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| Sponsor: | Chinese PLA General Hospital |
|---|---|
| Collaborator: |
AstraZeneca |
| Information provided by: | Chinese PLA General Hospital |
| ClinicalTrials.gov Identifier: | NCT00885872 |
Purpose
This study is to evaluate the effect of rosuvastatin 10-20 mg on carotid atherosclerosis progression in Chinese patients by evaluating the change in the percentage of volume of lipid rich necrotic core (LRNC) using high-resolution magnetic resonance imaging (MRI) after 24-months treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperlipidemia Atherosclerosis |
Drug: Rosuvastatin (Crestor) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A 104-week, Open-label, Single-group Study: Rosuvastatin Evaluation of Atherosclerotic Chinese Patients (REACH) |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treat
At visit 2 each eligible subject will be allocated to rosuvastatin. Subjects who reach the criteria at visit 3, dosage of rosuvastatin will be titrated. The subjects will be encouraged to take the study drug at the same time each day for 104 weeks.
|
Drug: Rosuvastatin (Crestor)
at visit 2 each eligible subject will be allocated to rosuvastatin. study medication wil be taken orally with water once daily, as directed by the study physician. subjects who meet the criteria at visit 3, dosage of rosuvastatin will be titrated.
Other Name: Crestor
|
The primary objective of this study is to evaluate the effect of rosuvastatin 10-20 mg on carotid atherosclerosis progression in Chinese patients by evaluating the change in the percentage of volume of lipid rich necrotic core (LRNC) using high-resolution magnetic resonance imaging (MRI) after 24-months treatment.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The patient have to take medicines as follow:
Contacts and Locations| Contact: Du Ruixue, Dr/ | 13693578338 | drx1972@hotmail.com |
| China, Beijing | |
| Chinese PLA General Hospital | Recruiting |
| Beijing, Beijing, China, 100000 | |
| Contact: Du Ruixue, Dr. 13693578338 drx1972@hotmail.com | |
| Principal Investigator: | Ping Ye, Doctor | Chinese PLA General Hospital |
More Information
| Responsible Party: | Ye Ping/ Director, Chinese PLA General Hospital |
| ClinicalTrials.gov Identifier: | NCT00885872 History of Changes |
| Other Study ID Numbers: | REACH, D3560L00091 |
| Study First Received: | April 21, 2009 |
| Last Updated: | May 26, 2010 |
| Health Authority: | China: State Food and Drug Administration |
|
Atherosclerosis Hyperlipidemias Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Rosuvastatin |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |