NCT04882293

Efficacy and Safety of the Fixed-dose Combination Atorvastatin/Fenofibrate vs Atorvastatin in Patients With T2D and DLP.

Confirmatory Study of the Efficacy and Safety of the Fixed-dose Combination Atorvastatin / Fenofibrate Versus Atorvastatin on the Lipid Profile of Patients With Type 2 Diabetes (T2D) and Dyslipidaemia (DLP).

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Phase IIIb, randomized, longitudinal, prospective, multicenter study to evaluate the efficacy and safety of the fixed-dose combination atorvastatin / fenofibrate versus atorvastatin on the lipid profile of patients with type 2 diabetes and dyslipidemia.

Detailed description

To assess the efficacy and safety of the fixed-dose combination atorvastatin / fenofibrate versus atorvastatin on the lipid profile of patients with type 2 diabetes and dyslipidemia. Assessing the magnitude of change in lipid profile numbers. And describing the effect on anthropometric, biochemical and clinical indicators, as well as events and adverse reactions that may occur. In patients diagnosed with type 2 diabetes and dyslipidemia (triglycerides\> 150 mg / dl, LDL (Low density lipoprotein) cholesterol\> 100 mg / dl) and who require pharmacological treatment for lipid control.

Conditions

• Dyslipidemia Associated With Type II Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose	1 tablet once a day, 20 mg /160 mg, Orally
DRUG	Atorvastatin (Lipitor ®)	1 tablet once a day, 20 mg, Orally

Timeline

• Start date: 2022-02-15
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2021-05-11
• Last updated: 2022-03-02

Locations

1 site across 1 country: Mexico