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A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Hypercholesterolemia.

NCT ID: NCT01982461

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rosuvastatin

One Rosuvastatin tablet 10mg taken once daily.

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

10mg,once daily

Crestor®

One Crestor® tablet 10mg taken once daily.

Group Type ACTIVE_COMPARATOR

Crestor®

Intervention Type DRUG

10mg,once daily

Interventions

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Rosuvastatin

10mg,once daily

Intervention Type DRUG

Crestor®

10mg,once daily

Intervention Type DRUG

Other Intervention Names

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Roty Rosuvastatin

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pin Siang Medical Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yi-Jen Hung, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Locations

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Tri-Service General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Lu-Hsin Lu, M.S.

Role: CONTACT

Phone: 886-2-26270255

Email: [email protected]

Facility Contacts

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Role: primary

Other Identifiers

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PSMB102ROS10-01

Identifier Type: -

Identifier Source: org_study_id