NCT02532309

A Study to Evaluate the Efficacy and Safety of Rosuvastatin in the Treatment of the Carotid Atherosclerotic Plaques

A 2-year, Open-label, Randomized Study to Evaluate the Efficacy of Rosuvastatin Dosing Adjustment by LDL-C Level Compared to That of 5mg Maintenance Dose in Chinese Patients With Carotid Atherosclerotic Plaques

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 308 (estimated)
• Sponsor: Wei Liu · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a 2-year, open-label, randomized study to evaluate the efficacy of Rosuvastatin dosing adjustment by LDL-C level compared to that of 5mg maintenance dose in chinese patients with Carotid Atherosclerosis.

Detailed description

This will be a 2-year, randomized, open-label, prospective, parallel-group study. It only be held in China-Japan Friendship Hospital. Subjects with Carotid Atherosclerosis Plaques who meet all inclusion and none of the exclusion criteria will be randomized in a 1:1 ratio to receive treatment of rosuvastatin (5 mg, 10mg, 20mg) dosing adjustment by LDL-c level or fixed dose 5 mg. The study will consist of two phases: the Screening/Baseline period（-1to week 0）and the Follow-up period(0 to month 24). The follow-up period will comprise seven visits.

Conditions

• Carotid Atherosclerosis

Interventions

Type	Name	Description
DRUG	Rosuvastatin (5mg，10mg，20mg)	Rosuvastatin dose adjusted by LDL-c level( If LDL-C\>1.1mmol/L and \<1.8mmol/L, administrated as 5mg/day.If LDL-C ≥1.8mmol/L, adjusted every 4 weeks as 5mg，10mg，20mg.
DRUG	Rosuvastatin 5mg	Rosuvastatin 5mg/day

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-04-01
• First posted: 2015-08-25
• Last updated: 2015-08-28

Locations

1 site across 1 country: China