Back to resultsA Study to Evaluate the Efficacy and Safety of Rosuvastatin in Hypercholesterolemia.
Primary Purpose
Hypercholesterolemia
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Rosuvastatin
Crestor®
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Tri-Service General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rosuvastatin
Crestor®
Arm Description
One Rosuvastatin tablet 10mg taken once daily.
One Crestor® tablet 10mg taken once daily.
Outcomes
Primary Outcome Measures
The primary efficacy variable will be defined as the percent mean change in LDL-C from baseline to 12 weeks.
Secondary Outcome Measures
The secondary efficacy variable will be described as the change of plasma AGE, sRAGE, Gas6 and sAx1.
Full Information
NCT ID
NCT01982461
First Posted
November 6, 2013
Last Updated
November 6, 2013
Sponsor
Pin Siang Medical Biotechnology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01982461
Brief Title
A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Hypercholesterolemia.
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pin Siang Medical Biotechnology Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rosuvastatin
Arm Type
Experimental
Arm Description
One Rosuvastatin tablet 10mg taken once daily.
Arm Title
Crestor®
Arm Type
Active Comparator
Arm Description
One Crestor® tablet 10mg taken once daily.
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Roty
Intervention Description
10mg,once daily
Intervention Type
Drug
Intervention Name(s)
Crestor®
Other Intervention Name(s)
Rosuvastatin
Intervention Description
10mg,once daily
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The secondary efficacy variable will be described as the change of plasma AGE, sRAGE, Gas6 and sAx1.
Time Frame
baseline to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lu-Hsin Lu, M.S.
Phone
886-2-26270255
Ext
206
Email
flora@twtungda.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Jen Hung, M.D.
Organizational Affiliation
Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
886-2-87923311
Ext
10552
Email
tsghirb@ndmctsgh.edu.tw
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Hypercholesterolemia.
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