Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
NCT04591808 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 146
Last updated 2023-10-18
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
- 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
-
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.
Sponsors & Collaborators
-
ADIR, a Servier Group company
collaborator INDUSTRY -
Institut de Recherches Internationales Servier
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-09
- Primary Completion
- 2022-04-08
- Completion
- 2022-04-08
Countries
- Georgia
- Russia
- Ukraine
Study Locations
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