NCT03418974

Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia

Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia: A Network Register-based Follow-up Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10,000 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to verify the clinical efficacy and safety of different statins in dyslipidemia patients, and explore the effects on glycometabolic in patients with impaired glucose regulation.

Detailed description

Study Objective: 1. The main Objective: To explore the effects of different statins lipid-lowering treatment on glucose metabolism in patients with impaired glucose regulation in a large sample of Chinese population; 2. The secondary Objective: To obtain real-world evidence of the clinical efficacy and safety of statins lipid-lowering therapy in Chinese patients. Study Design: The study was an open-label, multi-center network register-based follow-up study. The total sample size: 10000 participants.

Conditions

• Dyslipidemias

Interventions

Type	Name	Description
DRUG	Pitavastatin	Capsule/Tablet, oral, follow the doctor's advice Participants will receive pitavastatin treatment for 3 or 12 weeks.
DRUG	Atorvastatin	Capsule/Tablet, oral, follow the doctor's advice Participants will receive atorvastatin treatment for 3 or 12 weeks.
DRUG	Rosuvastatin	Capsule/Tablet, oral, follow the doctor's advice Participants will receive rosuvastatin treatment for 3 or 12 weeks.

Timeline

• Start date: 2017-11-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2018-02-01
• Last updated: 2018-02-01

Locations

2 sites across 1 country: China