NCT04591808

Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia

Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia, 8 Weeks, Phase 3, Randomized, Double-blind, Active-control, Multinational, Multi-center, Parallel Study

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Institut de Recherches Internationales Servier · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the superiority of atorvastatin/perindopril fixed dose combination (FDC) S05167 as compared to atorvastatin reference drug alone or perindopril drug alone on systolic blood pressure decrease and LDL cholesterol decrease respectively in patients presenting with hypertension and dyslipidemia after 8 weeks of treatment.

Conditions

• Dyslipidemias
• Hypertension

Interventions

Type	Name	Description
DRUG	Atorvastatin/Perindopril	1 over-encapsulated S05167 capsule, fixed dose combination of Atorvastatin/Perindopril Arginine 40/10 mg, will be administered once daily each day before breakfast during 8 weeks.
DRUG	Atorvastatin	1 over-encapsulated atorvastatin 40 mg tablet will be administered once daily each day before breakfast during 8 weeks.
DRUG	Perindopril	1 over-encapsulated perindopril 10 mg tablet will be administered once daily each day before breakfast during 8 weeks.

Timeline

• Start date: 2021-09-09
• Primary completion: 2022-04-08
• Completion: 2022-04-08
• First posted: 2020-10-19
• Last updated: 2023-10-18

Locations

43 sites across 3 countries: Georgia, Russia, Ukraine