
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 20 to 85;
- LDL - C between 130 mg/dL and 250 mg/dL;
- TG < 400 mg/dL;
- Who without use of any statin within 2 week prior to the trial;
- Informed consent given.
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(Child-Pugh C,ALT2×ULN);
- Treatment with Cyclosporin or any disallowed drug;
- Patients with unstable angina pectoris;
- Pregnant, lactating women;
- Patients who have severe medical condition(s) that in the view of the Investigator prohibits participation in the trial.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospital
Taipei, 11490
886-2-87923311 ext. 10552, tsghirb@ndmctsgh.edu.tw
About this study
Official title: A Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Roty F.C. Tablets 10mg Versus Crestor 10mg F.C. Tablets in Patients With Hypercholesterolemia
The objective of this trial is to assess the efficacy of reducing plasma low-density lipoprotein(LDL) cholesterol and safety in two different brand drugs, Roty F.C. Tablets 10mg and Crestor 10mg F.C. Tablets in hypercholesterolemia population.
- Conditions
- Hypercholesterolemia
- Being tested
- Rosuvastatin, Crestor®
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Roty
10mg,once daily
Crestor®Drug
Also called Rosuvastatin
10mg,once daily
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | One Rosuvastatin tablet 10mg taken once daily. Receives: Drug: Rosuvastatin |
| Crestor® | Active comparator | One Crestor® tablet 10mg taken once daily. Receives: Drug: Crestor® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable will be defined as the percent mean change in LDL-C from baseline to 12 weeks.
Measured: baseline to week 12
Secondary outcomes (1)
The secondary efficacy variable will be described as the change of plasma AGE, sRAGE, Gas6 and sAx1.
Measured: baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pin Siang Medical Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi-Jen Hung, M.D., Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982461
- Sponsor's protocol ID
- PSMB102ROS10-01
- Status last verified
- Nov 2013
- First submitted
- 6 Nov 2013
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Roty F.C. Tablets 10mg Versus Crestor 10mg F.C. Tablets in Patients With Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT01982461
- Acronym / sponsor ID
- PSMB102ROS10-01
- Conditions
- Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pin Siang Medical Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jan 2014 (estimated)
- First posted
- 13 Nov 2013 (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 objective of this trial is to assess the efficacy of reducing plasma low-density lipoprotein(LDL) cholesterol and safety in two different brand drugs, Roty F.C. Tablets 10mg and Crestor 10mg F.C. Tablets in hypercholesterolemia population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: RosuvastatinOne Rosuvastatin tablet 10mg taken once daily. |
| Crestor® | Active comparator | Drug: Crestor®One Crestor® tablet 10mg taken once daily. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged 20 to 85;
- LDL - C between 130 mg/dL and 250 mg/dL;
- TG < 400 mg/dL;
- Who without use of any statin within 2 week prior to the trial;
- Informed consent given.
Key exclusion criteria (6 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(Child-Pugh C,ALT2×ULN);
- Treatment with Cyclosporin or any disallowed drug;
- Patients with unstable angina pectoris;
- Pregnant, lactating women;
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: Roty10mg,once daily | Drug | Rosuvastatin |
| Crestor®Also: Rosuvastatin10mg,once daily | Drug | Crestor® |
Primary outcome
The primary efficacy variable will be defined as the percent mean change in LDL-C from baseline to 12 weeks.
Time frame: baseline to week 12
1 secondary outcome
The secondary efficacy variable will be described as the change of plasma AGE, sRAGE, Gas6 and sAx1.
Time frame: baseline to week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
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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.
Yi-Jen Hung, M.D. principal investigator
Tri-Service General Hospital (TSGH)
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 and Crestor® in people with Hypercholesterolemia, run by Pin Siang Medical Biotechnology Co., Ltd. at 1 site in Taiwan.
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 6 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 13 Nov 2013. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu-Hsin Lu, M.S. (886-2-26270255 ext. 206, flora@twtungda.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy variable will be defined as the percent mean change in LDL-C from baseline to 12 weeks. (time frame: baseline to week 12). 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 13 Nov 2013.