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

No results posted yet for this study

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

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

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.

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04591808 on ClinicalTrials.gov